Trial Outcomes & Findings for Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure (NCT NCT02446990)

NCT ID: NCT02446990

Last Updated: 2024-07-26

Results Overview

First event among cardiovascular death or non-fatal myocardial infarction

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 19102 participants
• Primary outcome timeframe: The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.
• Results posted on: 2024-07-26

Participant Flow

A total of 1181 centres in 51 countries screened at least one patient and 1139 centres included at least one patient.

A total of 23 164 patients were screened, 21 862 were selected and 19 107 were included. The Randomised Set comprised 19 102 patients: 9550 patients in the ivabradine group and 9552 in the placebo group. Of the 19 102 patients in the Randomised Set, 17 724 completed the study: 8830 patients in the ivabradine group and 8894 in the placebo group.

Participant milestones

Measure	Ivabradine Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 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 48 months.
Overall Study STARTED	9550	9552
Overall Study COMPLETED	8830	8894
Overall Study NOT COMPLETED	720	658

Reasons for withdrawal

Measure	Ivabradine Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 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 48 months.
Overall Study Death	485	458
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	231	199

Baseline Characteristics

Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure

Baseline characteristics by cohort

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.	Total n=19102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5109 Participants n=5 Participants	5096 Participants n=7 Participants	10205 Participants n=5 Participants
Age, Categorical >=65 years	4441 Participants n=5 Participants	4456 Participants n=7 Participants	8897 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 7.2 • n=5 Participants	65 years STANDARD_DEVIATION 7.3 • n=7 Participants	65 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	2601 Participants n=5 Participants	2662 Participants n=7 Participants	5263 Participants n=5 Participants
Sex: Female, Male Male	6949 Participants n=5 Participants	6890 Participants n=7 Participants	13839 Participants n=5 Participants

PRIMARY outcome

Timeframe: The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.

First event among cardiovascular death or non-fatal myocardial infarction

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Primary Composite Endpoint	654 participants	611 participants

SECONDARY outcome

Timeframe: From the date of randomisation to death, up to 48 months

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
All-cause Mortality	485 participants	458 participants

SECONDARY outcome

Timeframe: From the date of randomisation to death, up to 48 months

Component of the primary composite endpoint

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Cardiovascular Mortality	329 participants	301 participants

SECONDARY outcome

Timeframe: From the date of randomisation to death, up to 48 months

Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Coronary Mortality	263 participants	249 participants

SECONDARY outcome

Timeframe: From the date of randomisation to death, up to 48 months

Non-composite secondary endpoint

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Fatal Myocardial Infarction	51 participants	38 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Component of the primary composite endpoint

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Non-fatal Myocardial Infarction	351 participants	339 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Non-composite secondary endpoint

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Elective Coronary Revascularisation	270 participants	305 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Non-composite secondary endpoint

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Coronary Revascularisation (Elective or Not)	562 participants	564 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Fatal or non-fatal myocardial infarction

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Secondary Composite Endpoint	392 participants	372 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Fatal or non-fatal myocardial infarction, coronary revascularisation

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Secondary Composite Endpoint	718 participants	739 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Secondary Composite Endpoint	766 participants	782 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Secondary Composite Endpoint	774 participants	731 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Coronary death, non-fatal myocardial infarction

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Secondary Composite Endpoint	590 participants	562 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first occurrence of the event, up to 48 months

Non-fatal myocardial infarction, coronary revascularisation, unstable angina

Outcome measures

Measure	Ivabradine n=9550 Participants Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9552 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 48 months.
Secondary Composite Endpoint	734 participants	759 participants

Adverse Events

Ivabradine

Serious events: 3379 serious events

Other events: 6207 other events

Deaths: 0 deaths

Placebo

Serious events: 3263 serious events

Other events: 5525 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ivabradine n=9539 participants at risk Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9544 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 48 months.
Renal and urinary disorders Ureteric stenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urethral disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urethral obstruction	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urethral stenosis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urinary bladder polyp	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urinary incontinence	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urinary retention	0.13% 12/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Vesicoureteric reflux	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Acquired hydrocele	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Acquired phimosis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.24% 23/9539 • Number of events 23 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.29% 28/9544 • Number of events 28 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Breast disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Cystocele	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Epididymitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Genital prolapse	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Gynaecomastia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Pelvic adhesions	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Prostatitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Prostatomegaly	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Uterine prolapse	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Uterovaginal prolapse	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Varicocele	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Vulval disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Acquired tracheo-oesophageal fistula	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.32% 31/9539 • Number of events 33 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.31% 30/9544 • Number of events 32 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.14% 13/9539 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Asphyxia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Aspiration	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Asthma	0.22% 21/9539 • Number of events 22 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.17% 16/9544 • Number of events 21 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.05% 5/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Choking	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.67% 64/9539 • Number of events 84 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.54% 52/9544 • Number of events 62 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Cough	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Cyanosis central	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.24% 23/9539 • Number of events 25 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.24% 23/9544 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Emphysema	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Granulomatous pneumonitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Anaemia	0.31% 30/9539 • Number of events 30 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.47% 45/9544 • Number of events 45 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Anaemia folate deficiency	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Anaemia megaloblastic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Deficiency anaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Febrile neutropenia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Haemorrhagic anaemia	0.15% 14/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.16% 15/9544 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Haemorrhagic diathesis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Haemorrhagic disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.02% 2/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Hypochromic anaemia	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Hypoprothrombinaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Iron deficiency anaemia	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Leukocytosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Leukopenia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Lymphadenopathy	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Lymphopenia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Microcytic anaemia	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Nephrogenic anaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Neutropenia	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Pancytopenia	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Platelet dysfunction	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Sideroblastic anaemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Thrombocytopenia	0.16% 15/9539 • Number of events 17 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Thrombocytopenic purpura	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Blood and lymphatic system disorders Thrombocytosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Accelerated idioventricular rhythm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Acute coronary syndrome	0.18% 17/9539 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.22% 21/9544 • Number of events 24 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Acute left ventricular failure	0.02% 2/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Acute myocardial infarction	2.1% 200/9539 • Number of events 216 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.2% 208/9544 • Number of events 229 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Adams-Stokes syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Angina pectoris	3.1% 294/9539 • Number of events 314 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	3.5% 330/9544 • Number of events 361 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Angina unstable	4.3% 409/9539 • Number of events 479 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	4.5% 433/9544 • Number of events 524 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Aortic valve disease	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Aortic valve disease mixed	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Aortic valve incompetence	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Aortic valve sclerosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Aortic valve stenosis	0.13% 12/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Arrhythmia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Arrhythmia supraventricular	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Arteriosclerosis coronary artery	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Arteriospasm coronary	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrial fibrillation	3.5% 336/9539 • Number of events 381 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.4% 232/9544 • Number of events 262 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrial flutter	0.51% 49/9539 • Number of events 52 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.43% 41/9544 • Number of events 45 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrial tachycardia	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrioventricular block	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrioventricular block complete	0.18% 17/9539 • Number of events 17 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrioventricular block first degree	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrioventricular block second degree	0.23% 22/9539 • Number of events 22 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrioventricular dissociation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Bradycardia	1.1% 101/9539 • Number of events 102 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.22% 21/9544 • Number of events 21 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Bundle branch block	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Bundle branch block left	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac aneurysm	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac arrest	0.16% 15/9539 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac asthma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac failure	3.7% 357/9539 • Number of events 415 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	3.6% 346/9544 • Number of events 394 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac failure acute	0.39% 37/9539 • Number of events 45 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.24% 23/9544 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac failure chronic	0.26% 25/9539 • Number of events 28 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.30% 29/9544 • Number of events 36 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac failure congestive	0.32% 31/9539 • Number of events 33 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.25% 24/9544 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac tamponade	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardio-respiratory arrest	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiogenic shock	0.31% 30/9539 • Number of events 30 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.23% 22/9544 • Number of events 22 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiomegaly	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiomyopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiopulmonary failure	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiovascular insufficiency	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Congestive cardiomyopathy	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cor pulmonale	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cor pulmonale chronic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Coronary artery disease	0.21% 20/9539 • Number of events 21 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.26% 25/9544 • Number of events 25 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Coronary artery dissection	0.01% 1/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Coronary artery insufficiency	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Coronary artery occlusion	0.15% 14/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Coronary artery stenosis	0.19% 18/9539 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.27% 26/9544 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Coronary artery thrombosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Dressler's syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Endocarditis noninfective	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Heart valve incompetence	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Hypertensive heart disease	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Intracardiac thrombus	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Ischaemic cardiomyopathy	0.03% 3/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Left atrial dilatation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Left ventricular dysfunction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Left ventricular failure	0.09% 9/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Left ventricular hypertrophy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Low cardiac output syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Mitral valve incompetence	0.17% 16/9539 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.15% 14/9544 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Mitral valve prolapse	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Myocardial depression	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Myocardial fibrosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Myocardial infarction	1.0% 98/9539 • Number of events 104 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.87% 83/9544 • Number of events 88 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Myocardial ischaemia	0.24% 23/9539 • Number of events 23 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.28% 27/9544 • Number of events 27 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Myocarditis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Nodal arrhythmia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Nodal rhythm	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Palpitations	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Pericardial effusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Pericarditis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Postinfarction angina	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Prinzmetal angina	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Rhythm idioventricular	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Right ventricular failure	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sick sinus syndrome	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Silent myocardial infarction	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sinoatrial block	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sinus arrest	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sinus arrhythmia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sinus bradycardia	0.50% 48/9539 • Number of events 49 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sinus tachycardia	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Supraventricular extrasystoles	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.16% 15/9544 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Supraventricular tachyarrhythmia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Supraventricular tachycardia	0.18% 17/9539 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.22% 21/9544 • Number of events 24 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Tachyarrhythmia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Tachycardia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Torsade de pointes	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Tricuspid valve incompetence	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Trifascicular block	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Ventricular arrhythmia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Ventricular extrasystoles	0.34% 32/9539 • Number of events 32 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.22% 21/9544 • Number of events 21 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Ventricular failure	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Ventricular fibrillation	0.21% 20/9539 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.21% 20/9544 • Number of events 22 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Ventricular tachycardia	0.37% 35/9539 • Number of events 39 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.22% 21/9544 • Number of events 23 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Congenital, familial and genetic disorders Adenomatous polyposis coli	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Congenital, familial and genetic disorders Congenital umbilical hernia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Congenital, familial and genetic disorders Factor V Leiden mutation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Congenital, familial and genetic disorders Metabolic myopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Congenital, familial and genetic disorders Pyloric stenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Acute vestibular syndrome	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Deafness neurosensory	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Deafness unilateral	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Haematotympanum	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Hearing impaired	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Hypoacusis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Meniere's disease	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Neurosensory hypoacusis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Sudden hearing loss	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Tinnitus	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Tympanic membrane disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Vertigo	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Vestibular ataxia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Ear and labyrinth disorders Vestibular disorder	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Adrenal insufficiency	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Autoimmune thyroiditis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Basedow's disease	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Cushing's syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Empty sella syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Goitre	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Hyperthyroidism	0.06% 6/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Hypothyroidism	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Endocrine disorders Toxic nodular goitre	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Age-related macular degeneration	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Amaurosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Amaurosis fugax	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Angle closure glaucoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Blindness	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Blindness unilateral	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Cataract	0.41% 39/9539 • Number of events 43 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.34% 32/9544 • Number of events 32 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Cataract diabetic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Cataract nuclear	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Cataract subcapsular	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Choroidal effusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Choroidal neovascularisation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Conjunctival haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Dacryoadenitis acquired	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Dacryostenosis acquired	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Diabetic glaucoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Diabetic retinal oedema	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Diabetic retinopathy	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Diplopia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Eye haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Glaucoma	0.21% 20/9539 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.20% 19/9544 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Glaucomatous optic disc atrophy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Keratitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Macular degeneration	0.07% 7/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Macular fibrosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Macular oedema	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Normal tension glaucoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Ocular hypertension	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Ocular icterus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Open angle glaucoma	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Ophthalmoplegia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Optic atrophy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Optic ischaemic neuropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Papilloedema	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Periorbital oedema	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Photophobia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Photopsia	0.29% 28/9539 • Number of events 31 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Pterygium	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal aneurysm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal artery occlusion	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal artery thrombosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal detachment	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal haemorrhage	0.10% 10/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal tear	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal vascular thrombosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal vein occlusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinal vein thrombosis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinopathy haemorrhagic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinopathy hypertensive	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Retinoschisis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Vision blurred	0.14% 13/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Visual acuity reduced	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Visual impairment	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Vitreous detachment	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Vitreous floaters	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Vitreous haemorrhage	0.08% 8/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal adhesions	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal discomfort	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal distension	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal hernia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal hernia obstructive	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal pain	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal pain upper	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal rigidity	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Abdominal strangulated hernia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Acquired oesophageal web	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Acute abdomen	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Anal fissure	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Anal fistula	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Anal polyp	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Anal ulcer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Ascites	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Barrett's oesophagus	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Colitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Colitis ischaemic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Colitis ulcerative	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Colonic pseudo-obstruction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Colonic stenosis	0.01% 1/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Constipation	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Crohn's disease	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Dental alveolar anomaly	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diaphragmatic hernia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diarrhoea	0.10% 10/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diverticular perforation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diverticulitis intestinal haemorrhagic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diverticulum	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diverticulum intestinal	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.03% 3/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Dry mouth	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Duodenal obstruction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Duodenal polyp	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Duodenal ulcer	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Duodenal ulcer perforation	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Duodenitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Duodenitis haemorrhagic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Dyspepsia	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Dysphagia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Enteritis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Enterocolitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Enterocolitis haemorrhagic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Epigastric discomfort	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Erosive duodenitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Erosive oesophagitis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Faecal incontinence	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Flatulence	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Food poisoning	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric mucosa erythema	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric polyps	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric ulcer	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric ulcer haemorrhage	0.10% 10/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.16% 15/9544 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric ulcer perforation	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric varices	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastric varices haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastritis	0.15% 14/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastritis atrophic	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastritis erosive	0.10% 10/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastritis haemorrhagic	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastroduodenal haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastroduodenitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastroduodenitis haemorrhagic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastrointestinal angiodysplasia haemorrhagic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastrointestinal dysplasia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastrointestinal erosion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.14% 13/9539 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.13% 12/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastrooesophagitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Haematemesis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Haematochezia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Haemorrhoids	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Hernial eventration	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Hiatus hernia	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Ileal stenosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Ileus	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Ileus paralytic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Inguinal hernia	0.30% 29/9539 • Number of events 31 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Inguinal hernia strangulated	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Inguinal hernia, obstructive	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal angina	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal fistula	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal mass	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal obstruction	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal polyp	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Intestinal polyp haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Large intestinal haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Large intestine perforation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Large intestine polyp	0.12% 11/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Leukoplakia oral	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Lip swelling	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Mallory-Weiss syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Mechanical ileus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Melaena	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Mesenteric artery thrombosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Mesenteric haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Mesenteric occlusion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Mikulicz's disease	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Nausea	0.13% 12/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oedematous pancreatitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oesophageal achalasia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oesophagitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oesophagitis haemorrhagic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oesophagitis ulcerative	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Oral submucosal fibrosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Pancreatic pseudocyst	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Pancreatitis	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Pancreatitis acute	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.18% 17/9544 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Pancreatitis chronic	0.12% 11/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Peptic ulcer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Peptic ulcer haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Periproctitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Rectal haemorrhage	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Rectal polyp	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Rectal prolapse	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Rectal ulcer haemorrhage	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Reflux gastritis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Retching	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Retroperitoneal haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Salivary gland calculus	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Sigmoiditis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Small intestinal obstruction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Small intestinal perforation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Splenic artery aneurysm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Subileus	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Swollen tongue	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Thrombosis mesenteric vessel	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Tongue ulceration	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Umbilical hernia	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Umbilical hernia, obstructive	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Varices oesophageal	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Volvulus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Vomiting	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Apparent death	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Asthenia	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Cardiac death	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Chest discomfort	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Chest pain	0.34% 32/9539 • Number of events 35 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.38% 36/9544 • Number of events 50 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Chills	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Death	0.10% 10/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Device breakage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Device dislocation	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Device extrusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Device failure	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Device malfunction	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Device occlusion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Discomfort	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Drowning	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Drug interaction	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Exercise tolerance decreased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Face oedema	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Fatigue	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Feeling abnormal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Feeling cold	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Foreign body reaction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Gait disturbance	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders General physical health deterioration	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Generalised oedema	0.03% 3/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Hernia obstructive	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Impaired healing	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Inflammation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Irritability	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Malaise	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Medical device complication	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Multi-organ failure	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Non-cardiac chest pain	0.40% 38/9539 • Number of events 43 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.30% 29/9544 • Number of events 31 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Oedema peripheral	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Pacemaker generated arrhythmia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Pain	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Puncture site haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Pyrexia	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Spinal pain	0.03% 3/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Stent-graft endoleak	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Sudden cardiac death	0.45% 43/9539 • Number of events 43 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.48% 46/9544 • Number of events 46 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Sudden death	0.79% 75/9539 • Number of events 75 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.78% 74/9544 • Number of events 74 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Systemic inflammatory response syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Thrombosis in device	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Acute hepatic failure	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Alcoholic liver disease	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Bile duct stone	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Biliary cirrhosis primary	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Biliary colic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Biliary tract disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cholangitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cholangitis acute	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cholecystitis	0.09% 9/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cholecystitis acute	0.20% 19/9539 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.18% 17/9544 • Number of events 17 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cholecystitis chronic	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cholelithiasis	0.13% 12/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.21% 20/9544 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cholestasis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Chronic hepatitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Cirrhosis alcoholic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Drug-induced liver injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Gallbladder perforation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Gallbladder polyp	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatic cirrhosis	0.07% 7/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatic congestion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatic cyst	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatic failure	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatic mass	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatic steatosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatitis acute	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatitis alcoholic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatitis cholestatic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hepatomegaly	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Hyperbilirubinaemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Jaundice	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Jaundice cholestatic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Liver disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Liver injury	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Post cholecystectomy syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Immune system disorders Allergy to arthropod sting	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Immune system disorders Amyloidosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Immune system disorders Anaphylactic reaction	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Immune system disorders Anaphylactic shock	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Immune system disorders Drug hypersensitivity	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Immune system disorders Food allergy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Immune system disorders Hypersensitivity	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Abdominal wall abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Abscess jaw	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Abscess limb	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Acute hepatitis C	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Acute sinusitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Anal abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Anal candidiasis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Appendiceal abscess	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Appendicitis	0.17% 16/9539 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Appendicitis perforated	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Arteriosclerotic gangrene	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Arteriovenous graft site infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Arthritis bacterial	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Atypical pneumonia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bacteraemia	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bacterial diarrhoea	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bacterial infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bacterial prostatitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bacterial sepsis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Biliary tract infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Borrelia infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Brain abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bronchiolitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bronchitis	0.17% 16/9539 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.23% 22/9544 • Number of events 28 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bronchitis bacterial	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bronchopneumonia	0.30% 29/9539 • Number of events 33 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.25% 24/9544 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Campylobacter gastroenteritis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Candida pneumonia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Candidiasis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Carbuncle	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Cellulitis	0.24% 23/9539 • Number of events 23 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Cellulitis gangrenous	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Cervicitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Cholangitis suppurative	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Cholecystitis infective	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Chronic hepatitis C	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Chronic sinusitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Clostridium difficile colitis	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Cystitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Cystitis klebsiella	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Dengue fever	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Device related infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Diabetic foot infection	0.05% 5/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Diabetic gangrene	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Diarrhoea infectious	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Diverticulitis	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Ear infection	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Echinococciasis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Emphysematous cholecystitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Empyema	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Endocarditis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Endocarditis bacterial	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Endocarditis enterococcal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Endocarditis staphylococcal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Enterobacter sepsis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Enterococcal sepsis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Enterocolitis bacterial	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Enterocolitis infectious	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Epiglottitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Erysipelas	0.21% 20/9539 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.16% 15/9544 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Escherichia infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Escherichia urinary tract infection	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Folliculitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gallbladder empyema	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gangrene	0.07% 7/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastroenteritis	0.17% 16/9539 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.17% 16/9544 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastroenteritis bacterial	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastroenteritis clostridial	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastroenteritis salmonella	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastroenteritis shigella	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastroenteritis viral	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastrointestinal bacterial infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Gastrointestinal viral infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Groin abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Haemophilus infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Helicobacter gastritis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Helicobacter infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Hepatitis A	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Hepatitis B	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Hepatitis C	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Herpes zoster	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Herpes zoster infection neurological	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Herpes zoster ophthalmic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Herpes zoster oticus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infected cyst	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infected dermal cyst	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infected skin ulcer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infectious pleural effusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infective exacerbation of bronchiectasis	0.03% 3/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Infective myositis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Influenza	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Injection site abscess	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Intervertebral discitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Joint abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Keratitis herpetic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Laryngitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Laryngitis bacterial	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Laryngitis fungal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Legionella infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Liver abscess	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Lobar pneumonia	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Localised infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Lower respiratory tract infection	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Lower respiratory tract infection bacterial	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Lung abscess	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Lung infection	0.12% 11/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Lyme disease	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Lymphangitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Malaria	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Mastoiditis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Mediastinal abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Mediastinitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Meningitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Meningitis tuberculous	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Meningitis viral	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Muscle abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Necrotising fasciitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Oesophageal candidiasis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Orchitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Osteomyelitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Osteomyelitis bacterial	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Osteomyelitis chronic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Otitis media	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Otitis media acute	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Otitis media chronic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pelvic abscess	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Perihepatic abscess	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Perineal abscess	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Periodontitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Peritoneal abscess	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Peritonitis	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Peritonitis bacterial	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Peritonsillar abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pertussis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pharyngitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumococcal sepsis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia	1.3% 122/9539 • Number of events 129 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 102/9544 • Number of events 112 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia bacterial	0.07% 7/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia escherichia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia haemophilus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia klebsiella	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia moraxella	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia mycoplasmal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia pneumococcal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia pseudomonas aeruginosa	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia streptococcal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pneumonia viral	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Post procedural cellulitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Post procedural infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Post procedural sepsis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Postoperative abscess	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Postoperative wound infection	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pseudomembranous colitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pseudomonal bacteraemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pulmonary sepsis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pulmonary tuberculoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pulmonary tuberculosis	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Puncture site abscess	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Puncture site infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pyelonephritis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pyelonephritis acute	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pyelonephritis chronic	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pyoderma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Pyonephrosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Renal tuberculosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Respiratory moniliasis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Respiratory syncytial virus infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Respiratory tract infection	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Respiratory tract infection bacterial	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Respiratory tract infection viral	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Salmonellosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Scrotal abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Sepsis	0.12% 11/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Septic arthritis staphylococcal	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Septic shock	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Sinusitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Skin infection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Small intestine gangrene	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Sputum purulent	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Staphylococcal infection	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Staphylococcal sepsis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Streptococcal sepsis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Subcutaneous abscess	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Systemic candida	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Tonsillitis bacterial	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Tooth infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Toxic shock syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Tracheobronchitis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Tuberculosis gastrointestinal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Tuberculous pleurisy	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Tubo-ovarian abscess	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Typhoid fever	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Upper respiratory tract infection	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Urinary tract infection	0.27% 26/9539 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.18% 17/9544 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Urinary tract infection bacterial	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Urinary tract infection enterococcal	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Urosepsis	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Viral infection	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Viral pericarditis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Wound infection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Wound infection bacterial	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Wound infection pseudomonas	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Abdominal injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Accident	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Accident at home	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Agitation postoperative	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Anaemia postoperative	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Ankle fracture	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Aortic injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Arterial restenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Asbestosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Back injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Blindness traumatic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Bone fissure	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Brain contusion	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Burns second degree	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Cardiac contusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Cardiac procedure complication	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Cardiac valve replacement complication	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Cardiac valve rupture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Carotid artery restenosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Chest injury	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Clavicle fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Concussion	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Contusion	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Coronary artery restenosis	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Corrosive gastritis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Craniocerebral injury	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Crushing injury of trunk	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Eye contusion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Eye injury	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Face injury	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Facial bones fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Fall	1.00% 95/9539 • Number of events 96 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 109/9544 • Number of events 109 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Febrile nonhaemolytic transfusion reaction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Femoral neck fracture	0.14% 13/9539 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Femur fracture	0.16% 15/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Fibula fracture	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Foot fracture	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Forearm fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Foreign body	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Foreign body in eye	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Hand fracture	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Head injury	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Heat stroke	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Hip fracture	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Humerus fracture	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus	0.62% 59/9539 • Number of events 65 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.86% 82/9544 • Number of events 87 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Intervertebral disc injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Jaw fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Joint dislocation	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Joint dislocation postoperative	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Joint injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Kidney rupture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Laceration	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Ligament rupture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Limb crushing injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Limb injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Limb traumatic amputation	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Lip injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Lower limb fracture	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Meniscus injury	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Multiple fractures	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Multiple injuries	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Neck injury	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Osteoradionecrosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Pancreatic injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Pelvic fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Penetrating abdominal trauma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Periorbital haematoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Peripheral artery restenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Pneumoconiosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Pneumothorax traumatic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural complication	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural contusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural fistula	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural haematoma	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural hypothyroidism	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.15% 14/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post procedural pulmonary embolism	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post-thoracotomy pain syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Post-traumatic pain	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Postoperative ileus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Postoperative wound complication	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Procedural haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Procedural hypotension	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Procedural pain	0.02% 2/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Procedural site reaction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Pubis fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Radiation oesophagitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Radius fracture	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.16% 15/9544 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Renal haematoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Rib fracture	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.16% 15/9544 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Road traffic accident	0.24% 23/9539 • Number of events 23 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.27% 26/9544 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Seroma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Shunt thrombosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Silicosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Skull fracture	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Skull fractured base	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Spinal column injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 3/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Spinal fracture	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Splenic rupture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Stab wound	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Sternal fracture	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Subcutaneous haematoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Subdural haematoma	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Subdural haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Suture related complication	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Tendon injury	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Tendon rupture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.01% 1/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Tibia fracture	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Tongue injury	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Toxicity to various agents	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Transfusion reaction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Traumatic ulcer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Ulna fracture	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Upper limb fracture	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Vascular graft complication	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Vascular graft occlusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Vascular graft thrombosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Vasoplegia syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Wound complication	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Wrist fracture	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Alanine aminotransferase increased	0.12% 11/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Amylase increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Arteriogram carotid	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Arteriogram coronary	0.45% 43/9539 • Number of events 45 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.56% 53/9544 • Number of events 58 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Arthroscopy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Aspartate aminotransferase increased	0.13% 12/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Biopsy prostate	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood alkaline phosphatase increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood creatine phosphokinase increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood creatinine increased	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood glucose decreased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood glucose increased	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood iron decreased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood lactate dehydrogenase increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood parathyroid hormone decreased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood potassium decreased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood potassium increased	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood pressure decreased	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood pressure increased	0.25% 24/9539 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood pressure systolic decreased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood pressure systolic increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood triglycerides increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Body temperature increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations C-reactive protein increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Carbohydrate antigen 19-9 increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Cardiac enzymes increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Cardiac stress test abnormal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Cardiovascular evaluation	0.82% 78/9539 • Number of events 98 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.88% 84/9544 • Number of events 100 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Catheterisation cardiac	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Chest X-ray abnormal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Cystoscopy normal	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations ECG signs of myocardial ischaemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Ejection fraction decreased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram QT prolonged	0.60% 57/9539 • Number of events 60 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram ST segment depression	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram ST segment elevation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram T wave inversion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram ambulatory	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram change	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram repolarisation abnormality	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Fibrin D dimer increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Gamma-glutamyltransferase increased	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Gastrointestinal examination	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Haemoglobin decreased	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Heart rate decreased	0.58% 55/9539 • Number of events 55 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Hepatic enzyme increased	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations International normalised ratio increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Intraocular pressure increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Investigation	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Oxygen saturation decreased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Platelet count decreased	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Pulmonary arterial pressure increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Red blood cell sedimentation rate increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Romberg test positive	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Sleep study	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Streptococcus test positive	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Stress echocardiogram abnormal	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Thyroid function test abnormal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Treponema test positive	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Troponin increased	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Weight decreased	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations White blood cell count increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Acidosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Cachexia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Decreased appetite	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Dehydration	0.20% 19/9539 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.20% 19/9544 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.36% 34/9539 • Number of events 36 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.52% 50/9544 • Number of events 53 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Diabetic complication	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Fluid retention	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Gout	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hyperglycaemia	0.10% 10/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hyperkalaemia	0.14% 13/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypocalcaemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypoglycaemia	0.20% 19/9539 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypokalaemia	0.04% 4/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypomagnesaemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hyponatraemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Malnutrition	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Metabolic acidosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Obesity	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.26% 25/9539 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.49% 47/9544 • Number of events 52 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Type 3 diabetes mellitus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Amyotrophy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Arthralgia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Arthritis	0.01% 1/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Back pain	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Bursitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders CREST syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Chondromalacia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Costochondritis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Exostosis of jaw	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Fistula	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Foot deformity	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Gouty arthritis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Gouty tophus	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Groin pain	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.04% 4/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Intervertebral disc displacement	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.13% 12/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.21% 20/9544 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Kyphosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Muscle tightness	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.12% 11/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Myopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Myopathy toxic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Neck pain	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.48% 46/9539 • Number of events 47 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.45% 43/9544 • Number of events 48 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteochondritis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteochondrosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteoporosis postmenopausal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Pain in extremity	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Periarthritis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.01% 1/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Scoliosis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.19% 18/9539 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.17% 16/9544 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Sympathetic posterior cervical syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Synovitis	0.03% 3/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Systemic sclerosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenolymphoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell lung cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiofibroma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma, low grade	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B precursor type acute leukaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.25% 24/9539 • Number of events 25 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.22% 21/9544 • Number of events 23 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma of skin	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of prostate	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pleural neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage I, with cancer in situ	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage II	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage III	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain stem glioma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchioloalveolar carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the stomach	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carotid body tumour	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Castleman's disease	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral hygroma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage III	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia stage 2	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell sarcoma of soft tissue	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage 0	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage III	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage IV	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear neoplasm malignant	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage IV	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of bone	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer metastatic	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer stage II	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer metastatic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer recurrent	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer stage IV	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage II	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant glioma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of choroid	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of eyelid	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant oligodendroglioma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to abdominal cavity	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone marrow	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to eye	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to the mediastinum	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral haematoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic uterine cancer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative disorder	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodular melanoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IIIA	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma metastatic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary tumour of renal pelvis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penis carcinoma stage II	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer recurrent	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pineal parenchymal neoplasm malignant	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour recurrent	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell leukaemia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.40% 38/9539 • Number of events 38 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage IV	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer recurrent	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage 0	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage IV	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer stage I	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rhabdomyosarcoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland adenoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular cancer metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer metastatic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Altered state of consciousness	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Amnesia	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Anticholinergic syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Aphasia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Ataxia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Autonomic neuropathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Balance disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Brain hypoxia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Brain injury	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Brain oedema	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Brain stem infarction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid aneurysm rupture	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid arteriosclerosis	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid artery aneurysm	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid artery disease	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid artery dissection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid artery occlusion	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid artery stenosis	0.53% 51/9539 • Number of events 57 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.45% 43/9544 • Number of events 45 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carotid sinus syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Carpal tunnel syndrome	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebellar atrophy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebellar haemorrhage	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebellar ischaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebellar syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral arteriosclerosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral artery stenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral atrophy	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral haemorrhage	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral infarction	0.16% 15/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.14% 13/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral ischaemia	0.08% 8/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebral microangiopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebrovascular accident	0.32% 31/9539 • Number of events 32 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.42% 40/9544 • Number of events 44 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebrovascular disorder	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cervical cord compression	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cervical myelopathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cervicobrachial syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cognitive disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Coma	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Convulsion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Coordination abnormal	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cranial nerve disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cranial nerve paralysis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Cubital tunnel syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dementia	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dementia Alzheimer's type	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dementia of the Alzheimer's type, with delusions	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Demyelinating polyneuropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Depressed level of consciousness	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Diabetic hyperglycaemic coma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Diabetic neuropathy	0.10% 10/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dizziness	0.20% 19/9539 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 20 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dizziness postural	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Drop attacks	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dysarthria	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dystonic tremor	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Encephalitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Encephalomyelitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Encephalopathy	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Epilepsy	0.07% 7/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Essential tremor	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Extrapyramidal disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Facial nerve disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Facial paresis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Grand mal convulsion	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Guillain-Barre syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Haemorrhage intracranial	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Haemorrhagic stroke	0.05% 5/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Headache	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hemianopia homonymous	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hemiparesis	0.06% 6/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Horner's syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hydrocephalus	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hypertensive encephalopathy	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hypoaesthesia	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hypoglycaemic coma	0.02% 2/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hypoglycaemic unconsciousness	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hyporeflexia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders IIIrd nerve paralysis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Intercostal neuralgia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Intracranial aneurysm	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Intracranial hypotension	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Intracranial pressure increased	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Intracranial venous sinus thrombosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Ischaemic cerebral infarction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Ischaemic neuropathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Ischaemic stroke	1.0% 97/9539 • Number of events 100 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.94% 90/9544 • Number of events 95 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Lacunar infarction	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Lethargy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Loss of consciousness	0.34% 32/9539 • Number of events 32 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.23% 22/9544 • Number of events 22 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Lumbar radiculopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Memory impairment	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Migraine	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Monoplegia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Movement disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Multiple sclerosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Myasthenia gravis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Myelitis transverse	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Myelopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Nerve compression	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Nerve root compression	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Nerve root lesion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Neuralgia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Neuritis cranial	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Neurodegenerative disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Neurological decompensation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Neuropathy peripheral	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Normal pressure hydrocephalus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Paraesthesia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Paraplegia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Parkinson's disease	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Parkinsonism	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Partial seizures	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Peripheral sensory neuropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Petit mal epilepsy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Polyneuropathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Poor quality sleep	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Post-injection delirium sedation syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Post-traumatic headache	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Posterior reversible encephalopathy syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Presyncope	0.16% 15/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Psychomotor hyperactivity	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Pyramidal tract syndrome	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Radial nerve compression	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Radicular pain	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Radicular syndrome	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Radiculopathy	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Restless legs syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Retrograde amnesia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Sciatica	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Senile dementia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Somnolence	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Speech disorder	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Spinal cord compression	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Spinal vascular disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Spondylitic myelopathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Subarachnoid haemorrhage	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Subdural hygroma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Syncope	0.95% 91/9539 • Number of events 102 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.93% 89/9544 • Number of events 96 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Thalamic infarction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Thalamus haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Thrombotic stroke	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Tonic convulsion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Transient global amnesia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Transient ischaemic attack	0.59% 56/9539 • Number of events 59 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.52% 50/9544 • Number of events 50 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Tremor	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Ulnar neurapraxia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Ulnar tunnel syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders VIIth nerve paralysis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders VIth nerve disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders VIth nerve paralysis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Vascular dementia	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Vascular encephalopathy	0.12% 11/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Vertebral artery occlusion	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Vertebral artery stenosis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Vertebrobasilar insufficiency	0.16% 15/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Vertigo CNS origin	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Vocal cord paresis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Wernicke-Korsakoff syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Acute psychosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Aggression	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Agitated depression	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Agitation	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Alcohol abuse	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Alcohol withdrawal syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Alcoholism	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Anxiety	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Bipolar I disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Bipolar disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Completed suicide	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Confusional state	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Delirium	0.08% 8/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Delirium tremens	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Delusional disorder, unspecified type	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Depressed mood	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Depression	0.60% 57/9539 • Number of events 59 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.57% 54/9544 • Number of events 54 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Depression suicidal	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Depressive symptom	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Disorientation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Dysthymic disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Hallucination	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Hallucination, auditory	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Hallucination, visual	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Hallucinations, mixed	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Impulsive behaviour	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Insomnia	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Intentional drug misuse	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Major depression	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Mood disorder due to a general medical condition	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Nervousness	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Obsessive thoughts	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Panic attack	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Paranoia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Persecutory delusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Psychomotor retardation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Psychosomatic disease	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Psychotic disorder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Psychotic disorder due to a general medical condition	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Sleep disorder	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Sleep terror	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Stress	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Suicidal ideation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Suicide attempt	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Acute prerenal failure	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Anuria	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Bladder dilatation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Bladder diverticulum	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Bladder neck sclerosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Bladder perforation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Bladder prolapse	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Bladder stenosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Bladder tamponade	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Calculus bladder	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Calculus ureteric	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Calculus urethral	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Calculus urinary	0.10% 10/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Cystitis glandularis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Cystitis haemorrhagic	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Cystitis noninfective	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Diabetic nephropathy	0.12% 11/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Dysuria	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Glomerulonephritis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Haematuria	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Hydronephrosis	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Hydroureter	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Hypertensive nephropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Hypertonic bladder	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders IgA nephropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Incontinence	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Nephroangiosclerosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Nephrolithiasis	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.15% 14/9544 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Nephropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Nephropathy toxic	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Nephrotic syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Obstructive uropathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Pollakiuria	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Prerenal failure	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal artery occlusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal artery stenosis	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal artery thrombosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal colic	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal cyst	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal failure	0.40% 38/9539 • Number of events 39 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.31% 30/9544 • Number of events 30 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal failure acute	0.30% 29/9539 • Number of events 31 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.37% 35/9544 • Number of events 38 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal failure chronic	0.36% 34/9539 • Number of events 35 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.18% 17/9544 • Number of events 17 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal impairment	0.14% 13/9539 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal infarct	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal ischaemia	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Renal tubular acidosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Stress urinary incontinence	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Tubulointerstitial nephritis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Renal and urinary disorders Ureteric obstruction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Laryngeal stenosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Lung cyst	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pleural haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.07% 7/9539 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.16% 15/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.25% 24/9544 • Number of events 24 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.04% 4/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.20% 19/9539 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary microemboli	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.16% 15/9539 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Reflux laryngitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiration abnormal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.22% 21/9539 • Number of events 21 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.28% 27/9544 • Number of events 28 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Snoring	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Wheezing	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Angioedema	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Cold sweat	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Dermatitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Dermatitis bullous	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Dermatomyositis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Diabetic foot	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Dry gangrene	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Keloid scar	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Lichen planus	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Necrobiosis lipoidica diabeticorum	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Neuropathic ulcer	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Panniculitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Parapsoriasis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Pemphigus	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Pruritus allergic	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Psoriasis	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Purpura	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Rash generalised	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Skin ulcer	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Skin ulcer haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Toxic skin eruption	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Social circumstances Activities of daily living impaired	0.12% 11/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Social circumstances Alcohol use	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Social circumstances Immobile	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Social circumstances Impaired driving ability	0.16% 15/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Abdominal hernia repair	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Alcohol detoxification	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Aortic aneurysm repair	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Aortic bypass	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Aortic valve repair	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Aortic valve replacement	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Arterial bypass operation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Arterial stent insertion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Arteriovenous fistula operation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Bladder neoplasm surgery	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Blepharoplasty	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Bunion operation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Cardiac ablation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Cardiac aneurysm repair	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Cardiac rehabilitation therapy	0.24% 23/9539 • Number of events 30 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.20% 19/9544 • Number of events 27 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Carotid angioplasty	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Carotid artery bypass	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Carotid artery stent insertion	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Carotid endarterectomy	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Cataract operation	0.09% 9/9539 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Chemotherapy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Cholecystectomy	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Cholesteatoma removal	0.01% 1/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Circumcision	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Coronary angioplasty	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Coronary arterial stent insertion	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Coronary artery bypass	0.10% 10/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.19% 18/9544 • Number of events 18 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Coronary revascularisation	0.08% 8/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Diabetes mellitus management	0.04% 4/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Dupuytren's contracture operation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Fasciectomy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Femoral hernia repair	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Finger amputation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Gastrectomy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Gastric banding	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Gastric bypass	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Glaucoma surgery	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Hip arthroplasty	0.09% 9/9539 • Number of events 10 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Hospitalisation	0.08% 8/9539 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Hydrocele operation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Ileostomy closure	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Implantable defibrillator insertion	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Incisional hernia repair	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Infusion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Inguinal hernia repair	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.09% 9/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Internal fixation of fracture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Intraocular lens extraction	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Keratoplasty	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Knee arthroplasty	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 13 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Knee operation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Leg amputation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Lens extraction	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Liver operation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Medical device removal	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Meniscus removal	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Metatarsal excision	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Mitral valve repair	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Nasal polypectomy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Nasal septal operation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Obesity surgery	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Oophorectomy bilateral	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Percutaneous coronary intervention	0.16% 15/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.17% 16/9544 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Peripheral artery angioplasty	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Peripheral artery bypass	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Peripheral artery stent insertion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Physiotherapy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Radical hysterectomy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Radiotherapy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Rehabilitation therapy	0.08% 8/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.10% 10/9544 • Number of events 14 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Removal of internal fixation	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Renal artery ablation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Renal stone removal	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Retinal laser coagulation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Rotator cuff repair	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Shoulder arthroplasty	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Sinus operation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Skin neoplasm excision	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Spinal operation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Suture insertion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Thyroidectomy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Toe amputation	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Transurethral prostatectomy	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Umbilical hernia repair	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Urethral dilation procedure	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Urinary calculus removal	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Uterine polypectomy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Surgical and medical procedures Vaginal prolapse repair	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Aortic aneurysm	0.04% 4/9539 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Aortic aneurysm rupture	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Aortic arteriosclerosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Aortic dilatation	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Aortic dissection	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Aortic occlusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Aortic thrombosis	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Arterial rupture	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Arterial stenosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Arteriosclerosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Blood pressure fluctuation	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Blood pressure inadequately controlled	0.07% 7/9539 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Circulatory collapse	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Deep vein thrombosis	0.20% 19/9539 • Number of events 19 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.18% 17/9544 • Number of events 17 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Diabetic macroangiopathy	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Diabetic microangiopathy	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Diabetic vascular disorder	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Embolism	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Essential hypertension	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Extremity necrosis	0.05% 5/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.07% 7/9544 • Number of events 7 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Femoral artery aneurysm	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Femoral artery dissection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Femoral artery embolism	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Femoral artery occlusion	0.10% 10/9539 • Number of events 11 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.15% 14/9544 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Haemorrhage	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Hypertension	2.1% 204/9539 • Number of events 220 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.5% 144/9544 • Number of events 152 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Hypertensive crisis	1.1% 104/9539 • Number of events 117 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 105/9544 • Number of events 119 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Hypertensive emergency	0.14% 13/9539 • Number of events 15 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Hypotension	0.26% 25/9539 • Number of events 26 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.38% 36/9544 • Number of events 37 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Hypovolaemic shock	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Iliac artery occlusion	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.04% 4/9544 • Number of events 4 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Iliac artery rupture	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Intermittent claudication	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 9 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Jugular vein thrombosis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Labile blood pressure	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Labile hypertension	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Leriche syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Lymphoedema	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Lymphostasis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Malignant hypertension	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Orthostatic hypotension	0.13% 12/9539 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Pallor	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral arterial occlusive disease	0.55% 52/9539 • Number of events 58 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.70% 67/9544 • Number of events 70 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral artery aneurysm	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.03% 3/9544 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral artery dissection	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral artery stenosis	0.14% 13/9539 • Number of events 16 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.13% 12/9544 • Number of events 12 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral artery thrombosis	0.06% 6/9539 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral embolism	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral ischaemia	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.08% 8/9544 • Number of events 8 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Peripheral vascular disorder	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Phlebitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Phlebitis superficial	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Shock haemorrhagic	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.05% 5/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Subclavian artery occlusion	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Subclavian artery stenosis	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Subclavian steal syndrome	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Subgaleal haematoma	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Systolic hypertension	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Thrombophlebitis	0.05% 5/9539 • Number of events 5 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.06% 6/9544 • Number of events 6 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Thrombophlebitis superficial	0.02% 2/9539 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Thrombosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Varicose ulceration	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Varicose vein	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Vasculitis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Vasculitis necrotising	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Vena cava thrombosis	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Venous insufficiency	0.03% 3/9539 • Number of events 3 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.02% 2/9544 • Number of events 2 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Venous thrombosis	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Venous thrombosis limb	0.00% 0/9539 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.01% 1/9544 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Withdrawal hypertension	0.01% 1/9539 • Number of events 1 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.00% 0/9544 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).

Other adverse events

Measure	Ivabradine n=9539 participants at risk Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.	Placebo n=9544 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 48 months.
Blood and lymphatic system disorders Anaemia	1.9% 186/9539 • Number of events 191 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.1% 197/9544 • Number of events 204 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Angina pectoris	3.6% 340/9539 • Number of events 370 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	4.1% 388/9544 • Number of events 413 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrial fibrillation	1.4% 135/9539 • Number of events 157 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 101/9544 • Number of events 108 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Atrioventricular block first degree	2.6% 247/9539 • Number of events 265 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.1% 203/9544 • Number of events 221 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Bradycardia	5.0% 473/9539 • Number of events 511 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.60% 57/9544 • Number of events 63 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Cardiac failure	1.3% 125/9539 • Number of events 131 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.4% 132/9544 • Number of events 137 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sinus bradycardia	1.5% 144/9539 • Number of events 150 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.16% 15/9544 • Number of events 17 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Sinus tachycardia	0.42% 40/9539 • Number of events 40 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.7% 161/9544 • Number of events 181 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Supraventricular extrasystoles	1.8% 176/9539 • Number of events 186 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.3% 128/9544 • Number of events 129 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Cardiac disorders Ventricular extrasystoles	3.2% 310/9539 • Number of events 331 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.6% 244/9544 • Number of events 267 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Cataract	1.2% 118/9539 • Number of events 132 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.7% 158/9544 • Number of events 171 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Photopsia	5.1% 483/9539 • Number of events 536 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.50% 48/9544 • Number of events 49 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Eye disorders Vision blurred	1.1% 102/9539 • Number of events 105 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.32% 31/9544 • Number of events 31 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Constipation	1.00% 95/9539 • Number of events 102 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.0% 98/9544 • Number of events 102 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Diarrhoea	1.2% 117/9539 • Number of events 121 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.2% 112/9544 • Number of events 120 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Gastrointestinal disorders Gastritis	1.0% 96/9539 • Number of events 97 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.2% 111/9544 • Number of events 114 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Chest pain	0.83% 79/9539 • Number of events 86 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.0% 98/9544 • Number of events 108 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Fatigue	1.2% 119/9539 • Number of events 124 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 106/9544 • Number of events 112 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
General disorders Oedema peripheral	2.1% 205/9539 • Number of events 225 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.7% 165/9544 • Number of events 172 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Bronchitis	2.2% 214/9539 • Number of events 241 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.9% 182/9544 • Number of events 198 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Influenza	1.2% 113/9539 • Number of events 123 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.8% 168/9544 • Number of events 176 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Nasopharyngitis	1.8% 172/9539 • Number of events 195 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.8% 172/9544 • Number of events 198 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Upper respiratory tract infection	1.7% 166/9539 • Number of events 194 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.8% 175/9544 • Number of events 215 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Infections and infestations Urinary tract infection	1.1% 105/9539 • Number of events 111 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.0% 100/9544 • Number of events 118 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Injury, poisoning and procedural complications Fall	1.8% 174/9539 • Number of events 188 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.0% 194/9544 • Number of events 204 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood creatinine increased	1.2% 111/9539 • Number of events 115 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.92% 88/9544 • Number of events 89 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Blood pressure increased	1.00% 95/9539 • Number of events 119 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 106/9544 • Number of events 131 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations C-reactive protein increased	1.6% 154/9539 • Number of events 158 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.5% 139/9544 • Number of events 142 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Electrocardiogram QT prolonged	1.1% 106/9539 • Number of events 118 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.42% 40/9544 • Number of events 44 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Investigations Heart rate decreased	10.3% 985/9539 • Number of events 1118 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 105/9544 • Number of events 116 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus	1.9% 185/9539 • Number of events 199 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.6% 247/9544 • Number of events 260 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypercholesterolaemia	1.6% 155/9539 • Number of events 162 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.8% 174/9544 • Number of events 183 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hyperglycaemia	1.0% 99/9539 • Number of events 102 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.0% 99/9544 • Number of events 104 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hyperkalaemia	1.5% 140/9539 • Number of events 145 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.2% 111/9544 • Number of events 121 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Hypertriglyceridaemia	1.6% 150/9539 • Number of events 154 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.7% 158/9544 • Number of events 161 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.4% 136/9539 • Number of events 141 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.8% 173/9544 • Number of events 179 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Arthralgia	0.73% 70/9539 • Number of events 74 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.0% 96/9544 • Number of events 99 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Back pain	1.00% 95/9539 • Number of events 100 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 108/9544 • Number of events 114 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 105/9539 • Number of events 116 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.6% 155/9544 • Number of events 161 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.1% 107/9539 • Number of events 113 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.2% 118/9544 • Number of events 125 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Dizziness	2.9% 275/9539 • Number of events 292 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	2.1% 202/9544 • Number of events 215 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Nervous system disorders Headache	1.7% 165/9539 • Number of events 190 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.5% 139/9544 • Number of events 154 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Psychiatric disorders Insomnia	1.0% 98/9539 • Number of events 100 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.0% 98/9544 • Number of events 101 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Reproductive system and breast disorders Benign prostatic hyperplasia	1.0% 98/9539 • Number of events 98 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.1% 104/9544 • Number of events 104 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 113/9539 • Number of events 127 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.2% 112/9544 • Number of events 136 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Cough	1.5% 147/9539 • Number of events 158 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.4% 137/9544 • Number of events 144 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 114/9539 • Number of events 119 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	0.97% 93/9544 • Number of events 95 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Hypertension	10.1% 968/9539 • Number of events 1102 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	8.5% 810/9544 • Number of events 918 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).
Vascular disorders Hypotension	1.6% 155/9539 • Number of events 161 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 in the placebo group).	1.6% 155/9544 • Number of events 161 • From randomisation to death, up to 48 months The Randomised Set consisted of 19 102 patients (9550 patients in the ivabradine group and 9552 in the placebo group). The Safety Set consisted of 19 083 patients: 19 randomised patients were excluded from the Safety Set because they did not take any study medication (11 patients in the ivabradine group and 8 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