Trial Outcomes & Findings for Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial (NCT NCT00991029)

Last Updated: 2018-12-04

Results Overview

Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4881 participants

Primary outcome timeframe

Up to 90 days

Results posted on

2018-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Clopidogrel Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Overall Study STARTED	2432	2449
Overall Study COMPLETED	2276	2281
Overall Study NOT COMPLETED	156	168

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days	Total n=4881 Participants Total of all reporting groups
Age, Continuous	65.0 years n=2432 Participants	65.0 years n=2449 Participants	65.0 years n=4881 Participants
Sex: Female, Male Female	1097 Participants n=2432 Participants	1098 Participants n=2449 Participants	2195 Participants n=4881 Participants
Sex: Female, Male Male	1335 Participants n=2432 Participants	1351 Participants n=2449 Participants	2686 Participants n=4881 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	144 Participants n=2432 Participants	146 Participants n=2449 Participants	290 Participants n=4881 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2176 Participants n=2432 Participants	2182 Participants n=2449 Participants	4358 Participants n=4881 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	112 Participants n=2432 Participants	121 Participants n=2449 Participants	233 Participants n=4881 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=2432 Participants	16 Participants n=2449 Participants	23 Participants n=4881 Participants
Race (NIH/OMB) Asian	77 Participants n=2432 Participants	67 Participants n=2449 Participants	144 Participants n=4881 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	10 Participants n=2432 Participants	5 Participants n=2449 Participants	15 Participants n=4881 Participants
Race (NIH/OMB) Black or African American	473 Participants n=2432 Participants	493 Participants n=2449 Participants	966 Participants n=4881 Participants
Race (NIH/OMB) White	1774 Participants n=2432 Participants	1781 Participants n=2449 Participants	3555 Participants n=4881 Participants
Race (NIH/OMB) More than one race	4 Participants n=2432 Participants	5 Participants n=2449 Participants	9 Participants n=4881 Participants
Race (NIH/OMB) Unknown or Not Reported	87 Participants n=2432 Participants	82 Participants n=2449 Participants	169 Participants n=4881 Participants
Region of Enrollment New Zealand	3 Participants n=2432 Participants	4 Participants n=2449 Participants	7 Participants n=4881 Participants
Region of Enrollment Canada	121 Participants n=2432 Participants	119 Participants n=2449 Participants	240 Participants n=4881 Participants
Region of Enrollment United States	2014 Participants n=2432 Participants	2029 Participants n=2449 Participants	4043 Participants n=4881 Participants
Region of Enrollment Finland	25 Participants n=2432 Participants	25 Participants n=2449 Participants	50 Participants n=4881 Participants
Region of Enrollment Mexico	5 Participants n=2432 Participants	4 Participants n=2449 Participants	9 Participants n=4881 Participants
Region of Enrollment United Kingdom	33 Participants n=2432 Participants	38 Participants n=2449 Participants	71 Participants n=4881 Participants
Region of Enrollment Australia	53 Participants n=2432 Participants	51 Participants n=2449 Participants	104 Participants n=4881 Participants
Region of Enrollment France	51 Participants n=2432 Participants	47 Participants n=2449 Participants	98 Participants n=4881 Participants
Region of Enrollment Germany	8 Participants n=2432 Participants	10 Participants n=2449 Participants	18 Participants n=4881 Participants
Region of Enrollment Spain	119 Participants n=2432 Participants	122 Participants n=2449 Participants	241 Participants n=4881 Participants
Qualifying Event TIA	1056 Participants n=2432 Participants	1052 Participants n=2449 Participants	2108 Participants n=4881 Participants
Qualifying Event Ischemic Stroke	1376 Participants n=2432 Participants	1397 Participants n=2449 Participants	2773 Participants n=4881 Participants
Qualifying Neurologic Score ABCD2	5.0 units on a scale n=1055 Participants • ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).	5.0 units on a scale n=1049 Participants • ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).	5.0 units on a scale n=2104 Participants • ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).
Qualifying Neurologic Score National Institutes of Health Stroke Scale	2.0 units on a scale n=1365 Participants • ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).	2.0 units on a scale n=1385 Participants • ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).	2.0 units on a scale n=2750 Participants • ABCD2 scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the placebo group). NIHSS scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).

PRIMARY outcome

Timeframe: Up to 90 days

Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes	121 Participants	160 Participants

PRIMARY outcome

Timeframe: Up to 90 days

Primary safety outcome: Number of Participants with major hemorrhage

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Major Hemorrhage	23 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 90 days

Secondary efficacy outcome:Number of participants with Ischemic stroke

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Ischemic Stroke	112 Participants	155 Participants

SECONDARY outcome

Timeframe: Up to 90 days

Secondary efficacy outcome: Number of participants with Myocardial infarction

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Myocardial Infarction	10 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 90 days

Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Death From Ischemic Vascular Causes	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 90 days

Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Ischemic or Hemorrhagic Stroke	116 Participants	156 Participants

SECONDARY outcome

Timeframe: Up to 90 days

Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage	141 Participants	167 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days

Other safety outcome: Number of participants with Hemorrhagic stroke

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Hemorrhagic Stroke	5 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days

Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Symptomatic Intracerebral Hemorrhage	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days

Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Other Symptomatic Intracranial Hemorrhage	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days

Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Major Hemorrhage Other Than Intracranial Hemorrhage	17 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days

Other safety outcome:Number of Participants with Minor hemorrhage

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Minor Hemorrhage	40 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 90 days

Other safety outcome: Number of Participants with Death from any cause

Outcome measures

Outcome measures
Measure	Clopidogrel n=2432 Participants Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 Participants Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Death From Any Cause	18 Participants	12 Participants

Adverse Events

Clopidogrel

Serious events: 382 serious events

Other events: 89 other events

Deaths: 18 deaths

Placebo

Serious events: 382 serious events

Other events: 84 other events

Deaths: 12 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jordan Elm

Medical University of South Carolina

Phone: 843-876-1605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Clopidogrel n=2432 participants at risk Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 participants at risk Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Gastrointestinal disorders Abdominal pain	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Accelerated hypertension	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Acute coronary syndrome	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Acute myocardial infarction	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Psychiatric disorders Acute psychosis	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Psychiatric disorders Acute stress disorder	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Eye disorders Amaurosis fugax	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.08% 2/2449 • Number of events 3 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Blood and lymphatic system disorders Anaemia	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Angina pectoris	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Angina unstable	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.08% 2/2449 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Skin and subcutaneous tissue disorders Angioedema	0.12% 3/2432 • Number of events 3 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Psychiatric disorders Anxiety	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Aortic aneurysm	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Aortic dissection	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Aortic stenosis	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Arrhythmia	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Arterial occlusive disease	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Surgical and medical procedures Arterial repair	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Arteriosclerosis	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Arteriovenous fistula	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Musculoskeletal and connective tissue disorders Arthralgia	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Investigations Aspiration bronchial	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
General disorders Asthenia	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Atrial fibrillation	0.99% 24/2432 • Number of events 24 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.61% 15/2449 • Number of events 15 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Atrial flutter	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.08% 2/2449 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Congenital, familial and genetic disorders Atrial septal defect	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.08% 2/2449 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Atrioventricular block	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Atrioventricular block complete	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Musculoskeletal and connective tissue disorders Back pain	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Balance disorder	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Bradycardia	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Renal and urinary disorders Calculus ureteric	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.

Other adverse events
Measure	Clopidogrel n=2432 participants at risk Patients assigned to clopidogrel in addition to aspirin Clopidogrel: Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days	Placebo n=2449 participants at risk Patients assigned to placebo in addition to aspirin placebo: Loading dose of 8 tablets followed by one tablet daily for 89 days
Cardiac disorders Acute myocardial infarction	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Cerebral amyloid angiopathy	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Cerebrovascular accident	0.12% 3/2432 • Number of events 3 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.16% 4/2449 • Number of events 4 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Eye disorders Conjunctival haemorrhage	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Injury, poisoning and procedural complications Contusion	0.29% 7/2432 • Number of events 7 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Skin and subcutaneous tissue disorders Ecchymosis	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.16% 4/2432 • Number of events 4 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.16% 4/2449 • Number of events 4 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Gastrointestinal disorders Haematochezia	0.16% 4/2432 • Number of events 4 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Renal and urinary disorders Haematuria	0.08% 2/2432 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.08% 2/2449 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Vascular disorders Haemorrhage	0.29% 7/2432 • Number of events 7 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Haemorrhage intracranial	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Haemorrhagic transformation stroke	0.16% 4/2432 • Number of events 4 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.08% 2/2449 • Number of events 2 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Hypoaesthesia	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Ischaemic stroke	0.53% 13/2432 • Number of events 14 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.78% 19/2449 • Number of events 19 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Lacunar infarction	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Cardiac disorders Myocardial infarction	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Gastrointestinal disorders Rectal haemorrhage	0.12% 3/2432 • Number of events 3 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/2432 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.04% 1/2449 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Nervous system disorders Transient ischaemic attack	1.6% 40/2432 • Number of events 43 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	1.7% 42/2449 • Number of events 46 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.
Reproductive system and breast disorders Vaginal haemorrhage	0.04% 1/2432 • Number of events 1 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.	0.00% 0/2449 • 90 days from randomization Only serious adverse events or protocol-defined clinical outcomes were collected (not all non-serious adverse events). The clinical outcomes also have been reported under the outcomes section. Some, but not all, non-serious adverse events were collected and they are included in the 'Other (not including serious) Adverse Events' table below.