Trial Outcomes & Findings for [SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES] (NCT NCT01994720)

NCT ID: NCT01994720

Last Updated: 2017-06-12

Results Overview

Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

13307 participants

Primary outcome timeframe

From randomization up to 97 days

Results posted on

2017-06-12

Participant Flow

In total, 13307 patients were enrolled from 674 study sites in 33 countries. The first patient was enrolled on 07 January 2014. The last patient visit took place on 02 March 2016.

Enrolled patients randomised to study drug: 99.2%; n=13199 Patients who were not randomised: 0.8%; n=108 Patients with eligibility criteria not fulfilled: 0.7%; n=93 Patient decision: 0.1%; n=15

Participant milestones

Participant milestones
Measure
Ticagrelor 90 mg
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
ASA 100 mg once daily (OD)
Overall Study
STARTED
6589
6610
Overall Study
COMPLETED
6543
6554
Overall Study
NOT COMPLETED
46
56

Reasons for withdrawal

Reasons for withdrawal
Measure
Ticagrelor 90 mg
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
ASA 100 mg once daily (OD)
Overall Study
Withdrawal by Subject
46
56

Baseline Characteristics

[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Total
n=13199 Participants
Total of all reporting groups
Age, Continuous
65.8 Years
STANDARD_DEVIATION 11.23 • n=5 Participants
65.9 Years
STANDARD_DEVIATION 11.37 • n=7 Participants
65.9 Years
STANDARD_DEVIATION 11.30 • n=5 Participants
Age, Customized
<65 years
3021 Participants
n=5 Participants
3007 Participants
n=7 Participants
6028 Participants
n=5 Participants
Age, Customized
Between 65 and 75 years
2064 Participants
n=5 Participants
2112 Participants
n=7 Participants
4176 Participants
n=5 Participants
Age, Customized
>75 years
1504 Participants
n=5 Participants
1491 Participants
n=7 Participants
2995 Participants
n=5 Participants
Sex: Female, Male
Female
2759 Participants
n=5 Participants
2724 Participants
n=7 Participants
5483 Participants
n=5 Participants
Sex: Female, Male
Male
3830 Participants
n=5 Participants
3886 Participants
n=7 Participants
7716 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
566 Participants
n=5 Participants
558 Participants
n=7 Participants
1124 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6023 Participants
n=5 Participants
6050 Participants
n=7 Participants
12073 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
69 Participants
n=5 Participants
74 Participants
n=7 Participants
143 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
1957 Participants
n=5 Participants
1949 Participants
n=7 Participants
3906 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
119 Participants
n=5 Participants
120 Participants
n=7 Participants
239 Participants
n=5 Participants
Race/Ethnicity, Customized
White
4374 Participants
n=5 Participants
4410 Participants
n=7 Participants
8784 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
66 Participants
n=5 Participants
56 Participants
n=7 Participants
122 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With Composite of Stroke/MI/Death
442 Participants
497 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With Ischaemic Stroke
385 Participants
441 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Net Clinical Outcome
457 Participants
508 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
423 Participants
475 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With All-Cause Death
68 Participants
58 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With CV Death
41 Participants
35 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With MI
25 Participants
21 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set which included all randomized patients.

Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS. Modified Rankin Score: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Disability defined as mRS \> 1. Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables.

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants by Severity of Stroke and Overall Disability
1107 Participants
1194 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With Stroke
390 Participants
450 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With Fatal Stroke
18 Participants
17 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the full analysis set, which included all randomized patients.

Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6589 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6610 Participants
ASA 100 mg once daily (OD)
Number of Participants With Disabling Stroke
277 Participants
307 Participants

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: NIHSS in patients with an index stroke event

Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale): 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke.

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=4798 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=4869 Participants
ASA 100 mg once daily (OD)
Change in NIHSS
<=-5
132 Participants
127 Participants
Change in NIHSS
-4
403 Participants
438 Participants
Change in NIHSS
-3
779 Participants
810 Participants
Change in NIHSS
-2
1088 Participants
1073 Participants
Change in NIHSS
-1
1099 Participants
1131 Participants
Change in NIHSS
0
681 Participants
683 Participants
Change in NIHSS
1
67 Participants
79 Participants
Change in NIHSS
2
28 Participants
31 Participants
Change in NIHSS
3
18 Participants
16 Participants
Change in NIHSS
4
13 Participants
11 Participants
Change in NIHSS
5
6 Participants
6 Participants
Change in NIHSS
>5
10 Participants
14 Participants
Change in NIHSS
Missing
474 Participants
450 Participants

SECONDARY outcome

Timeframe: Visit 1 (Enrolment)

Population: Include only results from patients who visit the site in-person.

EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6497 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6512 Participants
ASA 100 mg once daily (OD)
EQ-5D at Visit 1 (Enrolment)
0.70 Index score
Standard Deviation 0.297
0.70 Index score
Standard Deviation 0.298

SECONDARY outcome

Timeframe: Visit 2 (Day 7+-2d)

Population: Include only results from patients who visit the site in-person.

EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=5883 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=5909 Participants
ASA 100 mg once daily (OD)
EQ-5D at Visit 2 (Day 7+-2d)
0.80 Index score
Standard Deviation 0.244
0.79 Index score
Standard Deviation 0.262

SECONDARY outcome

Timeframe: End of treatment visit (Day 90+-7d)

Population: Include only results from patients who visit the site in-person.

EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=5817 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=5893 Participants
ASA 100 mg once daily (OD)
EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
0.85 Index score
Standard Deviation 0.203
0.84 Index score
Standard Deviation 0.208

SECONDARY outcome

Timeframe: Premature treatment discontinuation visit(<15 days after last dose)

Population: Include only results from patients who visit the site in-person. The Premature Treatment Discontinuation visit (PTDV) is only done for patients who prematurely and permanently stop study medication.

EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=787 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=633 Participants
ASA 100 mg once daily (OD)
EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
0.72 Index score
Standard Deviation 0.330
0.68 Index score
Standard Deviation 0.364

SECONDARY outcome

Timeframe: From randomization up to 97 days

Population: The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.

Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). PLATO Major bleeding is defined as a bleed that is any one of: * Fatal * Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages \<10 mm evident only on gradient-echo MRI) * Intrapericardial bleed with cardiac tamponade * Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery * Significantly disabling (eg. intraocular with permanent vision loss) * Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L) * Transfusion of 2 or more units (whole blood or packed red blood cells \[PRBCs\]) for bleeding.

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6549 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6581 Participants
ASA 100 mg once daily (OD)
Number of Participants With PLATO Major Bleeding Event
31 Participants
38 Participants

SECONDARY outcome

Timeframe: Time from first dose and up to and including 7 days following the date of last dose of the study

Population: The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.

Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

Outcome measures

Outcome measures
Measure
Ticagrelor 90 mg
n=6549 Participants
Ticagrelor 90 mg twice daily (BD)
ASA 100 mg
n=6581 Participants
ASA 100 mg once daily (OD)
Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
82 Participants
37 Participants

Adverse Events

ASA 100mg

Serious events: 533 serious events
Other events: 85 other events
Deaths: 0 deaths

Ticagrelor 90mg

Serious events: 532 serious events
Other events: 383 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ASA 100mg
n=6581 participants at risk
ASA 100 mg once daily (OD)
Ticagrelor 90mg
n=6549 participants at risk
Ticagrelor 90 mg twice daily (BD)
Blood and lymphatic system disorders
Anaemia
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Nerve root injury
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Pelvic fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Post procedural haematoma
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Post procedural haematuria
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Procedural haemorrhage
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Pubis fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Rib fracture
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Spinal compression fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Spinal fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Subdural haematoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Tendon injury
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Toxicity to various agents
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Traumatic haematoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Traumatic haemothorax
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Wound necrosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Wrist fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Alanine aminotransferase increased
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Aspartate aminotransferase increased
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Blood creatinine increased
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Blood urea increased
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Cardiac function test abnormal
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Flavivirus test positive
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Haemoglobin decreased
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Platelet count increased
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
Transaminases increased
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Investigations
White blood cell count decreased
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Decreased appetite
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Dehydration
0.08%
5/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Diabetes mellitus
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Diabetic metabolic decompensation
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Gout
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Hypercalcaemia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Hyperglycaemia
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Hypoglycaemia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Hyponatraemia
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Hypovolaemia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Tetany
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Arthralgia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Foot deformity
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Peripheral artery aneurysm
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Peripheral artery thrombosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Myalgia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Periostitis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Spinal pain
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Musculoskeletal and connective tissue disorders
Synovial cyst
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Peripheral ischaemia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.06%
4/6549 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac neoplasm unspecified
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac valve fibroelastoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neoplasm
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Phlebitis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Subclavian artery aneurysm
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extraskeletal myxoid chondrosarcoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Subclavian artery stenosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Thrombophlebitis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Thrombophlebitis superficial
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Venous thrombosis limb
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Aphasia
0.02%
1/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Basilar artery stenosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Capsular warning syndrome
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Carotid arteriosclerosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Lumbosacral radiculopathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Carotid artery aneurysm
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Carotid artery dissection
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Carotid artery occlusion
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Carotid artery stenosis
0.41%
27/6581 • Number of events 27 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.43%
28/6549 • Number of events 28 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Carotid artery thrombosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Carotid sinus syndrome
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Cerebral amyloid angiopathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Cerebral artery occlusion
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Cerebral haemorrhage
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Cerebral infarction
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Cerebrovascular accident
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Cerebrovascular disorder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Cervicobrachial syndrome
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Clumsiness
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Dementia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Depressed level of consciousness
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Diabetic neuropathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Dizziness
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.09%
6/6549 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Dysaesthesia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Dysarthria
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Encephalopathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Epilepsy
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.06%
4/6549 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Facial paresis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Generalised tonic-clonic seizure
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Haemorrhage intracranial
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Haemorrhagic stroke
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Haemorrhagic transformation stroke
0.09%
6/6581 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Headache
0.08%
5/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Hemianopia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Hemiparesis
0.06%
4/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Hemiplegia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Hypertensive encephalopathy
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Hypoaesthesia
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Internal carotid artery kinking
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Intracranial aneurysm
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Intracranial haematoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Intracranial venous sinus thrombosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Ischaemic stroke
0.11%
7/6581 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.08%
5/6549 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Loss of consciousness
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Meningeal disorder
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Metabolic encephalopathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Migraine
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Migraine with aura
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Mononeuropathy
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Monoparesis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Multiple sclerosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Neurodegenerative disorder
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Neurological decompensation
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Neurological symptom
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Paraesthesia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Partial seizures
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Presyncope
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Reversible ischaemic neurological deficit
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Sciatica
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Seizure
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Spinal claudication
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Status epilepticus
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Stroke in evolution
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Subarachnoid haemorrhage
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Syncope
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.09%
6/6549 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Tension headache
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Toxic encephalopathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Transient ischaemic attack
1.0%
68/6581 • Number of events 74 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.84%
55/6549 • Number of events 57 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Tremor
0.02%
1/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Trigeminal nerve disorder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
VIIth nerve paralysis
0.08%
5/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Vascular encephalopathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Vasculitis cerebral
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Nervous system disorders
Vocal cord paresis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Abnormal behaviour
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Anxiety
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Anxiety disorder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Bipolar disorder
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Confusional state
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Depression
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Disorientation
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Generalised anxiety disorder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Hallucination
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Major depression
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Nervousness
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Personality disorder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Psychiatric decompensation
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Psychiatric disorders
Somatoform disorder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Acute kidney injury
0.11%
7/6581 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.09%
6/6549 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Calculus bladder
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Calculus ureteric
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Cystitis noninfective
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Haematuria
0.08%
5/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Hydronephrosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Malacoplakia vesicae
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Nephritis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Nephrolithiasis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Pelvi-ureteric obstruction
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Renal cyst haemorrhage
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Renal failure
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Renal impairment
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Tubulointerstitial nephritis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Renal and urinary disorders
Urinary retention
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Reproductive system and breast disorders
Menorrhagia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Reproductive system and breast disorders
Metrorrhagia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Reproductive system and breast disorders
Prostatitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Asthma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.08%
5/6581 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.17%
11/6549 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Platypnoea
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.15%
10/6581 • Number of events 10 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.06%
4/6549 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Angioedema
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Ecchymosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Swelling face
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Skin and subcutaneous tissue disorders
Urticaria
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Accelerated hypertension
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Aortic aneurysm
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Aortic aneurysm rupture
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Aortic dissection
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Blood pressure fluctuation
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Blood pressure inadequately controlled
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Circulatory collapse
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Deep vein thrombosis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Haemorrhagic infarction
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Hypertension
0.17%
11/6581 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.18%
12/6549 • Number of events 13 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Hypertensive crisis
0.11%
7/6581 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.11%
7/6549 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Hypertensive emergency
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Blood and lymphatic system disorders
Antiphospholipid syndrome
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Blood and lymphatic system disorders
Hypochromic anaemia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Blood and lymphatic system disorders
Lymphadenopathy
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Blood and lymphatic system disorders
Thrombocytosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Acute left ventricular failure
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Angina pectoris
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Angina unstable
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.17%
11/6549 • Number of events 11 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Aortic valve stenosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Arteriosclerosis coronary artery
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Atrial fibrillation
0.32%
21/6581 • Number of events 21 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.37%
24/6549 • Number of events 25 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Atrial flutter
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Atrial thrombosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Atrioventricular block complete
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Atrioventricular block second degree
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.09%
6/6549 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Bradyarrhythmia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Bradycardia
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Cardiac failure
0.11%
7/6581 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.11%
7/6549 • Number of events 7 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Cardiac failure acute
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Cardiac failure congestive
0.03%
2/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Cardiac ventricular thrombosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Cardio-respiratory arrest
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Cardiopulmonary failure
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Congestive cardiomyopathy
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Coronary artery disease
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Coronary artery stenosis
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.06%
4/6549 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Hypertensive heart disease
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Intracardiac mass
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Intracardiac thrombus
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Ischaemic cardiomyopathy
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Left ventricular failure
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Mitral valve disease
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Myocardial ischaemia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.06%
4/6549 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Pericardial effusion
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Pericarditis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Right ventricular failure
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Sinus arrest
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Sinus node dysfunction
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Supraventricular tachycardia
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Tachycardia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Ventricular asystole
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Cardiac disorders
Ventricular tachycardia
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Congenital, familial and genetic disorders
Atrial septal defect
0.09%
6/6581 • Number of events 6 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Ear and labyrinth disorders
Deafness permanent
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Ear and labyrinth disorders
Vertigo
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Ear and labyrinth disorders
Vertigo positional
0.06%
4/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Hypotension
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Conjunctival haemorrhage
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Diabetic retinopathy
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Intraocular haematoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Optic neuropathy
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Retinal haemorrhage
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Vision blurred
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Visual acuity reduced
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Vitreous detachment
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Eye disorders
Vitreous haemorrhage
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Abdominal pain
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Chronic gastritis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Diarrhoea
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Diverticulum intestinal
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Duodenal ulcer haemorrhage
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Dyspepsia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Dysphagia
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Enteritis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Enterocolitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastric haemorrhage
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastric ulcer
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastric ulcer haemorrhage
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastric ulcer perforation
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastritis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastritis erosive
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastritis haemorrhagic
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.08%
5/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Ischaemia
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Haemorrhagic erosive gastritis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Haemorrhoids
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Ileus
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Incarcerated inguinal hernia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Inguinal hernia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Intestinal haemorrhage
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Intestinal obstruction
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Vascular disorders
Leriche syndrome
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Intestinal perforation
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Mallory-Weiss syndrome
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Nausea
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Oesophagitis haemorrhagic
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Pancreatitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Pancreatitis acute
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Rectal haemorrhage
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Small intestinal obstruction
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.05%
3/6581 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Gastrointestinal disorders
Vomiting
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Asthenia
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Chest pain
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Fatigue
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Generalised oedema
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Malaise
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Multi-organ failure
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Non-cardiac chest pain
0.11%
7/6581 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.08%
5/6549 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
General disorders
Pyrexia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Bile duct stone
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Cholecystitis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Cholecystitis acute
0.08%
5/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Cholecystitis chronic
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Cholelithiasis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Drug-induced liver injury
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Hepatocellular injury
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Hepatotoxicity
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Hepatobiliary disorders
Jaundice
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Immune system disorders
Anaphylactic shock
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Abscess limb
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Acute endocarditis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Acute hepatitis C
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Acute sinusitis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Appendiceal abscess
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Biliary sepsis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Biliary tract infection
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Bronchitis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Cellulitis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Clostridial infection
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Device related infection
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Diabetic gangrene
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Diverticulitis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Encephalitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Endocarditis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Endophthalmitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Epididymitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Erysipelas
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Gangrene
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Gastroenteritis
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Gastroenteritis viral
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Gastrointestinal infection
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Hepatitis B
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Herpes zoster
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Influenza
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Kidney infection
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Lung infection
0.08%
5/6581 • Number of events 5 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Lyme disease
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Meningoencephalitis herpetic
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Neuroborreliosis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Osteomyelitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Otosalpingitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Pneumonia
0.35%
23/6581 • Number of events 25 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.29%
19/6549 • Number of events 19 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Pneumonia influenzal
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Postoperative wound infection
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Pseudomembranous colitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Pulmonary tuberculosis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Pyelonephritis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Pyelonephritis acute
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Respiratory tract infection
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Sepsis
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.06%
4/6549 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Septic shock
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Sinusitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.03%
2/6549 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Staphylococcal bacteraemia
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Subdural empyema
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Upper respiratory tract infection
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Urinary tract infection
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.12%
8/6549 • Number of events 8 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Urosepsis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.06%
4/6549 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Vestibular neuronitis
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Infections and infestations
Wound infection
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Ankle fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Back injury
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Clavicle fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Compression fracture
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Craniocerebral injury
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Extradural haematoma
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Facial bones fracture
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Fall
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Femoral neck fracture
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Femur fracture
0.06%
4/6581 • Number of events 4 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Forearm fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Head injury
0.00%
0/6581 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.02%
1/6549 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Hip fracture
0.03%
2/6581 • Number of events 2 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Intentional overdose
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Joint dislocation
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Ligament sprain
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.00%
0/6549 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
Injury, poisoning and procedural complications
Lower limb fracture
0.02%
1/6581 • Number of events 1 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
0.05%
3/6549 • Number of events 3 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.

Other adverse events

Other adverse events
Measure
ASA 100mg
n=6581 participants at risk
ASA 100 mg once daily (OD)
Ticagrelor 90mg
n=6549 participants at risk
Ticagrelor 90 mg twice daily (BD)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.3%
85/6581 • Number of events 86 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.
5.8%
383/6549 • Number of events 425 • On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.
The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available. These patients totaled 6549 for ticagrelor and 6581 for ASA.

Additional Information

Brilinta Global Clinical Lead

AstraZeneca R&D

Phone: +46 31 776 10 00

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place