Trial Outcomes & Findings for Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (NCT NCT01088503)

NCT ID: NCT01088503

Last Updated: 2016-01-29

Results Overview

MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) \* 100.

• Recruitment status: COMPLETED
• Target enrollment: 12227 participants
• Primary outcome timeframe: Baseline through 12 months
• Results posted on: 2016-01-29

Participant Flow

Centralized follow-up visits were conducted for all participants. Participants who completed 15-month active follow-up were considered to have completed the study.

Participant milestones

Measure	Prasugrel Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Ticlopidine/Ticagrelor Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Study STARTED	3123	8846	258
Overall Study COMPLETED	2941	8161	241
Overall Study NOT COMPLETED	182	685	17

Reasons for withdrawal

Measure	Prasugrel Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Ticlopidine/Ticagrelor Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
Overall Study Withdrawal by Subject	118	327	10
Overall Study Death	64	358	7

Baseline Characteristics

Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome

Baseline characteristics by cohort

Measure	Prasugrel n=3123 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8846 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Ticlopidine/Ticagrelor n=258 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.	Total n=12227 Participants Total of all reporting groups
Age, Customized ≥75 years	88 participants n=5 Participants	1341 participants n=7 Participants	33 participants n=5 Participants	1462 participants n=4 Participants
Age, Customized <75 years	3035 participants n=5 Participants	7505 participants n=7 Participants	225 participants n=5 Participants	10765 participants n=4 Participants
Sex: Female, Male Female	672 Participants n=5 Participants	2671 Participants n=7 Participants	91 Participants n=5 Participants	3434 Participants n=4 Participants
Sex: Female, Male Male	2451 Participants n=5 Participants	6175 Participants n=7 Participants	167 Participants n=5 Participants	8793 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	129 Participants n=5 Participants	271 Participants n=7 Participants	13 Participants n=5 Participants	413 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2986 Participants n=5 Participants	8525 Participants n=7 Participants	244 Participants n=5 Participants	11755 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	50 Participants n=7 Participants	1 Participants n=5 Participants	59 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	35 Participants n=5 Participants	39 Participants n=7 Participants	0 Participants n=5 Participants	74 Participants n=4 Participants
Race (NIH/OMB) Asian	55 Participants n=5 Participants	94 Participants n=7 Participants	1 Participants n=5 Participants	150 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	12 Participants n=5 Participants	13 Participants n=7 Participants	0 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) Black or African American	237 Participants n=5 Participants	820 Participants n=7 Participants	30 Participants n=5 Participants	1087 Participants n=4 Participants
Race (NIH/OMB) White	2750 Participants n=5 Participants	7778 Participants n=7 Participants	225 Participants n=5 Participants	10753 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	34 Participants n=5 Participants	102 Participants n=7 Participants	2 Participants n=5 Participants	138 Participants n=4 Participants
Region of Enrollment United States	3123 participants n=5 Participants	8846 participants n=7 Participants	258 participants n=5 Participants	12227 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline through 12 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.

MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) * 100.

Outcome measures

Measure	Prasugrel n=3123 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8838 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)	13.14 percentage of participants Interval 11.79 to 14.48	17.12 percentage of participants Interval 16.25 to 17.98

PRIMARY outcome

Timeframe: Day 0 (study enrollment)

Population: All enrolled participants

Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. <1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.

Outcome measures

Measure	Prasugrel n=3123 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=9104 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment Received DES	2365 participants	6282 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment Received only BMS	672 participants	2491 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment STEMI	1831 participants	4508 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment Other Race (Non-Caucasian)	365 participants	1049 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment Male Participants	2451 participants	6342 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment EQ-5D US index = 1 vs. <1	1516 participants	3873 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment Married Participants	2044 participants	5601 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment Participant has Diabetes	767 participants	2472 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment No BMS or DES	86 participants	331 participants
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment Cardiogenic Shock on Presentation	79 participants	176 participants

PRIMARY outcome

Timeframe: Day 0 (study enrollment)

Population: All enrolled participants who had pre-procedure hemoglobin evaluation.

Outcome measures

Measure	Prasugrel n=2806 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8246 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin	14.59 grams/deciliter (g/dL) Standard Deviation 1.702	14 grams/deciliter (g/dL) Standard Deviation 1.909

PRIMARY outcome

Timeframe: Day 0 (study enrollment)

Population: All enrolled participants who had Duke CAD Index completed.

The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.

Outcome measures

Measure	Prasugrel n=3101 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8923 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index	40.36 units on a scale Standard Deviation 14.43	41.87 units on a scale Standard Deviation 16.01

SECONDARY outcome

Timeframe: Baseline, 1, 6, 12 and 15 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment.

Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) * 100.

Outcome measures

Measure	Prasugrel n=3123 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8833 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Percentage of Participants With Cumulative Severe or Moderate Bleeding Events Baseline	0.54 percentage of participants Interval 0.34 to 0.87	0.45 percentage of participants Interval 0.33 to 0.62
Percentage of Participants With Cumulative Severe or Moderate Bleeding Events 6 months	1.93 percentage of participants Interval 1.5 to 2.48	2.77 percentage of participants Interval 2.45 to 3.13
Percentage of Participants With Cumulative Severe or Moderate Bleeding Events 12 months	2.72 percentage of participants Interval 2.2 to 3.36	3.86 percentage of participants Interval 3.48 to 4.29
Percentage of Participants With Cumulative Severe or Moderate Bleeding Events 1 month	1.22 percentage of participants Interval 0.89 to 1.67	1.62 percentage of participants Interval 1.38 to 1.91
Percentage of Participants With Cumulative Severe or Moderate Bleeding Events 15 months	3.10 percentage of participants Interval 2.55 to 3.79	4.21 percentage of participants Interval 3.81 to 4.66

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.

MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) * 100.

Outcome measures

Measure	Prasugrel n=3123 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8838 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years	12.67 percentage of participants Interval 11.3 to 14.03	15.89 percentage of participants Interval 14.92 to 16.85

SECONDARY outcome

Timeframe: Baseline through 1, 6 and 15 months

Population: Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.

MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.

Outcome measures

Measure	Prasugrel n=3123 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8838 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Percentage of Participants With MACE Over 1, 6 and 15 Months 1 month	4.63 percentage of participants Interval 3.87 to 5.39	5.40 percentage of participants Interval 4.88 to 5.85
Percentage of Participants With MACE Over 1, 6 and 15 Months 6 months	9.64 percentage of participants Interval 8.5 to 10.77	12.04 percentage of participants Interval 11.31 to 12.77
Percentage of Participants With MACE Over 1, 6 and 15 Months 15 months	14.26 percentage of participants Interval 12.82 to 15.7	19.13 percentage of participants Interval 18.2 to 20.07

SECONDARY outcome

Timeframe: Baseline through 15 months

Population: Participants who were treated with prasugrel or clopidogrel.

Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.

Outcome measures

Measure	Prasugrel n=3123 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.	Clopidogrel n=8846 Participants Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events	1.35 percentage of participants Interval 0.85 to 1.85	1.79 percentage of participants Interval 1.49 to 2.1

SECONDARY outcome

Timeframe: 15 months

Population: Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted.

Outcome measures

Outcome data not reported

Adverse Events

Prasugrel

Serious events: 865 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prasugrel n=3123 participants at risk Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Blood and lymphatic system disorders Anaemia	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Acute coronary syndrome	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Acute myocardial infarction	0.83% 26/3123 • Number of events 26 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Angina pectoris	0.74% 23/3123 • Number of events 23 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Angina unstable	0.77% 24/3123 • Number of events 25 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Arrhythmia	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Arteriosclerosis coronary artery	0.80% 25/3123 • Number of events 25 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Atrial fibrillation	0.29% 9/3123 • Number of events 11 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Atrial flutter	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Atrioventricular block complete	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiac arrest	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiac disorder	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiac failure	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiac failure acute	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiac failure congestive	0.61% 19/3123 • Number of events 22 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiac flutter	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiomegaly	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Cardiovascular disorder	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Coronary artery disease	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Coronary artery occlusion	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Dressler's syndrome	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Hypertensive heart disease	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Mitral valve incompetence	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Myocardial infarction	3.5% 109/3123 • Number of events 136 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Myocardial ischaemia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Palpitations	0.22% 7/3123 • Number of events 8 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Pericardial effusion	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Pericarditis	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Supraventricular tachycardia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Tachycardia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Ventricular fibrillation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Cardiac disorders Ventricular tachycardia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Ear and labyrinth disorders Ear pain	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Ear and labyrinth disorders Vertigo positional	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Eye disorders Amaurosis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Eye disorders Blindness	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Eye disorders Vitreous floaters	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Abdominal discomfort	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Abdominal distension	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Abdominal pain	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Abdominal pain upper	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Colitis	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Constipation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Crohn's disease	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Diarrhoea	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Diverticulum	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Dyspepsia	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Epigastric discomfort	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Faeces discoloured	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Food poisoning	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastric disorder	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastric haemorrhage	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastric ulcer	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastritis	0.10% 3/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastritis erosive	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastroduodenitis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastrointestinal disorder	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.26% 8/3123 • Number of events 9 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastrointestinal inflammation	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.10% 3/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Haematemesis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Haematochezia	0.10% 3/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Impaired gastric emptying	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Intestinal obstruction	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Large intestinal haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Large intestine polyp	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Mallory-weiss syndrome	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Melaena	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Nausea	0.26% 8/3123 • Number of events 8 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Oesophageal haemorrhage	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Oesophageal rupture	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Oesophageal spasm	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Pancreatitis	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Pancreatitis acute	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Rectal haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Small intestinal haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Gastrointestinal disorders Vomiting	0.32% 10/3123 • Number of events 10 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Adverse drug reaction	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Arterial restenosis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Asthenia	0.10% 3/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Chest discomfort	0.38% 12/3123 • Number of events 12 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Chest pain	7.9% 247/3123 • Number of events 309 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Coronary artery restenosis	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Death	1.6% 50/3123 • Number of events 53 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Device damage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Device dislocation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Device failure	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Device issue	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Device malfunction	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Device occlusion	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Effusion	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Fatigue	0.16% 5/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Feeling abnormal	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Gait disturbance	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Hyperthermia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Inflammation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Malaise	0.10% 3/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Non-cardiac chest pain	0.22% 7/3123 • Number of events 8 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Oedema	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Pain	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Peripheral swelling	0.10% 3/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Pyrexia	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Stent malfunction	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Swelling	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Systemic inflammatory response syndrome	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Thrombosis in device	0.29% 9/3123 • Number of events 9 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Ulcer haemorrhage	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Unevaluable event	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
General disorders Vessel puncture site haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Hepatobiliary disorders Cholelithiasis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Hepatobiliary disorders Gallbladder disorder	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Hepatobiliary disorders Gallbladder pain	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Immune system disorders Drug hypersensitivity	0.26% 8/3123 • Number of events 8 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Abscess	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Abscess limb	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Appendicitis perforated	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Bacterial infection	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Bronchitis	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Cellulitis	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Clostridium difficile colitis	0.03% 1/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Clostridium difficile infection	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Cystitis	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Device related infection	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Diverticulitis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Ear infection	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Escherichia infection	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Gastroenteritis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Gastrointestinal infection	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Groin infection	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Herpes zoster	0.03% 1/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Infection	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Influenza	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Kidney infection	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Localised infection	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Meningitis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Orchitis	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Pneumonia	0.67% 21/3123 • Number of events 22 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Sepsis	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Septic shock	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Sinusitis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Staphylococcal infection	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Urinary tract infection	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Infections and infestations Viral infection	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Abdominal injury	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Ankle fracture	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Chest injury	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Contrast media reaction	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Fall	0.32% 10/3123 • Number of events 10 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Femur fracture	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Fractured coccyx	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Gastrointestinal injury	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Head injury	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Humerus fracture	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Incision site haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Injury	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Intentional overdose	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Joint injury	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Limb injury	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Limb traumatic amputation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Muscle strain	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Overdose	0.06% 2/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Post procedural complication	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Post procedural haematoma	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Procedural complication	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Rib fracture	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Road traffic accident	0.16% 5/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Spinal fracture	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Thermal burn	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Traumatic haematoma	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.13% 4/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Angiogram	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Aspiration pleural cavity	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Barium enema	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Biopsy lung	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood glucose abnormal	0.06% 2/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood glucose decreased	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood glucose fluctuation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood glucose increased	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood potassium decreased	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood potassium increased	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood pressure decreased	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood pressure increased	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood triglycerides increased	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Blood urine present	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Cardiac stress test	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Catheterisation cardiac	2.6% 81/3123 • Number of events 87 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Colonoscopy	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Computerised tomogram	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Electrocardiogram	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Electrocardiogram abnormal	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Endoscopy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Enzyme level increased	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Haemoglobin decreased	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Haemoglobin increased	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Heart rate abnormal	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Heart rate decreased	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Heart rate increased	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Heart rate irregular	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Imaging procedure	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations International normalised ratio increased	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Investigations Oesophagogastroduodenoscopy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Metabolism and nutrition disorders Dehydration	0.29% 9/3123 • Number of events 9 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Metabolism and nutrition disorders Diabetes mellitus	0.13% 4/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Metabolism and nutrition disorders Diabetic complication	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.03% 1/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Metabolism and nutrition disorders Electrolyte imbalance	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Metabolism and nutrition disorders Fluid retention	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Metabolism and nutrition disorders Gout	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Arthropathy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Back disorder	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Back pain	0.16% 5/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Bursitis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Joint swelling	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Limb discomfort	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Muscle spasms	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Neck pain	0.03% 1/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Pain in extremity	0.29% 9/3123 • Number of events 10 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Musculoskeletal and connective tissue disorders Pain in jaw	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Brain injury	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Cerebral haemorrhage	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Cerebrovascular accident	0.54% 17/3123 • Number of events 22 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Coma	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Convulsion	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Dementia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Diabetic coma	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Dizziness	0.64% 20/3123 • Number of events 21 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Dyskinesia	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Embolic cerebral infarction	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Epilepsy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Haemorrhagic stroke	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Haemorrhagic transformation stroke	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Headache	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Hypoaesthesia	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Intracranial aneurysm	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Loss of consciousness	0.26% 8/3123 • Number of events 8 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Migraine	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Paraesthesia	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Syncope	0.38% 12/3123 • Number of events 12 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Thrombotic stroke	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Transient ischaemic attack	0.16% 5/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Nervous system disorders Unresponsive to stimuli	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Alcohol withdrawal syndrome	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Anxiety	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Confusional state	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Depression	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Fear	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Insomnia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Major depression	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Mental disorder	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Neurosis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Panic attack	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Suicidal ideation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Psychiatric disorders Suicide attempt	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Renal and urinary disorders Calculus urinary	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Renal and urinary disorders Haematuria	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Renal and urinary disorders Nephrolithiasis	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Renal and urinary disorders Renal failure	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Renal and urinary disorders Renal failure acute	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Renal and urinary disorders Renal failure chronic	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Reproductive system and breast disorders Menorrhagia	0.15% 1/672 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Reproductive system and breast disorders Ovarian cyst ruptured	0.15% 1/672 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Reproductive system and breast disorders Prostatic haemorrhage	0.04% 1/2451 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Reproductive system and breast disorders Testicular swelling	0.04% 1/2451 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Reproductive system and breast disorders Vaginal haemorrhage	0.30% 2/672 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Asthma	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Cough	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 38/3123 • Number of events 59 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.16% 5/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.16% 5/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Respiratory, thoracic and mediastinal disorders Wheezing	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Skin and subcutaneous tissue disorders Erythema	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.16% 5/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Skin and subcutaneous tissue disorders Pruritus	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Skin and subcutaneous tissue disorders Rash	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Skin and subcutaneous tissue disorders Urticaria	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Angioplasty	0.16% 5/3123 • Number of events 5 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Antibiotic therapy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Appendicectomy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Bladder irrigation	0.03% 1/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Cardiac ablation	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Cardiac operation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Cardiac pacemaker insertion	0.10% 3/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Cholecystostomy	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Coronary arterial stent insertion	1.0% 32/3123 • Number of events 32 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Coronary artery bypass	0.29% 9/3123 • Number of events 9 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Coronary revascularisation	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Dialysis	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Emergency care	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Exploratory operation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Hernia repair	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Hospitalisation	0.29% 9/3123 • Number of events 9 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Implantable defibrillator insertion	0.13% 4/3123 • Number of events 4 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Medical device removal	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Percutaneous coronary intervention	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Stent placement	0.77% 24/3123 • Number of events 24 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Surgery	0.06% 2/3123 • Number of events 3 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Therapy change	0.03% 1/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Transfusion	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Surgical and medical procedures Vascular cauterisation	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Arterial haemorrhage	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Arterial occlusive disease	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Arteriosclerosis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Haematoma	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Haemorrhage	1.2% 39/3123 • Number of events 39 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Hypertension	0.32% 10/3123 • Number of events 11 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Hypotension	0.19% 6/3123 • Number of events 6 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Neurogenic shock	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Orthostatic hypotension	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Peripheral artery aneurysm	0.06% 2/3123 • Number of events 2 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Shock	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Thrombosis	0.22% 7/3123 • Number of events 7 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Vasculitis	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.
Vascular disorders Venous occlusion	0.03% 1/3123 • Number of events 1 Per protocol, this study only required the collection and further evaluation of non-endpoint serious adverse events (SAEs) in prasugrel-treated participants. SAE collection began after the participant signed informed consent until 7 days after last dose of prasugrel.

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

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

Restriction type: GT60