Treatment With Adenosine Diphosphate (ADP) Receptor Inhib... | NCT01088503

ID	Type	Description	Link
H7T-US-B007	Other Identifier	Eli Lilly and Company

Name	Class
Daiichi Sankyo	INDUSTRY

Label	Type	Description	Intervention Names
ADP receptor inhibitor treatment		Participants admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) and treated with an ADP receptor inhibitor during the index hospitalization.	Drug: ADP receptor inhibitors

Name	Type	Description	Arm Group Labels	Other Names
ADP receptor inhibitors	Drug	Dosage regimen as determined by the treating physician.	ADP receptor inhibitor treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)	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.	Baseline through 12 months
Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment	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.	Day 0 (study enrollment)
Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin		Day 0 (study enrollment)
Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index	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.	Day 0 (study enrollment)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Cumulative Severe or Moderate Bleeding Events	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.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Birmingham	Alabama	35233

PubMed Identifier	Type	Citation	Retractions
31070112	Derived	Rymer JA, Kaltenbach LA, Doll JA, Messenger JC, Peterson ED, Wang TY. Safety of Dual-Antiplatelet Therapy After Myocardial Infarction Among Patients With Chronic Kidney Disease. J Am Heart Assoc. 2019 May 21;8(10):e012236. doi: 10.1161/JAHA.119.012236.
29895612	Derived	Warraich HJ, Kaltenbach LA, Fonarow GC, Peterson ED, Wang TY. Adverse Change in Employment Status After Acute Myocardial Infarction: Analysis From the TRANSLATE-ACS Study. Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004528. doi: 10.1161/CIRCOUTCOMES.117.004528.

ID	Title	Description
FG000	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.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Major Adverse Cardiovascular Events (MACE)

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through 12 months

ID	Title	Description
OG000	Prasugrel	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.
OG001	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.

Units	Counts
Participants	OG0003123 OG0018838

Title

Denominators

Categories

Title	Measurements
	OG00013.14(11.79 to 14.48) OG00117.12(16.25 to 17.98)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.7108	Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.	Hazard Ratio (HR)	1.03			2-Sided	95	0.88	1.22				No	Superiority or Other

Primary

Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment

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.

All enrolled participants

Posted

Number

participants

Day 0 (study enrollment)

ID	Title	Description
OG000	Prasugrel	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.
OG001	Other	Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician

Units	Counts

Secondary

Percentage of Participants With Cumulative Severe or Moderate Bleeding Events

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.

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.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, 1, 6, 12 and 15 months

ID	Title	Description
OG000	Prasugrel	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.

Secondary

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

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through 12 months

ID	Title	Description
OG000	Prasugrel	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.
OG001	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.

Secondary

Percentage of Participants With MACE Over 1, 6 and 15 Months

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through 1, 6 and 15 months

ID	Title	Description
OG000	Prasugrel	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.
OG001	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.

Units	Counts

Secondary

Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events

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.

Participants who were treated with prasugrel or clopidogrel.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through 15 months

ID	Title	Description
OG000	Prasugrel	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.
OG001	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.

Secondary

Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness

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.

Posted

15 months

ID	Title	Description
OG000	Prasugrel	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.
OG001	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.

Units	Counts
Participants	OG000

Primary

Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin

All enrolled participants who had pre-procedure hemoglobin evaluation.

Posted

Mean

Standard Deviation

grams/deciliter (g/dL)

Day 0 (study enrollment)

ID	Title	Description
OG000	Prasugrel	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.
OG001	Other	Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician

Units	Counts
Participants	OG000

Primary

Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index

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.

All enrolled participants who had Duke CAD Index completed.

Posted

Mean

Standard Deviation

units on a scale

Day 0 (study enrollment)

ID	Title	Description
OG000	Prasugrel	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.
OG001	Other	Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00026 events26 affected3,123 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00023 events23 affected3,123 at risk
Angina unstable	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00025 events24 affected3,123 at risk
Arrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00025 events25 affected3,123 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00011 events9 affected3,123 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Cardiac disorder	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Cardiac failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00022 events19 affected3,123 at risk
Cardiac flutter	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Cardiomegaly	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG000136 events109 affected3,123 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Palpitations	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0008 events7 affected3,123 at risk
Pericardial effusion	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Pericarditis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Amaurosis	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Blindness	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Vitreous floaters	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gastritis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected3,123 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0009 events8 affected3,123 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected3,123 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected3,123 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Melaena	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0008 events8 affected3,123 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00010 events10 affected3,123 at risk
Adverse drug reaction	General disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Arterial restenosis	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected3,123 at risk
Chest discomfort	General disorders	MedDRA 17.1	Systematic Assessment	EG00012 events12 affected3,123 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG000309 events247 affected3,123 at risk
Coronary artery restenosis	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Death	General disorders	MedDRA 17.1	Systematic Assessment	EG00053 events50 affected3,123 at risk
Device damage	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Device dislocation	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Device failure	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Device issue	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Device malfunction	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Device occlusion	General disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Effusion	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected3,123 at risk
Feeling abnormal	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gait disturbance	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Hyperthermia	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Inflammation	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Malaise	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected3,123 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0008 events7 affected3,123 at risk
Oedema	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Peripheral swelling	General disorders	MedDRA 17.1	Systematic Assessment	EG0005 events3 affected3,123 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Stent malfunction	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Swelling	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Thrombosis in device	General disorders	MedDRA 17.1	Systematic Assessment	EG0009 events9 affected3,123 at risk
Ulcer haemorrhage	General disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Unevaluable event	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Vessel puncture site haemorrhage	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gallbladder pain	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 17.1	Systematic Assessment	EG0008 events8 affected3,123 at risk
Abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Abscess limb	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Appendicitis perforated	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Bacterial infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected3,123 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Cystitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Device related infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Ear infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Escherichia infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Groin infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Herpes zoster	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected3,123 at risk
Infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Influenza	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Kidney infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Localised infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Meningitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Orchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00022 events21 affected3,123 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Septic shock	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Sinusitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Staphylococcal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Viral infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG00010 events10 affected3,123 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gastrointestinal injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected3,123 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected3,123 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0005 events4 affected3,123 at risk
Angiogram	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Aspiration pleural cavity	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Barium enema	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Biopsy lung	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Blood glucose abnormal	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected3,123 at risk
Blood glucose decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Blood glucose fluctuation	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Blood glucose increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Blood potassium decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Blood potassium increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Blood pressure decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Blood pressure increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Blood triglycerides increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Blood urine present	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Cardiac stress test	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Catheterisation cardiac	Investigations	MedDRA 17.1	Systematic Assessment	EG00087 events81 affected3,123 at risk
Colonoscopy	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Computerised tomogram	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Electrocardiogram	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Electrocardiogram abnormal	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Endoscopy	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Enzyme level increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Haemoglobin decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Haemoglobin increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Heart rate abnormal	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Heart rate decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Heart rate increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Heart rate irregular	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Imaging procedure	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
International normalised ratio increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Oesophagogastroduodenoscopy	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0009 events9 affected3,123 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0005 events4 affected3,123 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected3,123 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected3,123 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected3,123 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00010 events9 affected3,123 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Brain injury	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00022 events17 affected3,123 at risk
Coma	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Convulsion	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Dementia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Diabetic coma	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00021 events20 affected3,123 at risk
Dyskinesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Epilepsy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Loss of consciousness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0008 events8 affected3,123 at risk
Migraine	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Paraesthesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00012 events12 affected3,123 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected3,123 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Anxiety	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Confusional state	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Fear	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Major depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Mental disorder	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Neurosis	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Panic attack	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Suicide attempt	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Renal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected672 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected672 at risk
Prostatic haemorrhage	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected2,451 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected2,451 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected672 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00059 events38 affected3,123 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0006 events5 affected3,123 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected3,123 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected3,123 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Angioplasty	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected3,123 at risk
Antibiotic therapy	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Appendicectomy	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Bladder irrigation	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected3,123 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Cardiac operation	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected3,123 at risk
Cholecystostomy	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG00032 events32 affected3,123 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0009 events9 affected3,123 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Dialysis	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Emergency care	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Exploratory operation	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Hernia repair	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0009 events9 affected3,123 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected3,123 at risk
Medical device removal	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Stent placement	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG00024 events24 affected3,123 at risk
Surgery	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected3,123 at risk
Therapy change	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected3,123 at risk
Transfusion	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Vascular cauterisation	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Arteriosclerosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Haematoma	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Haemorrhage	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG00039 events39 affected3,123 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG00011 events10 affected3,123 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected3,123 at risk
Neurogenic shock	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected3,123 at risk
Shock	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0007 events7 affected3,123 at risk
Vasculitis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk
Venous occlusion	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected3,123 at risk

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Title	Description
BG000	Prasugrel	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups