JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Pr... | NCT00311402

Status Module

Label	Type	Description	Intervention Names
Aggrenox Capsule	Other		Drug: Aggrenox capsule
Acetylsalicylic Acid (ASA) 81 mg Tablet	Other		Other: Acetylsalicylic Acid (ASA)

Name	Type	Description	Arm Group Labels	Other Names
Aggrenox capsule	Drug	extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule, 2 capsules twice daily	Aggrenox Capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)	All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.	Up to 124 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients With Brain (Cerebral) Haemorrhage	All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.	Up to 124 weeks
Number of Patients With Subarachnoid Haemorrhage

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III.

Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions)
Patients who are 50 years or older
Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator
Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI)
Patients who have at least two of the following risk factors:
- diabetes
- hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension
- smoker (at the time of onset of cerebral infarction)
- obesity (Body mass index (BMI) is more than 25 kg/m2)
- previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction)
- end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria)
- hyperlipidaemia

Exclusion Criteria:

Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours
Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism
Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study
Patient with hypersensitivity to dipyridamole preparations
Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma
Patients with a history of peptic ulcer
Patients having undergone arterial reconstruction after development of cerebral infarction
Patients with very severe impairment (4 or 5 on Modified Rankin Scale)
Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.)
Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher)
Patients with complications such as serious cardiac, renal and hepatic disorders
Patients with a malignant tumour or having had a tumour treatment in the past 5 years
Women who are or may be pregnant or lactating women

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
9.178.060 Boehringer Ingelheim Investigational Site		Adachi-ku, Tokyo			Japan
9.178.017 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
21502757	Derived	Uchiyama S, Ikeda Y, Urano Y, Horie Y, Yamaguchi T. The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. Cerebrovasc Dis. 2011;31(6):601-13. doi: 10.1159/000327035. Epub 2011 Apr 19.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
FG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)

All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000652 OG001639

Title

Denominators

Categories

Title	Measurements
	OG00045 OG00132

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	Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.	Regression, Cox		0.097		Cox Proportional Hazard	1.47				95	0.93	2.31				Yes	Non-Inferiority or Equivalence	The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.

Secondary

Number of Patients With Brain (Cerebral) Haemorrhage

All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With Subarachnoid Haemorrhage

All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With Transient Ischemic Attack (TIA)

All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With Acute Coronary Syndrome (ACS)

ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With Other Vascular Events

This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Secondary

Number of Patients With Ischemic Vascular Event Composite Endpoint

This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants

Post-Hoc

Number of Patients With Stroke

This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Post-Hoc

Number of Patients With Intracranial Haemorrhage

All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Post-Hoc

Number of Patients With Composite Endpoint of Stroke or Major Bleeding

This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.

Posted

Number

patients

Up to 124 weeks

ID	Title	Description
OG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
OG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0013 affected639 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0010 affected639 at risk
Acute tonsillitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Bronchopulmonary aspergillosis allergic	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Diverticulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Gangrene	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Pleurisy viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0004 affected655 at risk EG0014 affected639 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected655 at risk EG0014 affected639 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected655 at risk EG0010 affected639 at risk
Large intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected655 at risk EG0010 affected639 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0012 affected639 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0011 affected639 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0011 affected639 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0011 affected639 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Hyperadrenalism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected655 at risk EG0012 affected639 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0011 affected639 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0012 affected639 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0010 affected639 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Completed suicide	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Schizophrenia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Cerebral infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00046 affected655 at risk EG00132 affected639 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected655 at risk EG0012 affected639 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected655 at risk EG0011 affected639 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0013 affected639 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0013 affected639 at risk
Epilepsy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0010 affected639 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0012 affected639 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0010 affected639 at risk
Basilar migraine	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Loss of consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Mental impairment	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Nystagmus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Putamen haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Cataract	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected655 at risk EG0016 affected639 at risk
Maculopathy	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0012 affected639 at risk
Eyelid ptosis	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Retinal artery occlusion	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Retinal detachment	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Retinal vein occlusion	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0012 affected639 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0012 affected639 at risk
Auricular perichondritis	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Vertigo labyrinthine	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Angina unstable	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0016 affected639 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected655 at risk EG0014 affected639 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0011 affected639 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Right ventricular failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Aortic aneurysm	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Thrombophlebitis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected655 at risk EG0018 affected639 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0014 affected639 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected655 at risk EG0012 affected639 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0013 affected639 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0012 affected639 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Colitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Gastritis atrophic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Subileus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0012 affected639 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Renal impairment	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0012 affected639 at risk
Pelvic haemorrhage	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Sudden death	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0014 affected639 at risk
Multi-organ failure	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0012 affected639 at risk
Chest pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Implant site inflammation	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Mass	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Non-cardiac chest pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Oedema due to renal disease	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Prostatic specific antigen increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0014 affected639 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0014 affected639 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0013 affected639 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0013 affected639 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0013 affected639 at risk
Cerebral haemorrhage traumatic	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0010 affected639 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0010 affected639 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0011 affected639 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0010 affected639 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected655 at risk EG0011 affected639 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Blast injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Burns first degree	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Diffuse axonal injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Fat embolism	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0011 affected639 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected655 at risk EG0010 affected639 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected655 at risk EG0011 affected639 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG000281 affected655 at risk EG001261 affected639 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG000293 affected655 at risk EG001187 affected639 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00058 affected655 at risk EG00155 affected639 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00037 affected655 at risk EG00153 affected639 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00078 affected655 at risk EG00142 affected639 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00034 affected655 at risk EG00160 affected639 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00040 affected655 at risk EG00142 affected639 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00030 affected655 at risk EG00142 affected639 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00058 affected655 at risk EG00159 affected639 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00034 affected655 at risk EG00139 affected639 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00058 affected655 at risk EG00169 affected639 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00046 affected655 at risk EG00160 affected639 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00046 affected655 at risk EG00143 affected639 at risk

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004176	Dipyridamole
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
BG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily			178	655	634	655
EG001	Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily			167	639	604	639

ID	Term
D000068342	Aspirin, Dipyridamole Drug Combination
D001241	Aspirin