Study to Assess Safety and Efficacy of Ticagrelor (AZD614... | NCT01294462

Label	Type	Description	Intervention Names
1	Experimental	Ticagrelor (AZD6140)	Drug: Ticagrelor Drug: Acetylsalicylic acid ASA
2	Active Comparator	Clopidogrel	Drug: Clopidogrel Drug: Acetylsalicylic acid ASA

Name	Type	Description	Arm Group Labels	Other Names
Ticagrelor	Drug	90 mg, oral dose twice daily	1	AZD6140

Measure	Description	Time Frame
Major Bleeding	Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.	Ongoing up to12 months
Major Adverse Cardiac Events (MACE)	Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.	Ongoing up to 12 months

Measure	Description	Time Frame
Major and Minor Bleeding	Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.	Ongoing up to12 months
Composite of All-cause Mortality, MI or Stroke

Name	Affiliation	Role
Judith Hsia, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Ichinomiya-shi	Aichi-ken		Japan
Research Site

Label	URL
CSR-D5130C00027.pdf	View source

ID	Title	Description
FG000	Ticagrelor (AZD6140)	Ticagrelor (AZD6140) 90 mg bid
FG001	Clopidogrel	Clopidogrel 75mg od

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

Major Bleeding

Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.

Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data

Posted

Number

Percent probability

Ongoing up to12 months

ID	Title	Description
OG000	Ticagrelor (AZD6140)	Ticagrelor (AZD6140) 90mg bid
OG001	Clopidogrel	Clopidogrel 75mg od

Units	Counts
Participants	OG000387 OG001380

Title

Denominators

Categories

Title	Measurements
	OG00011.2 OG0018.4

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	No formal statistical comparison.	Regression, Cox	Analyzed based on proportional hazards model including treatment group only.		No P-value provided since the objective was not to perform formal statistical comparison.	Hazard Ratio (HR)	1.54			2-Sided	95	0.94	2.53			Ticagrelor/Placebo	No	Superiority or Other

Primary

Major Adverse Cardiac Events (MACE)

Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.

Full Analysis set which includes all randomized patients with available post-randomization efficacy data

Posted

Number

Percent probability

Ongoing up to 12 months

ID	Title	Description
OG000	Ticagrelor (AZD6140)	Ticagrelor (AZD6140) 90mg bid
OG001	Clopidogrel	Clopidogrel 75mg od

Units	Counts
Participants	OG000

Secondary

Major and Minor Bleeding

Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.

Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data

Posted

Number

Percent probability

Ongoing up to12 months

ID	Title	Description
OG000	Ticagrelor (AZD6140)	Ticagrelor (AZD6140) 90mg bid
OG001	Clopidogrel	Clopidogrel 75mg od

Units	Counts
Participants	OG000

Secondary

Composite of All-cause Mortality, MI or Stroke

Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.

Full Analysis set which includes all randomized patients with available post-randomization efficacy data

Posted

Number

Percent probability

Ongoing up to 12 months

ID	Title	Description
OG000	Ticagrelor (AZD6140)	Ticagrelor (AZD6140) 90mg bid
OG001	Clopidogrel	Clopidogrel 75mg od

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery stenosis	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG00036 affected387 at risk EG00147 affected380 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 affected387 at risk EG0019 affected380 at risk
Angina unstable	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 affected387 at risk EG0015 affected380 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected387 at risk EG0013 affected380 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 affected387 at risk EG0012 affected380 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 affected387 at risk EG0011 affected380 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0013 affected380 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0012 affected380 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Pericardial effusion	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
supraventricular tachycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Postinfarction angina	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0012 affected380 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Myocarditis	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Pericarditis	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Sinus arrest	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
coronary artery perforation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG00011 affected387 at risk EG00110 affected380 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0006 affected387 at risk EG0018 affected380 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 affected387 at risk EG0011 affected380 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 affected387 at risk EG0011 affected380 at risk
patella fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Fat embolism	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Cerebral infarction	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 affected387 at risk EG0012 affected380 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Loss of consciousness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Embolic stroke	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Parkinson's disease	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Brain stem stroke	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0012 affected380 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0012 affected380 at risk
Herpes Zoster	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0012 affected380 at risk
Pyelonephritis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Bacteraemia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Groin abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Appendicitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Hepatitis C	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Otitis media acute	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Cellulitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Thrombosis in device	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected387 at risk EG0014 affected380 at risk
Device occlusion	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Chest pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0014 affected380 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0012 affected380 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0012 affected380 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Loose tooth	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Radicular cyst	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0012 affected380 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0012 affected380 at risk
Gout	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Lumber spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Aortic dissection	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Thrombosis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Aortic stenosis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0011 affected380 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Anomalous arrangement of pancreaticobiliary duct	Congenital, familial and genetic disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Cataract	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected387 at risk EG0011 affected380 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected387 at risk EG0010 affected380 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00059 affected387 at risk EG00155 affected380 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00026 affected387 at risk EG00123 affected380 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00021 affected387 at risk EG00127 affected380 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00021 affected387 at risk EG00126 affected380 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 affected387 at risk EG0019 affected380 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 affected387 at risk EG0013 affected380 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 affected387 at risk EG0018 affected380 at risk
Myocardial infarcion	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG00035 affected387 at risk EG00123 affected380 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG00016 affected387 at risk EG00122 affected380 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG00014 affected387 at risk EG00117 affected380 at risk
Bradycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG00011 affected387 at risk EG0018 affected380 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 affected387 at risk EG0018 affected380 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 affected387 at risk EG0018 affected380 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 affected387 at risk EG0016 affected380 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 affected387 at risk EG00110 affected380 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG00055 affected387 at risk EG00159 affected380 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG00010 affected387 at risk EG0015 affected380 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0008 affected387 at risk EG0013 affected380 at risk
Pyrexia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG00056 affected387 at risk EG00151 affected380 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 affected387 at risk EG0011 affected380 at risk
Oedema peripheral	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 affected387 at risk EG00112 affected380 at risk
Puncture site pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 affected387 at risk EG0017 affected380 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00044 affected387 at risk EG00146 affected380 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00015 affected387 at risk EG00110 affected380 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00011 affected387 at risk EG0016 affected380 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 affected387 at risk EG00111 affected380 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 affected387 at risk EG00110 affected380 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00016 affected387 at risk EG0019 affected380 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00013 affected387 at risk EG00120 affected380 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 affected387 at risk EG0018 affected380 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 affected387 at risk EG0015 affected380 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 affected387 at risk EG0018 affected380 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 affected387 at risk EG00111 affected380 at risk
Insomnia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00058 affected387 at risk EG00149 affected380 at risk
Restlessness	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00014 affected387 at risk EG0013 affected380 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00033 affected387 at risk EG00157 affected380 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00022 affected387 at risk EG00118 affected380 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 affected387 at risk EG00112 affected380 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG00013 affected387 at risk EG00112 affected380 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG00010 affected387 at risk EG0018 affected380 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0007 affected387 at risk EG0011 affected380 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0006 affected387 at risk EG0019 affected380 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00023 affected387 at risk EG00122 affected380 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00022 affected387 at risk EG0019 affected380 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 affected387 at risk EG0014 affected380 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 affected387 at risk EG0018 affected380 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG00023 affected387 at risk EG00127 affected380 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 affected387 at risk EG0016 affected380 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG00012 affected387 at risk EG0016 affected380 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 affected387 at risk EG0015 affected380 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 affected387 at risk EG0019 affected380 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 affected387 at risk EG0019 affected380 at risk

ID	Term
D054058	Acute Coronary Syndrome
D003327	Coronary Disease
D003324	Coronary Artery Disease

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

ID	Term
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

ID	Title	Description
BG000	Ticagrelor (AZD6140)	Ticagrelor (AZD6140) 90 mg bid
BG001	Clopidogrel	Clopidogrel 75mg od
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	Ticagrelor (AZD6140)	Ticagrelor (AZD6140) 90mg bid			92	387	327	387
EG001	Clopidogrel	Clopidogrel 75mg od			112	380	337	380