A Comparison of Ticagrelor (AZD6140) and Clopidogrel in P... | NCT00391872

ID	Type	Description	Link
PLATO

Label	Type	Description	Intervention Names
Clopidogrel	Active Comparator	Oral treatment	Drug: Clopidogrel
Ticagrelor	Experimental	Oral treatment	Drug: Ticagrelor

Name	Type	Description	Arm Group Labels	Other Names
Ticagrelor	Drug	Ticagrelor (AZD6140) 90 mg twice daily dose (BD)	Ticagrelor

Measure	Description	Time Frame
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke	Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 12 months
Participants With Any Major Bleeding Event	Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.	First dosing up to 12 months

Measure	Description	Time Frame
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization	Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.

Name	Affiliation	Role
Robert Harrington, MD	Duke Clinical Research Institute	Principal Investigator
Lars Wallentin, MD	Uppsala Clinical Research Centre	Principal Investigator
Jonathan C. Fox, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

PubMed Identifier	Type	Citation	Retractions
37713684	Derived	Serebruany VL, Tanguay JF, Gurvich ML, Marciniak TA, Atar D. Strokes and Transient Ischemic Attacks Occurrence During Annual Dual Antiplatelet Therapy. Am J Ther. 2023 Sep-Oct 01;30(5):e411-e415. doi: 10.1097/MJT.0000000000001622. Epub 2023 Mar 29.
36565198	Derived	Hjort M, Eggers KM, Lakic TG, Lindback J, Budaj A, Cornel JH, Giannitsis E, Katus HA, Siegbahn A, Storey RF, Becker RC, Wallentin L, Lindahl B; PLATO trial investigators*. Biomarker Concentrations and Their Temporal Changes in Patients With Myocardial Infarction and Nonobstructive Compared With Obstructive Coronary Arteries: Results From the PLATO Trial. J Am Heart Assoc. 2023 Jan 3;12(1):e027466. doi: 10.1161/JAHA.122.027466. Epub 2022 Dec 24.

ID	Title	Description
FG000	TICAGRELOR	Ticagrelor 90 mg twice daily dose (BD)
FG001	CLOPIDOGREL	Clopidogrel 75 mg once daily dose (ODD)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00035 affected9,333 at risk EG00125 affected9,291 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0018 affected9,291 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0016 affected9,291 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Microcytic Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Spontaneous Haematoma	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Haemorrhagic Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hypochromic Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Nephrogenic Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Normochromic Normocytic Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Splenic Lesion	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cardiac Failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG000122 affected9,333 at risk EG001129 affected9,291 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00070 affected9,333 at risk EG00168 affected9,291 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00060 affected9,333 at risk EG00166 affected9,291 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00048 affected9,333 at risk EG00164 affected9,291 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00051 affected9,333 at risk EG00146 affected9,291 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00038 affected9,333 at risk EG00144 affected9,291 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00029 affected9,333 at risk EG00133 affected9,291 at risk
Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00026 affected9,333 at risk EG00131 affected9,291 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00019 affected9,333 at risk EG00119 affected9,291 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00018 affected9,333 at risk EG00118 affected9,291 at risk
Cardiac Tamponade	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected9,333 at risk EG00116 affected9,291 at risk
Intracardiac Thrombus	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected9,333 at risk EG00115 affected9,291 at risk
Angina Pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG00114 affected9,291 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG00112 affected9,291 at risk
Atrial Flutter	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected9,333 at risk EG0017 affected9,291 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0015 affected9,291 at risk
Pericardial Effusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG00110 affected9,291 at risk
Arrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG0014 affected9,291 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG0017 affected9,291 at risk
Pericarditis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0018 affected9,291 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG0018 affected9,291 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0012 affected9,291 at risk
Cardiac Asthma	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0016 affected9,291 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0016 affected9,291 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0016 affected9,291 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0011 affected9,291 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0015 affected9,291 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0012 affected9,291 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Coronary Artery Dissection	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0010 affected9,291 at risk
Electromechanical Dissociation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0014 affected9,291 at risk
Myocardial Rupture	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0014 affected9,291 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0014 affected9,291 at risk
Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Acute Left Ventricular Failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Cardiac Aneurysm	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Coronary Artery Perforation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Coronary Artery Thrombosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Dressler's Syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Pericardial Haemorrhage	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Sinus Arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Ventricle Rupture	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Arrhythmia Supraventricular	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Coronary Artery Occlusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Nodal Rhythm	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Papillary Muscle Rupture	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Arteriospasm Coronary	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Atrial Rupture	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Bundle Branch Block	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Bundle Branch Block Left	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cardiac Disorder	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cardiac Valve Disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cardiovascular Disorder	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Chordae Tendinae Rupture	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Coronary Artery Insufficiency	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cyanosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Dissecting Coronary Artery Aneurysm	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Hypertrophic Cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Interventricular Septum Rupture	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Long Qt Syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Low Cardiac Output Syndrome	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Myocarditis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Papillary Muscle Disorder	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Stress Cardiomyopathy	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Torsade De Pointes	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Ventricular Dysfunction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Ventricular Tachyarrhythmia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Carbohydrate Metabolism Disorder	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Diverticulitis Meckel's	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gastrointestinal Angiodysplasia Haemorrhagic	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Haemorrhagic Arteriovenous Malformation	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Ventricular Septal Defect	Congenital, familial and genetic disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG0015 affected9,291 at risk
Vestibular Neuronitis	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Deafness	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Sudden Hearing Loss	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Goitre	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pituitary-Dependent Cushing's Syndrome	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thyrotoxic Crisis	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Diplopia	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Retinal Detachment	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Amaurosis	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Amaurosis Fugax	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Blindness	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cataract Nuclear	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Chorioretinitis	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Conjunctival Haemorrhage	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Diabetic Retinopathy	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Eye Haemorrhage	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Glaucoma	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Macular Degeneration	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Posterior Capsule Opacification	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Retinal Artery Embolism	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Visual Impairment	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00045 affected9,333 at risk EG00142 affected9,291 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00021 affected9,333 at risk EG00110 affected9,291 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG00115 affected9,291 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected9,333 at risk EG0019 affected9,291 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected9,333 at risk EG0016 affected9,291 at risk
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0012 affected9,291 at risk
Melaena	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0013 affected9,291 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0014 affected9,291 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG0019 affected9,291 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0017 affected9,291 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0017 affected9,291 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0016 affected9,291 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0015 affected9,291 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0015 affected9,291 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0011 affected9,291 at risk
Retroperitoneal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Gastric Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0014 affected9,291 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0014 affected9,291 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0014 affected9,291 at risk
Anal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Enteritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Gastrointestinal Necrosis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Peptic Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Retroperitoneal Haematoma	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Diverticulum Intestinal Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Faeces Discoloured	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Gastric Disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Gastritis Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Gastroduodenal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Rectal Polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Abdominal Hernia Obstructive	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Appendicitis Perforated	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Ascites	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Colonic Polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Diverticular Perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Diverticulitis Intestinal Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Enterocolitis Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Epigastric Discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Erosive Oesophagitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Faecal Incontinence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Gastritis Atrophic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Gastrointestinal Pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gastrointestinal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gingival Bleeding	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gingivitis Ulcerative	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Haemorrhagic Erosive Gastritis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Inguinal Hernia Strangulated	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intestinal Polyp	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Intra-Abdominal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Mallory-Weiss Syndrome	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Mesenteric Artery Embolism	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Oesophageal Food Impaction	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Oesophageal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Oesophageal Pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Oesophageal Varices Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Oesophagitis Haemorrhagic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pancreatic Disorder	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pancreatic Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pancreatitis Chronic	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Polyp Colorectal	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Proctitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Reflux Oesophagitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Retroperitoneal Fibrosis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Small Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Small Intestinal Perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Stomach Mass	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Subileus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thrombosis Mesenteric Vessel	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tongue Oedema	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Toothache	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Volvulus	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG000101 affected9,333 at risk EG001103 affected9,291 at risk
Chest Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG00054 affected9,333 at risk EG00163 affected9,291 at risk
Death	General disorders	MedDRA 10.0	Systematic Assessment	EG00021 affected9,333 at risk EG00131 affected9,291 at risk
Sudden Death	General disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected9,333 at risk EG00127 affected9,291 at risk
Sudden Cardiac Death	General disorders	MedDRA 10.0	Systematic Assessment	EG00014 affected9,333 at risk EG00125 affected9,291 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG00112 affected9,291 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0015 affected9,291 at risk
Multi-Organ Failure	General disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0019 affected9,291 at risk
Vessel Puncture Site Haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0016 affected9,291 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0014 affected9,291 at risk
Malaise	General disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0013 affected9,291 at risk
General Physical Health Deterioration	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0015 affected9,291 at risk
Chest Discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Impaired Healing	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Oedema Peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0011 affected9,291 at risk
Puncture Site Haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0011 affected9,291 at risk
Cardiac Death	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Catheter Site Haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Systemic Inflammatory Response Syndrome	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Accidental Death	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Alcohol Interaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Application Site Inflammation	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Discomfort	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Foaming At Mouth	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gait Disturbance	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Generalised Oedema	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hernia	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hypothermia	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Inflammation	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Inflammation Of Wound	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Injection Site Haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Injection Site Swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pelvic Mass	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Ulcer Haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Unevaluable Event	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG00110 affected9,291 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0019 affected9,291 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0017 affected9,291 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0014 affected9,291 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Biliary Colic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Jaundice	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gallbladder Disorder	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gallbladder Necrosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hepatitis Toxic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hepatocellular Injury	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Ischaemic Hepatitis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Liver Disorder	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Anaphylactic Shock	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Allergy To Arthropod Bite	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Contrast Media Allergy	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00069 affected9,333 at risk EG00195 affected9,291 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00017 affected9,333 at risk EG00127 affected9,291 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00025 affected9,333 at risk EG00119 affected9,291 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00017 affected9,333 at risk EG00111 affected9,291 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00013 affected9,333 at risk EG00115 affected9,291 at risk
Mediastinitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00011 affected9,333 at risk EG0014 affected9,291 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0014 affected9,291 at risk
Septic Shock	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG00110 affected9,291 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0019 affected9,291 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0013 affected9,291 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0015 affected9,291 at risk
Diverticulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0018 affected9,291 at risk
Wound Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0018 affected9,291 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0012 affected9,291 at risk
Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0015 affected9,291 at risk
Lung Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0014 affected9,291 at risk
Erysipelas	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0014 affected9,291 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0014 affected9,291 at risk
Urosepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Cystitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Endocarditis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Gangrene	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Osteomyelitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Pyelonephritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Abscess Limb	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Acute Tonsillitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Anal Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Bacteraemia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Gastroenteritis Caliciviral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Incision Site Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Lobar Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Localised Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Skin Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Tooth Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Abdominal Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Abdominal Wall Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Acquired Immunodeficiency Syndrome	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Acute Sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Arthritis Bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Arthritis Infective	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Bacterial Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Breast Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Bronchiectasis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Bronchitis Viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Catheter Related Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Catheter Site Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cholecystitis Infective	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Dengue Fever	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Device Related Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Endometritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Enterococcal Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Enterocolitis Infectious	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Febrile Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gastric Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gastroenteritis Rotavirus	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Gastroenteritis Salmonella	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Groin Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Groin Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Haematoma Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Helicobacter Gastritis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Hepatitis Viral	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Herpes Zoster	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Histoplasmosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Impetigo	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Incision Site Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Infective Exacerbation Of Chronic Obstructive Airways Disease	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Infective Tenosynovitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Inguinal Hernia Gangrenous	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Injection Site Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intervertebral Discitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Laryngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Liver Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Lyme Disease	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Meningitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Necrotising Fasciitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Orchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pancreatic Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Perineal Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pneumococcal Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pneumonia Staphylococcal	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Post Procedural Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Post Procedural Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Post Procedural Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pulmonary Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Puncture Site Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Puncture Site Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Pyothorax	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Rectal Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Renal Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Retroperitoneal Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Staphylococcal Mediastinitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Sternitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Syphilis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Tooth Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tracheitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Tracheobronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Viral Myocarditis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Viral Pericarditis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Thrombosis In Device	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00035 affected9,333 at risk EG00157 affected9,291 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00056 affected9,333 at risk EG00147 affected9,291 at risk
In-Stent Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00035 affected9,333 at risk EG00125 affected9,291 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00015 affected9,333 at risk EG00123 affected9,291 at risk
In-Stent Arterial Restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG00112 affected9,291 at risk
Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0019 affected9,291 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0017 affected9,291 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0011 affected9,291 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0015 affected9,291 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0015 affected9,291 at risk
Postpericardiotomy Syndrome	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0012 affected9,291 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0014 affected9,291 at risk
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0014 affected9,291 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0010 affected9,291 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Operative Haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Postoperative Thoracic Procedure Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Subcutaneous Haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Graft Thrombosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Limb Traumatic Amputation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Postoperative Thrombosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Procedural Hypotension	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Renal Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Stent Occlusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Traumatic Haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Anaemia Postoperative	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Brain Contusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cardiac Pacemaker Malfunction	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cardiac Procedure Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Chest Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Contrast Media Reaction	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Coronary Artery Reocclusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Device Breakage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Device Dislocation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Device Malfunction	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Device Migration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Fat Embolism	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Fractured Ischium	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Implantable Defibrillator Malfunction	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Incision Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Joint Sprain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Open Wound	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Post Procedural Haematuria	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Procedural Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Scrotal Haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Suture Rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Tracheal Haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tracheal Obstruction	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Transfusion Reaction	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Traumatic Intracranial Haemorrhage	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Urinary Bladder Rupture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Urinary Retention Postoperative	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vascular Procedure Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vascular Pseudoaneurysm Ruptured	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vertebral Injury	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Weaning Failure	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Wound Complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Haemoglobin Decreased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0018 affected9,291 at risk
Aspartate Aminotransferase Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Alanine Aminotransferase Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Blood Pressure Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Liver Function Test Abnormal	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Angiogram	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Blood Glucose Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Blood Potassium Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Body Temperature Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Hepatic Enzyme Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
International Normalised Ratio Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Troponin Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Antiphospholipid Antibodies	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Blood Creatine Phosphokinase Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Blood Creatinine Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Blood Potassium Decreased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Blood Pressure Decreased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Blood Sodium Decreased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Blood Urine Present	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
C-Reactive Protein Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cardiac Enzymes Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cardiac Stress Test Abnormal	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Electrocardiogram Qt Prolonged	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Electrocardiogram T Wave Inversion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Fibrin D Dimer Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Heart Rate Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intraocular Pressure Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Occult Blood	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pancreatic Enzymes Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Platelet Count Decreased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Prostatic Specific Antigen Abnormal	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Prostatic Specific Antigen Increased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Weight Decreased	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected9,333 at risk EG0015 affected9,291 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected9,333 at risk EG0018 affected9,291 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0019 affected9,291 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0017 affected9,291 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0012 affected9,291 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Gout	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Metabolic Disorder	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Diabetic Foot	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Electrolyte Depletion	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Hyperosmolar State	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Metabolic Syndrome	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00015 affected9,333 at risk EG00116 affected9,291 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0015 affected9,291 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0016 affected9,291 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0014 affected9,291 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0014 affected9,291 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Gouty Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Myalgia Intercostal	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Dupuytren's Contracture	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Intervertebral Disc Degeneration	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Polymyalgia Rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Spinal Disorder	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Wrist Deformity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0013 affected9,291 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG00110 affected9,291 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0019 affected9,291 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0018 affected9,291 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0015 affected9,291 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0016 affected9,291 at risk
Colon Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0015 affected9,291 at risk
Renal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Bronchial Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Metastases To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Bladder Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Chronic Lymphocytic Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Gastrointestinal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Hepatic Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Laryngeal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Metastases To Bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Metastases To Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Oesophageal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Abdominal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Benign Duodenal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Benign Neoplasm Of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Benign Uterine Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Bladder Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Bone Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Brain Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Breast Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Bronchial Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Carcinoid Tumour Of The Caecum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Carcinoid Tumour Of The Duodenum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Chronic Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Colon Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Colorectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Endometrial Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gastric Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Gastrointestinal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Haemangioma Of Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hepatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intestinal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Lip And/Or Oral Cavity Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Lymphangiosis Carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Lymphocytic Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Malignant Pleural Effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Metastases To Lymph Nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Myelodysplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Neoplasm Prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Nipple Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pancreatic Carcinoma Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pleural Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Polycythaemia Vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Prostate Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Prostate Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Prostatic Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Rectal Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Renal Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Retroperitoneal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Small Cell Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Small Cell Lung Cancer Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Spinal Cord Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Testis Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thyroid Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thyroid Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thyroid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tongue Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00075 affected9,333 at risk EG00150 affected9,291 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00032 affected9,333 at risk EG00130 affected9,291 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00020 affected9,333 at risk EG00128 affected9,291 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00019 affected9,333 at risk EG00123 affected9,291 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected9,333 at risk EG0017 affected9,291 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0013 affected9,291 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0018 affected9,291 at risk
Presyncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected9,333 at risk EG0012 affected9,291 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0017 affected9,291 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0013 affected9,291 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0012 affected9,291 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0014 affected9,291 at risk
Hemiparesis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Parkinson's Disease	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Syncope Vasovagal	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Convulsion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Depressed Level Of Consciousness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Hypotonia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Migraine	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Altered State Of Consciousness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Brain Stem Ischaemia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Cerebrovascular Disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Dementia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Hypoxic Encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Neuralgia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Partial Seizures	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Balance Disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Brain Oedema	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Brain Stem Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Brain Stem Stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Carotid Artery Disease	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Carotid Artery Occlusion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Carotid Artery Thrombosis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Carotid Sinus Syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Central Nervous System Lesion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cerebellar Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cerebral Atrophy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cerebral Disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cerebrovascular Insufficiency	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cervicobrachial Syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cognitive Disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Complex Partial Seizures	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Diabetic Hyperosmolar Coma	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Diabetic Neuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Dysphasia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Embolic Cerebral Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Encephalitis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Epilepsy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Extrapyramidal Disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Facial Paresis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Febrile Convulsion	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Haemorrhagic Cerebral Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Intracranial Haematoma	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Ischaemic Cerebral Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Lacunar Infarction	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Mental Impairment	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Myelitis Transverse	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Narcolepsy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Parkinsonism	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Phrenic Nerve Paralysis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Post Herpetic Neuralgia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Progressive Supranuclear Palsy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Psychomotor Hyperactivity	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Sciatica	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Speech Disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Spinal Cord Disorder	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thalamus Haemorrhage	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thrombotic Stroke	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vascular Encephalopathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vertebrobasilar Insufficiency	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Vith Nerve Paralysis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Vocal Cord Paresis	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Anxiety	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0016 affected9,291 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected9,333 at risk EG0017 affected9,291 at risk
Confusional State	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0012 affected9,291 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Acute Stress Disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Agitation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Alcohol Abuse	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Alcoholism	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Completed Suicide	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Delirium	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Drug Abuse	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Mania	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Mental Disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Nervousness	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Neurosis	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Panic Attack	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Post-Traumatic Amnestic Disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Schizophrenia, Paranoid Type	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Sleep Disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Tension	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Transient Psychosis	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00034 affected9,333 at risk EG00125 affected9,291 at risk
Renal Failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00025 affected9,333 at risk EG00124 affected9,291 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00015 affected9,333 at risk EG00110 affected9,291 at risk
Renal Failure Chronic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0017 affected9,291 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0017 affected9,291 at risk
Renal Impairment	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0014 affected9,291 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0014 affected9,291 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Haemorrhage Urinary Tract	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Nephropathy Toxic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Renal Colic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Azotaemia	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Urinary Bladder Haemorrhage	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Urinary Bladder Polyp	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Anuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Bladder Mass	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Bladder Prolapse	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Bladder Tamponade	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Calculus Bladder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Calculus Urethral	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cystitis Haemorrhagic	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cystitis Noninfective	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Dysuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Glomerulonephritis Membranous	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Glomerulonephritis Minimal Lesion	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Nephritis Autoimmune	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Nephrotic Syndrome	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Obstructive Uropathy	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Oliguria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Renal Artery Thrombosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Renal Disorder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Renal Haemorrhage	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Renal Mass	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Urethral Haemorrhage	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0011 affected9,291 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Balanitis	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Cervical Dysplasia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Prostatic Haemorrhage	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Spermatocele	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00075 affected9,333 at risk EG00150 affected9,291 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00033 affected9,333 at risk EG00153 affected9,291 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00020 affected9,333 at risk EG00132 affected9,291 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00031 affected9,333 at risk EG00120 affected9,291 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00022 affected9,333 at risk EG00117 affected9,291 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00021 affected9,333 at risk EG00119 affected9,291 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00016 affected9,333 at risk EG00116 affected9,291 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00015 affected9,333 at risk EG0019 affected9,291 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0019 affected9,291 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0018 affected9,291 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0016 affected9,291 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0016 affected9,291 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0015 affected9,291 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0013 affected9,291 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Pulmonary Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Alveolitis Fibrosing	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Brain Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Bronchial Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Bronchial Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Dyspnoea Paroxysmal Nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Laryngeal Leukoplakia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Laryngeal Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Laryngeal Stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Lower Respiratory Tract Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Lung Consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Mediastinal Haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Mediastinal Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Nasal Polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Nocturnal Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pulmonary Alveolar Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Pulmonary Haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Respiratory Tract Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Systemic Sclerosis Pulmonary	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thoracic Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Tonsillar Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Tracheal Stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Vocal Cord Polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Wegener's Granulomatosis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0016 affected9,291 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0014 affected9,291 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0013 affected9,291 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0014 affected9,291 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0010 affected9,291 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Dry Gangrene	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Eczema Nummular	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Hypoaesthesia Facial	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Increased Tendency To Bruise	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Leukocytoclastic Vasculitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Rash Erythematous	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Rash Generalised	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Seborrhoeic Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Skin Inflammation	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Cardiac Pacemaker Insertion	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Coronary Artery Bypass	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Implantable Defibrillator Insertion	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Leg Amputation	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Thoracic Cavity Drainage	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected9,333 at risk EG00124 affected9,291 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00018 affected9,333 at risk EG00121 affected9,291 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG00112 affected9,291 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected9,333 at risk EG0017 affected9,291 at risk
Haematoma	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0018 affected9,291 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0017 affected9,291 at risk
Shock	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected9,333 at risk EG0013 affected9,291 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0016 affected9,291 at risk
Intermittent Claudication	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected9,333 at risk EG0016 affected9,291 at risk
Accelerated Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0015 affected9,291 at risk
Arterial Thrombosis Limb	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0014 affected9,291 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0015 affected9,291 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected9,333 at risk EG0013 affected9,291 at risk
Aortic Dissection	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0014 affected9,291 at risk
Arterial Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0014 affected9,291 at risk
Circulatory Collapse	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0010 affected9,291 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected9,333 at risk EG0013 affected9,291 at risk
Aortic Stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0013 affected9,291 at risk
Arteriosclerosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Femoral Artery Aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0013 affected9,291 at risk
Haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0013 affected9,291 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected9,333 at risk EG0012 affected9,291 at risk
Thrombophlebitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Venous Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0013 affected9,291 at risk
Aortic Aneurysm Rupture	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Arterial Occlusive Disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Arteriosclerosis Obliterans	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Arteriovenous Fistula	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Artery Dissection	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Cardiovascular Insufficiency	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0012 affected9,291 at risk
Iliac Artery Stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0012 affected9,291 at risk
Leriche Syndrome	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Shock Haemorrhagic	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0011 affected9,291 at risk
Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected9,333 at risk EG0010 affected9,291 at risk
Venous Thrombosis Limb	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0012 affected9,291 at risk
Aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Aneurysm Ruptured	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Angiodysplasia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Aortic Dilatation	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Arterial Disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Arterial Rupture	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Arteritis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Bleeding Varicose Vein	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Blood Pressure Inadequately Controlled	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Embolism	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Embolism Venous	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Extremity Necrosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Femoral Arterial Stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Haemodynamic Instability	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Iliac Artery Occlusion	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Iliac Artery Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Peripheral Artery Aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Peripheral Artery Dissection	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Peripheral Embolism	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0011 affected9,291 at risk
Phlebitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Reperfusion Injury	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Subclavian Artery Stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Subclavian Artery Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Subclavian Vein Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vascular Occlusion	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vasculitis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Vena Cava Thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk
Venous Insufficiency	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected9,333 at risk EG0011 affected9,291 at risk
Wound Haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected9,333 at risk EG0010 affected9,291 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TICAGRELOR	Ticagrelor 90 mg twice daily dose (BD)			2,108		2,278
EG001	CLOPIDOGREL	Clopidogrel 75 mg once daily dose (ODD)			2,117		1,665

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D000787	Angina Pectoris
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D003327	Coronary Disease
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

ID	Title	Description
BG000	TICAGRELOR	Ticagrelor 90 mg twice daily dose (BD)
BG001	CLOPIDOGREL	Clopidogrel 75 mg once daily dose (ODD)
BG002	Total	Total of all reporting groups

ID	Term
D054058	Acute Coronary Syndrome
D009203	Myocardial Infarction
D000789	Angina, Unstable
D003324	Coronary Artery Disease