AURORA: Crestor 10mg Versus Placebo in Subjects With End-... | NCT00240331

ID	Type	Description	Link
D3562C00096

Label	Type	Description	Intervention Names
Rosuvastatin 10mg	Experimental		Drug: 10mg Rosuvastatin
Placebo	Placebo Comparator	matching Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
10mg Rosuvastatin	Drug		Rosuvastatin 10mg
Placebo

Measure	Description	Time Frame
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Measure	Description	Time Frame
Number of Randomised Participants That Died From Any Cause.		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause

Name	Affiliation	Role
AstraZeneca Crestor Medical Sciences Director, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		St Leonards	New South Wales		Australia
Research Site

PubMed Identifier	Type	Citation	Retractions
19332456	Derived	Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.

ID	Title	Description
FG000	Rosuvastatin 10mg	Rosuvastatin 10 mg oral tablets
FG001	Placebo	Matching placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0012 affected1,378 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Nephrogenic Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Haemorrhagic Diathesis	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Splenic Infarction	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Anaemia Megaloblastic	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lymphadenopathy Mediastinal	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00053 affected1,389 at risk EG00152 affected1,378 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00039 affected1,389 at risk EG00145 affected1,378 at risk
Cardiac Failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00030 affected1,389 at risk EG00135 affected1,378 at risk
Angina Pectoris	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00021 affected1,389 at risk EG00131 affected1,378 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00022 affected1,389 at risk EG00126 affected1,378 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected1,389 at risk EG00110 affected1,378 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG00112 affected1,378 at risk
Bradycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00012 affected1,389 at risk EG0015 affected1,378 at risk
Angina Unstable	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG00110 affected1,378 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG00110 affected1,378 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected1,389 at risk EG0016 affected1,378 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected1,389 at risk EG0017 affected1,378 at risk
Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0019 affected1,378 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG0015 affected1,378 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0015 affected1,378 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0015 affected1,378 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0014 affected1,378 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0013 affected1,378 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0015 affected1,378 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0014 affected1,378 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Atrial Flutter	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Cardiac Asthma	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Hypertensive Cardiomyopathy	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0013 affected1,378 at risk
Acute Left Ventricular Failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Pericarditis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Congestive Cardiomyopathy	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Pericardial Effusion	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Cardiac Tamponade	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Palpitations	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Arrhythmia Supraventricular	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Bundle Branch Block Right	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Coronary Artery Insufficiency	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pericarditis Constrictive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Prinzmetal Angina	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Silent Myocardial Infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Sinus Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Trifascicular Block	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Atrioventricular Block First Degree	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cardiac Failure High Output	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Diastolic Dysfunction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hypertensive Heart Disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Nodal Rhythm	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pericardial Haemorrhage	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Torsade De Pointes	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Atrial Septal Defect	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gastrointestinal Angiodysplasia Haemorrhagic	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gastrointestinal Angiodysplasia	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Polycystic Liver Disease	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pyloric Stenosis	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Meniere's Disease	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Sudden Hearing Loss	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG00018 affected1,389 at risk EG0019 affected1,378 at risk
Hyperparathyroidism Secondary	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0017 affected1,378 at risk
Hyperparathyroidism Tertiary	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Hypopituitarism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cataract	Eye disorders	MedDRA 11.1	Systematic Assessment	EG00016 affected1,389 at risk EG00111 affected1,378 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Angle Closure Glaucoma	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Glaucoma	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Papilloedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Retinal Detachment	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Retinal Vein Occlusion	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Retinopathy	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Diabetic Retinopathy	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Diplopia	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Endophthalmitis	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Eye Haemorrhage	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Retinal Artery Occlusion	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00025 affected1,389 at risk EG00118 affected1,378 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00017 affected1,389 at risk EG00112 affected1,378 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected1,389 at risk EG0019 affected1,378 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG0014 affected1,378 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG0018 affected1,378 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0018 affected1,378 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0017 affected1,378 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0016 affected1,378 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0015 affected1,378 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0015 affected1,378 at risk
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0015 affected1,378 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0015 affected1,378 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0015 affected1,378 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0015 affected1,378 at risk
Melaena	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0015 affected1,378 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0014 affected1,378 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0014 affected1,378 at risk
Ileus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0014 affected1,378 at risk
Colitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Subileus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0010 affected1,378 at risk
Colonic Polyp	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0013 affected1,378 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0012 affected1,378 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0012 affected1,378 at risk
Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Abdominal Symptom	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Enteritis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Gastric Polyps	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Intra-Abdominal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Sigmoiditis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Ascites	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Intestinal Infarction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Colonic Pseudo-Obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Enterocutaneous Fistula	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Enterovesical Fistula	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Gastric Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Gastric Stenosis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gastric Ulcer Perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gastritis Haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Gastrointestinal Ischaemia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gastrointestinal Perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Ileitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Inguinal Hernia, Obstructive	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Intestinal Angina	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Intra-Abdominal Haematoma	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Mechanical Ileus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Mesenteric Artery Embolism	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Mesenteric Vascular Insufficiency	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Oesophagitis Haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pancreatic Cyst	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Periodontitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Proctocolitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Rectal Polyp	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Sclerosing Encapsulating Peritonitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Acute Abdomen	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Diverticular Perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Gastrointestinal Motility Disorder	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Gingival Bleeding	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Intestinal Strangulation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Large Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Mesenteric Artery Stenosis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Mesenteric Artery Thrombosis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Oesophageal Ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Oesophageal Varices Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Peritoneal Effusion	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Reflux Oesophagitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Retroperitoneal Effusion	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Retroperitoneal Haematoma	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Varices Oesophageal	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Sudden Death	General disorders	MedDRA 11.1	Systematic Assessment	EG00033 affected1,389 at risk EG00130 affected1,378 at risk
Death	General disorders	MedDRA 11.1	Systematic Assessment	EG00030 affected1,389 at risk EG00130 affected1,378 at risk
Catheter Related Complication	General disorders	MedDRA 11.1	Systematic Assessment	EG00014 affected1,389 at risk EG00117 affected1,378 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected1,389 at risk EG00115 affected1,378 at risk
Catheter Thrombosis	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG00110 affected1,378 at risk
Malaise	General disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG00110 affected1,378 at risk
Sudden Cardiac Death	General disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0012 affected1,378 at risk
Catheter Site Haemorrhage	General disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0017 affected1,378 at risk
General Physical Health Deterioration	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0017 affected1,378 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0012 affected1,378 at risk
Chest Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0015 affected1,378 at risk
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Cardiac Death	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Chills	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0013 affected1,378 at risk
Discomfort	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Inflammation	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Multi-Organ Failure	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Oedema Peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Wound Necrosis	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Gait Disturbance	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Catheter Site Haematoma	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Catheter Site Inflammation	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Haemorrhagic Cyst	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hyperpyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Ulcer Haemorrhage	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Chest Discomfort	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Drug Interaction	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hypothermia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Influenza Like Illness	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Necrosis	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Systemic Inflammatory Response Syndrome	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG0012 affected1,378 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0015 affected1,378 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Biliary Dilatation	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Gallbladder Perforation	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hepatic Cyst	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Hepatitis Toxic	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Jaundice	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Biliary Colic	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hepatic Necrosis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Portal Vein Occlusion	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Amyloidosis	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Kidney Transplant Rejection	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Anaphylactic Shock	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00092 affected1,389 at risk EG00196 affected1,378 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00065 affected1,389 at risk EG00170 affected1,378 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00020 affected1,389 at risk EG00122 affected1,378 at risk
Bronchopneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00019 affected1,389 at risk EG00118 affected1,378 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00019 affected1,389 at risk EG00112 affected1,378 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00016 affected1,389 at risk EG00110 affected1,378 at risk
Catheter Related Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00014 affected1,389 at risk EG00115 affected1,378 at risk
Arteriovenous Fistula Site Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00015 affected1,389 at risk EG00113 affected1,378 at risk
Gangrene	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00010 affected1,389 at risk EG00114 affected1,378 at risk
Septic Shock	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00013 affected1,389 at risk EG0019 affected1,378 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00011 affected1,389 at risk EG00111 affected1,378 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00010 affected1,389 at risk EG00111 affected1,378 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG00110 affected1,378 at risk
Arthritis Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0019 affected1,378 at risk
Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG0018 affected1,378 at risk
Lobar Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0018 affected1,378 at risk
Localised Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0018 affected1,378 at risk
Diverticulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0017 affected1,378 at risk
Erysipelas	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0017 affected1,378 at risk
Viral Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0015 affected1,378 at risk
Catheter Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0016 affected1,378 at risk
Endocarditis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0016 affected1,378 at risk
Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0016 affected1,378 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0016 affected1,378 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0016 affected1,378 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0012 affected1,378 at risk
Appendicitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0015 affected1,378 at risk
Arteriovenous Graft Site Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0015 affected1,378 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0015 affected1,378 at risk
Osteomyelitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0015 affected1,378 at risk
Shunt Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0015 affected1,378 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0015 affected1,378 at risk
Central Line Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0014 affected1,378 at risk
Wound Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0013 affected1,378 at risk
Catheter Site Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0014 affected1,378 at risk
Lung Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0014 affected1,378 at risk
Graft Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Cystitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0013 affected1,378 at risk
Hepatitis C	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0013 affected1,378 at risk
Herpes Zoster	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Intervertebral Discitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Arthritis Infective	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Bacterial Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Device Related Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Post Procedural Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Postoperative Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Renal Cyst Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0012 affected1,378 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Abdominal Wall Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Abscess Limb	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Bacterial Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Diabetic Gangrene	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Empyema	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Endocarditis Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Enterococcal Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Hepatic Cyst Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Influenza	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Meningitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Pyelonephritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Pyonephrosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Skin Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Streptococcal Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Cytomegalovirus Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Tooth Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Abscess Intestinal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Abscess Neck	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Anal Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Arteriosclerotic Gangrene	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Bone Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Bronchiectasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Candida Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Escherichia Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Escherichia Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Febrile Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Fungal Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gallbladder Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gallbladder Empyema	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Groin Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Haemophilus Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Helicobacter Gastritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hepatitis B	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hypopyon	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Klebsiella Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Klebsiella Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Listeriosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Liver Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Mastoiditis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Myocarditis Septic	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Oesophageal Candidiasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Oral Fungal Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Orchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Pancreas Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pelvic Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pelvic Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Penile Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Perinephric Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Peritoneal Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Pneumonia Moraxella	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pneumonia Pneumococcal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pseudomembranous Colitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pseudomonas Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pyothorax	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Rectal Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Salmonellosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Scrotal Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Sepsis Syndrome	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Streptococcal Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Streptococcal Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Tuberculosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Urinary Tract Infection Staphylococcal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Urosepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Abdominal Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Abdominal Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Bronchitis Viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Chronic Tonsillitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Citrobacter Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Clostridial Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Clostridium Colitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Diabetic Foot Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Endocarditis Staphylococcal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Enteritis Infectious	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Eye Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Fungal Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Furuncle	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Herpes Simplex	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Infective Exacerbation Of Chronic Obstructive Airways Disease	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Infective Spondylitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lung Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lung Infection Pseudomonal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Meningitis Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Otitis Externa	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Otitis Media	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Peridiverticular Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Perihepatic Abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Peritonitis Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pneumococcal Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pneumonia Klebsiella	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pseudomonal Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Respiratory Tract Infection Bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Toxoplasmosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Tuberculous Pleurisy	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Urinary Tract Infection Pseudomonal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Arteriovenous Fistula Site Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00054 affected1,389 at risk EG00160 affected1,378 at risk
Arteriovenous Fistula Thrombosis	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00053 affected1,389 at risk EG00145 affected1,378 at risk
Vascular Access Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00030 affected1,389 at risk EG00140 affected1,378 at risk
Arteriovenous Fistula Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00020 affected1,389 at risk EG00124 affected1,378 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG00119 affected1,378 at risk
Arteriovenous Fistula Aneurysm	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00013 affected1,389 at risk EG00118 affected1,378 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00013 affected1,389 at risk EG00114 affected1,378 at risk
Shunt Thrombosis	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00012 affected1,389 at risk EG0019 affected1,378 at risk
Shunt Stenosis	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00011 affected1,389 at risk EG0014 affected1,378 at risk
Vascular Graft Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00011 affected1,389 at risk EG0018 affected1,378 at risk
Graft Thrombosis	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG00110 affected1,378 at risk
Arteriovenous Graft Thrombosis	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00010 affected1,389 at risk EG0017 affected1,378 at risk
Arteriovenous Fistula Occlusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0019 affected1,378 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0019 affected1,378 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG0017 affected1,378 at risk
Haemodialysis-Induced Symptom	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0018 affected1,378 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0014 affected1,378 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0013 affected1,378 at risk
Procedural Hypotension	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0014 affected1,378 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0016 affected1,378 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0010 affected1,378 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0015 affected1,378 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0015 affected1,378 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0015 affected1,378 at risk
Shunt Occlusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0015 affected1,378 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0013 affected1,378 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0012 affected1,378 at risk
Arteriovenous Fistula Site Haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0014 affected1,378 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Arteriovenous Graft Aneurysm	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0013 affected1,378 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Post-Traumatic Pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0012 affected1,378 at risk
Pubic Rami Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0012 affected1,378 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0012 affected1,378 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Arteriovenous Graft Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Complications Of Transplanted Kidney	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Shunt Malfunction	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Therapeutic Agent Toxicity	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Vascular Procedure Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Arteriovenous Graft Site Haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Dialysis Device Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Acetabulum Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cerebral Haemorrhage Traumatic	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cervical Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Chest Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Extrusion Of Device	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Foreign Body Trauma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Graft Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Graft Haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Heat Illness	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Medical Device Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Medical Device Pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Multiple Fractures	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Multiple Injuries	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Narcotic Intoxication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Periorbital Haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Perirenal Haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Post Procedural Fistula	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Shunt Aneurysm	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Skeletal Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Sternal Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Anaemia Postoperative	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Arterial Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cardiac Pacemaker Malfunction	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cardiac Procedure Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Collapse Of Lung	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Comminuted Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dialysis Disequilibrium Syndrome	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dislocation Of Joint Prosthesis	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dislocation Of Vertebra	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Drug Toxicity	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Fractured Sacrum	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Haemolytic Transfusion Reaction	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Ilium Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Operative Haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pacemaker Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Peripheral Nerve Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Procedural Vomiting	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Skull Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Stent-Graft Endoleak	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Subdural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Suture Related Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Transfusion Reaction	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Traumatic Brain Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Traumatic Intracranial Haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Vascular Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Venous Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Weight Decreased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0014 affected1,378 at risk
International Normalised Ratio Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Blood Calcium Decreased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Blood Pressure Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Blood Glucose Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
C-Reactive Protein Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Electrocardiogram Q Wave Abnormal	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Electrocardiogram T Wave Inversion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Occult Blood Positive	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Urine Cytology Abnormal	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Alanine Aminotransferase Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Blood Creatinine Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Blood Culture Positive	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Blood Potassium Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Electrocardiogram T Wave Amplitude Increased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Haemoglobin Decreased	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Liver Function Test Abnormal	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG00113 affected1,378 at risk
Diabetic Foot	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG00112 affected1,378 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG00110 affected1,378 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0018 affected1,378 at risk
Fluid Retention	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0016 affected1,378 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0012 affected1,378 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Metabolic Disorder	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0015 affected1,378 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0017 affected1,378 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0017 affected1,378 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0017 affected1,378 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0014 affected1,378 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0010 affected1,378 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0013 affected1,378 at risk
Muscle Haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Chondrocalcinosis Pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Polymyalgia Rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Soft Tissue Haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Bone Cyst	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dupuytren's Contracture	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Intervertebral Disc Space Narrowing	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Nodal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Osteitis Deformans	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Psoriatic Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0017 affected1,378 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0014 affected1,378 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0014 affected1,378 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0014 affected1,378 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0014 affected1,378 at risk
Metastases To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0011 affected1,378 at risk
Parathyroid Tumour Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0010 affected1,378 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Metastases To Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0010 affected1,378 at risk
Oesophageal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Skin Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Squamous Cell Carcinoma Of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Hepatic Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Lip Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Rectosigmoid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Bile Duct Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Bladder Transitional Cell Carcinoma Stage Iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cervix Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Colon Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Epiglottic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gallbladder Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Gastrointestinal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Laryngeal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Laryngeal Cancer Stage Iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Metastatic Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Metastatic Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Metastatic Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Non-Hodgkin's Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Prostate Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Prostatic Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Renal Oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Uterine Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Benign Breast Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Benign Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Benign Neoplasm Of Testis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Benign Small Intestinal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Bladder Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Bone Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Breast Cancer Female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Carcinoid Tumour Of The Stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Choroid Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Colon Cancer Stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Follicle Centre Lymphoma, Follicular Grade I, Ii, Iii Stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Gastrointestinal Tract Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lung Squamous Cell Carcinoma Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lymphocytic Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Metastatic Carcinoma Of The Bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Multiple Myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Non-Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pancreatic Carcinoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Rectal Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Rectal Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Tongue Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00030 affected1,389 at risk EG00129 affected1,378 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected1,389 at risk EG00110 affected1,378 at risk
Syncope	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected1,389 at risk EG0017 affected1,378 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected1,389 at risk EG0011 affected1,378 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0018 affected1,378 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0018 affected1,378 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0015 affected1,378 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0010 affected1,378 at risk
Epilepsy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Dysarthria	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Hypoglycaemic Coma	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Sciatica	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Somnolence	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Vertebrobasilar Insufficiency	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Carotid Arteriosclerosis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Cerebellar Haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Coma	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Dementia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Depressed Level Of Consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Hypertensive Encephalopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Uraemic Encephalopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Balance Disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Brain Oedema	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cerebral Arteriosclerosis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cerebral Artery Thrombosis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Cerebrovascular Disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cervical Cord Compression	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Cognitive Disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Coma Hepatic	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Coma Uraemic	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Demyelination	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Diabetic Neuropathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Encephalopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Hemiplegia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Lacunar Infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Memory Impairment	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Nervous System Disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Neuralgia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Neurodegenerative Disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Peripheral Motor Neuropathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Spondylitic Myelopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Status Epilepticus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Stupor	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Altered State Of Consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Amnesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Anoxic Encephalopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Arachnoid Cyst	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Brain Compression	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cerebral Disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Diabetic Autonomic Neuropathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Guillain-Barre Syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hemiparesis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hydrocephalus	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Intercostal Neuralgia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Intracranial Aneurysm	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Intracranial Haematoma	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Intraventricular Haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Metabolic Encephalopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Monoparesis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Parkinson's Disease	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Presenile Dementia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Quadriparesis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Simple Partial Seizures	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Vascular Dementia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Vascular Encephalopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Confusional State	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG00110 affected1,378 at risk
Delirium	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Sleep Disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Alcohol Abuse	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Anxiety	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Completed Suicide	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Disorientation	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Impaired Self-Care	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Delusional Disorder, Persecutory Type	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Insomnia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Mental Disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Psychotic Disorder Due To A General Medical Condition	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Renal Failure Chronic	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0019 affected1,378 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0018 affected1,378 at risk
Azotaemia	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0014 affected1,378 at risk
Renal Haemorrhage	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0011 affected1,378 at risk
Renal Colic	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Renal Failure	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Calculus Bladder	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Renal Cyst	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Extravasation Of Urine	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hypertonic Bladder	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Pyuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Ureteric Obstruction	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Calculus Urethral	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cystitis Haemorrhagic	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Renal Cyst Ruptured	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Urinary Bladder Haemorrhage	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Endometrial Hypertrophy	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Uterine Prolapse	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Balanitis	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dysfunctional Uterine Bleeding	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected1,389 at risk EG00125 affected1,378 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00019 affected1,389 at risk EG00122 affected1,378 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG00118 affected1,378 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG00114 affected1,378 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG00111 affected1,378 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0013 affected1,378 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0016 affected1,378 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0012 affected1,378 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0015 affected1,378 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0014 affected1,378 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0014 affected1,378 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,389 at risk EG0013 affected1,378 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Foreign Body Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Bronchial Fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Lung Consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Respiratory Acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Pulmonary Necrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Wegener's Granulomatosis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected1,389 at risk EG00110 affected1,378 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Diabetic Ulcer	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Cutaneous Vasculitis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Dermatitis Exfoliative	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Pemphigus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Dry Gangrene	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Nail Discolouration	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Refusal Of Treatment By Patient	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Arterial Bypass Operation	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Catheter Placement	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Chemotherapy Neurotoxicity Attenuation	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Parathyroidectomy	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00024 affected1,389 at risk EG00114 affected1,378 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00014 affected1,389 at risk EG00120 affected1,378 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00015 affected1,389 at risk EG00110 affected1,378 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00011 affected1,389 at risk EG00111 affected1,378 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG00110 affected1,378 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,389 at risk EG0016 affected1,378 at risk
Extremity Necrosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0007 affected1,389 at risk EG0014 affected1,378 at risk
Arteriosclerosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,389 at risk EG0016 affected1,378 at risk
Haematoma	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,389 at risk EG0013 affected1,378 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0014 affected1,378 at risk
Arteritis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0014 affected1,378 at risk
Aortic Aneurysm Rupture	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Cardiovascular Insufficiency	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0013 affected1,378 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0013 affected1,378 at risk
Shock	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0013 affected1,378 at risk
Venous Stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,389 at risk EG0013 affected1,378 at risk
Aortic Stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Circulatory Collapse	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0012 affected1,378 at risk
Intermittent Claudication	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Peripheral Artery Aneurysm	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Steal Syndrome	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Superior Vena Caval Stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Vena Cava Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0012 affected1,378 at risk
Venous Occlusion	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0012 affected1,378 at risk
Arterial Stenosis Limb	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Femoral Arterial Stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Iliac Artery Stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0011 affected1,378 at risk
Subclavian Artery Stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,389 at risk EG0010 affected1,378 at risk
Aneurysm	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Aneurysm Ruptured	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Aortic Dissection	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Arterial Disorder	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Arterial Stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Arterial Thrombosis Limb	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Arteriosclerosis Obliterans	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Blue Toe Syndrome	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Diabetic Vascular Disorder	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Iliac Artery Occlusion	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Ischaemic Limb Pain	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Lymphoedema	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Necrosis Ischaemic	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Poor Peripheral Circulation	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Shock Haemorrhagic	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0011 affected1,378 at risk
Subclavian Vein Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Thrombophlebitis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Vascular Calcification	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Venous Aneurysm	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,389 at risk EG0011 affected1,378 at risk
Aortic Occlusion	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Arterial Insufficiency	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Lymphocele	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Peripheral Embolism	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Secondary Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Vasculitis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Venous Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk
Venous Thrombosis Limb	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,389 at risk EG0010 affected1,378 at risk

ID	Term
D051437	Renal Insufficiency
D051436	Renal Insufficiency, Chronic

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes
D006845	Hydrocarbons, Fluorinated
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Rosuvastatin 10mg	Rosuvastatin 10 mg oral tablets
BG001	Placebo	Matching placebo
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rosuvastatin 10mg	Rosuvastatin 10 mg oral tablets			1,140		620	1,389
EG001	Placebo	Matching placebo			1,159		635	1,378

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG00081 affected1,389 at risk EG00162 affected1,378 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG00070 affected1,389 at risk EG00159 affected1,378 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG000202 affected1,389 at risk EG001188 affected1,378 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG000112 affected1,389 at risk EG001127 affected1,378 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG000121 affected1,389 at risk EG00197 affected1,378 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00082 affected1,389 at risk EG00180 affected1,378 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00080 affected1,389 at risk EG00174 affected1,378 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG000129 affected1,389 at risk EG001133 affected1,378 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG000127 affected1,389 at risk EG001116 affected1,378 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00092 affected1,389 at risk EG00183 affected1,378 at risk
Arteriovenous Fistula Site Complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG000131 affected1,389 at risk EG001131 affected1,378 at risk
Haemodialysis-Induced Symptom	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00079 affected1,389 at risk EG00178 affected1,378 at risk
Procedural Hypotension	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00076 affected1,389 at risk EG00175 affected1,378 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG000110 affected1,389 at risk EG00193 affected1,378 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00090 affected1,389 at risk EG001101 affected1,378 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00097 affected1,389 at risk EG00192 affected1,378 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG00097 affected1,389 at risk EG00181 affected1,378 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG000109 affected1,389 at risk EG001112 affected1,378 at risk
Insomnia	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG00068 affected1,389 at risk EG00177 affected1,378 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG000120 affected1,389 at risk EG001125 affected1,378 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG000102 affected1,389 at risk EG00199 affected1,378 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00083 affected1,389 at risk EG00169 affected1,378 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG000115 affected1,389 at risk EG001109 affected1,378 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG000102 affected1,389 at risk EG00192 affected1,378 at risk