Effect of Dalcetrapib vs Placebo on CV Risk in a Genetica... | NCT02525939

Name	Class
The Montreal Health Innovations Coordinating Center (MHICC)	OTHER
Medpace, Inc.	INDUSTRY
Roche Molecular Systems, Inc	INDUSTRY

Label	Type	Description	Intervention Names
Dalcetrapib	Active Comparator	Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets	Drug: dalcetrapib
Placebo	Placebo Comparator	Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
dalcetrapib	Drug	Cholesterol Ester Transfer Protein inhibitor	Dalcetrapib

Measure	Description	Time Frame
Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke	All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the CEC.	From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)

Measure	Description	Time Frame
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization	All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, hospitalization for acute coronary syndrome (with electrocardiogram abnormalities) or unanticipated coronary revascularization, as positively adjudicated by the CEC.

Name	Affiliation	Role
Donald M Black, MD	DalCor Pharmaceuticals	Study Director

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

PubMed Identifier	Type	Citation	Retractions
35856777	Derived	Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374.
34173811

ID	Title	Description
FG000	Dalcetrapib	Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
FG001	Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 11, 2021	Aug 16, 2022

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG00021 affected3,076 at risk EG00119 affected3,071 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Hemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Hypchromic anaemia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Non-Hodgkin's lymphoma recurrent	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Splenic haematoma	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Splenic vein thrombosis	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Adams-Stokes Syndrome	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG00050 affected3,076 at risk EG00152 affected3,071 at risk
Angina unstable	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG00023 affected3,076 at risk EG00119 affected3,071 at risk
Aortic valve disease	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0011 affected3,071 at risk
Arrhythmia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG00036 affected3,076 at risk EG00131 affected3,071 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0014 affected3,071 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Atrioventricular block	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0011 affected3,071 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0014 affected3,071 at risk
Bradycardia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0017 affected3,071 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0015 affected3,071 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0017 affected3,071 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0014 affected3,071 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Carditis	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Chest pain	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cor pulmonale	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG00023 affected3,076 at risk EG00130 affected3,071 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Coronary artery perforation	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0007 affected3,076 at risk EG0017 affected3,071 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0013 affected3,071 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Left ventricular failure	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Long QT syndrome	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Myocardial haemorrhage	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Myocardia ischaemia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG00012 affected3,076 at risk EG00112 affected3,071 at risk
Myocarditis	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Palpitations	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Pericardial effusion	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Pericarditis	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0013 affected3,071 at risk
Right ventricular failure	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Sinus arrest	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0011 affected3,071 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0014 affected3,071 at risk
Systolic dysfunction	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Tachycardia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0018 affected3,071 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Bicuspid aortic valve	Congenital, familial and genetic disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Ear canal stenosis	Ear and labyrinth disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Thyroid mass	Endocrine disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Toxic goitre	Endocrine disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Blindness transient	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cataract	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Lens dislocation	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Optic nerve disorder	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Retinal detachment	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Retinal tear	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Retinopathy of prematurity	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Visual acuity reduced	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0017 affected3,071 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0012 affected3,071 at risk
Adenocarcinoma pancreas	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ascites	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Auriculotemporal syndrome	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Coeliac artery stenosis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Colitis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0014 affected3,071 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0015 affected3,071 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0012 affected3,071 at risk
Enteritis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0015 affected3,071 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0014 affected3,071 at risk
Gingival recession	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0013 affected3,071 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0015 affected3,071 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0013 affected3,071 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Large intestinal polyp	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Melaena	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0012 affected3,071 at risk
Mesenteric panniculitis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Oesophageal dysplasia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0017 affected3,071 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG00014 affected3,076 at risk EG0016 affected3,071 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Portal venous gas	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0013 affected3,071 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0015 affected3,071 at risk
Small intestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Subileus	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0012 affected3,071 at risk
Volvulus	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0014 affected3,071 at risk
Asthenia	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0013 affected3,071 at risk
Cardiac death	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Chest discomfort	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0007 affected3,076 at risk EG0011 affected3,071 at risk
Chest pain	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG00079 affected3,076 at risk EG00181 affected3,071 at risk
Death of unknown cause	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG00117 affected3,071 at risk
Drowning	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Drug intolerance	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Exercise tolerance decreased	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Fatigue	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
General physical health deterioration	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Generalized oedema	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Impaired self-care	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Nodule	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Non-cardiac chest pain	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG00028 affected3,076 at risk EG00141 affected3,071 at risk
Oedema	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Oedema peripheral	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pacemaker generated arrhythmia	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Polyp	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Pyrexia	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Sudden cardiac death	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0018 affected3,071 at risk
Sudden death	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG00014 affected3,076 at risk EG00116 affected3,071 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Vascular stent restenosis	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Vascular stent stenosis	General disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG00010 affected3,076 at risk EG0018 affected3,071 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0018 affected3,071 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0015 affected3,071 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Jaundice	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Liver injury	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Food allergy	Immune system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hypersensitivity	Immune system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Sarcoidosis	Immune system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Abdominal abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Abscess limb	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Abscess of salivary gland	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Abscess oral	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Anal abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0013 affected3,071 at risk
Appendicitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0017 affected3,071 at risk
Appendicitis perforated	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Arteriosclerotic gangrene	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Arthritis bacterial	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Bacteraemia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Bacterial infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Biliary sepsis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Brain abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Bronchitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0014 affected3,071 at risk
Cardiac valve vegetation	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cellulitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG00012 affected3,076 at risk EG00112 affected3,071 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Central nervous system infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cholecystitis infective	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Colonic abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Corona virus infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG00043 affected3,076 at risk EG00145 affected3,071 at risk
Creutzfeldt-Jakob disease	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cystitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0013 affected3,071 at risk
Device related infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Diabetic foot infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Diverticulitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0017 affected3,071 at risk
Ear infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Eczema infected	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Empyema	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Endocarditis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Epididymitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Erysipelas	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Escherichia infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Gangrene	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Gastric ulcer helicobacter	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Gastritis bacterial	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG00010 affected3,076 at risk EG0018 affected3,071 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0014 affected3,071 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Haematoma infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Haemophilus bacteraemia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Helicobacter infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Hepatitis C	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Herpes zoster	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Herpes zoster oticus	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Implant site infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Infected lymphocele	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Infectious colitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0013 affected3,071 at risk
Influenza	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0013 affected3,071 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Liver abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Localized infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0013 affected3,071 at risk
Lung abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Lung infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Nosocomial infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Ophthalmic herpes simplex	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Orchitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Osteomyelitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0013 affected3,071 at risk
Pancreas infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Perirectal abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Peritonitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Pneumonia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG00041 affected3,076 at risk EG00139 affected3,071 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Pneumonia legionella	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pneumonia necrotising	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pneumonia viral	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Postoperative wound infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Pyelonephritis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0017 affected3,071 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0012 affected3,071 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Respiratory syncytial viral infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0013 affected3,071 at risk
Respiratory tract infection bacterial	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Scrotal abscess	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Sepsis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG00019 affected3,076 at risk EG00114 affected3,071 at risk
Septic shock	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG00110 affected3,071 at risk
Serratia bacteraemia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Shunt infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Sinusitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Tracheobronchitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Tuberculosis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0007 affected3,076 at risk EG00117 affected3,071 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Urosepsis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0013 affected3,071 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Viral infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Wound infection	Infections and infestations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Anastomotic complication	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0013 affected3,071 at risk
Arterial bypass thrombosis	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Bile duct stenosis traumatic	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0013 affected3,071 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Costal cartilage fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Electric shock	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Eye burns	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG00111 affected3,071 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0010 affected3,071 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0015 affected3,071 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Haematuria traumatic	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0013 affected3,071 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0014 affected3,071 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0013 affected3,071 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Incomplete spinal fusion	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0014 affected3,071 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pst procedural discomfort	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0014 affected3,071 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0015 affected3,071 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Snake bite	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0014 affected3,071 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Vascular psudoaneurysm	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Angiogram	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Arteriogram coronary	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0014 affected3,071 at risk
Biopsy prostate	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Blood creatinine increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Blood folate decreased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Blood potassium increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Blood pressure increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cardiac murmur	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cardiac stress test abnormal	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Carotid bruit	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Catheterization cardiac	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Catheterisation cardiac abnormal	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cystoscopy	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Diagnostic procedure	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ejection fraction decreased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Fibrin D dimer increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Haemoglobin decreased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Hepatic enzyme increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
International normalised ratio increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Liver function test abnormal	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Occult blood positive	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Pancreatic enzymes increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Sleep study	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Staphylococcus test positive	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Stress echocardiogram abnormal	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Troponin increased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Utereroscopy	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Weight decreased	Investigations	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0013 affected3,071 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0013 affected3,071 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0013 affected3,071 at risk
Diabetes with hyperosmolarity	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gout	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0013 affected3,071 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0014 affected3,071 at risk
Hyperosmolar hyperglycemic state	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0010 affected3,071 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0015 affected3,071 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0009 affected3,076 at risk EG0014 affected3,071 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0016 affected3,071 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Knee impingement syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Limb deformity	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0014 affected3,071 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0009 affected3,076 at risk EG0017 affected3,071 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0013 affected3,071 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG00027 affected3,076 at risk EG00123 affected3,071 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0015 affected3,071 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0014 affected3,071 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0017 affected3,071 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Vertebral osteophyte	Musculoskeletal and connective tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0013 affected3,071 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Atypical fibroxanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0015 affected3,071 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Benign neoplasm of prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0009 affected3,076 at risk EG0013 affected3,071 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0014 affected3,071 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0016 affected3,071 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Chest wall tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Chronic lymphocytic leukaemia stage 1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0014 affected3,071 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Colon cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Endometrial sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Epstein-Barr virus associated lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Giant cell tumour of tendon sheath	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Hepatic cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Intestina adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Laryngeal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0013 affected3,071 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Lung adenocarcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0016 affected3,071 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Malignant polyp	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Oropharyngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0006 affected3,076 at risk EG0013 affected3,071 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Plasma cell myeloma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pleural neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG00027 affected3,076 at risk EG00110 affected3,071 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0011 affected3,071 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0011 affected3,071 at risk
Prostate cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Tongue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Ureteral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Balance disorder	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Burning sensation	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Carotid artery disease	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0011 affected3,071 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Cerebral artery stenosis	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Cognitive disorder	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Coma	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Dementia	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Diabetic ketoacidotic hyperglycaemic coma	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Disturbance in attention	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Dizziness	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0013 affected3,071 at risk
Encephalopathy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Epilepsy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Generalized tonic-clonic seizure	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Headache	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0015 affected3,071 at risk
Hemiparesis	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Hydrocephalus	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Lumbosacral radicuopathy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Memory impairment	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Migraine	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Monoparesis	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Nervous system disorder	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Neuralgia	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Parkinson's disease	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Polyneuropathy	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Presyncope	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Radicular pain	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Sciatica	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Seizure	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Status epilepticus	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Syncope	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG00028 affected3,076 at risk EG00124 affected3,071 at risk
Transient ischemic attack	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG00010 affected3,076 at risk EG0016 affected3,071 at risk
Tremor	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Vascular dementia	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Device dislocation	Product Issues	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Device material issue	Product Issues	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Alcoholism	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Anxiety	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Aphasia	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Confusional state	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0013 affected3,071 at risk
Conversion disorder	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Delirium	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Depression	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Hallucinations, mixed	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Mania	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Mental status changes	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Somatic symptom disorder	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Substance abuse	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG00020 affected3,076 at risk EG00118 affected3,071 at risk
Anuria	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Bladder dysplasia	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0009 affected3,076 at risk EG00113 affected3,071 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0017 affected3,071 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Proteinuria	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Renal colic	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0014 affected3,071 at risk
Renal impairment	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0013 affected3,071 at risk
Renal injury	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Renal pain	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0015 affected3,071 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0019 affected3,071 at risk
Urinary tract infection	Renal and urinary disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0019 affected3,071 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Breast disorder	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG0016 affected3,071 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Bullous lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG00019 affected3,076 at risk EG00115 affected3,071 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0008 affected3,076 at risk EG00116 affected3,071 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0018 affected3,071 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Laryngeal granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Non-cardiogenic pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0010 affected3,071 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0017 affected3,071 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0010 affected3,071 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0018 affected3,071 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0012 affected3,071 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Xanthelasma	Skin and subcutaneous tissue disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Alcohol use	Social circumstances	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Sight disability	Social circumstances	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Aneurysm repair	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Angioplasty	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Arthrodesis	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Atherectomy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Blood pressure management	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Bone lesion excision	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Cardiac rehabilitation therapy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cardiac resynchronisation therapy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cataract operation	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Cholelithotomy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Colostomy closure	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Finger amputation	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Gastrectomy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Heart transplant	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Hepatectomy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Hernia repair	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0011 affected3,071 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG00011 affected3,076 at risk EG0012 affected3,071 at risk
Insertion of ambulatory peritoneal catheter	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Keratoplasty	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Left atrial appendage occlusion	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Limb amputation	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Lithotripsy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Medical device change	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ophthalmic fluid drainage	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ossiculoplasty	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Renal transpant	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Soft tissue flap operation	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Stem cell transplant	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Tumour excision	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Urethral dilation procedure	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Vascular graft	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Vitrectomy	Surgical and medical procedures	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Accelerated hypertension	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Aortic aneurysm	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0014 affected3,071 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Aortic dissection	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0012 affected3,071 at risk
Aortic intramural haematoma	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Aortic stenosis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0009 affected3,076 at risk EG0014 affected3,071 at risk
Arterial insufficiency	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Arterial perforation	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Arterial stenosis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Arteriosclerosis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Arteritis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0014 affected3,071 at risk
Embolism arterial	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Embolism venous	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Extremity necrosis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Haematoma	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Hypertension	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG00010 affected3,076 at risk EG0017 affected3,071 at risk
Hypertensive crisis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0016 affected3,071 at risk
Hypertensive emergency	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0010 affected3,071 at risk
Hypotension	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0007 affected3,076 at risk EG0017 affected3,071 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Intermittent claudication	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0013 affected3,071 at risk
Internal haemorrhage	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Ischaemia	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0011 affected3,071 at risk
Lymphocele	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Malignant hypertension	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0015 affected3,071 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0017 affected3,071 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0012 affected3,071 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0003 affected3,076 at risk EG0012 affected3,071 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0004 affected3,076 at risk EG0011 affected3,071 at risk
Peripheral embolism	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0005 affected3,076 at risk EG0014 affected3,071 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0002 affected3,076 at risk EG0017 affected3,071 at risk
Phlebitis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Shock	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Thromboangiitis obliterans	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Thrombophlebitis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0011 affected3,071 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0000 affected3,076 at risk EG0011 affected3,071 at risk
Thrombosis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Varicose vein	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Vasculitis	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 19.1 or later	Systematic Assessment	EG0001 affected3,076 at risk EG0010 affected3,071 at risk

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

ID	Title	Description
BG000	Dalcetrapib	Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
BG001	Placebo	Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets
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	Placebo	Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	180	3,076	923	3,076	818	3,076
EG001	Dalcetrapib	Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets	182	3,071	900	3,071	971	3,071