An Investigational Drug on Clinical Outcomes in Patients... | NCT00092677

ID	Type	Description	Link
2004_050	Other Identifier	Merck Study Number

Label	Type	Description	Intervention Names
EZ/Simva 10/40 mg	Experimental	Ezetimibe 10 mg + Simvastatin 40 mg	Drug: ezetimibe (+) simvastatin
Placebo	Placebo Comparator		Drug: Comparator: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ezetimibe (+) simvastatin	Drug	Duration of Treatment: 4 years	EZ/Simva 10/40 mg

Measure	Description	Time Frame
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)	Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke	Entire follow-up (median = 4.35 years)

Measure	Description	Time Frame
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)	Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death	Entire follow-up (median = 4.35 years)
Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)

Measure	Description	Time Frame
Cardiovascular Death	Number of participants that experienced cardiovascular death	Entire follow-up (median = 4.35 years)
Aortic Valve Replacement (AVR)	Number of participants that experienced aortic valve replacement (AVR)

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
18765433	Background	Rossebo AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Barwolf C, Holme I, Kesaniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R; SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med. 2008 Sep 25;359(13):1343-56. doi: 10.1056/NEJMoa0804602. Epub 2008 Sep 2.
18805118

ID	Title	Description
FG000	EZ/Simva 10/40 mg	Ezetimibe 10 mg + Simvastatin 40 mg
FG001	Placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG00012 affected943 at risk EG0018 affected929 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
AV dissociation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Angina pectoris	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0018 affected929 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG00069 affected943 at risk EG00160 affected929 at risk
Arrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG00045 affected943 at risk EG00127 affected929 at risk
Atrial flutter	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0008 affected943 at risk EG0011 affected929 at risk
Atrial tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Atrial thrombosis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Atrioventricular block	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0006 affected943 at risk EG0015 affected929 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0013 affected929 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Bradycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cardiac amyloidosis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Cardiac disorder	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cardiac failure	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0005 affected943 at risk EG0016 affected929 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Cardiac tamponade	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0015 affected929 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Dressler's syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Extrasystoles	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hypertrophic cardiomyopathy	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG0017 affected929 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0010 affected929 at risk
Myocarditis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Palpitations	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0005 affected943 at risk EG0017 affected929 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0016 affected929 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Sinoatrial block	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0011 affected929 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Gastrointestinal angiodysplasia	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Gastrointestinal angiodysplasia haemorrhagic	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0006 affected943 at risk EG0017 affected929 at risk
Goitre	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Hyperthyroidism	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Amaurosis fugax	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cataract	Eye disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0016 affected929 at risk
Dacryostenosis acquired	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Diplopia	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Eye haemorrhage	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Glaucoma	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0013 affected929 at risk
Retinal artery occlusion	Eye disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0011 affected929 at risk
Retinal detachment	Eye disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Vitreous haemorrhage	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0009 affected943 at risk EG0015 affected929 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0013 affected929 at risk
Anal polyp	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Appendicitis perforated	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0012 affected929 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0013 affected929 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG0012 affected929 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0013 affected929 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Heyde's syndrome	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Ileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00015 affected943 at risk EG00115 affected929 at risk
Intestinal ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0015 affected929 at risk
Necrotising oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Peritonitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0011 affected929 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Alanine aminotransferase increased	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Aspartate aminotransferase increased	General disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0010 affected929 at risk
Blood creatine phosphokinase increased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Blood creatinine increased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Blood potassium increased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Blood sodium decreased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Blood urine present	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
C-reactive protein increased	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cardiac output decreased	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Ejection fraction decreased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Electrocardiogram abnormal	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Haemoglobin decreased	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
International normalised ratio	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
International normalised ratio decreased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
International normalised ratio increased	General disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0014 affected929 at risk
Occult blood positive	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Platelet count decreased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Prostatic specific antigen increased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Pulmonary function test decreased	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Total lung capacity decreased	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Weight decreased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Adverse drug reaction	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Asthenia	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Atrophy	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Catheter related complication	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Catheter site haemorrhage	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Chest discomfort	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Chest pain	General disorders	MedDRA	Non-systematic Assessment	EG00021 affected943 at risk EG00115 affected929 at risk
Death	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Drowning	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Fatigue	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
General physical health deterioration	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Hernia	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Impaired healing	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Inflammation	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Malaise	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Mechanical complication of implant	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Multi-organ failure	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0013 affected929 at risk
Necrosis	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Non-cardiac chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0005 affected943 at risk EG0013 affected929 at risk
Oedema peripheral	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Pain	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0006 affected943 at risk EG0012 affected929 at risk
Sudden cardiac death	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Sudden death	General disorders	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG0016 affected929 at risk
Ulcer	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cholangitis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0014 affected929 at risk
Gallbladder pain	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Anaphylactic reaction	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Corneal graft rejection	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Secondary immunodeficiency	Immune system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Anal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Arthritis infective	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0011 affected929 at risk
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Chronic sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Chronic tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0010 affected929 at risk
Cystitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Diverticulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0014 affected929 at risk
Endocarditis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG00111 affected929 at risk
Endocarditis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Enterococcal sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Erysipelas	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0016 affected929 at risk
Febrile infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Fungal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Gangrene	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG0011 affected929 at risk
Groin abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Haematoma infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Herpes zoster	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Intestinal gangrene	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Klebsiella sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Laryngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Localised infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Lung infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Mastoiditis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Mediastinitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Neuroborreliosis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Orchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Peritonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG00028 affected943 at risk EG00131 affected929 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Post procedural infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Pseudomonas infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Pyelonephritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Pyothorax	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Rash pustular	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0006 affected943 at risk EG0016 affected929 at risk
Sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Skin infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Sternitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Streptococcal sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Subcutaneous abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Tooth abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00010 affected943 at risk EG00113 affected929 at risk
Urosepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0011 affected929 at risk
Wound infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Asbestosis	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cardiac pacemaker malfunction	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cerebral haemorrhage traumatic	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Device failure	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Device occlusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Drug administration error	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG0013 affected929 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0015 affected929 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0016 affected929 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0014 affected929 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Open wound	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0014 affected929 at risk
Postoperative constipation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Postpericardiotomy syndrome	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Renal haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Snake bite	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Podagra	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0011 affected929 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0012 affected929 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0010 affected929 at risk
Articular calcification	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0012 affected929 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
CREST syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0010 affected929 at risk
Joint ankylosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Limb deformity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Muscle necrosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Myalgia intercostal	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Myosclerosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG00019 affected943 at risk EG00121 affected929 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0015 affected929 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Spondylolysis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0013 affected929 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0009 affected943 at risk EG0014 affected929 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0014 affected929 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Bone neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0008 affected943 at risk EG0012 affected929 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cerebellar tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0014 affected929 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Lip neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0013 affected929 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0012 affected929 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Metastases to bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Metastases to gallbladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Myeloproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Non-Hodgkin's lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0013 affected929 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Pelvic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG00021 affected943 at risk EG00114 affected929 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0013 affected929 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0011 affected929 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Balance disorder	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0014 affected929 at risk
Cognitive disorder	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Dementia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Dizziness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG0013 affected929 at risk
Encephalitis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Epilepsy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0007 affected943 at risk EG0012 affected929 at risk
Facial palsy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Global amnesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Hemiparesis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Motor neurone disease	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Narcolepsy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Presyncope	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0015 affected929 at risk
Radicular syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Senile dementia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Spinal cord compression	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Subdural hygroma	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Syncope	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00014 affected943 at risk EG00119 affected929 at risk
Syncope vasovagal	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00011 affected943 at risk EG00111 affected929 at risk
Anxiety	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Completed suicide	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Confusional state	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0010 affected929 at risk
Delusional disorder, persecutory type	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0012 affected929 at risk
Major depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Mental disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Mental disorder due to a general medical condition	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Panic attack	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Psychosomatic disease	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Anuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Azotaemia	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Calculus bladder	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Calculus urinary	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Haematuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0013 affected929 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Nephritis interstitial	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0011 affected929 at risk
Renal artery arteriosclerosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Renal failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0015 affected929 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0014 affected929 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Bartholinitis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0019 affected929 at risk
Cystocele	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Prostatism	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Spermatocele	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Uterine malposition	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Cheyne-Stokes respiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0015 affected929 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00012 affected943 at risk EG00112 affected929 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Eosinophilic pneumonia chronic	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0009 affected943 at risk EG0011 affected929 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0009 affected943 at risk EG0017 affected929 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0010 affected929 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0010 affected929 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0014 affected929 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0014 affected929 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Vasculitic rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Cardiac assistance device user	Social circumstances	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Angiodysplasia	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Non-systematic Assessment	EG0006 affected943 at risk EG0014 affected929 at risk
Aortic dissection	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Aortic rupture	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Arteriovenous fistula	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Bleeding varicose vein	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Circulatory collapse	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0012 affected929 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Haematoma	Vascular disorders	MedDRA	Non-systematic Assessment	EG0003 affected943 at risk EG0013 affected929 at risk
Haemorrhage	Vascular disorders	MedDRA	Non-systematic Assessment	EG0004 affected943 at risk EG0011 affected929 at risk
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0013 affected929 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0012 affected929 at risk
Hypotension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Intermittent claudication	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0013 affected929 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0010 affected929 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Phlebitis superficial	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Shock	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Shock haemorrhagic	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk
Thrombophlebitis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0011 affected929 at risk
Varicose vein	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Vascular occlusion	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Vascular pseudoaneurysm	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0012 affected929 at risk
Venous stasis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected943 at risk EG0011 affected929 at risk
Venous thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected943 at risk EG0011 affected929 at risk
Venous thrombosis limb	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected943 at risk EG0010 affected929 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	EZ/Simva 10/40 mg	Ezetimibe 10 mg + Simvastatin 40 mg			471		703
EG001	Placebo				465		706

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction

ID	Term
D019821	Simvastatin
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D000069438	Ezetimibe
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011083	Polycyclic Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	EZ/Simva 10/40 mg	Ezetimibe 10 mg + Simvastatin 40 mg
BG001	Placebo
BG002	Total	Total of all reporting groups