Fourier Open-label Extension Study in Subjects With Clini... | NCT03080935

ID	Type	Description	Link
2016-004066-26	EudraCT Number

Label	Type	Description	Intervention Names
Evolocumab	Experimental	Single arm study administering Evolocumab.	Drug: Evolocumab

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Drug	Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.	Evolocumab

Measure	Description	Time Frame
Number of Participants Who Experienced an Adverse Event	All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.	Up to 5 years

Measure	Description	Time Frame
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit		Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Algemeen Stedelijk Ziekenhuis Aalst		Aalst		9300	Belgium
Onze Lieve Vrouw Ziekenhuis Aalst

PubMed Identifier	Type	Citation	Retractions
36031810	Background	O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
38325990

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study	Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 19, 2020	Nov 17, 2022

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Haemorrhagic disorder	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Necrotic lymphadenopathy	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0017 affected854 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00018 affected745 at risk EG00115 affected854 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00026 affected745 at risk EG00124 affected854 at risk
Angina unstable	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00015 affected745 at risk EG00113 affected854 at risk
Aortic valve calcification	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00015 affected745 at risk EG00122 affected854 at risk
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Atrioventricular block	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0013 affected854 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Bundle branch block left	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Cardiac failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00017 affected745 at risk EG00127 affected854 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0016 affected854 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected745 at risk EG0015 affected854 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Chronic coronary syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected745 at risk EG00110 affected854 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected745 at risk EG00111 affected854 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0010 affected854 at risk
Left ventricular failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0014 affected854 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected745 at risk EG0019 affected854 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected745 at risk EG0013 affected854 at risk
Palpitations	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Sinoatrial block	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0013 affected854 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected745 at risk EG0014 affected854 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Von Hippel-Lindau disease	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0013 affected854 at risk
Adrenal haemorrhage	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hypercalcaemia of malignancy	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Blepharitis	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Blindness	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Corneal oedema	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Diplopia	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Glaucoma	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Keratopathy	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lens dislocation	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Retinal detachment	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Visual impairment	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0015 affected854 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Dental caries	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Enlarged uvula	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Gastric cyst	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gastrointestinal vascular malformation haemorrhagic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Melaena	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Peritoneal haematoma	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Chest discomfort	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0017 affected854 at risk
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Disease progression	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Fibrosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
General physical health deterioration	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Impaired healing	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Incarcerated hernia	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Inflammation	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Malaise	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Necrosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG00110 affected854 at risk
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Stent-graft endoleak	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Sudden cardiac death	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Sudden death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Unevaluable event	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Vascular stent occlusion	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Vascular stent stenosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0012 affected854 at risk
Vascular stent thrombosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Biliary polyp	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0013 affected854 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0019 affected854 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0015 affected854 at risk
Cholelithiasis obstructive	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Abdominal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Abscess jaw	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Appendicitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0014 affected854 at risk
Arthritis bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Bacterial infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0013 affected854 at risk
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0006 affected745 at risk EG0015 affected854 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0013 affected854 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0014 affected854 at risk
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Cholecystitis infective	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Dermo-hypodermitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Diverticulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Empyema	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Epididymitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Erysipelas	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0007 affected745 at risk EG0014 affected854 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Groin abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hepatitis A	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Herpes zoster cutaneous disseminated	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0015 affected854 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Influenza	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0011 affected854 at risk
Intervertebral discitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Klebsiella infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Liver abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Localised infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lymphangitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Mediastinal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Meningitis streptococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Oral infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Peritonitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00015 affected745 at risk EG00119 affected854 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0010 affected854 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Pneumonia viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Post procedural infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Postoperative wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Prostatitis Escherichia coli	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0012 affected854 at risk
Septic embolus	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Septic shock	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0010 affected854 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Staphylococcal infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Stomatococcal infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Tracheobronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0013 affected854 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0014 affected854 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0014 affected854 at risk
Vascular device infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0010 affected854 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0014 affected854 at risk
Electric injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0016 affected854 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0012 affected854 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Haematuria traumatic	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Hyphaema	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Joint dislocation postoperative	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Medical device monitoring error	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Muscle contusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Postpericardiotomy syndrome	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Restenosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Splinter	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0014 affected854 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Traumatic arthrosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Vascular anastomosis aneurysm	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Blood pressure orthostatic	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
C-reactive protein increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Cardiac function test abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Echocardiogram abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ejection fraction decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hepatic enzyme increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
International normalised ratio abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Oxygen saturation abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
SARS-CoV-2 antibody test positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Transvalvular pressure gradient increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Troponin increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Weight decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0011 affected854 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0015 affected854 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0011 affected854 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Overweight	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Steroid diabetes	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Inclusion body myositis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0016 affected854 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected745 at risk EG00115 affected854 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected745 at risk EG0011 affected854 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Angiosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Benign anorectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Bladder cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Bladder transitional cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Breast cancer male	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Cancer fatigue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Chromophobe renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Colon cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Colon cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Enchondromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gastrooesophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Lentigo maligna stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0013 affected854 at risk
Lung adenocarcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Lung squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Malignant palate neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Nasal neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Neuroendocrine tumour of the lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pancoast's tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0013 affected854 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0014 affected854 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Pleural mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Pleural neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0006 affected745 at risk EG0017 affected854 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Prostate cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0014 affected854 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Richter's syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Skin angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Small intestine carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Amputation stump pain	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0010 affected854 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0011 affected854 at risk
Cerebral thrombosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0016 affected854 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Coma	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Dementia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Dementia with Lewy bodies	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0011 affected854 at risk
Dysaesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Embolic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Essential tremor	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hemiplegia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Hydrocephalus	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected745 at risk EG00114 affected854 at risk
Memory impairment	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Nerve compression	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Peripheral nerve lesion	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Piriformis syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Post-traumatic headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Presyncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Sciatic nerve neuropathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Sciatica	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Syncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00010 affected745 at risk EG00110 affected854 at risk
Transient global amnesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected745 at risk EG0013 affected854 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Device dislocation	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Device material issue	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Device occlusion	Product Issues	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Device physical property issue	Product Issues	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Device power source issue	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Alcoholism	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Confusional state	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Eating disorder	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hallucination	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Insomnia	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Psychiatric decompensation	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Suicide attempt	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected745 at risk EG0018 affected854 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0015 affected854 at risk
Nephropathy	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Paroxysmal nocturnal haemoglobinuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Renal failure	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Renal impairment	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Urinary retention	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0010 affected854 at risk
Urinoma	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0015 affected854 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0012 affected854 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0010 affected854 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected745 at risk EG0014 affected854 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Hypersensitivity pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0013 affected854 at risk
Pulmonary granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0013 affected854 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hypertrichosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Ileectomy	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Mitral valve repair	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Aortic aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0013 affected854 at risk
Aortic stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Arterial stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Arteriosclerosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Extremity necrosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0012 affected854 at risk
Hypertensive crisis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0011 affected854 at risk
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0011 affected854 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0013 affected854 at risk
Intermittent claudication	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0012 affected854 at risk
Ischaemic limb pain	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Lymphocele	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0012 affected854 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00012 affected745 at risk EG00112 affected854 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected745 at risk EG0012 affected854 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected745 at risk EG0014 affected854 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected745 at risk EG0014 affected854 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0015 affected854 at risk
Peripheral vein stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected745 at risk EG0010 affected854 at risk
Thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Vascular pain	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected745 at risk EG0011 affected854 at risk

ID	Title	Description
BG000	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study	Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.
BG001	Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study	Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.
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 in Parent Study	Participants with Placebo in Parent Study	35	745	323	745	451	745
EG001	Evolocumab in Parent Study	Participants with Evolocumab in Parent Study	51	855	410	854	528	854

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases