Further Cardiovascular Outcomes Research With PCSK9 Inhib... | NCT02867813

ID	Type	Description	Link
2015-004780-36	EudraCT Number

Label	Type	Description	Intervention Names
evolocumab (AMG 145)	Experimental	All subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference.	Biological: Evolocumab

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Biological	subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.	evolocumab (AMG 145)

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		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
Research Site		Birmingham	Alabama	35294	United States
Research Site

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.
36779348

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study	Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly 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 26, 2020	Feb 2, 2023

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00013 affected2,532 at risk EG00118 affected2,499 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0018 affected2,499 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0012 affected2,499 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Acute cardiac event	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00010 affected2,532 at risk EG0016 affected2,499 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0013 affected2,499 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00074 affected2,532 at risk EG00152 affected2,499 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00056 affected2,532 at risk EG00152 affected2,499 at risk
Angina unstable	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00049 affected2,532 at risk EG00137 affected2,499 at risk
Aortic valve disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Arrhythmic storm	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00057 affected2,532 at risk EG00147 affected2,499 at risk
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected2,532 at risk EG00113 affected2,499 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Atrioventricular block	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected2,532 at risk EG0019 affected2,499 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0015 affected2,499 at risk
Bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG0019 affected2,499 at risk
Bundle branch block left	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00016 affected2,532 at risk EG00113 affected2,499 at risk
Cardiac asthma	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Cardiac disorder	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Cardiac failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00046 affected2,532 at risk EG00144 affected2,499 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00021 affected2,532 at risk EG00117 affected2,499 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00013 affected2,532 at risk EG00123 affected2,499 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00037 affected2,532 at risk EG00140 affected2,499 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0012 affected2,499 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0010 affected2,499 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0013 affected2,499 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00041 affected2,532 at risk EG00130 affected2,499 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0015 affected2,499 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG0014 affected2,499 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0015 affected2,499 at risk
Left ventricular failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG0014 affected2,499 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00025 affected2,532 at risk EG00120 affected2,499 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00015 affected2,532 at risk EG00111 affected2,499 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Palpitations	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Paroxysmal atrioventricular block	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pericarditis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Right ventricular failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0018 affected2,499 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0018 affected2,499 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0016 affected2,499 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0013 affected2,499 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG00017 affected2,532 at risk EG00114 affected2,499 at risk
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Talipes	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Deafness	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
External ear disorder	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Neurosensory hypoacusis	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0010 affected2,499 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0014 affected2,499 at risk
Vertigo labyrinthine	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Vestibular ataxia	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Goitre	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Amaurosis fugax	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Cataract	Eye disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected2,532 at risk EG0018 affected2,499 at risk
Choroidal detachment	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Diabetic retinopathy	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Diplopia	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Epiretinal membrane	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Eyelid bleeding	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Eyelid ptosis	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Glaucoma	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Macular rupture	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Retinal detachment	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Vision blurred	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Visual impairment	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0012 affected2,499 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Abdominal symptom	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Abnormal faeces	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0015 affected2,499 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Colon dysplasia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0013 affected2,499 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0011 affected2,499 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Femoral hernia strangulated	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Gastric volvulus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0012 affected2,499 at risk
Gastritis alcoholic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected2,532 at risk EG00116 affected2,499 at risk
Gastrointestinal vascular malformation haemorrhagic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0012 affected2,499 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG00111 affected2,499 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Intestinal angina	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0016 affected2,499 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0012 affected2,499 at risk
Melaena	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Pancreatic failure	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0011 affected2,499 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG00110 affected2,499 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Proctitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0014 affected2,499 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Salivary gland cyst	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0014 affected2,499 at risk
Subileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0012 affected2,499 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0018 affected2,499 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Adverse drug reaction	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0011 affected2,499 at risk
Chest discomfort	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG00015 affected2,532 at risk EG0017 affected2,499 at risk
Complication associated with device	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected2,532 at risk EG00110 affected2,499 at risk
Exercise tolerance decreased	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hernia	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Impaired healing	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Implant site haematoma	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Implant site pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Inflammation	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0016 affected2,499 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG00026 affected2,532 at risk EG00137 affected2,499 at risk
Pneumatosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Prosthetic cardiac valve stenosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Stent-graft endoleak	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Sudden cardiac death	General disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0013 affected2,499 at risk
Sudden death	General disorders	MedDRA 24.1	Systematic Assessment	EG00010 affected2,532 at risk EG0016 affected2,499 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Vascular stent occlusion	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Vascular stent stenosis	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Alcoholic liver disease	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0014 affected2,499 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG00110 affected2,499 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG00013 affected2,532 at risk EG00111 affected2,499 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Hyperplastic cholecystopathy	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Liver injury	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Contrast media allergy	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Abdominal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Abscess bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Abscess limb	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Acute endocarditis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Appendicitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0011 affected2,499 at risk
Appendicitis perforated	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0010 affected2,499 at risk
Arthritis bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Arthritis infective	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Atypical pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Bacterial infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Breast abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG00110 affected2,499 at risk
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00015 affected2,532 at risk EG00115 affected2,499 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00032 affected2,532 at risk EG00123 affected2,499 at risk
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00017 affected2,532 at risk EG00120 affected2,499 at risk
Cholecystitis infective	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Cholera	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Coccidioidomycosis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Colonic abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Coronavirus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Cystitis klebsiella	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Device related infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Diabetic foot infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Diabetic gangrene	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Diverticulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00011 affected2,532 at risk EG0017 affected2,499 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Eczema infected	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Epididymitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Erysipelas	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Escherichia sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Extradural abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Fungal skin infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Gallbladder abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gallbladder empyema	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Gangrene	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0015 affected2,499 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0011 affected2,499 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Groin abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Herpes zoster	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Infected skin ulcer	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Influenza	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00011 affected2,532 at risk EG0016 affected2,499 at risk
Intervertebral discitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Joint abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Kidney infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Klebsiella infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Localised infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Lung abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Lyme disease	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Meningoencephalitis viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Orchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Osteomyelitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0012 affected2,499 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Otitis media chronic	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Paronychia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Parotid abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Perihepatic abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Perineal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Peritonitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00050 affected2,532 at risk EG00174 affected2,499 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0015 affected2,499 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0009 affected2,532 at risk EG0013 affected2,499 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pneumonia legionella	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pneumonia viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Post procedural infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Post procedural sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Postoperative wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0012 affected2,499 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Rectal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Rocky mountain spotted fever	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00014 affected2,532 at risk EG00123 affected2,499 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Septic shock	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Serratia infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Staphylococcal infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Tracheobronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Tuberculosis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00014 affected2,532 at risk EG00113 affected2,499 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0014 affected2,499 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Wound infection bacterial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Wound sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0012 affected2,499 at risk
Aortic pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Coronary artery reocclusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Crush injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Dislocation of sternum	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Dural tear	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0009 affected2,532 at risk EG00110 affected2,499 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Femoral nerve injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0013 affected2,499 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Frostbite	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0019 affected2,499 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0015 affected2,499 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Intervertebral disc injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0012 affected2,499 at risk
Pelvic organ injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Periprocedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0013 affected2,499 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Post procedural hypotension	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Post procedural pulmonary embolism	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0016 affected2,499 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0014 affected2,499 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0015 affected2,499 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0010 affected2,499 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0013 affected2,499 at risk
Vascular pseudoaneurysm ruptured	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anticoagulation drug level below therapeutic	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hepatic enzyme increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
International normalised ratio decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
International normalised ratio increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Respiratory syncytial virus test positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Squamous cell carcinoma antigen	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Transaminases increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Troponin I increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Troponin increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG00110 affected2,499 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG00112 affected2,499 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0014 affected2,499 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0012 affected2,499 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0010 affected2,499 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0015 affected2,499 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Mineral deficiency	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0013 affected2,499 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0018 affected2,499 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0011 affected2,499 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0013 affected2,499 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0011 affected2,499 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG0016 affected2,499 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Knee impingement syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0019 affected2,499 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0016 affected2,499 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00037 affected2,532 at risk EG00136 affected2,499 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0012 affected2,499 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0018 affected2,499 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0015 affected2,499 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG00110 affected2,499 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Anal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Benign male reproductive tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Benign neoplasm of ampulla of Vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Benign spleen tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Bladder adenocarcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0015 affected2,499 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Bladder cancer stage I, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Bladder cancer stage I, without cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0015 affected2,499 at risk
Bladder transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0013 affected2,499 at risk
Diffuse large B-cell lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ductal adenocarcinoma of pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Follicular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Gastrointestinal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Glottis carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0013 affected2,499 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Laryngeal cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Laryngeal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG00010 affected2,532 at risk EG0016 affected2,499 at risk
Lung adenocarcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Lung carcinoma cell type unspecified stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0016 affected2,499 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Mantle cell lymphoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Metastases to spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0012 affected2,499 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Oesophageal adenocarcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Ovarian cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Paget's disease of nipple	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0015 affected2,499 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Pancreatic carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pelvic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Penile cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Phosphaturic mesenchymal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Pleomorphic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Porocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG00018 affected2,532 at risk EG00116 affected2,499 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Prostate cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Prostate cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Renal cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Renal cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0014 affected2,499 at risk
Small cell lung cancer extensive stage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Soft tissue sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Squamous cell carcinoma of the hypopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0012 affected2,499 at risk
Transitional cell carcinoma urethra	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Vulval cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Aphasia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Axonal neuropathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Balance disorder	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Basilar artery stenosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Carotid artery disease	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0013 affected2,499 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected2,532 at risk EG00110 affected2,499 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Cerebral amyloid angiopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cerebral ataxia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0012 affected2,499 at risk
Cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0011 affected2,499 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00025 affected2,532 at risk EG00120 affected2,499 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Cognitive disorder	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Dementia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG0012 affected2,499 at risk
Dizziness postural	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Embolic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0011 affected2,499 at risk
Encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Facial paralysis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Facial paresis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Focal dyscognitive seizures	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0012 affected2,499 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0012 affected2,499 at risk
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0013 affected2,499 at risk
Hemianopia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hemiparaesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hemiparesis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00018 affected2,532 at risk EG00127 affected2,499 at risk
Lacunar infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Lacunar stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Loss of consciousness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Memory impairment	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Migraine	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Monoparesis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Moyamoya disease	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Myelopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Nerve compression	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Paraesthesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Paresis cranial nerve	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Parkinson's disease	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Partial seizures	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Peripheral nerve lesion	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Phantom limb syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Polyneuropathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Post stroke epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Presyncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Psychogenic seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Radiculopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Sciatica	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0010 affected2,499 at risk
Seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Spinal cord compression	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0014 affected2,499 at risk
Syncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00019 affected2,532 at risk EG00114 affected2,499 at risk
Thalamic infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Transient global amnesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00011 affected2,532 at risk EG00114 affected2,499 at risk
Vascular dementia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0012 affected2,499 at risk
Vertebrobasilar stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Device dislocation	Product Issues	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Device failure	Product Issues	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Device loosening	Product Issues	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Device malfunction	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Device mechanical issue	Product Issues	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Device occlusion	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Device power source issue	Product Issues	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Device stimulation issue	Product Issues	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Lead dislodgement	Product Issues	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Acute psychosis	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0014 affected2,499 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Anxiety	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Anxiety disorder due to a general medical condition	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Completed suicide	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Confusional state	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Delirium	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Major depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Mania	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Mental status changes	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected2,532 at risk EG0013 affected2,499 at risk
Paranoia	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Stress	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG00025 affected2,532 at risk EG00130 affected2,499 at risk
Bladder stenosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0016 affected2,499 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0014 affected2,499 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0012 affected2,499 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Incontinence	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0019 affected2,499 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Obstructive nephropathy	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Renal colic	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Renal cyst	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Renal embolism	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal failure	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Renal haematoma	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Renal impairment	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Renal mass	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0015 affected2,499 at risk
Urethral perforation	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Urinary retention	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0009 affected2,532 at risk EG0017 affected2,499 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Genital haemorrhage	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pelvic organ prolapse	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Prostatic dysplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Uterine inflammation	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0008 affected2,532 at risk EG00123 affected2,499 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0014 affected2,499 at risk
Asthma late onset	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Bronchopulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00025 affected2,532 at risk EG00130 affected2,499 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG0019 affected2,499 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Epiglottic mass	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0013 affected2,499 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0015 affected2,499 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Pneumonitis aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00012 affected2,532 at risk EG00112 affected2,499 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0012 affected2,499 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00013 affected2,532 at risk EG00116 affected2,499 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0011 affected2,499 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Dermatitis herpetiformis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0014 affected2,499 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Tissue expansion procedure	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Accelerated hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Aortic aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00013 affected2,532 at risk EG00110 affected2,499 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0011 affected2,499 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Aortic dissection	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Aortic stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG00110 affected2,499 at risk
Aortic thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Arterial perforation	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Arterial stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Arteriosclerosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0017 affected2,499 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Blue toe syndrome	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Circulatory collapse	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0014 affected2,499 at risk
Diabetic macroangiopathy	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Dry gangrene	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0015 affected2,499 at risk
Embolism arterial	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Extremity necrosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Giant cell arteritis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00020 affected2,532 at risk EG00110 affected2,499 at risk
Hypertensive crisis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0014 affected2,499 at risk
Hypertensive emergency	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Hypertensive urgency	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0007 affected2,532 at risk EG0015 affected2,499 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Iliac artery embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0010 affected2,499 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Intermittent claudication	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0012 affected2,499 at risk
Internal haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Leriche syndrome	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected2,532 at risk EG0010 affected2,499 at risk
Lymphoedema	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected2,532 at risk EG0015 affected2,499 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00024 affected2,532 at risk EG00126 affected2,499 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG0011 affected2,499 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0013 affected2,499 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Peripheral circulatory failure	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Peripheral embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0006 affected2,532 at risk EG00110 affected2,499 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected2,532 at risk EG00110 affected2,499 at risk
Peripheral venous disease	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0011 affected2,499 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Shock	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0011 affected2,499 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Subclavian artery embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Subclavian artery occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0011 affected2,499 at risk
Subclavian vein occlusion	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Superior vena cava stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Thrombophlebitis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected2,532 at risk EG0014 affected2,499 at risk
Varicose vein	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Venous haemorrhage	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected2,532 at risk EG0010 affected2,499 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected2,532 at risk EG0012 affected2,499 at risk

ID	Title	Description
BG000	Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study	Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference.
BG001	Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study	Participants in the parent study who received evolocumab 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.
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	309	2,535	1,077	2,532	956	2,532
EG001	Evolocumab in Parent Study	Participants with Evolocumab in Parent Study	287	2,500	1,045	2,499	959	2,499

ID	Term
D050171	Dyslipidemias
D006937	Hypercholesterolemia

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D006949	Hyperlipidemias