Prospective Randomized Evaluation Of Celecoxib Integrated... | NCT00346216

ID	Type	Description	Link
2004-002441-13	EudraCT Number
PRECISION TRIAL	Other Identifier	Alias Study Number

Name	Class
The Cleveland Clinic	OTHER

Label	Type	Description	Intervention Names
celecoxib	Experimental	subject receives celecoxib and dummy (placebo) ibuprofen and naproxen	Drug: celecoxib
ibuprofen	Active Comparator	subject receives ibuprofen and dummy (placebo) celecoxib and naproxen	Drug: Ibuprofen
naproxen	Active Comparator	subject receives naproxen and dummy (placebo) celecoxib and ibuprofen	Drug: Naproxen

Name	Type	Description	Arm Group Labels	Other Names
celecoxib	Drug	100 to 200 mg twice daily, taken by mouth	celecoxib

Measure	Description	Time Frame
The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).	APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).	Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months

Measure	Description	Time Frame
The First Occurrence of a Major Adverse Cardiovascular Events (MACE)	MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA	ITT Population - 30 months; MITT Population - 42 months
The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Carol M. Johnson MD, LLC		Alabaster	Alabama	35007	United States
Orthopaedics West

PubMed Identifier	Type	Citation	Retractions
40627752	Derived	Agarwal N, St John J, Sunder V, Sarraju A, Laffin LJ. Association of Systolic Blood Pressure Time in Target Range With Cardiovascular Events Among PRECISION Participants. J Clin Hypertens (Greenwich). 2025 Jul;27(7):e70009. doi: 10.1111/jch.70009.
35234840	Derived	Obeid S, Libby P, Husni E, Wang Q, Wisniewski LM, Davey DA, Wolski KE, Xia F, Bao W, Walker C, Ruschitzka F, Nissen SE, Luscher TF. Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trial. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 3;8(6):611-621. doi: 10.1093/ehjcvp/pvac015.

ID	Title	Description
FG000	Celecoxib	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
FG001	Ibuprofen	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG00015 affected8,030 at risk EG00134 affected7,992 at risk EG00224 affected7,933 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG00110 affected7,992 at risk EG00211 affected7,933 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0025 affected7,933 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG0017 affected7,992 at risk EG0023 affected7,933 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00022 affected8,030 at risk EG00120 affected7,992 at risk EG00218 affected7,933 at risk
Angina pectoris	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00013 affected8,030 at risk EG00111 affected7,992 at risk EG00213 affected7,933 at risk
Angina unstable	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00045 affected8,030 at risk EG00141 affected7,992 at risk EG00260 affected7,933 at risk
Aortic valve disease	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Arrhythmia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0017 affected7,992 at risk EG0023 affected7,933 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0015 affected7,992 at risk EG0027 affected7,933 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00035 affected8,030 at risk EG00139 affected7,992 at risk EG00236 affected7,933 at risk
Atrial flutter	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Atrioventricular block	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0017 affected7,992 at risk EG0022 affected7,933 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Atrioventricular dissociation	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bradycardia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00010 affected8,030 at risk EG00111 affected7,992 at risk EG0026 affected7,933 at risk
Bundle branch block left	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Bundle branch block right	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cardiac arrest	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0019 affected7,992 at risk EG0026 affected7,933 at risk
Cardiac disorder	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Cardiac failure	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0018 affected7,992 at risk EG0024 affected7,933 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00031 affected8,030 at risk EG00141 affected7,992 at risk EG00241 affected7,933 at risk
Cardiac tamponade	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cardiac valve disease	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0015 affected7,992 at risk EG0024 affected7,933 at risk
Cardiogenic shock	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0022 affected7,933 at risk
Cardiomyopathy	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0014 affected7,992 at risk EG0022 affected7,933 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Cor pulmonale chronic	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Coronary artery disease	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00042 affected8,030 at risk EG00140 affected7,992 at risk EG00244 affected7,933 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0009 affected8,030 at risk EG0018 affected7,992 at risk EG0028 affected7,933 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0019 affected7,992 at risk EG0026 affected7,933 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Extrasystoles	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Heart valve incompetence	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hypertensive cardiomyopathy	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Left ventricular failure	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Mitral valve disease	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Myocardial infarction	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG00045 affected8,030 at risk EG00170 affected7,992 at risk EG00248 affected7,933 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0017 affected7,992 at risk EG0023 affected7,933 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Palpitations	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0024 affected7,933 at risk
Pericardial effusion	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Pericarditis	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0024 affected7,933 at risk
Pleuropericarditis	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Postinfarction angina	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Prinzmetal angina	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Sinus bradycardia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0024 affected7,933 at risk
Sinus tachycardia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0018 affected7,992 at risk EG0024 affected7,933 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Tachycardia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0025 affected7,933 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Cardiac septal defect	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cerebrovascular arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Choledochal cyst	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Diverticulitis Meckel's	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Haemorrhagic arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Renal hypoplasia	Congenital, familial and genetic disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Deafness	Ear and labyrinth disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0012 affected7,992 at risk EG0028 affected7,933 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Adrenal haemorrhage	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Goitre	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0020 affected7,933 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0014 affected7,992 at risk EG0020 affected7,933 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hyperthyroidism	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hypogonadism	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hypoparathyroidism	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Myxoedema	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Parathyroid disorder	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Thyroid mass	Endocrine disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cataract	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Diplopia	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Eye haemorrhage	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Glaucoma	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Optic neuropathy	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Retinal detachment	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Retinal haemorrhage	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Retinal vein occlusion	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Vision blurred	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Visual impairment	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Vitreous detachment	Eye disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0014 affected7,992 at risk EG0027 affected7,933 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG00014 affected8,030 at risk EG0017 affected7,992 at risk EG00213 affected7,933 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0022 affected7,933 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Ascites	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Autoimmune pancreatitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Colitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Constipation	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0018 affected7,992 at risk EG0025 affected7,933 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Diverticulum	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Duodenitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Enteritis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Enterocele	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Faecaloma	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Food poisoning	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG00112 affected7,992 at risk EG0025 affected7,933 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastric varices	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gastric volvulus	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Gastritis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0016 affected7,992 at risk EG0025 affected7,933 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0016 affected7,992 at risk EG0021 affected7,933 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Gastroduodenal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0022 affected7,933 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG0018 affected7,992 at risk EG0028 affected7,933 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal stenosis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0024 affected7,933 at risk
Haematochezia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Ileal ulcer	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Ileus	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Intestinal dilatation	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0025 affected7,933 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Intestinal ulcer	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Megacolon	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Melaena	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Nausea	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0013 affected7,992 at risk EG0026 affected7,933 at risk
Necrotising colitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Oedematous pancreatitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG00112 affected7,992 at risk EG00212 affected7,933 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0014 affected7,992 at risk EG0026 affected7,933 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0014 affected7,992 at risk EG0022 affected7,933 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Retroperitoneal mass	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG0019 affected7,992 at risk EG0028 affected7,933 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Volvulus	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Vomiting	Gastrointestinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0017 affected7,992 at risk EG0027 affected7,933 at risk
Adverse drug reaction	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Asthenia	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0015 affected7,992 at risk EG0024 affected7,933 at risk
Cardiac death	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Chest discomfort	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0015 affected7,992 at risk EG0024 affected7,933 at risk
Chest pain	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG00052 affected8,030 at risk EG00184 affected7,992 at risk EG00273 affected7,933 at risk
Complication associated with device	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Cyst rupture	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Death	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0013 affected7,992 at risk EG0027 affected7,933 at risk
Device related thrombosis	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Drowning	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Drug interaction	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Electrocution	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Fatigue	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Feeling hot	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
General physical health deterioration	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Generalised oedema	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Granuloma	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hernia	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Ill-defined disorder	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Impaired healing	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Incarcerated hernia	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Influenza like illness	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Local swelling	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Malaise	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Necrosis	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Non-cardiac chest pain	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG00023 affected8,030 at risk EG00119 affected7,992 at risk EG00223 affected7,933 at risk
Oedema peripheral	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Organ failure	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pain	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pelvic mass	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Peripheral swelling	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Polyp	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pyrexia	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0014 affected7,992 at risk EG0023 affected7,933 at risk
Sudden cardiac death	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Sudden death	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Surgical failure	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Vascular stent stenosis	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Vascular stent thrombosis	General disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0025 affected7,933 at risk
Biliary colic	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cholangitis	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG00110 affected7,992 at risk EG00211 affected7,933 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0009 affected8,030 at risk EG00111 affected7,992 at risk EG0025 affected7,933 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG00024 affected8,030 at risk EG00123 affected7,992 at risk EG00212 affected7,933 at risk
Cholestasis	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hepatic vein thrombosis	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hepatitis	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Jaundice hepatocellular	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Liver disorder	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Anaphylactic reaction	Immune system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Anaphylactic shock	Immune system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Hypersensitivity	Immune system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Sarcoidosis	Immune system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Abdominal abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Abdominal infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Abdominal wall abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Abscess intestinal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Abscess limb	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0022 affected7,933 at risk
Abscess neck	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Acute sinusitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Anal abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Appendiceal abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Appendicitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG0017 affected7,992 at risk EG0027 affected7,933 at risk
Appendicitis perforated	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0022 affected7,933 at risk
Arthritis bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Arthritis infective	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Atypical pneumonia	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Bacteraemia	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bacterial disease carrier	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bacterial infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Bacterial sepsis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bone tuberculosis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Breast abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Bronchitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG00010 affected8,030 at risk EG00116 affected7,992 at risk EG00217 affected7,933 at risk
Bronchitis bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bursitis infective	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cellulitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG00029 affected8,030 at risk EG00132 affected7,992 at risk EG00232 affected7,933 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Cholecystitis infective	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Chronic pulmonary histoplasmosis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Chronic sinusitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Clostridium difficile infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Cystitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Dengue fever	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Device related infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0023 affected7,933 at risk
Diabetic foot infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Diverticulitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG00012 affected8,030 at risk EG00113 affected7,992 at risk EG00217 affected7,933 at risk
Embolic pneumonia	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Empyema	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Encephalitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Endocarditis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Epididymitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Erysipelas	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Escherichia infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Escherichia sepsis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Extradural abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Gangrene	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Gastroenteritis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG00012 affected8,030 at risk EG00121 affected7,992 at risk EG0027 affected7,933 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0014 affected7,992 at risk EG0023 affected7,933 at risk
Gastrointestinal infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Genitourinary tract infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Groin abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
H1N1 influenza	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
HIV infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Haemophilus infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Helicobacter gastritis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hepatic infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Herpes oesophagitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Herpes simplex	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Herpes zoster	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Incision site infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Infected skin ulcer	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Infectious colitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Infectious pleural effusion	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Infective tenosynovitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Influenza	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0021 affected7,933 at risk
Intervertebral discitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Joint abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Kidney infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Klebsiella infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Liver abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Localised infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0012 affected7,992 at risk EG0025 affected7,933 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Lung infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Lymphangitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Meningitis bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Necrotising fasciitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Nosocomial infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Oral candidiasis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Orchitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Osteomyelitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0009 affected8,030 at risk EG0016 affected7,992 at risk EG0028 affected7,933 at risk
Osteomyelitis acute	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Otitis media	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pancreatic abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Pancreatitis bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Pancreatitis viral	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Parametritis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Paraspinal abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Parotitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Periodontitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Perirectal abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Peritonitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Peritonitis bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Peritonsillar abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pharyngitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pleurisy viral	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pneumonia	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG00064 affected8,030 at risk EG00179 affected7,992 at risk EG00269 affected7,933 at risk
Pneumonia bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pneumonia fungal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Post procedural infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Postoperative abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Postoperative wound infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Prostate infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Proteus infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pyelonephritis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0019 affected7,992 at risk EG0028 affected7,933 at risk
Pyelonephritis acute	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pyometra	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Respiratory tract infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Sepsis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG00019 affected8,030 at risk EG00120 affected7,992 at risk EG00212 affected7,933 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Septic shock	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0015 affected7,992 at risk EG0024 affected7,933 at risk
Sinusitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0015 affected7,992 at risk EG0020 affected7,933 at risk
Skin infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Spinal cord abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Staphylococcal abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Staphylococcal infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0012 affected7,992 at risk EG0024 affected7,933 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Stenotrophomonas infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Subcutaneous abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Tinea pedis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Tonsillitis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Tooth abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Tooth infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Tuberculosis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Urinary tract infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG00016 affected8,030 at risk EG00122 affected7,992 at risk EG00220 affected7,933 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Urosepsis	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0009 affected8,030 at risk EG0018 affected7,992 at risk EG0026 affected7,933 at risk
Viral diarrhoea	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Viral infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Vulval abscess	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Wound infection	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG00010 affected8,030 at risk EG0015 affected7,992 at risk EG0029 affected7,933 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0010 affected7,992 at risk EG0025 affected7,933 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0024 affected7,933 at risk
Delayed spinal fusion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG00111 affected7,992 at risk EG00210 affected7,933 at risk
Fat embolism	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG00011 affected8,030 at risk EG0017 affected7,992 at risk EG00218 affected7,933 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Foetal exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hepatic rupture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG00111 affected7,992 at risk EG00216 affected7,933 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0015 affected7,992 at risk EG0025 affected7,933 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Intervertebral disc injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0015 affected7,992 at risk EG0023 affected7,933 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0020 affected7,933 at risk
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0023 affected7,933 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Nerve injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0014 affected7,992 at risk EG0021 affected7,933 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Post procedural constipation	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0009 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0015 affected7,992 at risk EG0028 affected7,933 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0019 affected7,992 at risk EG0026 affected7,933 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG00210 affected7,933 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0024 affected7,933 at risk
Spinal shock	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0016 affected7,992 at risk EG0021 affected7,933 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0016 affected7,992 at risk EG0022 affected7,933 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0026 affected7,933 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0024 affected7,933 at risk
Traumatic arthritis	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Traumatic renal injury	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0024 affected7,933 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Urostomy complication	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Wound	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Wound decomposition	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Alanine aminotransferase increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Aspiration bronchial	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Biopsy anus	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Biopsy breast	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Blood bilirubin increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Blood chromium increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Blood creatine abnormal	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Blood creatinine increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Blood glucose abnormal	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Blood glucose increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Blood iron decreased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Blood pressure increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Blood pressure systolic increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Blood triglycerides increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Clostridium test positive	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Ejection fraction	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Ejection fraction decreased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Electrocardiogram abnormal	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Endoscopy gastrointestinal	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Fibrin D dimer increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Haemoglobin decreased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Heart rate irregular	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hepatic enzyme increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Liver function test increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Occult blood positive	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Oxygen saturation decreased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Platelet count decreased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Platelet function test abnormal	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Staphylococcus test positive	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Transaminases increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Troponin increased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Weight decreased	Investigations	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG00010 affected8,030 at risk EG00120 affected7,992 at risk EG00213 affected7,933 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0012 affected7,992 at risk EG0026 affected7,933 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0024 affected7,933 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Gout	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0013 affected7,992 at risk EG0027 affected7,933 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0022 affected7,933 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hyperosmolar hyperglycaemic state	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0017 affected7,992 at risk EG0028 affected7,933 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG0019 affected7,992 at risk EG0025 affected7,933 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG0018 affected7,992 at risk EG0025 affected7,933 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Obesity	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0015 affected7,992 at risk EG0025 affected7,933 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG00044 affected8,030 at risk EG00133 affected7,992 at risk EG00239 affected7,933 at risk
Arthrofibrosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG00014 affected8,030 at risk EG00117 affected7,992 at risk EG00220 affected7,933 at risk
Bone cyst	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Bone erosion	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG0017 affected7,992 at risk EG0022 affected7,933 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Felty's syndrome	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Fracture malunion	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG00113 affected7,992 at risk EG00211 affected7,933 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0010 affected7,992 at risk EG0025 affected7,933 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG00019 affected8,030 at risk EG00116 affected7,992 at risk EG00216 affected7,933 at risk
Joint ankylosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG00013 affected8,030 at risk EG00115 affected7,992 at risk EG00220 affected7,933 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG00031 affected8,030 at risk EG00133 affected7,992 at risk EG00232 affected7,933 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0027 affected7,933 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0015 affected7,992 at risk EG0026 affected7,933 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG000201 affected8,030 at risk EG001206 affected7,992 at risk EG002189 affected7,933 at risk
Osteoarthropathy	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0017 affected7,992 at risk EG0021 affected7,933 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0014 affected7,992 at risk EG0021 affected7,933 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG0015 affected7,992 at risk EG0023 affected7,933 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG00010 affected8,030 at risk EG0017 affected7,992 at risk EG00210 affected7,933 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG00013 affected8,030 at risk EG00112 affected7,992 at risk EG0027 affected7,933 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG00116 affected7,992 at risk EG0024 affected7,933 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG0017 affected7,992 at risk EG00210 affected7,933 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Vertebral osteophyte	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0018 affected7,992 at risk EG0024 affected7,933 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0013 affected7,992 at risk EG0022 affected7,933 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG00020 affected8,030 at risk EG00111 affected7,992 at risk EG00210 affected7,933 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Breast cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Bronchioloalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Carcinoid tumour of the duodenum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Carcinoid tumour of the stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Colon cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Colon cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Diffuse large B-cell lymphoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0024 affected7,933 at risk
Endometrial cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Endometrial cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Female reproductive neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Follicle centre lymphoma, follicular grade I, II, III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Gastrointestinal stromal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hairy cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Head and neck cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0013 affected7,992 at risk EG0025 affected7,933 at risk
Large cell lung cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Lip neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Lobular breast carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Lung adenocarcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Lung carcinoma cell type unspecified stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG00014 affected8,030 at risk EG0017 affected7,992 at risk EG00212 affected7,933 at risk
Lung squamous cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Malignant mediastinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Non-Hodgkin's lymphoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Ovarian cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0017 affected7,992 at risk EG0023 affected7,933 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pancreatic carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Pancreatic carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Paraproteinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Parathyroid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG00119 affected7,992 at risk EG00220 affected7,933 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0022 affected7,933 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Sweat gland tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Triple negative breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0014 affected7,992 at risk EG0021 affected7,933 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0015 affected7,992 at risk EG0023 affected7,933 at risk
Altered state of consciousness	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Amnesia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Aphasia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Ataxia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Balance disorder	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Basal ganglia stroke	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Brachial plexopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Brain oedema	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Carotid artery disease	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Carotid artery dissection	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0015 affected7,992 at risk EG0023 affected7,933 at risk
Carotid artery thrombosis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Central nervous system lesion	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Central-alveolar hypoventilation	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cerebellar infarction	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Cerebral cyst	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cerebral haematoma	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cerebral infarction	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0021 affected7,933 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG00039 affected8,030 at risk EG00134 affected7,992 at risk EG00234 affected7,933 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cervical cord compression	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cervical myelopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0015 affected7,992 at risk EG0022 affected7,933 at risk
Chorea	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Cognitive disorder	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Complex regional pain syndrome	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Dementia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Dizziness	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0015 affected7,992 at risk EG0026 affected7,933 at risk
Dural arteriovenous fistula	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Dysarthria	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0023 affected7,933 at risk
Dyskinesia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Embolic stroke	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Encephalomalacia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Encephalopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Epidural lipomatosis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Epilepsy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Facial paralysis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Facial paresis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Headache	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0016 affected7,992 at risk EG0020 affected7,933 at risk
Hemiparesis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Hydrocephalus	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0020 affected7,933 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0023 affected7,933 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0028 affected7,933 at risk
Lacunar infarction	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Lacunar stroke	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Loss of consciousness	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0023 affected7,933 at risk
Mental impairment	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Migraine	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0005 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Migraine with aura	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Monoparesis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Myelopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Nerve compression	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Nerve root compression	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Nervous system disorder	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Neurological symptom	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Neuromyopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Paraesthesia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Paraplegia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Parkinsonism	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Presyncope	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0016 affected7,992 at risk EG0024 affected7,933 at risk
Quadriparesis	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Quadriplegia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Radial nerve palsy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Radicular pain	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Radiculopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Sacral radiculopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Sciatica	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Seizure	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0018 affected7,992 at risk EG0024 affected7,933 at risk
Senile dementia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Spinal claudication	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Spinal cord compression	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Status epilepticus	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Syncope	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG00019 affected8,030 at risk EG00121 affected7,992 at risk EG00231 affected7,933 at risk
Thalamic infarction	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Transient global amnesia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG00022 affected8,030 at risk EG00129 affected7,992 at risk EG00228 affected7,933 at risk
Tremor	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Device breakage	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Device connection issue	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Device dislocation	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0024 affected7,933 at risk
Device failure	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0024 affected7,933 at risk
Device loosening	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Device malfunction	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Device material issue	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lead dislodgement	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Stent malfunction	Product Issues	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Acute psychosis	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Anxiety	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0024 affected7,933 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bipolar disorder	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Confusional state	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Delirium	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0024 affected7,933 at risk
Depression	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0015 affected7,992 at risk EG0023 affected7,933 at risk
Depression suicidal	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Disorientation	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Drug abuse	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Dysphoria	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hypomania	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Major depression	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Mental status changes	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG00010 affected8,030 at risk EG0015 affected7,992 at risk EG0028 affected7,933 at risk
Panic attack	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Paranoia	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Schizophrenia	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Substance abuse	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Suicidal ideation	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Suicide attempt	Psychiatric disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG00036 affected8,030 at risk EG00139 affected7,992 at risk EG00231 affected7,933 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Bladder spasm	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Calculus bladder	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Calculus urethral	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Calculus urinary	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Dysuria	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Haematuria	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Incontinence	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG00110 affected7,992 at risk EG00211 affected7,933 at risk
Nephropathy	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Renal colic	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Renal failure	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG00121 affected7,992 at risk EG00218 affected7,933 at risk
Renal haematoma	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Renal impairment	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Renal injury	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Renal mass	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Stag horn calculus	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Urinary retention	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0013 affected7,992 at risk EG0020 affected7,933 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0015 affected7,992 at risk EG0024 affected7,933 at risk
Breast disorder	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Breast mass	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Colpocele	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cystocele	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Ovarian mass	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pelvic floor muscle weakness	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Rectocele	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Spermatocele	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG00111 affected7,992 at risk EG0024 affected7,933 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0009 affected8,030 at risk EG00113 affected7,992 at risk EG00210 affected7,933 at risk
Asthma-chronic obstructive pulmonary disease overlap syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG00029 affected8,030 at risk EG00130 affected7,992 at risk EG00231 affected7,933 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG00016 affected8,030 at risk EG00124 affected7,992 at risk EG00224 affected7,933 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Eosinophilic pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0016 affected7,992 at risk EG0026 affected7,933 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Mediastinal mass	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0006 affected8,030 at risk EG0012 affected7,992 at risk EG0026 affected7,933 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG00018 affected8,030 at risk EG00110 affected7,992 at risk EG00221 affected7,933 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0024 affected7,933 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0013 affected7,992 at risk EG0022 affected7,933 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0014 affected7,992 at risk EG0023 affected7,933 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0008 affected8,030 at risk EG00114 affected7,992 at risk EG00210 affected7,933 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Vocal cord inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0014 affected7,992 at risk EG0021 affected7,933 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0015 affected7,992 at risk EG0021 affected7,933 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Leukoplakia	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Melanocytic hyperplasia	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0014 affected7,992 at risk EG0021 affected7,933 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Activities of daily living impaired	Social circumstances	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Immobile	Social circumstances	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Physical assault	Social circumstances	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bladder operation	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Colporrhaphy	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Cystocele repair	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Gastric banding	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hernia repair	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Hysterectomy	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Joint fluid drainage	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0023 affected7,933 at risk
Ligament operation	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Medical device removal	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Oophorectomy	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Parovarian cystectomy	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Renal artery stent placement	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Renal stone removal	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Shoulder arthroplasty	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Shoulder operation	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Spinal decompression	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Spinal operation	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Tenoplasty	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Vascular operation	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Wound drainage	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Accelerated hypertension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Aneurysm	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Angiopathy	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Aortic aneurysm	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG00010 affected8,030 at risk EG0014 affected7,992 at risk EG0024 affected7,933 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Aortic calcification	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Aortic dilatation	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Aortic dissection	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Aortic stenosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0027 affected7,933 at risk
Arterial occlusive disease	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Arteriosclerosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Arteriovenous fistula	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bleeding varicose vein	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Blue toe syndrome	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG00012 affected8,030 at risk EG00111 affected7,992 at risk EG00212 affected7,933 at risk
Extravasation blood	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Extremity necrosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Haematoma	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0024 affected7,933 at risk
Hypertension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG00018 affected8,030 at risk EG00135 affected7,992 at risk EG00221 affected7,933 at risk
Hypertensive crisis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0017 affected7,992 at risk EG00214 affected7,933 at risk
Hypertensive emergency	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0022 affected7,933 at risk
Hypotension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0007 affected8,030 at risk EG00113 affected7,992 at risk EG0029 affected7,933 at risk
Hypovolaemic shock	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Intermittent claudication	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Internal haemorrhage	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Ischaemia	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Labile hypertension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Leriche syndrome	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Lymphoedema	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Malignant hypertension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0012 affected7,992 at risk EG0023 affected7,933 at risk
Neurogenic shock	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Orthostatic hypertension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0023 affected7,933 at risk
Arterial thrombosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Penetrating aortic ulcer	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0012 affected7,992 at risk EG0024 affected7,933 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0013 affected7,992 at risk EG0021 affected7,933 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0004 affected8,030 at risk EG0013 affected7,992 at risk EG0025 affected7,933 at risk
Peripheral venous disease	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Phlebitis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0022 affected7,933 at risk
Shock	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0020 affected7,933 at risk
Systolic hypertension	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Temporal arteritis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Thrombophlebitis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0002 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0022 affected7,933 at risk
Thrombosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0003 affected8,030 at risk EG0012 affected7,992 at risk EG0021 affected7,933 at risk
Varicose vein	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0001 affected8,030 at risk EG0011 affected7,992 at risk EG0021 affected7,933 at risk
Vascular stenosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Venous thrombosis	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0012 affected7,992 at risk EG0020 affected7,933 at risk
Venous thrombosis limb	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment		EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Bradycardia and atrial flutter with hospitalization cardiorespiratory arrest and ischemia dilated	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Cardiomyopathy and non-ST elevation MI and atherosclerosis	Cardiac disorders	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Femoral popliteal occlusive disease	Vascular disorders	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Large granular lymphocyte	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Left hip surgical error	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Metastatic hepatic adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Metastatic tumor possibly from squamous cell lung cancer and metastatic tumor cerebral tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
MRSA	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Osteoarthritis with tibial component loosening	Musculoskeletal and connective tissue disorders	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0000 affected8,030 at risk EG0010 affected7,992 at risk EG0021 affected7,933 at risk
Pyelonephritis with sepsis NFI	Infections and infestations	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk
Worsening osteoarthritis right hip replacement	Surgical and medical procedures	MedDRA v 19.0	Non-systematic Assessment	Being Queried	EG0001 affected8,030 at risk EG0010 affected7,992 at risk EG0020 affected7,933 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Celecoxib	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
BG001	Ibuprofen	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
BG002	Naproxen	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Celecoxib	Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily	1,473	8,030	4,268	8,030
EG001	Ibuprofen	Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily	1,624	7,992	4,363	7,992
EG002	Naproxen	Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.	1,611	7,933	4,337	7,933