Multicenter Trial to Evaluate the Effect of Dapagliflozin... | NCT01730534

Name	Class
Bristol-Myers Squibb	INDUSTRY
The TIMI Study Group	OTHER
Hadassah Medical Organization	OTHER

Label	Type	Description	Intervention Names
Dapagliflozin	Experimental	Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors	Drug: Dapagliflozin 10 mg
Placebo	Placebo Comparator	Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors	Drug: Placebo tablet

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin 10 mg	Drug	Oral dose (od)	Dapagliflozin
Placebo tablet

Measure	Description	Time Frame
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke	Safety and co-primary efficacy	up to 5.2 years
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	Co-primary efficacy	up to 5.2 years

Measure	Description	Time Frame
Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.	Secondary	up to 5.2 years
Subjects Included in the Endpoint of All-cause Mortality.

Name	Affiliation	Role
Anna Maria Langkilde, MD	AstraZeneca Sweden	Study Director
Marc S Sabatine, MD, MPH	TIMI Study Group, Boston, MA, USA	Study Chair
Itamar Raz, MD	Hadassah Medical Organization	Principal Investigator
Stephen D Wiviott, MD	TIMI Study Group, MA, USA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Alexander City	Alabama	35010	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
40952180	Derived	Haller PM, Wiviott SD, Berg DD, Jarolim P, Goodrich EL, Bhatt DL, Gause-Nilsson I, Leiter LA, McGuire DK, Wilding JPH, Raz I, Sabatine MS, Morrow DA. Galectin-3 and kidney function in type 2 diabetes treated with dapagliflozin: Analysis from DECLARE-TIMI 58. ESC Heart Fail. 2025 Dec;12(6):3981-3986. doi: 10.1002/ehf2.15415. Epub 2025 Sep 15.
38770818

Label	URL
CSP redacted	View source

ID	Title	Description
FG000	Dapa 10 mg	Dapagliflozin 10 mg tablets administered orally once daily
FG001	Placebo	Matching placebo for dapagliflozin 10 mg administered orally once daily

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 25, 2016	Sep 9, 2019

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG00020 events20 affected8,574 at risk EG00130 events28 affected8,569 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Anaemia vitamin b12 deficiency	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Elephantiasis	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0014 events4 affected8,569 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Hilar lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG00014 events12 affected8,574 at risk EG00118 events18 affected8,569 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Plasmacytosis	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Splenic cyst	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events3 affected8,569 at risk
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Acute cardiac event	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00022 events17 affected8,574 at risk EG00133 events31 affected8,569 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00022 events16 affected8,574 at risk EG00123 events17 affected8,569 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000293 events265 affected8,574 at risk EG001264 events233 affected8,569 at risk
Adams-stokes syndrome	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Angina pectoris	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000178 events154 affected8,574 at risk EG001175 events159 affected8,569 at risk
Angina unstable	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000349 events271 affected8,574 at risk EG001332 events269 affected8,569 at risk
Aortic valve calcification	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Aortic valve disease	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG0012 events2 affected8,569 at risk
Arrhythmia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0016 events6 affected8,569 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG00121 events16 affected8,569 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000138 events117 affected8,574 at risk EG001177 events139 affected8,569 at risk
Atrial flutter	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00025 events21 affected8,574 at risk EG00144 events34 affected8,569 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Atrioventricular block	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0017 events7 affected8,569 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00019 events19 affected8,574 at risk EG00114 events14 affected8,569 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG0017 events7 affected8,569 at risk
Bifascicular block	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bradycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00017 events16 affected8,574 at risk EG00122 events21 affected8,569 at risk
Bundle branch block left	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00034 events33 affected8,574 at risk EG00132 events31 affected8,569 at risk
Cardiac asthma	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0018 events5 affected8,569 at risk
Cardiac disorder	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cardiac failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000199 events147 affected8,574 at risk EG001252 events188 affected8,569 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00025 events22 affected8,574 at risk EG00139 events31 affected8,569 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00014 events12 affected8,574 at risk EG00123 events20 affected8,569 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000177 events121 affected8,574 at risk EG001205 events147 affected8,569 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0015 events5 affected8,569 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG00111 events11 affected8,569 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00019 events19 affected8,574 at risk EG00116 events13 affected8,569 at risk
Cardiomegaly	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG0018 events8 affected8,569 at risk
Cardiomyopathy acute	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0017 events7 affected8,569 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chronotropic incompetence	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Conduction disorder	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Cor pulmonale	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Coronary artery aneurysm	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000113 events106 affected8,574 at risk EG00187 events84 affected8,569 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG0015 events5 affected8,569 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00013 events12 affected8,574 at risk EG00123 events22 affected8,569 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Extrasystoles	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Heart valve stenosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG00118 events18 affected8,569 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Left ventricular failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00015 events11 affected8,574 at risk EG00113 events13 affected8,569 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG0016 events6 affected8,569 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG000104 events96 affected8,574 at risk EG001111 events108 affected8,569 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00049 events47 affected8,574 at risk EG00161 events54 affected8,569 at risk
Myocarditis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Palpitations	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Pericarditis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00012 events8 affected8,574 at risk EG0015 events4 affected8,569 at risk
Postinfarction angina	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Rheumatic heart disease	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Right ventricular failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0014 events4 affected8,569 at risk
Sinus arrest	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events5 affected8,569 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG00114 events13 affected8,569 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG0017 events6 affected8,569 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Tachycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0006 events5 affected8,574 at risk EG0016 events5 affected8,569 at risk
Torsade de pointes	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Trifascicular block	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events2 affected8,569 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Ventricular failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0008 events8 affected8,574 at risk EG00111 events9 affected8,569 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00023 events19 affected8,574 at risk EG00121 events15 affected8,569 at risk
Adenomatous polyposis coli	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Congenital hepatobiliary anomaly	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diverticulitis meckel's	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Heart disease congenital	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vitello-intestinal duct remnant	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG00011 events11 affected8,574 at risk EG00113 events12 affected8,569 at risk
Vertigo labyrinthine	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0018 events8 affected8,569 at risk
Vestibular ataxia	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Adrenal mass	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Adrenomegaly	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Basedow's disease	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Goitre	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0018 events8 affected8,569 at risk
Hyperadrenalism	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypopituitarism	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Thyroid mass	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Amaurosis	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Amaurosis fugax	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Amblyopia	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Astigmatism	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Blindness transient	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cataract	Eye disorders	MedDRA 21	Systematic Assessment	EG00031 events28 affected8,574 at risk EG00132 events26 affected8,569 at risk
Cataract nuclear	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cataract subcapsular	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Corneal deposits	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic retinopathy	Eye disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Diplopia	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Endocrine ophthalmopathy	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Exophthalmos	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Eye haemorrhage	Eye disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Glaucoma	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Iridocyclitis	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Iritis	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lagophthalmos	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Macular degeneration	Eye disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Macular fibrosis	Eye disorders	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Macular oedema	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Maculopathy	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Retinal artery occlusion	Eye disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Retinal detachment	Eye disorders	MedDRA 21	Systematic Assessment	EG0004 events2 affected8,574 at risk EG0016 events4 affected8,569 at risk
Retinal haemorrhage	Eye disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Retinal tear	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Retinal vascular occlusion	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Retinal vein occlusion	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tolosa-hunt syndrome	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tractional retinal detachment	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ulcerative keratitis	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vision blurred	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Visual impairment	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0017 events6 affected8,569 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0017 events7 affected8,569 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00013 events13 affected8,574 at risk EG0019 events9 affected8,569 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0017 events5 affected8,569 at risk
Acute haemorrhagic ulcerative colitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ascites	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Colitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG00111 events11 affected8,569 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0012 events2 affected8,569 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events2 affected8,569 at risk
Constipation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00014 events13 affected8,574 at risk EG0013 events3 affected8,569 at risk
Diabetic gastroenteropathy	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00011 events10 affected8,574 at risk EG00111 events11 affected8,569 at risk
Dieulafoy's vascular malformation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0006 events5 affected8,574 at risk EG0012 events2 affected8,569 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0005 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0006 events5 affected8,574 at risk EG0012 events2 affected8,569 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Epiploic appendagitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0010 events0 affected8,569 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Gastric stenosis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG00111 events11 affected8,569 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00015 events13 affected8,574 at risk EG00120 events20 affected8,569 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00018 events17 affected8,574 at risk EG00118 events18 affected8,569 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG00110 events10 affected8,569 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Ileus	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00011 events10 affected8,574 at risk EG00113 events13 affected8,569 at risk
Intestinal fibrosis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0011 events1 affected8,569 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Intussusception	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Jejunal perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Large intestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG0019 events9 affected8,569 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Melaena	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Mesenteric artery embolism	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Mesenteric panniculitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Mesenteric vascular insufficiency	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Nausea	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Palatal oedema	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pancreatic duct obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG00112 events12 affected8,569 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00013 events13 affected8,574 at risk EG00117 events15 affected8,569 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Pancreatolithiasis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peritoneal adhesions	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Portal hypertensive gastropathy	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Proctitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0012 events2 affected8,569 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Salivary gland cyst	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG0019 events9 affected8,569 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Small intestine ulcer	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Steatorrhoea	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG00110 events9 affected8,569 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0018 events8 affected8,569 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events2 affected8,569 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0019 events9 affected8,569 at risk
Adverse drug reaction	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Asthenia	General disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG00110 events10 affected8,569 at risk
Cardiac death	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Chest pain	General disorders	MedDRA 21	Systematic Assessment	EG00034 events29 affected8,574 at risk EG00120 events20 affected8,569 at risk
Complication associated with device	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Critical illness	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Death	General disorders	MedDRA 21	Systematic Assessment	EG00081 events81 affected8,574 at risk EG00189 events89 affected8,569 at risk
Dehiscence	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Drowning	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Drug intolerance	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Drug withdrawal syndrome	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Exercise tolerance decreased	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gait disturbance	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
General physical health deterioration	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events5 affected8,569 at risk
Generalised oedema	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Granuloma	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hernia	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypothermia	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Impaired healing	General disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0013 events3 affected8,569 at risk
Implant site inflammation	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Incarcerated hernia	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Inflammation	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Malaise	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Medical device pain	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Medical device site irritation	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Microlithiasis	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG0018 events8 affected8,569 at risk
Necrobiosis	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Necrosis	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Non-cardiac chest pain	General disorders	MedDRA 21	Systematic Assessment	EG000110 events93 affected8,574 at risk EG001120 events107 affected8,569 at risk
Oedema	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Oedema peripheral	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0015 events5 affected8,569 at risk
Organ failure	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pacemaker syndrome	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pain	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pelvic mass	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peripheral swelling	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Pyrexia	General disorders	MedDRA 21	Systematic Assessment	EG00014 events7 affected8,574 at risk EG00113 events13 affected8,569 at risk
Soft tissue inflammation	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Stent-graft endoleak	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Submandibular mass	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Sudden cardiac death	General disorders	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG00116 events16 affected8,569 at risk
Sudden death	General disorders	MedDRA 21	Systematic Assessment	EG00021 events21 affected8,574 at risk EG00123 events23 affected8,569 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Vascular stent occlusion	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vascular stent stenosis	General disorders	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG0018 events8 affected8,569 at risk
Vascular stent thrombosis	General disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG00010 events9 affected8,574 at risk EG0018 events8 affected8,569 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Biliary dyspepsia	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG00012 events11 affected8,574 at risk EG0016 events5 affected8,569 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0005 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG00018 events18 affected8,574 at risk EG00123 events22 affected8,569 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG00025 events25 affected8,574 at risk EG00122 events22 affected8,569 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0016 events6 affected8,569 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG00026 events26 affected8,574 at risk EG00140 events38 affected8,569 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gallbladder cholesterolosis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG00113 events11 affected8,569 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0014 events3 affected8,569 at risk
Hepatic fibrosis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Jaundice	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Liver injury	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Porcelain gallbladder	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Allergy to metals	Immune system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Allergy to vaccine	Immune system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Anaphylactic shock	Immune system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0015 events5 affected8,569 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Hashitoxicosis	Immune system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hypersensitivity	Immune system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Sarcoidosis	Immune system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Abdominal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Abdominal sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Abscess limb	Infections and infestations	MedDRA 21	Systematic Assessment	EG0008 events8 affected8,574 at risk EG00110 events9 affected8,569 at risk
Acquired immunodeficiency syndrome	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Acute endocarditis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Acute hepatitis b	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Acute sinusitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Amoebiasis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Anal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0015 events5 affected8,569 at risk
Appendiceal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Appendicitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG00112 events12 affected8,569 at risk
Appendicitis perforated	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Arthritis bacterial	Infections and infestations	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG00113 events11 affected8,569 at risk
Arthritis infective	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aspergilloma	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Atypical pneumonia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bacteraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0013 events3 affected8,569 at risk
Bacterascites	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bacterial colitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bacterial sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bacterial tracheitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bacteriuria	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Biliary sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bone abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Brain abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Breast abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bronchitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00016 events15 affected8,574 at risk EG00135 events35 affected8,569 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bronchitis viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Burn infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bursitis infective	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cellulitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG000100 events84 affected8,574 at risk EG001117 events93 affected8,569 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cellulitis orbital	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Central nervous system infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chest wall abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cholecystitis infective	Infections and infestations	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0013 events3 affected8,569 at risk
Chronic hepatitis c	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Chronic sinusitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Clostridial sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0012 events2 affected8,569 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0005 events4 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cystitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG0013 events3 affected8,569 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Dengue fever	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Device related infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Diabetic foot infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG00011 events10 affected8,574 at risk EG00113 events13 affected8,569 at risk
Diabetic gangrene	Infections and infestations	MedDRA 21	Systematic Assessment	EG0009 events7 affected8,574 at risk EG00111 events11 affected8,569 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diverticulitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00024 events20 affected8,574 at risk EG00122 events20 affected8,569 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Empyema	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Encephalitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Encephalomyelitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Endocarditis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Endocarditis enterococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Endocarditis staphylococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Endometritis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Enteritis infectious	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Epididymitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Epiglottitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Erysipelas	Infections and infestations	MedDRA 21	Systematic Assessment	EG00012 events11 affected8,574 at risk EG00113 events13 affected8,569 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Escherichia sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0010 events0 affected8,569 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
External ear cellulitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Extradural abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events3 affected8,569 at risk
Fungal infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gangrene	Infections and infestations	MedDRA 21	Systematic Assessment	EG00023 events22 affected8,574 at risk EG00140 events30 affected8,569 at risk
Gas gangrene	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastric infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastroenteritis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00027 events26 affected8,574 at risk EG00127 events27 affected8,569 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0015 events5 affected8,569 at risk
Giardiasis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Groin abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
H1n1 influenza	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hiv infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hiv-associated neurocognitive disorder	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Haematoma infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Helicobacter infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Hepatitis a	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hepatitis b	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hepatitis e	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hepatitis viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Herpes zoster	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Human anaplasmosis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Implant site infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Infected skin ulcer	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0016 events6 affected8,569 at risk
Infectious colitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Infective gastroduodenitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Influenza	Infections and infestations	MedDRA 21	Systematic Assessment	EG00017 events17 affected8,574 at risk EG00115 events15 affected8,569 at risk
Intervertebral discitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Legionella infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Liver abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Localised infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG00016 events16 affected8,574 at risk EG00111 events10 affected8,569 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG00011 events9 affected8,574 at risk EG00110 events10 affected8,569 at risk
Lung abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lung infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Lyme disease	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Malaria	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Mastitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Mastoiditis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Mediastinitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Medical device site abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Medical device site infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Medical device site joint infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Meningitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Meningitis aseptic	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Meningitis viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Mucormycosis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Muscle abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Neurosyphilis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Onychomycosis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oral candidiasis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Orchitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Osteomyelitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00035 events26 affected8,574 at risk EG00146 events39 affected8,569 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Otitis externa	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Otitis media	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Otitis media chronic	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pancreatic abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Parotitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Pelvic abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Perineal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Perinephric abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Periodontitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peritonitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events5 affected8,569 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pharyngitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Pleurisy viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pneumococcal infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pneumonia	Infections and infestations	MedDRA 21	Systematic Assessment	EG000212 events194 affected8,574 at risk EG001246 events219 affected8,569 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0015 events5 affected8,569 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pneumonia viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events4 affected8,569 at risk
Post procedural cellulitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Post procedural infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG0015 events5 affected8,569 at risk
Postoperative abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG00011 events11 affected8,574 at risk EG00113 events13 affected8,569 at risk
Prostatic abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Pyelitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pyelonephritis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG00115 events14 affected8,569 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG00115 events15 affected8,569 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Rectal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Renal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0017 events5 affected8,569 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Rhinitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Rickettsiosis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Rotavirus infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Salmonella bacteraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Scrotal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events4 affected8,569 at risk
Scrub typhus	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00084 events77 affected8,574 at risk EG00171 events70 affected8,569 at risk
Sepsis syndrome	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Septic shock	Infections and infestations	MedDRA 21	Systematic Assessment	EG00022 events21 affected8,574 at risk EG00127 events24 affected8,569 at risk
Sinusitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Sinusitis fungal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Skin bacterial infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Skin infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Soft tissue infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Splenic abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0015 events5 affected8,569 at risk
Streptococcal abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tick-borne fever	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tonsillitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tooth abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Tooth infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Tracheitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Tracheobronchitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Tuberculosis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0015 events5 affected8,569 at risk
Urinary tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG00053 events49 affected8,574 at risk EG00171 events67 affected8,569 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Urosepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG00023 events22 affected8,574 at risk EG00126 events25 affected8,569 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Viraemia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Viral infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0018 events7 affected8,569 at risk
Viral myocarditis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Viral sinusitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
West nile viral infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Wound abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Wound infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG00012 events11 affected8,574 at risk EG00111 events10 affected8,569 at risk
Wound infection pseudomonas	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Abdominal wall wound	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Accidental poisoning	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00019 events19 affected8,574 at risk EG00114 events14 affected8,569 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0004 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Carotid artery restenosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cement embolism	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events4 affected8,569 at risk
Chest crushing	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Complications of transplanted liver	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0017 events7 affected8,569 at risk
Confusion postoperative	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0014 events4 affected8,569 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Coronary bypass stenosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Costal cartilage fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0013 events3 affected8,569 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Eyelid injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG0014 events4 affected8,569 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG00120 events20 affected8,569 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0019 events9 affected8,569 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00016 events16 affected8,574 at risk EG00118 events18 affected8,569 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0014 events4 affected8,569 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events5 affected8,569 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Foreign body in respiratory tract	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Haematuria traumatic	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events4 affected8,574 at risk EG0018 events8 affected8,569 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00013 events13 affected8,574 at risk EG00116 events15 affected8,569 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00012 events11 affected8,574 at risk EG00120 events20 affected8,569 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events1 affected8,569 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0012 events2 affected8,569 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0011 events1 affected8,569 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0004 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Limb fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG0014 events4 affected8,569 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lisfranc fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0019 events9 affected8,569 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0016 events6 affected8,569 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0012 events2 affected8,569 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Nerve injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events1 affected8,569 at risk
Ocular procedural complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0016 events6 affected8,569 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0015 events3 affected8,569 at risk
Periprocedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pneumoconiosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0008 events8 affected8,574 at risk EG00114 events14 affected8,569 at risk
Post procedural constipation	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0011 events1 affected8,569 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00012 events11 affected8,574 at risk EG0015 events4 affected8,569 at risk
Post procedural inflammation	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Procedural shock	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG00110 events10 affected8,569 at risk
Rectal laceration postoperative	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00013 events12 affected8,574 at risk EG00117 events15 affected8,569 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0008 events8 affected8,574 at risk EG0017 events7 affected8,569 at risk
Sedation complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0016 events6 affected8,569 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG0014 events4 affected8,569 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0014 events4 affected8,569 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0019 events9 affected8,569 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0009 events8 affected8,574 at risk EG00113 events11 affected8,569 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0018 events8 affected8,569 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0016 events6 affected8,569 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG0015 events5 affected8,569 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Traumatic arthritis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0008 events8 affected8,574 at risk EG0014 events4 affected8,569 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vascular graft restenosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0015 events5 affected8,569 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Wound haematoma	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0015 events5 affected8,569 at risk
Anticoagulation drug level below therapeutic	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Blood creatinine increased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Blood glucose abnormal	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Blood glucose increased	Investigations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Blood pressure decreased	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Blood pressure increased	Investigations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Brain natriuretic peptide increased	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Catheterisation cardiac	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Electrocardiogram qt prolonged	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Electrocardiogram st segment elevation	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
General physical condition abnormal	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hepatic enzyme increased	Investigations	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hepatitis c antibody positive	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events1 affected8,569 at risk
International normalised ratio increased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Liver function test increased	Investigations	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Transaminases increased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Troponin i increased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Troponin t increased	Investigations	MedDRA 21	Systematic Assessment	EG0004 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Troponin increased	Investigations	MedDRA 21	Systematic Assessment	EG00012 events11 affected8,574 at risk EG0018 events7 affected8,569 at risk
Urine cytology abnormal	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Weight decreased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Alcoholic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00021 events20 affected8,574 at risk EG00119 events19 affected8,569 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0006 events5 affected8,574 at risk EG00113 events13 affected8,569 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG00134 events29 affected8,569 at risk
Diabetes with hyperosmolarity	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00029 events27 affected8,574 at risk EG00127 events23 affected8,569 at risk
Diabetic ketosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00023 events17 affected8,574 at risk EG00135 events27 affected8,569 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Euglycaemic diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gout	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0017 events6 affected8,569 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00049 events37 affected8,574 at risk EG00156 events55 affected8,569 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0017 events6 affected8,569 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00086 events69 affected8,574 at risk EG001101 events86 affected8,569 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0014 events4 affected8,569 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00010 events9 affected8,574 at risk EG0019 events9 affected8,569 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG0014 events4 affected8,569 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG0012 events2 affected8,569 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Latent autoimmune diabetes in adults	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lipomatosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0018 events8 affected8,569 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0017 events7 affected8,569 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0012 events2 affected8,569 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG0019 events9 affected8,569 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Articular calcification	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0006 events5 affected8,574 at risk EG0019 events9 affected8,569 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0013 events3 affected8,569 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0016 events6 affected8,569 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diastasis recti abdominis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Extraskeletal ossification	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Fracture malunion	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events4 affected8,569 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Immunoglobulin g4 related disease	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0016 events6 affected8,569 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG00025 events24 affected8,574 at risk EG00118 events17 affected8,569 at risk
Jaw cyst	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Joint ankylosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ligament calcification	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG00015 events14 affected8,574 at risk EG00118 events18 affected8,569 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Muscle fibrosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0016 events6 affected8,569 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG00125 events24 affected8,569 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG000114 events103 affected8,574 at risk EG001102 events92 affected8,569 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0017 events7 affected8,569 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0008 events7 affected8,574 at risk EG0014 events4 affected8,569 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG00116 events16 affected8,569 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG00011 events11 affected8,574 at risk EG00113 events12 affected8,569 at risk
Spinal ligament ossification	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG0013 events3 affected8,569 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0005 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0016 events5 affected8,569 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vertebral lesion	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Acral lentiginous melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events2 affected8,569 at risk
Acute myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00020 events20 affected8,574 at risk EG00118 events18 affected8,569 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Adenoid cystic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Adrenocortical carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Anaplastic astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anaplastic large-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00042 events34 affected8,574 at risk EG00137 events27 affected8,569 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign ear neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Benign hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Benign laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Benign lymph node neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Benign neoplasm of adrenal gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign neoplasm of spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Benign soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG00125 events25 affected8,569 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Bladder cancer stage 0, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bladder cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events5 affected8,569 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0018 events8 affected8,569 at risk
Bladder transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00020 events19 affected8,574 at risk EG00122 events20 affected8,569 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events4 affected8,569 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Carcinoid tumour of the duodenum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0017 events7 affected8,569 at risk
Chondromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chondrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chronic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0016 events6 affected8,569 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0010 events0 affected8,569 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0008 events8 affected8,574 at risk EG0017 events7 affected8,569 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00017 events16 affected8,574 at risk EG00116 events16 affected8,569 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Dermatofibrosarcoma protuberans	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Diffuse large b-cell lymphoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ductal adenocarcinoma of pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0018 events7 affected8,569 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Endometrial cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Fallopian tube cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gallbladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0018 events8 affected8,569 at risk
Gastric cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastric cancer stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Gastrointestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Gastrointestinal stromal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Gingival cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Glottis carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Haemangiopericytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hairy cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0015 events5 affected8,569 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0009 events8 affected8,574 at risk EG0014 events4 affected8,569 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0012 events2 affected8,569 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG0015 events5 affected8,569 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Juvenile melanoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Laryngeal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0017 events6 affected8,569 at risk
Lung adenocarcinoma stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00012 events11 affected8,574 at risk EG00114 events14 affected8,569 at risk
Lung carcinoma cell type unspecified stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lung carcinoma cell type unspecified stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00013 events12 affected8,574 at risk EG00121 events21 affected8,569 at risk
Lung squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0011 events1 affected8,569 at risk
Malignant anorectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00017 events13 affected8,574 at risk EG00112 events12 affected8,569 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0007 events6 affected8,574 at risk EG0014 events4 affected8,569 at risk
Malignant neoplasm of ampulla of vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Malignant neoplasm of pleura metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Melanoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0011 events1 affected8,569 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastases to rectum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Metastases to spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events3 affected8,574 at risk EG0017 events5 affected8,569 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0011 events1 affected8,569 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0010 events0 affected8,569 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neuroendocrine tumour of the lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neuroendocrine tumour of the lung metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Non-hodgkin's lymphoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Non-small cell lung cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Non-small cell lung cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ocular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events4 affected8,569 at risk
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oral neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Osteoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0009 events9 affected8,574 at risk EG0018 events8 affected8,569 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0009 events8 affected8,574 at risk EG00110 events9 affected8,569 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pancreatic neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pancreatoblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Papillary serous endometrial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Papillary tumour of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Pelvic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Penile squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peritoneal carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0016 events6 affected8,569 at risk
Pleomorphic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00070 events69 affected8,574 at risk EG00155 events55 affected8,569 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0017 events7 affected8,569 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Prostate cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events4 affected8,569 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0014 events4 affected8,569 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG0018 events7 affected8,569 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00010 events10 affected8,574 at risk EG0018 events8 affected8,569 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0014 events4 affected8,569 at risk
Retro-orbital neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Sebaceous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Signet-ring cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0013 events3 affected8,569 at risk
Small cell lung cancer extensive stage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0014 events4 affected8,569 at risk
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Soft tissue sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Spinal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00012 events8 affected8,574 at risk EG00110 events10 affected8,569 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG00112 events9 affected8,569 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG00011 events11 affected8,574 at risk EG00114 events12 affected8,569 at risk
Transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Tumour obstruction	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0012 events2 affected8,569 at risk
Vaginal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0003 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vocal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0012 events1 affected8,569 at risk
Vulval cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Amnesia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aphasia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events1 affected8,569 at risk
Arachnoid cyst	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ataxia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Autonomic failure syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Balance disorder	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Basilar artery perforation	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Brain injury	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0016 events6 affected8,569 at risk
Brain oedema	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Brain stem infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0008 events6 affected8,574 at risk EG0013 events3 affected8,569 at risk
Brain stem stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Burning sensation	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Carotid artery insufficiency	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0011 events1 affected8,569 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG00027 events27 affected8,574 at risk EG00122 events21 affected8,569 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Cerebellar ataxia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cerebral artery occlusion	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0016 events6 affected8,569 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG00027 events24 affected8,574 at risk EG00133 events32 affected8,569 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG00110 events9 affected8,569 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21	Systematic Assessment	EG000112 events102 affected8,574 at risk EG00194 events88 affected8,569 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cervical cord compression	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cluster headache	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cognitive disorder	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Coma	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cranial nerve palsies multiple	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Dementia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Dementia with lewy bodies	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic autonomic neuropathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diabetic coma	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0015 events4 affected8,569 at risk
Dizziness	Nervous system disorders	MedDRA 21	Systematic Assessment	EG00014 events14 affected8,574 at risk EG0019 events9 affected8,569 at risk
Dizziness postural	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Dysarthria	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Dystonic tremor	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Embolic stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0018 events8 affected8,569 at risk
Epilepsy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0015 events5 affected8,569 at risk
Essential tremor	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Facial paralysis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0018 events8 affected8,569 at risk
Facial paresis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Focal dyscognitive seizures	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events2 affected8,569 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG00111 events11 affected8,569 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0014 events4 affected8,569 at risk
Headache	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Hemianopia homonymous	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hemiparesis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected8,574 at risk EG0015 events4 affected8,569 at risk
Hydrocephalus	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypokinesia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Iiird nerve paralysis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Intensive care unit acquired weakness	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG000105 events97 affected8,574 at risk EG00199 events90 affected8,569 at risk
Lacunar infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0009 events8 affected8,574 at risk EG00114 events14 affected8,569 at risk
Lacunar stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lateral medullary syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0016 events6 affected8,569 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0016 events6 affected8,569 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Medication overuse headache	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Memory impairment	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0013 events3 affected8,569 at risk
Migraine	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Multiple system atrophy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Muscle contractions involuntary	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Myelopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Nerve compression	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Nervous system disorder	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Neuralgia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neurodegenerative disorder	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Neurological symptom	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Occipital neuralgia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Paraesthesia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Paraparesis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Parkinson's disease	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0016 events3 affected8,569 at risk
Partial seizures	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Polyneuropathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postictal paralysis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Presyncope	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Quadriplegia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Radicular pain	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Radicular syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Radiculopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Sciatica	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0017 events7 affected8,569 at risk
Seizure	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0006 events5 affected8,574 at risk EG00110 events10 affected8,569 at risk
Simple partial seizures	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Somnolence	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Spinal claudication	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Status epilepticus	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Stiff person syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Stroke in evolution	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Subdural hygroma	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Syncope	Nervous system disorders	MedDRA 21	Systematic Assessment	EG00038 events37 affected8,574 at risk EG00144 events41 affected8,569 at risk
Tension headache	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Thalamic infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Thoracic outlet syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Toxic neuropathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21	Systematic Assessment	EG00076 events68 affected8,574 at risk EG00159 events54 affected8,569 at risk
Tremor	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vith nerve paralysis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vith nerve paresis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vascular dementia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Vertigo cns origin	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Wernicke-korsakoff syndrome	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Device breakage	Product Issues	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Device dislocation	Product Issues	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Device failure	Product Issues	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Device lead damage	Product Issues	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Device malfunction	Product Issues	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events1 affected8,569 at risk
Device occlusion	Product Issues	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Stent malfunction	Product Issues	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Acute psychosis	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Agitation	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Anxiety	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Completed suicide	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Confusional state	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG00112 events12 affected8,569 at risk
Conversion disorder	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Delirium	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0014 events4 affected8,569 at risk
Depressed mood	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Depression	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG00115 events13 affected8,569 at risk
Drug abuse	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hallucination	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypomania	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Major depression	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0016 events6 affected8,569 at risk
Mental status changes	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0017 events7 affected8,569 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Panic attack	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Restlessness	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events1 affected8,569 at risk
Schizoaffective disorder depressive type	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Schizophrenia	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Sleep disorder	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Stress	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Suicide attempt	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events2 affected8,569 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG00096 events94 affected8,574 at risk EG001152 events127 affected8,569 at risk
Azotaemia	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bladder disorder	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bladder mass	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bladder perforation	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0016 events6 affected8,569 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0014 events4 affected8,569 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG00010 events9 affected8,574 at risk EG00117 events13 affected8,569 at risk
Cystitis glandularis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cystitis ulcerative	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events2 affected8,569 at risk
Dysuria	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0018 events7 affected8,569 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Haematuria	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG00119 events16 affected8,569 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0016 events6 affected8,569 at risk
Ketonuria	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Myeloma cast nephropathy	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG00016 events14 affected8,574 at risk EG00118 events18 affected8,569 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Oedematous kidney	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Proteinuria	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Renal colic	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0015 events5 affected8,569 at risk
Renal cyst	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Renal disorder	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Renal failure	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG00011 events10 affected8,574 at risk EG00117 events17 affected8,569 at risk
Renal haematoma	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG00112 events12 affected8,569 at risk
Renal infarct	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Renal injury	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Renal tubular acidosis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0007 events5 affected8,574 at risk EG00121 events17 affected8,569 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0016 events5 affected8,569 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0008 events8 affected8,574 at risk EG00110 events10 affected8,569 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events5 affected8,569 at risk
Acquired phimosis	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG00011 events11 affected8,574 at risk EG0011 events1 affected8,569 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG00030 events28 affected8,574 at risk EG00131 events31 affected8,569 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Colpocele	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hydrosalpinx	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pelvic haemorrhage	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Penile necrosis	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Peyronie's disease	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Prostatic disorder	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0019 events8 affected8,569 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0015 events5 affected8,569 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Testicular cyst	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0012 events2 affected8,569 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Vaginal dysplasia	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Varicocele	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0018 events8 affected8,569 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0014 events4 affected8,569 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG00041 events37 affected8,574 at risk EG00150 events43 affected8,569 at risk
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG00121 events18 affected8,569 at risk
Asthma-chronic obstructive pulmonary disease overlap syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG00081 events54 affected8,574 at risk EG00190 events54 affected8,569 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0014 events4 affected8,569 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG00122 events21 affected8,569 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0012 events2 affected8,569 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0013 events3 affected8,569 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0015 events5 affected8,569 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Paraneoplastic pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0007 events6 affected8,574 at risk EG00114 events13 affected8,569 at risk
Pleural thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG00019 events18 affected8,574 at risk EG00110 events10 affected8,569 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0015 events5 affected8,569 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG0014 events4 affected8,569 at risk
Pulmonary amyloidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events2 affected8,569 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG00026 events26 affected8,574 at risk EG00127 events27 affected8,569 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG00119 events4 affected8,569 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG00111 events11 affected8,569 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG00116 events15 affected8,569 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG00030 events29 affected8,574 at risk EG00128 events24 affected8,569 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Rheumatoid lung	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Rhinitis hypertrophic	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0011 events1 affected8,569 at risk
Vocal cord leukoplakia	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0003 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Diabetic bullosis	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG00045 events37 affected8,574 at risk EG00134 events29 affected8,569 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Fixed eruption	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Henoch-schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lichen sclerosus	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Melanocytic hyperplasia	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Skin swelling	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG00028 events24 affected8,574 at risk EG00126 events23 affected8,569 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0013 events3 affected8,569 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Accelerated hypertension	Vascular disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Angiopathy	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aortic aneurysm	Vascular disorders	MedDRA 21	Systematic Assessment	EG00012 events12 affected8,574 at risk EG00111 events10 affected8,569 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Aortic dilatation	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aortic dissection	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Aortic stenosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG00022 events22 affected8,574 at risk EG00117 events17 affected8,569 at risk
Arterial disorder	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Arterial insufficiency	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Arterial perforation	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Arterial thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Arteriosclerosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected8,574 at risk EG0015 events5 affected8,569 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Arteritis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Circulatory collapse	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0013 events3 affected8,569 at risk
Claudication of jaw muscles	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG00018 events17 affected8,574 at risk EG00112 events12 affected8,569 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Dry gangrene	Vascular disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Embolism	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0012 events2 affected8,569 at risk
Essential hypertension	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0013 events3 affected8,569 at risk
Extremity necrosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0007 events7 affected8,574 at risk EG0014 events4 affected8,569 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Femoral artery embolism	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Haematoma	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0016 events6 affected8,569 at risk
Haemorrhagic vasculitis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Hypertension	Vascular disorders	MedDRA 21	Systematic Assessment	EG00028 events27 affected8,574 at risk EG00131 events27 affected8,569 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21	Systematic Assessment	EG00021 events14 affected8,574 at risk EG00128 events24 affected8,569 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0017 events7 affected8,569 at risk
Hypotension	Vascular disorders	MedDRA 21	Systematic Assessment	EG00029 events28 affected8,574 at risk EG00114 events14 affected8,569 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0012 events2 affected8,569 at risk
Iliac artery disease	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Iliac artery embolism	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0012 events2 affected8,569 at risk
Intermittent claudication	Vascular disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected8,574 at risk EG0013 events3 affected8,569 at risk
Internal haemorrhage	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Ischaemia	Vascular disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0010 events0 affected8,569 at risk
Ischaemic limb pain	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Leriche syndrome	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Lymphatic fistula	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Lymphoedema	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Malignant hypertension	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Microangiopathy	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected8,574 at risk EG00113 events12 affected8,569 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21	Systematic Assessment	EG00056 events43 affected8,574 at risk EG00153 events49 affected8,569 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peripheral artery dissection	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Peripheral artery haematoma	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 21	Systematic Assessment	EG00018 events14 affected8,574 at risk EG00120 events15 affected8,569 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG00036 events23 affected8,574 at risk EG00122 events20 affected8,569 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0005 events4 affected8,574 at risk EG0014 events4 affected8,569 at risk
Peripheral embolism	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21	Systematic Assessment	EG00032 events30 affected8,574 at risk EG00141 events35 affected8,569 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 21	Systematic Assessment	EG00046 events34 affected8,574 at risk EG00121 events19 affected8,569 at risk
Peripheral venous disease	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Phlebitis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Shock	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0012 events2 affected8,569 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Subclavian artery occlusion	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Subclavian steal syndrome	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Superior vena cava stenosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Temporal arteritis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected8,574 at risk EG0013 events2 affected8,569 at risk
Thromboangiitis obliterans	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected8,574 at risk EG0011 events1 affected8,569 at risk
Thrombophlebitis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0011 events1 affected8,569 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected8,574 at risk EG0010 events0 affected8,569 at risk
Thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected8,574 at risk EG0011 events1 affected8,569 at risk
Varicose ulceration	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Varicose vein	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0016 events5 affected8,569 at risk
Vascular occlusion	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vasculitis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Vasospasm	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Venous thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected8,574 at risk EG0010 events0 affected8,569 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dapa 10 mg	Description (Arm-group)	529	8,582	3,205	8,574	268	8,574
EG001	Placebo	Description (Arm-group)	570	8,578	3,418	8,569	342	8,569

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Dapa 10 mg	Dapagliflozin 10 mg tablets administered orally once daily
BG001	Placebo	Matching placebo for dapagliflozin 10 mg administered orally once daily
BG002	Total	Total of all reporting groups