Does Saxagliptin Reduce the Risk of Cardiovascular Events... | NCT01107886

ID	Type	Description	Link
EudraCT No 2009-017358-10

Name	Class
Bristol-Myers Squibb	INDUSTRY

Label	Type	Description	Intervention Names
Saxagliptin	Experimental		Drug: Saxagliptin
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Saxagliptin	Drug	5 mg or 2.5 mg once daily	Saxagliptin	Onglyza

Measure	Description	Time Frame
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke	Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.	Randomization (day 0) up to 2.9 years

Measure	Description	Time Frame
Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation	Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.

Name	Affiliation	Role
Eugene Braunwald	TIMI	Study Chair
Itamar Raz	Hadassah Medical Organization	Principal Investigator
Deepak Bhatt	TIMI	Principal Investigator

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

PubMed Identifier	Type	Citation	Retractions
33832610	Derived	Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030. No abstract available.
31474116	Derived

Label	URL
D1680C00003 Clinical Study Protocol	View source

ID	Title	Description
FG000	Saxagliptin	5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
FG001	Placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG00027 events26 affected8,212 at risk EG00119 events17 affected8,280 at risk
Anaemia megaloblastic	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hypereosinophilic syndrome	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0015 events5 affected8,280 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events4 affected8,280 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0015 events5 affected8,280 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0015 events5 affected8,280 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0016 events6 affected8,280 at risk
Adams-Stokes syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG000116 events106 affected8,212 at risk EG00198 events89 affected8,280 at risk
Angina unstable	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00079 events63 affected8,212 at risk EG00148 events44 affected8,280 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0016 events6 affected8,280 at risk
Arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00090 events76 affected8,212 at risk EG00185 events78 affected8,280 at risk
Atrial flutter	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00013 events11 affected8,212 at risk EG00125 events22 affected8,280 at risk
Atrial septal defect acquired	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Atrioventricular block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0013 events3 affected8,280 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00013 events13 affected8,212 at risk EG0016 events6 affected8,280 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0006 events5 affected8,212 at risk EG0012 events2 affected8,280 at risk
Bifascicular block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bradycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected8,212 at risk EG00115 events14 affected8,280 at risk
Bundle branch block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bundle branch block left	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0015 events5 affected8,280 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00024 events24 affected8,212 at risk EG00122 events21 affected8,280 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00022 events21 affected8,212 at risk EG00130 events30 affected8,280 at risk
Cardiac fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Cor pulmonale	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00019 events18 affected8,212 at risk EG00117 events17 affected8,280 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hypertrophic cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0007 events6 affected8,212 at risk EG0013 events3 affected8,280 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Left ventricular failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events2 affected8,280 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0013 events3 affected8,280 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0013 events3 affected8,280 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected8,212 at risk EG0017 events7 affected8,280 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Palpitations	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Pericardial effusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Pericarditis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Right ventricular dysfunction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00014 events14 affected8,212 at risk EG00110 events10 affected8,280 at risk
Sinoatrial block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0013 events3 affected8,280 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG00110 events9 affected8,280 at risk
Systolic dysfunction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected8,212 at risk EG0018 events8 affected8,280 at risk
Torsade de pointes	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Trifascicular block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0013 events3 affected8,280 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00016 events11 affected8,212 at risk EG00117 events16 affected8,280 at risk
Deafness	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events1 affected8,280 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events1 affected8,280 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected8,212 at risk EG00116 events16 affected8,280 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Goitre	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Hypercorticoidism	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0016 events6 affected8,280 at risk
Hypothyroidism	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Angle closure glaucoma	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cataract	Eye disorders	MedDRA 15.1	Systematic Assessment	EG00015 events13 affected8,212 at risk EG0019 events7 affected8,280 at risk
Cataract cortical	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diabetic retinopathy	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0017 events6 affected8,280 at risk
Diplopia	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Eye haemorrhage	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Glaucoma	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Macular oedema	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Retinal artery occlusion	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Retinal detachment	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Retinal haemorrhage	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Retinal ischaemia	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ulcerative keratitis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Vision blurred	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0013 events3 affected8,280 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00014 events13 affected8,212 at risk EG00117 events17 affected8,280 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0014 events4 affected8,280 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Anal polyp	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ascites	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Colitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0014 events4 affected8,280 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0016 events6 affected8,280 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0016 events6 affected8,280 at risk
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0014 events4 affected8,280 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00015 events15 affected8,212 at risk EG00113 events12 affected8,280 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diverticulitis intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Diverticulum oesophageal	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0014 events4 affected8,280 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Dyskinesia oesophageal	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Enteritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0013 events3 affected8,280 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00012 events11 affected8,212 at risk EG00115 events15 affected8,280 at risk
Gastritis atrophic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00025 events18 affected8,212 at risk EG00115 events15 affected8,280 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Gastrointestinal telangiectasia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastrointestinal vascular malformation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG0017 events7 affected8,280 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0015 events5 affected8,280 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Ileus	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0016 events6 affected8,280 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0015 events5 affected8,280 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Intestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Megacolon	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Mesenteric vascular insufficiency	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events4 affected8,280 at risk
Oesophageal fibrosis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events4 affected8,280 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Omental infarction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00014 events12 affected8,212 at risk EG00119 events18 affected8,280 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0015 events4 affected8,280 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Pancreatolithiasis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Retroperitoneal fibrosis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 events4 affected8,212 at risk EG0014 events4 affected8,280 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Tongue disorder	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0015 events5 affected8,280 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00010 events9 affected8,212 at risk EG0015 events5 affected8,280 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0016 events6 affected8,280 at risk
Adverse drug reaction	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Application site pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Catheter site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Chest discomfort	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected8,212 at risk EG00114 events14 affected8,280 at risk
Cyst	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Death	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0015 events5 affected8,280 at risk
Device battery issue	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Device breakage	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Device damage	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Device dislocation	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Device failure	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Device lead damage	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Device malfunction	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events4 affected8,280 at risk
Exercise tolerance decreased	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Feeling cold	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Foaming at mouth	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gait disturbance	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
General physical health deterioration	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
General symptom	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Generalised oedema	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hernia	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hernia obstructive	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hypothermia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Impaired healing	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Implant site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Inflammation	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Ischaemic ulcer	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lipogranuloma	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Malaise	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Medical device complication	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Multi-organ disorder	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Multi-organ failure	General disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0017 events7 affected8,280 at risk
Necrobiosis	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Necrosis	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events1 affected8,280 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG000131 events109 affected8,212 at risk EG001125 events108 affected8,280 at risk
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Organ failure	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Polyp	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0017 events7 affected8,280 at risk
Spinal pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0013 events3 affected8,280 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Biliary polyp	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG00012 events10 affected8,212 at risk EG00113 events13 affected8,280 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG00014 events14 affected8,212 at risk EG00122 events22 affected8,280 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG00028 events27 affected8,212 at risk EG00127 events26 affected8,280 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0012 events2 affected8,280 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hepatic ischaemia	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Jaundice	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Allergy to venom	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Anaphylactic shock	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Autoimmune disorder	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cryoglobulinaemia	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0014 events4 affected8,280 at risk
Hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Sarcoidosis	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Abdominal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Abscess limb	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0015 events5 affected8,280 at risk
Abscess soft tissue	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Acarodermatitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Acinetobacter bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Acute sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Adenovirus infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Anal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Appendicitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected8,212 at risk EG0017 events7 affected8,280 at risk
Appendicitis perforated	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Arthritis bacterial	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Arthritis infective	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Bacterial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bacterial sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bone abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Breast cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Breast infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bronchiolitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00035 events35 affected8,212 at risk EG00123 events23 affected8,280 at risk
Bronchitis viral	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bronchopneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0009 events8 affected8,212 at risk EG00110 events10 affected8,280 at risk
Bursitis infective	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Campylobacter infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Carbuncle	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00070 events65 affected8,212 at risk EG00170 events58 affected8,280 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cervicitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Chest wall abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cholangitis suppurative	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cholecystitis infective	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Chronic sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Clostridial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0012 events2 affected8,280 at risk
Clostridium difficile sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Creutzfeldt-Jakob disease	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cystitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0014 events2 affected8,280 at risk
Dengue fever	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Device related infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Diabetic foot infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG00111 events10 affected8,280 at risk
Diabetic gangrene	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0019 events9 affected8,280 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Diverticulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00013 events10 affected8,212 at risk EG00111 events10 affected8,280 at risk
Ear infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Emphysematous cystitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Empyema	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Endocarditis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Endocarditis enterococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Endophthalmitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Enterobacter infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Erysipelas	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0016 events6 affected8,280 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Escherichia infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Escherichia sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Febrile infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Furuncle	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gallbladder abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gangrene	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00017 events16 affected8,212 at risk EG00123 events22 affected8,280 at risk
Gastric ulcer helicobacter	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00017 events17 affected8,212 at risk EG00129 events28 affected8,280 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Graft infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Groin abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Groin infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
H1N1 influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
HIV infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Helicobacter infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hepatitis B	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Herpes zoster	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Implant site cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Incision site infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Infected dermal cyst	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Infected fistula	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Infected skin ulcer	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0009 events8 affected8,212 at risk EG0014 events4 affected8,280 at risk
Infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Infectious peritonitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Infectious thyroiditis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0016 events6 affected8,280 at risk
Intestinal gangrene	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Klebsiella infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Labyrinthitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Liver abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lobar pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG00116 events16 affected8,280 at risk
Localised infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected8,212 at risk EG0018 events8 affected8,280 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0016 events4 affected8,280 at risk
Ludwig angina	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lyme disease	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Mastoiditis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Mediastinitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Meningitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Orchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Osteomyelitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00025 events24 affected8,212 at risk EG00123 events18 affected8,280 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Otitis externa	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Parametritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pelvic abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Peridiverticular abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Perihepatic abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Perineal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Perinephric abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Perirectal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Peritoneal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Peritonitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0015 events5 affected8,280 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pilonidal cyst	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pneumococcal bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pneumocystis jiroveci infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG000127 events118 affected8,212 at risk EG001168 events151 affected8,280 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pneumonia chlamydial	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pneumonia fungal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pneumonia legionella	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pneumonia viral	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Post procedural infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Post procedural sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Postoperative abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Postoperative wound infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00010 events9 affected8,212 at risk EG0019 events8 affected8,280 at risk
Prostatic abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0016 events6 affected8,280 at risk
Pyelonephritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG00111 events11 affected8,280 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0016 events5 affected8,280 at risk
Rectal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Renal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Rhinitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00022 events20 affected8,212 at risk EG00121 events21 affected8,280 at risk
Sepsis syndrome	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Septic shock	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected8,212 at risk EG00111 events11 affected8,280 at risk
Sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Skin bacterial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Skin infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Staphylococcal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0015 events3 affected8,280 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Streptococcal urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0014 events4 affected8,280 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Syphilis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Testicular abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Thrombophlebitis septic	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Tracheobronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Typhoid fever	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0018 events7 affected8,280 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00050 events49 affected8,212 at risk EG00142 events40 affected8,280 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Urosepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG00110 events10 affected8,280 at risk
Vaginal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Viral infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0011 events1 affected8,280 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Vulval abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Wound infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0017 events7 affected8,280 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Wound sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Anastomotic ulcer haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG0013 events3 affected8,280 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Arteriovenous graft site haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Brachial plexus injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0015 events5 affected8,280 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG0016 events6 affected8,280 at risk
Feeding tube complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG00110 events10 affected8,280 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected8,212 at risk EG00115 events13 affected8,280 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0011 events1 affected8,280 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Graft complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events1 affected8,280 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0015 events5 affected8,280 at risk
Heart injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected8,212 at risk EG0019 events8 affected8,280 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0019 events9 affected8,280 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0016 events6 affected8,280 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0017 events7 affected8,280 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Multiple drug overdose intentional	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Near drowning	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0015 events5 affected8,280 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Post embolisation syndrome	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0006 events5 affected8,212 at risk EG0011 events1 affected8,280 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0015 events5 affected8,280 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0015 events5 affected8,280 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0014 events4 affected8,280 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0012 events2 affected8,280 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Splenic haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG0019 events9 affected8,280 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Suture related complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0013 events3 affected8,280 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0015 events5 affected8,280 at risk
Tracheal injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Traumatic ulcer	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0014 events4 affected8,280 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0016 events6 affected8,280 at risk
Alanine aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Arteriogram coronary	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Blood bilirubin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Blood creatinine increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Blood glucose increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Blood potassium increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Blood pressure abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Blood pressure increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
C-reactive protein increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cardiac stress test abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Chest X-ray abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Clostridium test positive	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Coagulation factor VIII level increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Coagulation test abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ejection fraction decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Electrocardiogram abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Haemoglobin decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Heart rate increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hepatic enzyme increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0015 events5 affected8,280 at risk
International normalised ratio increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Liver function test abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Prostatic specific antigen increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Transaminases increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events4 affected8,280 at risk
Troponin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Weight decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00018 events17 affected8,212 at risk EG00113 events13 affected8,280 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00014 events13 affected8,212 at risk EG00114 events12 affected8,280 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00013 events11 affected8,212 at risk EG00112 events10 affected8,280 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0006 events5 affected8,212 at risk EG00110 events8 affected8,280 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0011 events1 affected8,280 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gout	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0018 events8 affected8,280 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00062 events58 affected8,212 at risk EG00155 events51 affected8,280 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00015 events13 affected8,212 at risk EG00117 events17 affected8,280 at risk
Hyperosmolar state	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0008 events7 affected8,212 at risk EG0013 events3 affected8,280 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0018 events8 affected8,280 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0013 events3 affected8,280 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Articular calcification	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected8,212 at risk EG0019 events9 affected8,280 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0015 events5 affected8,280 at risk
Carpal collapse	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Diabetic amyotrophy	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Extraskeletal ossification	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hip deformity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0015 events4 affected8,280 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00014 events13 affected8,212 at risk EG00110 events9 affected8,280 at risk
Joint ankylosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0016 events6 affected8,280 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events4 affected8,280 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00035 events32 affected8,212 at risk EG00123 events23 affected8,280 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00042 events40 affected8,212 at risk EG00151 events49 affected8,280 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0018 events8 affected8,280 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Polymyositis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0012 events2 affected8,280 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0017 events7 affected8,280 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Vertebral column mass	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Angiocentric lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events1 affected8,280 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG00057 events42 affected8,212 at risk EG00158 events52 affected8,280 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Benign neoplasm of choroid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected8,212 at risk EG00113 events12 affected8,280 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0012 events2 affected8,280 at risk
Bladder cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0012 events2 affected8,280 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Bladder transitional cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Blast crisis in myelogenous leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bone neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG00012 events12 affected8,212 at risk EG00110 events10 affected8,280 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Carcinoid tumour of the gastrointestinal tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events2 affected8,280 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG00018 events18 affected8,212 at risk EG00113 events13 affected8,280 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0014 events3 affected8,280 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0012 events2 affected8,280 at risk
Endometrial cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG00011 events9 affected8,212 at risk EG0016 events6 affected8,280 at risk
Gastric cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastrointestinal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Head and neck cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0017 events7 affected8,280 at risk
Hepatic neoplasm malignant recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hodgkin's disease nodular sclerosis stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Laryngeal cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lip neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0012 events2 affected8,280 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lung adenocarcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0016 events6 affected8,280 at risk
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lung carcinoma cell type unspecified stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lung carcinoma cell type unspecified stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0016 events6 affected8,280 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG00016 events15 affected8,212 at risk EG00120 events19 affected8,280 at risk
Lung squamous cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0014 events4 affected8,280 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0015 events5 affected8,280 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected8,212 at risk EG00111 events11 affected8,280 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Malignant palate neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Malignant urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Myeloproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ocular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG0012 events2 affected8,280 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pancreatic neuroendocrine tumour metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG00034 events34 affected8,212 at risk EG00143 events41 affected8,280 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0011 events1 affected8,280 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Prostate cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0010 events0 affected8,280 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0014 events4 affected8,280 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG0014 events4 affected8,280 at risk
Renal cell carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Retroperitoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Sarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Sinonasal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0015 events5 affected8,280 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0011 events1 affected8,280 at risk
Small intestine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG00032 events30 affected8,212 at risk EG00119 events18 affected8,280 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0017 events7 affected8,280 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0007 events6 affected8,212 at risk EG0011 events1 affected8,280 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Vascular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Amnesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Aphasia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Arachnoid cyst	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ataxia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Balance disorder	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Brain injury	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Brain mass	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Carotid artery aneurysm	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Carotid artery disease	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events3 affected8,280 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected8,212 at risk EG00129 events29 affected8,280 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events1 affected8,280 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cerebral circulatory failure	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Cerebral infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cerebral microangiopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00014 events14 affected8,212 at risk EG00112 events12 affected8,280 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cervical myelopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cervical root pain	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cognitive disorder	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Coma	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Complex partial seizures	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Convulsion	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Dementia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events2 affected8,280 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diabetic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0017 events7 affected8,280 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00011 events10 affected8,212 at risk EG00116 events16 affected8,280 at risk
Dysarthria	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Encephalitis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Encephalomalacia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Epilepsy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0008 events7 affected8,212 at risk EG0012 events2 affected8,280 at risk
Fahr's disease	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Hemiparesis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0014 events4 affected8,280 at risk
Hemiplegia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hemisensory neglect	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hydrocephalus	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
IIIrd nerve paresis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
IVth nerve paralysis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Lacunar infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Mental impairment	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Migraine	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Monoplegia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Movement disorder	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Nerve root compression	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Neuralgia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Neurological symptom	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Occipital neuralgia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Optic neuritis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Orthostatic intolerance	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Parkinson's disease	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Parkinsonism	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Polyneuropathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Presyncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0015 events5 affected8,280 at risk
Radicular pain	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Radicular syndrome	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Sciatica	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Sensory disturbance	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Speech disorder	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Spinal cord infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0014 events4 affected8,280 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00033 events32 affected8,212 at risk EG00139 events37 affected8,280 at risk
Tension headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00064 events60 affected8,212 at risk EG00149 events48 affected8,280 at risk
Ulnar nerve palsy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0018 events8 affected8,280 at risk
Vascular dementia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0013 events3 affected8,280 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
White matter lesion	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Agitation	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Alcoholism	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Anxiety	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Completed suicide	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Confusional state	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0018 events7 affected8,280 at risk
Delirium	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Depression	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0008 events6 affected8,212 at risk EG0015 events5 affected8,280 at risk
Drug abuse	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hallucination	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Insomnia	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Major depression	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Mental status changes	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0018 events7 affected8,280 at risk
Psychosomatic disease	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Stress	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Suicide attempt	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0013 events3 affected8,280 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Azotaemia	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0013 events3 affected8,280 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0008 events7 affected8,212 at risk EG0017 events5 affected8,280 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Glomerulonephritis membranoproliferative	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Haematuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0016 events5 affected8,280 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected8,212 at risk EG00116 events13 affected8,280 at risk
Nephropathy	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Renal colic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Renal cyst	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG00020 events20 affected8,212 at risk EG00123 events23 affected8,280 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG00071 events65 affected8,212 at risk EG00189 events80 affected8,280 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG00018 events17 affected8,212 at risk EG00119 events18 affected8,280 at risk
Renal impairment	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG00025 events24 affected8,212 at risk EG00125 events22 affected8,280 at risk
Renal infarct	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Renal mass	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0016 events5 affected8,280 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0018 events8 affected8,280 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Acquired phimosis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Balanitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG00013 events13 affected8,212 at risk EG00113 events13 affected8,280 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Colpocele	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0011 events1 affected8,280 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Testicular cyst	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events1 affected8,280 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Acute lung injury	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0014 events4 affected8,280 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG00112 events12 affected8,280 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0007 events6 affected8,212 at risk EG00120 events15 affected8,280 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Bullous lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00079 events53 affected8,212 at risk EG00188 events71 affected8,280 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00024 events24 affected8,212 at risk EG00119 events18 affected8,280 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected8,212 at risk EG0012 events2 affected8,280 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0019 events8 affected8,280 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events4 affected8,212 at risk EG0010 events0 affected8,280 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Nocturnal dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events2 affected8,280 at risk
Pharyngeal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0009 events8 affected8,212 at risk EG0015 events5 affected8,280 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG00110 events10 affected8,280 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected8,212 at risk EG00111 events11 affected8,280 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0015 events3 affected8,280 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0014 events4 affected8,280 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0008 events7 affected8,212 at risk EG0018 events8 affected8,280 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 events11 affected8,212 at risk EG00110 events9 affected8,280 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected8,212 at risk EG0012 events2 affected8,280 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0015 events5 affected8,280 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0014 events4 affected8,280 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00025 events23 affected8,212 at risk EG00124 events22 affected8,280 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Dyshidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Skin fibrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00024 events22 affected8,212 at risk EG00122 events21 affected8,280 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Accelerated hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Aortic aneurysm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected8,212 at risk EG0014 events4 affected8,280 at risk
Aortic calcification	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Aortic occlusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0012 events2 affected8,280 at risk
Aortic stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected8,212 at risk EG0014 events4 affected8,280 at risk
Arterial insufficiency	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Arteriosclerosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected8,212 at risk EG0012 events2 affected8,280 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Circulatory collapse	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected8,212 at risk EG0018 events8 affected8,280 at risk
Diabetic macroangiopathy	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Embolism venous	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Extremity necrosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0016 events6 affected8,280 at risk
Femoral artery embolism	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0008 events7 affected8,212 at risk EG0012 events2 affected8,280 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Haematoma	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0015 events5 affected8,280 at risk
Haemorrhage	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Haemorrhagic infarction	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00033 events30 affected8,212 at risk EG00132 events29 affected8,280 at risk
Hypertensive crisis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00017 events16 affected8,212 at risk EG00118 events17 affected8,280 at risk
Hypertensive emergency	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0012 events2 affected8,280 at risk
Hypoperfusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00018 events17 affected8,212 at risk EG00122 events19 affected8,280 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0013 events3 affected8,280 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0011 events1 affected8,280 at risk
Intermittent claudication	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00011 events10 affected8,212 at risk EG00111 events10 affected8,280 at risk
Necrosis ischaemic	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0006 events5 affected8,212 at risk EG0016 events6 affected8,280 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00049 events43 affected8,212 at risk EG00125 events24 affected8,280 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected8,212 at risk EG0011 events1 affected8,280 at risk
Peripheral artery dissection	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0009 events8 affected8,212 at risk EG00120 events18 affected8,280 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0012 events2 affected8,280 at risk
Peripheral embolism	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00046 events39 affected8,212 at risk EG00135 events24 affected8,280 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00022 events20 affected8,212 at risk EG00124 events21 affected8,280 at risk
Shock	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Subclavian artery occlusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected8,212 at risk EG0010 events0 affected8,280 at risk
Thrombophlebitis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0013 events3 affected8,280 at risk
Varicose vein	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0012 events2 affected8,280 at risk
Vascular occlusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk
Vascular stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Vasculitis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Venous insufficiency	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected8,212 at risk EG0011 events1 affected8,280 at risk
Venous thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected8,212 at risk EG0011 events1 affected8,280 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected8,212 at risk EG0010 events0 affected8,280 at risk

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	Saxagliptin	5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
BG001	Placebo	Matching Placebo
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching Placebo			2,075	8,212	3,641	8,212
EG001	Saxagliptin	5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).			2,114	8,280	3,504	8,280