A Study Comparing Cardiovascular Effects of Ticagrelor Ve... | NCT01991795

Label	Type	Description	Intervention Names
Ticagrelor 60 mg	Experimental	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Drug: Ticagrelor 60 mg
Ticagrelor placebo	Placebo Comparator	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	Drug: Ticagrelor placebo

Name	Type	Description	Arm Group Labels	Other Names
Ticagrelor 60 mg	Drug	Ticagrelor 60 mg bd taken orally as tablets	Ticagrelor 60 mg

Measure	Description	Time Frame
Composite of Cardiovascular (CV) Death, MI or Stroke	Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.	From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.

Measure	Description	Time Frame
CV Death	Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.	From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
MI

Measure	Description	Time Frame
TIMI Major Bleeding Event (Primary Safety Objective)	Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication	From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.

Name	Affiliation	Role
Philippe Gabriel Steg, MD	Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris	Principal Investigator
Deepak L. Bhatt, MD	Brigham and Women's Hospital75 Francis Street, Boston	Principal Investigator

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

PubMed Identifier	Type	Citation	Retractions
31475798	Background	Steg PG, Bhatt DL, Simon T, Fox K, Mehta SR, Harrington RA, Held C, Andersson M, Himmelmann A, Ridderstrale W, Leonsson-Zachrisson M, Liu Y, Opolski G, Zateyshchikov D, Ge J, Nicolau JC, Corbalan R, Cornel JH, Widimsky P, Leiter LA; THEMIS Steering Committee and Investigators. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1.
31484629

Label	URL
D513BC00001\_CSP\_redacted	View source

ID	Title	Description
FG000	Ticagrelor 60 mg	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
FG001	Ticagrelor Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 7, 2017	Mar 4, 2020

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG00020 events20 affected9,562 at risk EG00114 events14 affected9,531 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Anaemia vitamin b12 deficiency	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG00010 events10 affected9,562 at risk EG0013 events3 affected9,531 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG00026 events26 affected9,562 at risk EG0016 events6 affected9,531 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Spontaneous haemorrhage	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00020 events20 affected9,562 at risk EG00122 events22 affected9,531 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0006 events5 affected9,562 at risk EG0012 events2 affected9,531 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG000133 events126 affected9,562 at risk EG001203 events197 affected9,531 at risk
Adams-stokes syndrome	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG000239 events200 affected9,562 at risk EG001267 events251 affected9,531 at risk
Angina unstable	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG000403 events354 affected9,562 at risk EG001449 events405 affected9,531 at risk
Aortic valve disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG00114 events14 affected9,531 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0015 events3 affected9,531 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG0018 events8 affected9,531 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00084 events82 affected9,562 at risk EG00180 events76 affected9,531 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00013 events12 affected9,562 at risk EG00114 events13 affected9,531 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0014 events4 affected9,531 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Atrioventricular block	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00016 events16 affected9,562 at risk EG00118 events18 affected9,531 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00012 events12 affected9,562 at risk EG0016 events6 affected9,531 at risk
Bifascicular block	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Bradycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00015 events15 affected9,562 at risk EG0016 events6 affected9,531 at risk
Bundle branch block left	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG00112 events12 affected9,531 at risk
Cardiac disorder	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00084 events64 affected9,562 at risk EG001108 events87 affected9,531 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00027 events20 affected9,562 at risk EG00115 events14 affected9,531 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00019 events18 affected9,562 at risk EG00144 events30 affected9,531 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00071 events60 affected9,562 at risk EG00153 events47 affected9,531 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cardiac ventricular scarring	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0014 events4 affected9,531 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00089 events85 affected9,562 at risk EG00195 events90 affected9,531 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00014 events14 affected9,562 at risk EG0014 events4 affected9,531 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Extrasystoles	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events2 affected9,531 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Left ventricular failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0008 events7 affected9,562 at risk EG0014 events4 affected9,531 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00043 events41 affected9,562 at risk EG00166 events65 affected9,531 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00037 events36 affected9,562 at risk EG00150 events47 affected9,531 at risk
Myocarditis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Palpitations	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pericarditis	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0014 events3 affected9,531 at risk
Pulmonary valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Right ventricular failure	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Sinoatrial block	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0014 events4 affected9,531 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0014 events4 affected9,531 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG00111 events9 affected9,531 at risk
Tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0014 events4 affected9,531 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Ventricular asystole	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0017 events7 affected9,531 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG00010 events10 affected9,562 at risk EG0016 events6 affected9,531 at risk
Corneal dystrophy	Congenital, familial and genetic disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Glucose-6-phosphate dehydrogenase deficiency	Congenital, familial and genetic disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Neurofibromatosis	Congenital, familial and genetic disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Deafness	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Inner ear disorder	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tympanosclerosis	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG00013 events13 affected9,562 at risk EG0017 events7 affected9,531 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0013 events3 affected9,531 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Goitre	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0006 events5 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thyroiditis subacute	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Age-related macular degeneration	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Aphakia	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cataract	Eye disorders	MedDRA 21.1	Systematic Assessment	EG00026 events22 affected9,562 at risk EG00135 events30 affected9,531 at risk
Cataract cortical	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cataract diabetic	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cataract nuclear	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Corneal degeneration	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diabetic retinopathy	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0005 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Entropion	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Eye haemorrhage	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0011 events1 affected9,531 at risk
Eyelid ptosis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Glaucoma	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0014 events3 affected9,531 at risk
Lacrimal disorder	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Macular degeneration	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Macular fibrosis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Macular oedema	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Macular pseudohole	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Maculopathy	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Open angle glaucoma	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Retinal artery occlusion	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Retinal artery thrombosis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Retinal degeneration	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Retinal detachment	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Retinal haemorrhage	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0015 events5 affected9,531 at risk
Retinal vein occlusion	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Retinal vein thrombosis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Retinopathy	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Retinopathy proliferative	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Strabismus	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Trichiasis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ulcerative keratitis	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Visual impairment	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG0015 events5 affected9,531 at risk
Vitreous opacities	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0014 events4 affected9,531 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0015 events5 affected9,531 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Appendicitis noninfective	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Appendix disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bezoar	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Change of bowel habit	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0014 events4 affected9,531 at risk
Chronic gastrointestinal bleeding	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Coeliac disease	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0015 events5 affected9,531 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0013 events3 affected9,531 at risk
Dental caries	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00018 events18 affected9,562 at risk EG0018 events8 affected9,531 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diverticulitis oesophageal	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0014 events4 affected9,531 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events5 affected9,562 at risk EG0012 events2 affected9,531 at risk
Duodenal polyp	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0013 events3 affected9,531 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0008 events7 affected9,562 at risk EG0014 events4 affected9,531 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0014 events4 affected9,531 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0018 events6 affected9,531 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00018 events18 affected9,562 at risk EG0019 events9 affected9,531 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0013 events3 affected9,531 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG00112 events12 affected9,531 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG0012 events2 affected9,531 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00044 events43 affected9,562 at risk EG00123 events22 affected9,531 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal ischaemia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal stenosis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events5 affected9,562 at risk EG0017 events7 affected9,531 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0012 events2 affected9,531 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0005 events4 affected9,562 at risk EG0013 events3 affected9,531 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00016 events16 affected9,562 at risk EG00120 events20 affected9,531 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0013 events3 affected9,531 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events4 affected9,562 at risk EG0015 events5 affected9,531 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Intestinal strangulation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00018 events18 affected9,562 at risk EG00114 events14 affected9,531 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Melaena	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00012 events12 affected9,562 at risk EG0014 events4 affected9,531 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Oesophageal motility disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00014 events11 affected9,562 at risk EG0017 events7 affected9,531 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0016 events5 affected9,531 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pancreatolithiasis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Peritoneal adhesions	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Proctitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00013 events13 affected9,562 at risk EG0012 events2 affected9,531 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Subileus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Tooth socket haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Ulcerative gastritis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0012 events2 affected9,531 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG00023 events22 affected9,562 at risk EG00110 events10 affected9,531 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Administration site phlebitis	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Asthenia	General disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0011 events1 affected9,531 at risk
Capsular contracture associated with breast implant	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cardiac death	General disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0011 events1 affected9,531 at risk
Catheter site haemorrhage	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Chest discomfort	General disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0010 events0 affected9,531 at risk
Chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG00111 events11 affected9,531 at risk
Complication associated with device	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Death	General disorders	MedDRA 21.1	Systematic Assessment	EG00052 events52 affected9,562 at risk EG00160 events60 affected9,531 at risk
Drowning	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Facial pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Foreign body reaction	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gait disturbance	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gait inability	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
General physical health deterioration	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Impaired healing	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Medical device site haemorrhage	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Mucosal exfoliation	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Necrobiosis	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Necrosis	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Nodule	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG00060 events54 affected9,562 at risk EG00172 events66 affected9,531 at risk
Oedema	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Oedema peripheral	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0014 events4 affected9,531 at risk
Pacemaker generated arrhythmia	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Peripheral swelling	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0016 events6 affected9,531 at risk
Sudden cardiac death	General disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0018 events8 affected9,531 at risk
Sudden death	General disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0015 events5 affected9,531 at risk
Ulcer haemorrhage	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Vascular stent occlusion	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vascular stent stenosis	General disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0015 events4 affected9,531 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0013 events3 affected9,531 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0015 events4 affected9,531 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Cholangitis chronic	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG00014 events13 affected9,562 at risk EG00127 events23 affected9,531 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG00019 events19 affected9,562 at risk EG00115 events14 affected9,531 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0016 events6 affected9,531 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG00024 events23 affected9,562 at risk EG00125 events25 affected9,531 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Chronic hepatitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0017 events7 affected9,531 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Jaundice	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Liver injury	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Steatohepatitis	Hepatobiliary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0014 events4 affected9,531 at risk
Anaphylactic shock	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Contrast media allergy	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0014 events4 affected9,531 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Sarcoidosis	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Transplant rejection	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Abdominal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Abdominal sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Abscess jaw	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Abscess limb	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0011 events1 affected9,531 at risk
Abscess neck	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Acinetobacter infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Acute endocarditis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Acute hepatitis b	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Acute sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Anal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Anal fistula infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Appendiceal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Appendicitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00014 events13 affected9,562 at risk EG00110 events10 affected9,531 at risk
Appendicitis perforated	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Arthritis infective	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Atypical pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bacteraemia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bacterial sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Biliary sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Brain abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Breast abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Breast cellulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bronchiolitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00018 events18 affected9,562 at risk EG00123 events22 affected9,531 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bursitis infective	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cellulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00040 events35 affected9,562 at risk EG00151 events45 affected9,531 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cholangitis infective	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cholecystitis infective	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Chronic hepatitis c	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Chronic sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0015 events3 affected9,531 at risk
Complicated appendicitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cystitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0014 events4 affected9,531 at risk
Dacryocystitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Dengue fever	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Dengue haemorrhagic fever	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Device related infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Device related sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diabetic foot infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 events3 affected9,562 at risk EG0014 events3 affected9,531 at risk
Diabetic gangrene	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diverticulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00012 events11 affected9,562 at risk EG0014 events4 affected9,531 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Dysentery	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ear infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Emphysematous cystitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Endocarditis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0015 events5 affected9,531 at risk
Endophthalmitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Enteritis infectious	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Enterobacter pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Epididymitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0010 events0 affected9,531 at risk
Epiglottitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events2 affected9,531 at risk
Erysipelas	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00012 events12 affected9,562 at risk EG00113 events10 affected9,531 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Eye infection viral	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Febrile infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Fungal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gangrene	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG00113 events12 affected9,531 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00015 events14 affected9,562 at risk EG00119 events18 affected9,531 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Genitourinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Graft infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Groin abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
H1n1 influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Helicobacter infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hepatitis a	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hepatitis c	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hepatitis e	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Herpes ophthalmic	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Herpes virus infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Herpes zoster	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0015 events5 affected9,531 at risk
Incision site abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Infected bite	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Infected cyst	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Infected dermal cyst	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Infected skin ulcer	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Infectious colitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events2 affected9,531 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG00110 events10 affected9,531 at risk
Joint abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Kidney infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Labyrinthitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Liver abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Localised infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0008 events7 affected9,562 at risk EG0018 events7 affected9,531 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0015 events5 affected9,531 at risk
Ludwig angina	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lung abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Lung infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00012 events10 affected9,562 at risk EG0017 events6 affected9,531 at risk
Meningitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Meningitis bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Meningococcal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Orchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0011 events1 affected9,531 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00016 events14 affected9,562 at risk EG0018 events7 affected9,531 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Otitis media	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Otitis media acute	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Otitis media chronic	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pancreas infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Papilloma viral infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Parotitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Perineal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Periodontitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Peritonitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pneumocystis jirovecii infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG000137 events130 affected9,562 at risk EG001153 events147 affected9,531 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pneumonia viral	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Post procedural infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Post procedural sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Postoperative abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0017 events7 affected9,531 at risk
Prostatic abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Prostatitis escherichia coli	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0014 events4 affected9,531 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG00112 events12 affected9,531 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Rectal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0015 events5 affected9,531 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Salmonellosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Scrotal abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00015 events14 affected9,562 at risk EG00120 events20 affected9,531 at risk
Septic shock	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0017 events7 affected9,531 at risk
Sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Skin infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Soft tissue infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Streptococcal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0010 events0 affected9,531 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Tonsillitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Tooth abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Tracheobronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Tracheobronchitis mycoplasmal	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tuberculosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tuberculosis of genitourinary system	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0015 events5 affected9,531 at risk
Ureteritis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00037 events33 affected9,562 at risk EG00150 events36 affected9,531 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Urosepsis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00013 events12 affected9,562 at risk EG00111 events10 affected9,531 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Viral infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0016 events6 affected9,531 at risk
Vulval abscess	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Vulval cellulitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
West nile viral infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Wound infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0015 events4 affected9,531 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Accident at home	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Adrenal gland injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0018 events8 affected9,531 at risk
Arterial bypass thrombosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Carotid artery restenosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cataract traumatic	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0017 events7 affected9,531 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Coronary vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Coronary vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0011 events1 affected9,531 at risk
Dislocation of sternum	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Epidural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Extraskeletal ossification	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Failure to anastomose	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0012 events1 affected9,531 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG00115 events15 affected9,531 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0014 events4 affected9,531 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0013 events3 affected9,531 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0019 events9 affected9,531 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG00012 events12 affected9,562 at risk EG0018 events8 affected9,531 at risk
Hyphaema	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Intervertebral disc injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0012 events2 affected9,531 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG00013 events12 affected9,562 at risk EG0018 events7 affected9,531 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Lumbosacral plexus injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Median nerve injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG0015 events5 affected9,531 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Nail injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Nerve injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Nerve root injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Nerve root injury lumbar	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Periorbital haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Periprocedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0011 events1 affected9,531 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG00011 events11 affected9,562 at risk EG0015 events5 affected9,531 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0007 events6 affected9,562 at risk EG0018 events8 affected9,531 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG00110 events10 affected9,531 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Shunt malfunction	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0016 events6 affected9,531 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0017 events7 affected9,531 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG00023 events23 affected9,562 at risk EG0016 events6 affected9,531 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0015 events5 affected9,531 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0018 events8 affected9,531 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0016 events6 affected9,531 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0012 events2 affected9,531 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG00011 events11 affected9,562 at risk EG0017 events7 affected9,531 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0010 events0 affected9,531 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bile output decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Blood follicle stimulating hormone increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Blood glucose fluctuation	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Blood glucose increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0013 events3 affected9,531 at risk
Blood lactic acid increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Blood potassium increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events2 affected9,531 at risk
Blood pressure increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Blood urine present	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cardiac stress test abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Electrocardiogram qrs complex prolonged	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Electrocardiogram st segment depression	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Electrocardiogram abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Haemoglobin decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Heart rate irregular	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hepatitis b surface antigen positive	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Occult blood positive	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Oxygen saturation decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Prostatic specific antigen increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Troponin increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Weight decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
White blood cell count decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0007 events6 affected9,562 at risk EG0015 events5 affected9,531 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG00028 events24 affected9,562 at risk EG00146 events42 affected9,531 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG00055 events50 affected9,562 at risk EG00178 events60 affected9,531 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG00011 events10 affected9,562 at risk EG00113 events11 affected9,531 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG00117 events17 affected9,531 at risk
Euglycaemic diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events1 affected9,531 at risk
Gout	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0007 events5 affected9,562 at risk EG0016 events6 affected9,531 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG00021 events20 affected9,562 at risk EG00124 events22 affected9,531 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0014 events4 affected9,531 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG00039 events33 affected9,562 at risk EG00126 events25 affected9,531 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG00012 events12 affected9,562 at risk EG00119 events19 affected9,531 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0016 events6 affected9,531 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0015 events5 affected9,531 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00011 events10 affected9,562 at risk EG00115 events14 affected9,531 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0014 events4 affected9,531 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Chest wall mass	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Crystal arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diabetic amyotrophy	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Facial asymmetry	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0015 events5 affected9,531 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events1 affected9,531 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00017 events16 affected9,562 at risk EG00120 events19 affected9,531 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Loose body in joint	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00013 events13 affected9,562 at risk EG0017 events7 affected9,531 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Muscle disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG00115 events15 affected9,531 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0019 events9 affected9,531 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Myofascitis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG00051 events47 affected9,562 at risk EG00157 events55 affected9,531 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Osteorrhagia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0013 events3 affected9,531 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events2 affected9,531 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0013 events3 affected9,531 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0018 events8 affected9,531 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Seronegative arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Soft tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0014 events4 affected9,531 at risk
Spinal ligament ossification	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG00112 events11 affected9,531 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0011 events1 affected9,531 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Acute promyelocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00014 events14 affected9,562 at risk EG0016 events6 affected9,531 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
B-cell lymphoma stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0006 events5 affected9,562 at risk EG00110 events9 affected9,531 at risk
Benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0019 events9 affected9,531 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0014 events4 affected9,531 at risk
Bladder transitional cell carcinoma stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG0014 events4 affected9,531 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cerebellopontine angle tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cervix carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0004 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Chordoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00012 events12 affected9,562 at risk EG00116 events16 affected9,531 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0014 events4 affected9,531 at risk
Cutaneous lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Endometrial cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Endometrial cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Endometrial cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gallbladder adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gallbladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG00110 events10 affected9,531 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Gastrointestinal lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hepatobiliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00010 events9 affected9,562 at risk EG0014 events4 affected9,531 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events2 affected9,531 at risk
Lip neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Lipofibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0016 events6 affected9,531 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00014 events14 affected9,562 at risk EG00120 events20 affected9,531 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0014 events4 affected9,531 at risk
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Malignant neoplasm papilla of vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events1 affected9,531 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Muscle neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Musculoskeletal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0014 events4 affected9,531 at risk
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Oral neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Osteoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events2 affected9,531 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ovarian granulosa cell tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00013 events12 affected9,562 at risk EG00112 events12 affected9,531 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pancreatic neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pancreatic sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Penis carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Phyllodes tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pleomorphic liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pleural neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG00031 events31 affected9,562 at risk EG00136 events36 affected9,531 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0014 events4 affected9,531 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Prostate cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Prostate cancer stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG0013 events3 affected9,531 at risk
Rectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Rectosigmoid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0017 events7 affected9,531 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0013 events3 affected9,531 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Retroperitoneal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Small cell lung cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Soft tissue sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0015 events5 affected9,531 at risk
Thyroid cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0005 events4 affected9,562 at risk EG0011 events1 affected9,531 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Ageusia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Amnesia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Ataxia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Balance disorder	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Brain hypoxia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Brain injury	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Brain stem infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Brain stem stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Carotid artery disease	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00018 events18 affected9,562 at risk EG00122 events21 affected9,531 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0016 events6 affected9,531 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00019 events18 affected9,562 at risk EG00128 events27 affected9,531 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0009 events7 affected9,562 at risk EG0013 events3 affected9,531 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0019 events9 affected9,531 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cervical cord compression	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Cluster headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cognitive disorder	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Coma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Dementia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0014 events4 affected9,531 at risk
Dementia with lewy bodies	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diabetic coma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00010 events9 affected9,562 at risk EG00114 events13 affected9,531 at risk
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00015 events14 affected9,562 at risk EG00112 events12 affected9,531 at risk
Dysarthria	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Embolic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Epilepsy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0017 events5 affected9,531 at risk
Epileptic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Essential tremor	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Facial paralysis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Focal dyscognitive seizures	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0014 events4 affected9,531 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00010 events10 affected9,562 at risk EG0019 events9 affected9,531 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hemianopia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hemiparesis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hydrocephalus	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events1 affected9,531 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Iiird nerve paralysis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00088 events85 affected9,562 at risk EG001127 events119 affected9,531 at risk
Lacunar infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00010 events9 affected9,562 at risk EG0015 events5 affected9,531 at risk
Lacunar stroke	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0014 events4 affected9,531 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Microsleep	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Migraine	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Miller fisher syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Myelopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Nerve compression	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Paralysis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Parkinson's disease	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0018 events7 affected9,531 at risk
Parkinsonism	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Peripheral nerve lesion	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Polyneuropathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Post-traumatic headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Presyncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0014 events4 affected9,531 at risk
Pseudoradicular syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Putamen haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Radicular pain	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Radiculopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Sciatica	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0019 events9 affected9,531 at risk
Sedation	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Seizure	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0017 events6 affected9,531 at risk
Spinal cord compression	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Spinal epidural haematoma	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events3 affected9,531 at risk
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00029 events26 affected9,562 at risk EG00128 events27 affected9,531 at risk
Tension headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Thalamic infarction	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thoracic outlet syndrome	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Transient global amnesia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG00039 events39 affected9,562 at risk EG00134 events33 affected9,531 at risk
Tremor	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vith nerve disorder	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vith nerve paralysis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vith nerve paresis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vascular dementia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Vertebral artery dissection	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vertigo cns origin	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0012 events1 affected9,531 at risk
Device dislocation	Product Issues	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Device failure	Product Issues	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Device loosening	Product Issues	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Device malfunction	Product Issues	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Device occlusion	Product Issues	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Affective disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Anxiety	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Completed suicide	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Confusional state	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events1 affected9,531 at risk
Delirium	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Delirium tremens	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Depression	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0007 events6 affected9,562 at risk EG0014 events4 affected9,531 at risk
Depression suicidal	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Disorientation	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Illness anxiety disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Insomnia	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Major depression	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0012 events1 affected9,531 at risk
Mental disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Mental status changes	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Neuropsychiatric symptoms	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Suicide attempt	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00059 events56 affected9,562 at risk EG00143 events39 affected9,531 at risk
Azotaemia	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Bladder neck sclerosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0017 events7 affected9,531 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0007 events6 affected9,562 at risk EG0013 events3 affected9,531 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00010 events9 affected9,562 at risk EG00115 events15 affected9,531 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0013 events3 affected9,531 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0013 events3 affected9,531 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Glomerulosclerosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00033 events32 affected9,562 at risk EG00113 events13 affected9,531 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0017 events7 affected9,531 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Nephritic syndrome	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00019 events16 affected9,562 at risk EG00124 events21 affected9,531 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0014 events4 affected9,531 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Perinephritis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Proteinuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Renal artery arteriosclerosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Renal artery occlusion	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Renal colic	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Renal cyst	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Renal disorder	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00017 events16 affected9,562 at risk EG00115 events15 affected9,531 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Renal hypertension	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Renal impairment	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00010 events10 affected9,562 at risk EG0018 events8 affected9,531 at risk
Renal injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Renal mass	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG00020 events18 affected9,562 at risk EG00114 events13 affected9,531 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0010 events0 affected9,531 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events1 affected9,531 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0017 events7 affected9,531 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Acquired phimosis	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG00026 events26 affected9,562 at risk EG00121 events21 affected9,531 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Cervix disorder	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Endometrial atrophy	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Genital haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Prostatic fibrosis	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Prostatic haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0015 events5 affected9,531 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Uterine fibrosis	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0008 events6 affected9,562 at risk EG0017 events7 affected9,531 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00012 events11 affected9,562 at risk EG0017 events7 affected9,531 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00018 events14 affected9,562 at risk EG0019 events7 affected9,531 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bronchial disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00041 events27 affected9,562 at risk EG00157 events41 affected9,531 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events2 affected9,531 at risk
Diaphragmatic paralysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00036 events35 affected9,562 at risk EG00129 events29 affected9,531 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0018 events8 affected9,531 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Epiglottic cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00020 events20 affected9,562 at risk EG00112 events11 affected9,531 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0012 events2 affected9,531 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Idiopathic interstitial pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0010 events0 affected9,531 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events1 affected9,531 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Mediastinal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0011 events1 affected9,531 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0016 events5 affected9,531 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00016 events16 affected9,562 at risk EG00119 events19 affected9,531 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG00010 events10 affected9,562 at risk EG0015 events5 affected9,531 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0009 events8 affected9,562 at risk EG0018 events8 affected9,531 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0010 events0 affected9,531 at risk
Actinic elastosis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0013 events3 affected9,531 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00032 events29 affected9,562 at risk EG00125 events18 affected9,531 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Henoch-schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events1 affected9,531 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Myxoid cyst	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Necrobiosis lipoidica diabeticorum	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG00112 events12 affected9,531 at risk
Stevens-johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0011 events1 affected9,531 at risk
Accelerated hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0012 events2 affected9,531 at risk
Air embolism	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Angiopathy	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Aortic aneurysm	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0008 events8 affected9,562 at risk EG0019 events9 affected9,531 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Aortic dissection	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Aortic stenosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0005 events5 affected9,562 at risk EG0018 events7 affected9,531 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Arterial stenosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Arterial thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Arteriosclerosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Artery dissection	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Atherosclerotic plaque rupture	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Circulatory collapse	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0006 events6 affected9,562 at risk EG0018 events8 affected9,531 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0013 events3 affected9,531 at risk
Embolism arterial	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Embolism venous	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Extremity necrosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0006 events5 affected9,562 at risk EG0011 events1 affected9,531 at risk
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00040 events36 affected9,562 at risk EG00145 events45 affected9,531 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00017 events15 affected9,562 at risk EG00125 events23 affected9,531 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0004 events4 affected9,562 at risk EG0012 events2 affected9,531 at risk
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00010 events9 affected9,562 at risk EG0017 events6 affected9,531 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Iliac artery disease	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Iliac artery embolism	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Intermittent claudication	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0009 events9 affected9,562 at risk EG0018 events7 affected9,531 at risk
Labile blood pressure	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Lymphocele	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Lymphoedema	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Malignant hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Necrosis ischaemic	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Neurogenic shock	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0007 events7 affected9,562 at risk EG0012 events2 affected9,531 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00038 events31 affected9,562 at risk EG00160 events48 affected9,531 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0013 events2 affected9,531 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00010 events10 affected9,562 at risk EG0014 events4 affected9,531 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0006 events5 affected9,562 at risk EG0016 events6 affected9,531 at risk
Peripheral coldness	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Peripheral embolism	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00017 events14 affected9,562 at risk EG00119 events18 affected9,531 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0016 events5 affected9,531 at risk
Peripheral venous disease	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0003 events3 affected9,562 at risk EG0013 events3 affected9,531 at risk
Rheumatoid vasculitis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Shock	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 events2 affected9,562 at risk EG0010 events0 affected9,531 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Subgaleal haematoma	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Temporal arteritis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thrombophlebitis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk
Thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0011 events1 affected9,531 at risk
Varicose vein	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vascular compression	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0011 events1 affected9,531 at risk
Vascular occlusion	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 events1 affected9,562 at risk EG0010 events0 affected9,531 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 events0 affected9,562 at risk EG0012 events2 affected9,531 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ticagrelor 60 mg	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	589	9,619	3,049	9,562	1,951	9,562
EG001	Ticagrelor Placebo	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.	602	9,601	3,210	9,531	610	9,531

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus
D003324	Coronary Artery Disease

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Title	Description
BG000	Ticagrelor 60 mg	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
BG001	Ticagrelor Placebo	Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
BG002	Total	Total of all reporting groups