Post-marketing Observational Study in Subjects With Rheum... | NCT00234884

Label	Type	Description	Intervention Names
Adalimumab		RA patients in treatment with commercial adalimumab	Biological: adalimumab

Name	Type	Description	Arm Group Labels	Other Names
adalimumab	Biological	commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)

Measure	Description	Time Frame
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)	DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 20% (ACR20) Response Rate	ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 50% (ACR50) Response Rate	ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).	Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
American College of Rheumatology 70% (ACR70) Response Rate	ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

Name	Affiliation	Role
Laura Redden, MD, PhD	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Ref # / Investigator 5606		Camperdown	New South Wales	2050	Australia
Site Ref # / Investigator 49504

PubMed Identifier	Type	Citation	Retractions
24460746	Derived	Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.

ID	Title	Description
FG000	Adalimumab	Participants were treated with commercially available adalimumab in normal clinical practice.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypereosinophilic syndrome	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Lymphoadenopathy	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0008 events8 affected3,435 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00012 events12 affected3,435 at risk
Angina unstable	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events1 affected3,435 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Arrhythmia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00020 events17 affected3,435 at risk
Atrial flutter	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Atrioventricular block	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cardiac arrest	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cardiac failure	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00011 events9 affected3,435 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00011 events9 affected3,435 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00010 events10 affected3,435 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Left ventricular failure	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG00025 events25 affected3,435 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Pericardial effusion	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Branchial cyst	Congenital, familial and genetic disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gastrointestinal angiodysplasia haemorrhagic	Congenital, familial and genetic disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Odontogenic cyst	Congenital, familial and genetic disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Polydactyly	Congenital, familial and genetic disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events1 affected3,435 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Goitre	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Cataract	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Entropion	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Macular degeneration	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Retinal degeneration	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Retinal detachment	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events1 affected3,435 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Anorectal stenosis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Caecitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Colitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Colitis collagenous	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0008 events8 affected3,435 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Duodenal fistula	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Polyp colorectal	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Vasculitis gastrointestinal	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Chest pain	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0008 events8 affected3,435 at risk
Death	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Device dislocation	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Device occlusion	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Impaired healing	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Multi-organ failure	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Pyrexia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0009 events9 affected3,435 at risk
Soft tissue inflammation	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Sudden death	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Biliary cirrhosis primary	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 events7 affected3,435 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG00020 events18 affected3,435 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Amyloidosis	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypersensitivity	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Sarcoidosis	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Secondary amyloidosis	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abdominal abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Abscess neck	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Anal abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events2 affected3,435 at risk
Appendicitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Arthritis bacterial	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG00012 events11 affected3,435 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Bacteraemia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Bronchopneumonia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Bursitis infective	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0007 events7 affected3,435 at risk
Chronic sinusitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Cystitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Device related infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Diverticulitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Endocarditis staphylococcal	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Extrapulmonary tuberculosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gangrene	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
H1N1 influenza	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Haematoma infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hepatic echinococciasis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Herpes zoster	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Histoplasmosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events1 affected3,435 at risk
Infected skin ulcer	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events1 affected3,435 at risk
Influenza	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Joint tuberculosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Leishmaniasis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Listeria sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lobar pneumonia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Localised infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Lung abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lung infections	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG00010 events9 affected3,435 at risk
Lyme disease	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lymphadenitis bacterial	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Meningitis meningococcal	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Mucocutaneous leishmaniasis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Mycobacterium avium complex infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Mycobacterium fortuitum infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Oseophageal candidiasis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Orchitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Osteomyelitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0004 events3 affected3,435 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Peritoneal infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Peritoneal tuberculosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pharyngitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pleurisy viral	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG00044 events42 affected3,435 at risk
Pneumonia legionella	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pneumonia primary atypical	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Postoperative wound infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Pyelonephritis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Pyothorax	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Respiratory tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0008 events7 affected3,435 at risk
Salmonellosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG00010 events10 affected3,435 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Septic shock	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Skin infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Tonsillitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Tooth infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Tracheobronchitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Tuberculosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG00011 events11 affected3,435 at risk
Urosepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Vaginal abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Varicella	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Viral infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Viral pericarditis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Visceral leishmaniasis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Wound infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Erysipelas	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG00015 events13 affected3,435 at risk
Escherichia sepsis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Decompression sickness	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Diffuse axonal injury	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0009 events9 affected3,435 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0007 events7 affected3,435 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Fractured ischium	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0009 events9 affected3,435 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0007 events6 affected3,435 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Antiphospholipid antibodies	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Blood amylase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
C-reactive protein increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Mycobacterium test positive	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Platelet count decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Red blood cell sedimentation rate increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Weight decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Central obesity	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Gout	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Atlantoaxial instability	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events2 affected3,435 at risk
Bone formation decreased	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Felty's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0008 events8 affected3,435 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Joint destruction	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Lupus-like syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG00019 events18 affected3,435 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Periostitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pseudarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 events7 affected3,435 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 events3 affected3,435 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
B-cell lymphoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG00015 events15 affected3,435 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cerebellopontine angle tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Colon cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Conjunctival melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Desmoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Glomus jugulare tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hodgkin's disease stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hodgkin's disease stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Intraductal papilloma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Myeloproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ovarian granulosa-theca cell tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Primary mediastinal large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Prostate cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Prostate cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG00010 events10 affected3,435 at risk
Amnestic disorder	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Cerebellar atrophy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cerebral infarction	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cerebral venous thrombosis	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG00011 events11 affected3,435 at risk
Cervical myelopathy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Coma	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Dysaesthesia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Encephalitis	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Epilepsy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Facial palsy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Headache	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypoxic encephalopathy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Loss off consciousness	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Mononeuropathy multiplex	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Optic neuritis	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Parkinson's disease	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Partial seizures	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Sciatica	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Speech disorder	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Transient global amnesia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected3,435 at risk
Vascular dementia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Intra-uterine death	Pregnancy, puerperium and perinatal conditions	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Placenta previa	Pregnancy, puerperium and perinatal conditions	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Anxiety	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Disorientation	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Suicide attempt	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events4 affected3,435 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 events5 affected3,435 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Renal colic	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Renal failure	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 events7 affected3,435 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 events7 affected3,435 at risk
Ureteric rupture	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events1 affected3,435 at risk
Adnexa uteri cyst	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pelvic fluid collection	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Prostatic disorder	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Anoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 events6 affected3,435 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Diaphragmatic hernia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Nasal tubinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pleural disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00011 events11 affected3,435 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00010 events9 affected3,435 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events3 affected3,435 at risk
Pulmonary granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Rheumatoid lung	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Alopecia effluvium	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Cutaneous lupus erythematosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Cutaneous vasculitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Scar	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 events5 affected3,435 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Abortion induced	Surgical and medical procedures	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Blepharoplasty	Surgical and medical procedures	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Removal of internal fixation	Surgical and medical procedures	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Aortic aneurysm	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Aortic stenosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Arteritis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 events5 affected3,435 at risk
Haematoma	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Haemodynamic instability	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Hypertensive crisis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events3 affected3,435 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Lymphoedema	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 events3 affected3,435 at risk
Phlebitis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Thrombophlebitis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Thrombosis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 events4 affected3,435 at risk
Varicose vein	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Vasculitis	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected3,435 at risk
Venous insufficiency	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected3,435 at risk

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins