Safety and Efficacy Study of Roxadustat to Treat Anemia i... | NCT02174731

Name	Class
Kyntra Bio	INDUSTRY

Label	Type	Description	Intervention Names
Roxadustat	Experimental		Drug: Roxadustat
Epoetin alfa	Active Comparator		Drug: Epoetin alfa

Name	Type	Description	Arm Group Labels	Other Names
Roxadustat	Drug	Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.	Roxadustat

Measure	Description	Time Frame
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52	Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean estimates of change from baseline during Week 28 to Week 52 are presented.	Baseline (Day 1, Week 0), Week 28 to 52

Measure	Description	Time Frame
Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period	Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 36,without having received rescue therapy within 6 weeks prior to and during this 8 week evaluation period was analysed using Mixed Model of Repeated Measures (MMRM). Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 36 are presented for participants that did not receive rescue therapy within 6 weeks prior to and during this 8-week evaluation period.

Name	Affiliation	Role
Steven Fishbane, MD	Chief Division of Kidney Diseases and Hypertension, North Shore University Hospital, Great Neck, NY, USA	Principal Investigator
Mark Houser, MD	AZ R&D, Gaithersburg, USA	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Huntsville	Alabama	35805	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
38363466	Derived	Hamano T, Yamaguchi Y, Goto K, Martin S, Jiletcovici A, Dellanna F, Akizawa T, Barratt J. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Four Global Roxadustat Phase 3 Trials. Adv Ther. 2024 Apr;41(4):1553-1575. doi: 10.1007/s12325-023-02728-2. Epub 2024 Feb 16.
36749544	Derived

Label	URL
Related Info	View source

ID	Title	Description
FG000	Roxadustat	Participants received roxadustat tablets orally three times a week (TIW) throughout the treatment period (up to 4 years). For hemodialysis (HD) participants, it was recommended that roxadustat was taken after completion of the HD session. For participants treated with an erythropoietin analogue at study entry, selection of initial roxadustat dose was based on the participant's erythropoietin analogue dose at screening Visit 1. Participants not treated with an erythropoietin analogue at study entry initiated roxadustat using a tiered, weight-based dosing scheme. Doses were titrated to achieve and maintain hemoglobin (Hb) values of 11±1 grams per deciliter (g/dL). Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks using a dose adjustment algorithm.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 19, 2018	Nov 27, 2019

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Bone marrow reticulin fibrosis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hilar lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0011 events1 affected1,053 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00049 events39 affected1,048 at risk EG00146 events41 affected1,053 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00012 events10 affected1,048 at risk EG00121 events18 affected1,053 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bundle branch block left	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cardiac disorder	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00011 events10 affected1,048 at risk EG0015 events5 affected1,053 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0015 events5 affected1,053 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00035 events24 affected1,048 at risk EG00143 events29 affected1,053 at risk
Cardiac perforation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cardiomegaly	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cor pulmonale acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00017 events17 affected1,048 at risk EG00118 events16 affected1,053 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00015 events14 affected1,048 at risk EG0016 events6 affected1,053 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0016 events6 affected1,053 at risk
Palpitations	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pericardial effusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Pericarditis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pericarditis uraemic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Right ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events3 affected1,053 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Tricuspid valve disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Trifascicular block	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0014 events4 affected1,053 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0014 events4 affected1,053 at risk
Fibrous dysplasia of bone	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hyperparathyroidism tertiary	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Retinal artery embolism	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Retinal haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0010 events0 affected1,053 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events3 affected1,053 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0018 events7 affected1,053 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected1,048 at risk EG0011 events1 affected1,053 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Enteritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Flatulence	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0015 events4 affected1,053 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gastrointestinal erosion	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Oesophageal motility disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected1,048 at risk EG0015 events4 affected1,053 at risk
Catheter site haemorrhage	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Influenza like illness	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Sudden cardiac death	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0013 events3 affected1,053 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Dialysis membrane reaction	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abdominal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Appendicitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0013 events3 affected1,053 at risk
Arthritis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events3 affected1,053 at risk
Bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected1,048 at risk EG0012 events2 affected1,053 at risk
Bacterial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Bacteriuria	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00013 events12 affected1,048 at risk EG00118 events16 affected1,053 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Clostridium bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0014 events3 affected1,053 at risk
Cystitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0010 events0 affected1,053 at risk
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00012 events11 affected1,048 at risk EG00115 events11 affected1,053 at risk
Device related sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0018 events7 affected1,053 at risk
Diabetic foot infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Diabetic gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Empyema	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Escherichia sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00010 events9 affected1,048 at risk EG00113 events11 affected1,053 at risk
Gas gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00013 events11 affected1,048 at risk EG0016 events6 affected1,053 at risk
Gastroenteritis aeromonas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gastrointestinal bacterial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Graft infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hiv infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hepatitis b	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hepatitis c	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Implant site cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Incision site abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Infected cyst	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Infected fistula	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Infected seroma	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events1 affected1,053 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected1,048 at risk EG0012 events2 affected1,053 at risk
Intervertebral discitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events3 affected1,053 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0014 events3 affected1,053 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events2 affected1,053 at risk
Lyme disease	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Neurocysticercosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00017 events10 affected1,048 at risk EG00110 events10 affected1,053 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Parasitic gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Paraspinal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pelvic abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Perineal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Peritonitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00028 events24 affected1,048 at risk EG00137 events24 affected1,053 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00080 events70 affected1,048 at risk EG00192 events78 affected1,053 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0013 events3 affected1,053 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pyonephrosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Renal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Rhinovirus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00044 events40 affected1,048 at risk EG00146 events40 affected1,053 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00013 events12 affected1,048 at risk EG00115 events13 affected1,053 at risk
Shunt infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Skin infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Stenotrophomonas infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Tetanus	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Tonsillitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Tracheobronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0015 events3 affected1,053 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Varicella	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Viral pericarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Vulval abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Arteriovenous graft site stenosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00013 events6 affected1,048 at risk EG00113 events10 affected1,053 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events1 affected1,053 at risk
Haemodialysis-induced symptom	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Kidney rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0014 events4 affected1,053 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vascular access malfunction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0014 events4 affected1,053 at risk
Vascular access site thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00020 events16 affected1,048 at risk EG00115 events13 affected1,053 at risk
Vascular pseudoaneurysm ruptured	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Blood potassium increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Stress echocardiogram abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Synovial fluid crystal present	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00010 events7 affected1,048 at risk EG0017 events3 affected1,053 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0014 events4 affected1,053 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0014 events4 affected1,053 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Spinal ligament ossification	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
5q minus syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events3 affected1,053 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Osteochondroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Skin angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Brain hypoxia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Brain injury	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0010 events0 affected1,053 at risk
Brain oedema	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0010 events0 affected1,053 at risk
Brain stem stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0012 events2 affected1,053 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00014 events14 affected1,048 at risk EG00112 events12 affected1,053 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cervical cord compression	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0008 events8 affected1,048 at risk EG0016 events6 affected1,053 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0012 events2 affected1,053 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0016 events6 affected1,053 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hydrocephalus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Intracranial haematoma	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00010 events10 affected1,048 at risk EG00112 events11 affected1,053 at risk
Lacunar infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Myoclonus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Postresuscitation encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Sciatic nerve neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected1,048 at risk EG00113 events11 affected1,053 at risk
Tardive dyskinesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Tonic convulsion	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vertigo cns origin	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Device failure	Product Issues	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Device leakage	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Device malfunction	Product Issues	MedDRA 20.0	Systematic Assessment	EG0007 events5 affected1,048 at risk EG0013 events3 affected1,053 at risk
Device occlusion	Product Issues	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Thrombosis in device	Product Issues	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0011 events1 affected1,053 at risk
Delirium	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Illusion	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0016 events6 affected1,053 at risk
Panic attack	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Azotaemia	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG00015 events13 affected1,048 at risk EG00112 events11 affected1,053 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0011 events1 affected1,053 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0014 events4 affected1,053 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Renal cyst	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0014 events4 affected1,053 at risk
Renal haematoma	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Urinary retention	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Varicocele	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG00111 events7 affected1,053 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00013 events13 affected1,048 at risk EG00110 events9 affected1,053 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00012 events6 affected1,048 at risk EG00114 events7 affected1,053 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00011 events9 affected1,048 at risk EG0019 events7 affected1,053 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 events7 affected1,048 at risk EG0013 events3 affected1,053 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events3 affected1,053 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0018 events8 affected1,053 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00013 events10 affected1,048 at risk EG00122 events20 affected1,053 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events3 affected1,053 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0017 events6 affected1,053 at risk
Stevens-johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Aortic aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Aortic stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0007 events4 affected1,048 at risk EG0011 events1 affected1,053 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Arteriosclerosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Brachiocephalic vein occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00011 events11 affected1,048 at risk EG0010 events0 affected1,053 at risk
Diabetic microangiopathy	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Dry gangrene	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Haemorrhage	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0015 events3 affected1,053 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00016 events12 affected1,048 at risk EG00113 events12 affected1,053 at risk
Hypertensive crisis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00032 events24 affected1,048 at risk EG00138 events36 affected1,053 at risk
Hypertensive emergency	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00026 events24 affected1,048 at risk EG00133 events31 affected1,053 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00018 events17 affected1,048 at risk EG00120 events18 affected1,053 at risk
Ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Malignant hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0013 events2 affected1,053 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected1,048 at risk EG0011 events1 affected1,053 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0004 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0007 events5 affected1,048 at risk EG0015 events5 affected1,053 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events3 affected1,053 at risk
Steal syndrome	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Superior vena cava stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Thrombophlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Venous stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00013 events8 affected1,048 at risk EG0018 events8 affected1,053 at risk
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0008 events5 affected1,048 at risk EG0016 events6 affected1,053 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected1,048 at risk EG0013 events3 affected1,053 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0010 events0 affected1,053 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Atrioventricular block	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0010 events0 affected1,053 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Atrioventricular dissociation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0012 events2 affected1,053 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0017 events7 affected1,053 at risk
Cardiac asthma	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00014 events13 affected1,048 at risk EG00110 events10 affected1,053 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0007 events7 affected1,048 at risk EG0014 events4 affected1,053 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0014 events4 affected1,053 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0015 events4 affected1,053 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hypothyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Blindness unilateral	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events2 affected1,053 at risk
Diabetic retinopathy	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Eye haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Glaucoma	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Retinal vein occlusion	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ulcerative keratitis	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00015 events10 affected1,048 at risk EG00110 events10 affected1,053 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events3 affected1,053 at risk
Abdominal wall mass	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ascites	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events2 affected1,053 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0010 events0 affected1,053 at risk
Dental caries	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events2 affected1,053 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00015 events11 affected1,048 at risk EG0015 events5 affected1,053 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00024 events22 affected1,048 at risk EG00125 events21 affected1,053 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0014 events4 affected1,053 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 events5 affected1,048 at risk EG0014 events4 affected1,053 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Intestinal metaplasia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0012 events2 affected1,053 at risk
Malabsorption	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pancreatic disorder	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0016 events5 affected1,053 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Proctitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected1,048 at risk EG0019 events8 affected1,053 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 events8 affected1,048 at risk EG00113 events9 affected1,053 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0015 events5 affected1,053 at risk
Adverse drug reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0014 events4 affected1,053 at risk
Complication associated with device	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Complication of device insertion	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG00021 events21 affected1,048 at risk EG00123 events23 affected1,053 at risk
Device related thrombosis	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Generalised oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Haemorrhagic cyst	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Impaired healing	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0014 events4 affected1,053 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG00015 events12 affected1,048 at risk EG00111 events9 affected1,053 at risk
Oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Peripheral swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0008 events8 affected1,048 at risk EG00110 events8 affected1,053 at risk
Sudden death	General disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0015 events5 affected1,053 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events1 affected1,053 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0014 events4 affected1,053 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0016 events6 affected1,053 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0005 events3 affected1,048 at risk EG0010 events0 affected1,053 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events1 affected1,053 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Jaundice	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Contrast media allergy	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Transplant rejection	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Abdominal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abscess jaw	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abscess limb	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abscess neck	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Abscess of salivary gland	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Abscess soft tissue	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Acute endocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Appendicitis perforated	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Arteriosclerotic gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Arthritis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bacterial colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bacterial sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Balanoposthitis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bone tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0007 events5 affected1,048 at risk EG0015 events5 affected1,053 at risk
Campylobacter colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Candida pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Catheter site abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Catheter site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cholecystitis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Chronic hepatitis c	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Citrobacter sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events3 affected1,053 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Endocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0012 events2 affected1,053 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Endophthalmitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Fungal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Fungal peritonitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Fungal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events3 affected1,053 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Herpes zoster infection neurological	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Infected skin ulcer	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events1 affected1,053 at risk
Joint abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Labyrinthitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Localised infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Mycobacterium abscessus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Otitis media	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pilonidal cyst	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pneumonia viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Postoperative wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events3 affected1,053 at risk
Renal cyst infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0013 events1 affected1,053 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0017 events7 affected1,053 at risk
Septic embolus	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Septic encephalopathy	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected1,048 at risk EG0010 events0 affected1,053 at risk
Staphylococcal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0013 events3 affected1,053 at risk
Systemic viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0008 events8 affected1,048 at risk EG00113 events13 affected1,053 at risk
Urosepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Vascular access site infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0014 events4 affected1,053 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vulval cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Wound abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0013 events3 affected1,053 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00010 events9 affected1,048 at risk EG0016 events5 affected1,053 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0014 events3 affected1,053 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00046 events37 affected1,048 at risk EG00135 events31 affected1,053 at risk
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0018 events6 affected1,053 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0012 events2 affected1,053 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0016 events6 affected1,053 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events1 affected1,053 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events3 affected1,053 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Frostbite	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0005 events4 affected1,048 at risk EG0016 events6 affected1,053 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Nerve root injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Peritoneal dialysis complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0012 events2 affected1,053 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0016 events6 affected1,053 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0012 events2 affected1,053 at risk
Vascular access site occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vascular access site pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Vascular injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Blood pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Coagulation test abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Echocardiogram abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Electrocardiogram qt prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Haemoglobin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Human rhinovirus test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Platelet count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pulse absent	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Respirovirus test positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00055 events32 affected1,048 at risk EG00135 events29 affected1,053 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00010 events8 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00032 events27 affected1,048 at risk EG00126 events21 affected1,053 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG00022 events19 affected1,048 at risk EG00111 events11 affected1,053 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0012 events2 affected1,053 at risk
Calcification of muscle	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0014 events4 affected1,053 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events3 affected1,048 at risk EG0013 events3 affected1,053 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Osteitis deformans	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bladder cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Lung carcinoma cell type unspecified stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Parathyroid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0011 events1 affected1,053 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Aphasia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events3 affected1,048 at risk EG0010 events0 affected1,053 at risk
Ataxia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Carotid artery aneurysm	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0014 events4 affected1,053 at risk
Cognitive disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Coma	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Diabetic hyperglycaemic coma	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Embolic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Epilepsy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0014 events4 affected1,053 at risk
Lacunar stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0013 events3 affected1,053 at risk
Partial seizures	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Polyneuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00014 events13 affected1,048 at risk EG0017 events7 affected1,053 at risk
Spinal cord compression	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Subdural hygroma	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00013 events10 affected1,048 at risk EG0016 events6 affected1,053 at risk
Device dislocation	Product Issues	MedDRA 20.0	Systematic Assessment	EG0006 events5 affected1,048 at risk EG0011 events1 affected1,053 at risk
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hallucination	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Major depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0007 events7 affected1,048 at risk EG0011 events1 affected1,053 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Dysuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Glomerulonephritis chronic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0012 events2 affected1,053 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00018 events15 affected1,048 at risk EG00119 events14 affected1,053 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0012 events2 affected1,053 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0019 events9 affected1,053 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0010 events0 affected1,053 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Red man syndrome	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Accelerated hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0007 events6 affected1,048 at risk EG0018 events6 affected1,053 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Brachiocephalic vein stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Brachiocephalic vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Circulatory collapse	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Extremity necrosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0013 events3 affected1,053 at risk
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0010 events0 affected1,053 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected1,048 at risk EG0012 events2 affected1,053 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0011 events1 affected1,053 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0006 events6 affected1,048 at risk EG0015 events3 affected1,053 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected1,048 at risk EG0013 events2 affected1,053 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0005 events5 affected1,048 at risk EG0016 events6 affected1,053 at risk
Phlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected1,048 at risk EG0011 events1 affected1,053 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Vascular compression	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk
Venous aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected1,048 at risk EG0011 events1 affected1,053 at risk

ID	Title	Description
BG000	Roxadustat	Participants received roxadustat tablets orally TIW throughout the treatment period (up to 4 years). For HD participants, it was recommended that roxadustat was taken after completion of the HD session. For participants treated with an erythropoietin analogue at study entry, selection of initial roxadustat dose was based on the participant's erythropoietin analogue dose at screening Visit 1. Participants not treated with an erythropoietin analogue at study entry initiated roxadustat using a tiered, weight-based dosing scheme. Doses were titrated to achieve and maintain Hb values of 11±1 g/dL. Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks using a dose adjustment algorithm.
BG001	Epoetin Alfa	Participants received epoetin alfa (only use of Procrit®, Eprex® and Epogen® permitted in the study) SC or IV injection TIW, except for participants treated with epoetin alfa in a less frequent regimen prior to study entry. For participants treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was the actual dose administered at screening Visit 1. Participants treated with darbepoetin alfa or methoxy polyethylene glycol-epoetin beta prior to study entry initially received epoetin alfa at doses based on a conversion factor. For participants not treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was 50 IU/kg TIW. Dose adjustments were to be consistent with local approved prescribing information.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Roxadustat	Participants received roxadustat tablets orally TIW throughout the treatment period (up to 4 years). For HD participants, it was recommended that roxadustat was taken after completion of the HD session. For participants treated with an erythropoietin analogue at study entry, selection of initial roxadustat dose was based on the participant's erythropoietin analogue dose at screening Visit 1. Participants not treated with an erythropoietin analogue at study entry initiated roxadustat using a tiered, weight-based dosing scheme. Doses were titrated to achieve and maintain Hb values of 11±1 g/dL. Dose adjustments were permitted starting at Week 4 and at intervals of every 4 weeks using a dose adjustment algorithm.	247	1,048	604	1,048	391	1,048
EG001	Epoetin Alfa	Participants received epoetin alfa (only use of Procrit®, Eprex® and Epogen® permitted in the study) SC or IV injection TIW, except for participants treated with epoetin alfa in a less frequent regimen prior to study entry. For participants treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was the actual dose administered at screening Visit 1. Participants treated with darbepoetin alfa or methoxy polyethylene glycol-epoetin beta prior to study entry initially received epoetin alfa at doses based on a conversion factor. For participants not treated with an erythropoietin analogue at study entry, the initial dose of epoetin alfa was 50 IU/kg TIW. Dose adjustments were to be consistent with local approved prescribing information.	231	1,053	606	1,053	360	1,053

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors