Peginterferon Dose Evaluations for Previously Untreated S... | NCT00081770

ID	Type	Description	Link
2552898

Label	Type	Description	Intervention Names
PegIntron 1.5 ug/kg/wk plus REBETOL	Experimental	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)
PegIntron 1.0 ug/kg/wk plus REBETOL	Experimental	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)
PEGASYS 180 ug/wk Plus COPEGUS	Active Comparator	PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up	Biological: PEGASYS (peginterferon alfa-2a) Drug: COPEGUS (ribavirin)

Name	Type	Description	Arm Group Labels	Other Names
PegIntron (peginterferon alfa-2b; SCH 54031)	Biological	1.5 ug/kg/week subcutaneously (SC) for 48 weeks	PegIntron 1.5 ug/kg/wk plus REBETOL

Measure	Description	Time Frame
Sustained Virologic Response (SVR) Rate	SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.	Assessed at the end of a 24-week post-treatment follow-up

Measure	Description	Time Frame
Mean Change From Baseline in the Log Viral Load at Treatment Week 4	The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.	Assessed at Baseline and Treatment Week 4

PubMed Identifier	Type	Citation	Retractions
19625712	Result	McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009 Aug 6;361(6):580-93. doi: 10.1056/NEJMoa0808010. Epub 2009 Jul 22.
21488082

ID	Title	Description
FG000	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
FG001	PegIntron 1.0 ug/kg/wk Plus REBETOL

ID	Title	Description
BG000	PegIntron 1.5 ug/kg/wk Plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
BG001	PegIntron 1.0 ug/kg/wk Plus REBETOL	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
BG002	PEGASYS 180 ug/wk Plus COPEGUS	PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0001019 BG0011016 BG0021035 BG0033070

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PegIntron 1.5 ug/kg/wk Plus REBETOL	88	1,019	996	1,019
EG001	PegIntron 1.0 ug/kg/wk Plus REBETOL	94	1,016	1,000	1,016
EG002	PEGASYS 180 ug/wk Plus COPEGUS	121	1,035	1,018	1,035

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0021 events1 affected1,035 at risk
APLASTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
LYMPHADENITIS	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events2 affected1,035 at risk
THROMBOTIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CORONARY ARTERY RESTENOSIS	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CYANOSIS	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0022 events2 affected1,035 at risk
PALPITATIONS	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
PERICARDITIS	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0020 events0 affected1,035 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
WOLFF-PARKINSON-WHITE SYNDROME	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HEARING IMPAIRED	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
CATARACT	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events1 affected1,035 at risk
MACULOPATHY	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
PAPILLOEDEMA	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
RETINAL HAEMORRHAGE	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 events2 affected1,019 at risk EG0015 events4 affected1,016 at risk EG0024 events4 affected1,035 at risk
APPENDICITIS PERFORATED	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
COLITIS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
EROSIVE OESOPHAGITIS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
FOOD POISONING	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
GASTROINTESTINAL PAIN	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ILEUS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0020 events0 affected1,035 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
LARGE INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0025 events5 affected1,035 at risk
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PANCREATIC CYST	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PANCREATIC ENLARGEMENT	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PANCREATIC MASS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0020 events0 affected1,035 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
PERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
SALIVARY DUCT OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0024 events4 affected1,035 at risk
CHEST DISCOMFORT	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0023 events3 affected1,035 at risk
CHEST PAIN	General disorders	MedDRA 10.1	Systematic Assessment	EG0008 events8 affected1,019 at risk EG0018 events8 affected1,016 at risk EG0028 events8 affected1,035 at risk
DEATH	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
DRUG WITHDRAWAL SYNDROME	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
FACE OEDEMA	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
FATIGUE	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HERNIA OBSTRUCTIVE	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0021 events1 affected1,035 at risk
PYREXIA	General disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0020 events0 affected1,035 at risk
BILE DUCT STENOSIS	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
BILIARY DYSKINESIA	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0005 events5 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0023 events3 affected1,035 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events1 affected1,035 at risk
PORTAL HYPERTENSIVE GASTROPATHY	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
SARCOIDOSIS	Immune system disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0023 events3 affected1,035 at risk
ABDOMINAL WALL INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ANOGENITAL WARTS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
APPENDICITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0014 events4 affected1,016 at risk EG0025 events4 affected1,035 at risk
BLASTOMYCOSIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
BRONCHITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
BURSITIS INFECTIVE STAPHYLOCOCCAL	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CELLULITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0015 events5 affected1,016 at risk EG0026 events6 affected1,035 at risk
CHOLECYSTITIS INFECTIVE	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ENCEPHALITIS VIRAL	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ENTEROCOLITIS INFECTIOUS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
FOLLICULITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HERPES OESOPHAGITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
INFECTIVE TENOSYNOVITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
INJECTION SITE ABSCESS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
INJECTION SITE CELLULITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
KIDNEY INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
LUNG ABSCESS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
MENINGITIS VIRAL	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ORCHITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PERITONEAL ABSCESS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events2 affected1,035 at risk
PNEUMONIA	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0026 events6 affected1,035 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0023 events3 affected1,035 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0021 events1 affected1,035 at risk
SEPSIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SEPSIS SYNDROME	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SINUSITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
STAPHYLOCOCCAL ABSCESS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events2 affected1,035 at risk
STAPHYLOCOCCAL SKIN INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ARTHROPOD BITE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
BACK INJURY	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
CERVICAL VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
DRUG TOXICITY	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0020 events0 affected1,035 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
GUN SHOT WOUND	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HEPATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
HUMAN BITE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
JAW FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0013 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
LUNG INJURY	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0022 events2 affected1,035 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
POST PROCEDURAL BILE LEAK	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0021 events1 affected1,035 at risk
SCAPULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
THERAPEUTIC AGENT TOXICITY	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
TOOTH FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
TRAUMATIC BRAIN INJURY	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
GRIP STRENGTH DECREASED	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0023 events3 affected1,035 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0022 events2 affected1,035 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0020 events0 affected1,035 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
GOUTY ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
JOINT INSTABILITY	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0022 events1 affected1,035 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
WEIGHT BEARING DIFFICULTY	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ACOUSTIC NEUROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0022 events2 affected1,035 at risk
HAEMANGIOMA OF LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
HEPATIC NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events2 affected1,035 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
MALIGNANT NEOPLASM OF AMPULLA OF VATER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
OROPHARYNGEAL CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
OVARIAN ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0002 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
AKATHISIA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ANOXIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
COMA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CONVULSION	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events2 affected1,035 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0020 events0 affected1,035 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
FACIAL PALSY	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0022 events1 affected1,035 at risk
INTRACRANIAL ANEURYSM	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
MIGRAINE	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0012 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
PARAPLEGIA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PERONEAL NERVE PALSY	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
SCIATICA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SPINAL CORD INFARCTION	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events1 affected1,035 at risk
SYNCOPE	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0004 events4 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0023 events3 affected1,035 at risk
SYNCOPE VASOVAGAL	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0020 events0 affected1,035 at risk
ACUTE PSYCHOSIS	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
AFFECTIVE DISORDER	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
AGITATION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ANGER	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ANXIETY	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0021 events1 affected1,035 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
DEPENDENCE	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
DEPRESSION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0009 events5 affected1,019 at risk EG0013 events3 affected1,016 at risk EG0023 events3 affected1,035 at risk
DISORIENTATION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
DRUG ABUSE	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events2 affected1,035 at risk
DRUG DEPENDENCE	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HALLUCINATION, AUDITORY	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HALLUCINATION, VISUAL	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
HOMICIDAL IDEATION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0003 events2 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0020 events0 affected1,035 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
PARANOIA	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG00017 events13 affected1,019 at risk EG0018 events8 affected1,016 at risk EG0025 events5 affected1,035 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0022 events2 affected1,035 at risk
BLADDER DISORDER	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
NEPHROTIC SYNDROME	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
RENAL PAIN	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
CERVICAL DYSPLASIA	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
CYSTOCELE	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
RECTOCELE	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
UTERINE HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
VAGINAL PROLAPSE	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0012 events2 affected1,016 at risk EG0023 events2 affected1,035 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0015 events5 affected1,016 at risk EG0023 events3 affected1,035 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
PLEURISY	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0023 events3 affected1,035 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
PULMONARY SARCOIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ERYTHEMA MULTIFORME	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
PHYSICAL ASSAULT	Social circumstances	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0020 events0 affected1,035 at risk
CYSTOPEXY	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HYSTERECTOMY	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
RECTOCELE REPAIR	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
SALPINGO-OOPHORECTOMY UNILATERAL	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk
SPINAL FUSION SURGERY	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected1,019 at risk EG0011 events1 affected1,016 at risk EG0021 events1 affected1,035 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
HYPOTENSION	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0021 events1 affected1,035 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected1,019 at risk EG0010 events0 affected1,016 at risk EG0020 events0 affected1,035 at risk

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Term
C417083	peginterferon alfa-2b
D012254	Ribavirin
C100416	peginterferon alfa-2a