A Study of Venetoclax in Combination With Azacitidine Ver... | NCT02993523

ID	Type	Description	Link
2016-001466-28	EudraCT Number

Name	Class
Genentech, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2	Placebo Comparator	Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, every day (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).	Drug: Azacitidine Drug: Placebo
Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2	Active Comparator	Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).	Drug: Azacitidine Drug: Venetoclax
Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2	Active Comparator	Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).	Drug: Azacitidine

Name	Type	Description	Arm Group Labels	Other Names
Azacitidine	Drug	Solution for subcutaneous or intravenous administration.	Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.	From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)
Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)	CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count >10^3/ microliter (mcL), platelets >10^5/mcL, red cell transfusion independence, and bone marrow with <5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10^3/mcL or platelets ≤10^5/mcL. Percentages are rounded off to whole number at the nearest decimal.	From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)

Measure	Description	Time Frame
Event-free Survival (EFS)	EFS will be defined as the number of days from randomization to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.	Measured up to 2 years after the last participant is randomized
Global Health Status/Quality of Life (GHS/QoL)

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope /ID# 154105		Duarte	California	91010	United States
University of California, Los Angeles /ID# 154107

PubMed Identifier	Type	Citation	Retractions
40913104	Derived	Venditti A, Hou JZ, Fenaux P, Jonas BA, Vrhovac R, Montesinos P, Garcia JS, Rizzieri D, Thirman MJ, Zhang M, Potluri J, Miller C, Dhalla M, Pullarkat V. Outcomes of patients treated with venetoclax plus azacitidine versus azacitidine alone stratified by advanced age and acute myeloid leukemia composite model. Leukemia. 2025 Nov;39(11):2697-2707. doi: 10.1038/s41375-025-02730-3. Epub 2025 Sep 5.
39133921

Label	URL
Related Info	View source

ID	Title	Description
FG000	Group 1: Placebo + Azacitidine 75 mg/m^2	Participants enrolled under original protocol received venetoclax-matching placebo, orally, once daily (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 1, 2020	Nov 28, 2022

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00013 events9 affected144 at risk EG00123 events19 affected283 at risk EG0020 events0 affected10 at risk
CYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00021 events15 affected144 at risk EG001132 events88 affected283 at risk EG0022 events2 affected10 at risk
HAEMOLYSIS	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0015 events4 affected283 at risk EG0020 events0 affected10 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected144 at risk EG00115 events14 affected283 at risk EG0023 events3 affected10 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0015 events5 affected283 at risk EG0020 events0 affected10 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG00114 events14 affected283 at risk EG0024 events3 affected10 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG00115 events13 affected283 at risk EG0020 events0 affected10 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG0018 events7 affected283 at risk EG0021 events1 affected10 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
CARDIOVASCULAR DISORDER	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CARDIOVASCULAR INSUFFICIENCY	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
MYOCARDIAL OEDEMA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PERICARDITIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RIGHT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
SUPRAVENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
TORSADE DE POINTES	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
ANAL FISTULA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
COLITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected144 at risk EG0016 events6 affected283 at risk EG0020 events0 affected10 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
GASTRITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
GASTRODUODENITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
HYPERTROPHIC ANAL PAPILLA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ILEUS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
MELAENA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
NECROTISING COLITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
NEUTROPENIC COLITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
PALATAL ULCER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
PROCTALGIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PROCTITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
VOMITING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ASTHENIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0014 events4 affected283 at risk EG0020 events0 affected10 at risk
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
CHILLS	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0014 events4 affected283 at risk EG0020 events0 affected10 at risk
DISCOMFORT	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected144 at risk EG0016 events5 affected283 at risk EG0020 events0 affected10 at risk
IMPAIRED SELF-CARE	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INCARCERATED HERNIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INJECTION SITE EXTRAVASATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INJECTION SITE INFLAMMATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
PERIPHERAL SWELLING	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PYREXIA	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG00110 events9 affected283 at risk EG0020 events0 affected10 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
SUDDEN DEATH	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0014 events3 affected283 at risk EG0020 events0 affected10 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEPATIC CONGESTION	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEPATITIS ACUTE	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEPATITIS CHOLESTATIC	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ABSCESS FUNGAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ACINETOBACTER BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ACUTE SINUSITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ALVEOLAR OSTEITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ANAL ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0015 events3 affected283 at risk EG0020 events0 affected10 at risk
ANORECTAL CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
ASPERGILLUS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
ATYPICAL PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0019 events7 affected283 at risk EG0020 events0 affected10 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BRONCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BRONCHITIS BACTERIAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
BRONCHITIS MORAXELLA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
BURKHOLDERIA INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CAMPYLOBACTER GASTROENTERITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CANDIDA SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
CANDIDURIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected144 at risk EG0019 events7 affected283 at risk EG0020 events0 affected10 at risk
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CELLULITIS ORBITAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CELLULITIS STAPHYLOCOCCAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CITROBACTER INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CLOSTRIDIAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CORONA VIRUS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
DERMATITIS INFECTED	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0019 events6 affected283 at risk EG0020 events0 affected10 at risk
EAR INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ENTEROBACTER PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ENTEROCOCCAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
ENTEROCOCCAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ERYSIPELAS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0018 events7 affected283 at risk EG0020 events0 affected10 at risk
ESCHERICHIA INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG00110 events9 affected283 at risk EG0020 events0 affected10 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
EYE INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
FUNGAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
GASTROENTERITIS SALMONELLA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
GINGIVITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INFECTIOUS THYROIDITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
INFLUENZA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0019 events8 affected283 at risk EG0020 events0 affected10 at risk
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
KLEBSIELLA BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
KLEBSIELLA INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
KLEBSIELLA SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
LIVER ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LUNG INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG00110 events10 affected283 at risk EG0022 events2 affected10 at risk
MEDICAL DEVICE SITE CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
MENINGITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ORAL HERPES	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ORCHITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
OROPHARYNGEAL CANDIDIASIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
OTITIS MEDIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PARAINFLUENZAE VIRUS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PAROTITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
PERICORONITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
PHARYNGITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
PHARYNGOTONSILLITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PNEUMOCYSTIS JIROVECII INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00046 events35 affected144 at risk EG00171 events55 affected283 at risk EG0020 events0 affected10 at risk
PNEUMONIA FUNGAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0014 events4 affected283 at risk EG0020 events0 affected10 at risk
PNEUMONIA KLEBSIELLA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PROTEUS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
PSEUDOMONAL BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
PSEUDOMONAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0012 events2 affected283 at risk EG0021 events1 affected10 at risk
PSEUDOMONAS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
PSOAS ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
PULMONARY MYCOSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PULMONARY NOCARDIOSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PULPITIS DENTAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RECTAL ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
RHINITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RHINOVIRUS INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected144 at risk EG00129 events20 affected283 at risk EG0020 events0 affected10 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG00111 events8 affected283 at risk EG0020 events0 affected10 at risk
SINUSITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
SKIN INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
SOFT TISSUE INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
STREPTOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
STREPTOCOCCAL SEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
SYSTEMIC CANDIDA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SYSTEMIC INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SYSTEMIC MYCOSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
TONSILLITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
TOOTH ABSCESS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0015 events5 affected283 at risk EG0020 events0 affected10 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected144 at risk EG00111 events10 affected283 at risk EG0020 events0 affected10 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
URINARY TRACT INFECTION ENTEROCOCCAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
UROSEPSIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
VASCULAR DEVICE INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0015 events5 affected283 at risk EG0020 events0 affected10 at risk
WATERHOUSE-FRIDERICHSEN SYNDROME	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
WOUND INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ARTERIAL BYPASS OCCLUSION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
EXTRADURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG0014 events3 affected283 at risk EG0020 events0 affected10 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
INCISION SITE HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LIGAMENT SPRAIN	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PUBIS FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SUBARACHNOID HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
TRANSFUSION REACTION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
CLOSTRIDIUM TEST POSITIVE	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
COMPUTERISED TOMOGRAM HEAD ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
GENERAL PHYSICAL CONDITION ABNORMAL	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
POLYOMAVIRUS TEST POSITIVE	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
STAPHYLOCOCCUS TEST POSITIVE	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
WEIGHT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
CHONDROCALCINOSIS PYROPHOSPHATE	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
SERONEGATIVE ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SOFT TISSUE HAEMORRHAGE	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ERYTHROLEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEPATIC CANCER STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
MALIGNANT NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
CEREBRAL HAEMATOMA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0014 events3 affected283 at risk EG0020 events0 affected10 at risk
COMA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
DIZZINESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEADACHE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
MOTOR NEURONE DISEASE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PARESIS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PERIPHERAL SENSORIMOTOR NEUROPATHY	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
SEIZURE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
SYNCOPE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0016 events6 affected283 at risk EG0020 events0 affected10 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
DELIRIUM	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
DEPRESSION	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected144 at risk EG0015 events5 affected283 at risk EG0020 events0 affected10 at risk
AZOTAEMIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events3 affected283 at risk EG0020 events0 affected10 at risk
HAEMORRHAGE URINARY TRACT	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
RENAL MASS	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
STRANGURY	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events1 affected283 at risk EG0020 events0 affected10 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0016 events5 affected283 at risk EG0020 events0 affected10 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
LUNG CONSOLIDATION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG0013 events2 affected283 at risk EG0020 events0 affected10 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0014 events2 affected283 at risk EG0020 events0 affected10 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PNEUMOTHORAX SPONTANEOUS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PULMONARY ARTERY THROMBOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0016 events5 affected283 at risk EG0020 events0 affected10 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RASH GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
ARTERIAL HAEMORRHAGE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0020 events0 affected10 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
COELIAC ARTERY OCCLUSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HAEMORRHAGIC VASCULITIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk
HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected144 at risk EG0015 events5 affected283 at risk EG0020 events0 affected10 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0020 events0 affected10 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0020 events0 affected10 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00030 events24 affected144 at risk EG001102 events68 affected283 at risk EG00211 events6 affected10 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00016 events12 affected144 at risk EG00144 events33 affected283 at risk EG0023 events3 affected10 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00046 events20 affected144 at risk EG001133 events54 affected283 at risk EG00220 events10 affected10 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0014 events4 affected283 at risk EG0021 events1 affected10 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected144 at risk EG00116 events8 affected283 at risk EG0021 events1 affected10 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00066 events38 affected144 at risk EG001245 events107 affected283 at risk EG0026 events5 affected10 at risk
SPLENIC INFARCTION	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00094 events57 affected144 at risk EG001246 events120 affected283 at risk EG00215 events6 affected10 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0021 events1 affected10 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00015 events13 affected144 at risk EG00126 events22 affected283 at risk EG0020 events0 affected10 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0015 events5 affected283 at risk EG0021 events1 affected10 at risk
VESTIBULAR DISORDER	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
CATARACT	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0018 events8 affected283 at risk EG0021 events1 affected10 at risk
CONJUNCTIVAL DISORDER	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
KERATITIS	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
OPTIC ATROPHY	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
VISION BLURRED	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0014 events3 affected283 at risk EG0021 events1 affected10 at risk
XEROPHTHALMIA	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected144 at risk EG0018 events6 affected283 at risk EG0023 events2 affected10 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected144 at risk EG00111 events9 affected283 at risk EG0021 events1 affected10 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected144 at risk EG00142 events34 affected283 at risk EG0021 events1 affected10 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected144 at risk EG00119 events17 affected283 at risk EG0020 events0 affected10 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00066 events55 affected144 at risk EG001158 events121 affected283 at risk EG0029 events7 affected10 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00065 events46 affected144 at risk EG001182 events122 affected283 at risk EG0025 events5 affected10 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected144 at risk EG00123 events20 affected283 at risk EG0020 events0 affected10 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG0016 events5 affected283 at risk EG0021 events1 affected10 at risk
GINGIVAL PAIN	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected144 at risk EG0016 events6 affected283 at risk EG0022 events2 affected10 at risk
GINGIVAL SWELLING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0012 events2 affected283 at risk EG0022 events2 affected10 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected144 at risk EG00131 events29 affected283 at risk EG0020 events0 affected10 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00065 events53 affected144 at risk EG001178 events123 affected283 at risk EG0026 events4 affected10 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected144 at risk EG00139 events32 affected283 at risk EG0020 events0 affected10 at risk
VOMITING	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00044 events33 affected144 at risk EG001128 events84 affected283 at risk EG0029 events5 affected10 at risk
ASTHENIA	General disorders	MedDRA 21.0	Systematic Assessment	EG00017 events12 affected144 at risk EG00155 events45 affected283 at risk EG0020 events0 affected10 at risk
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG00029 events24 affected144 at risk EG00183 events61 affected283 at risk EG0020 events0 affected10 at risk
INJECTION SITE ERYTHEMA	General disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected144 at risk EG00119 events17 affected283 at risk EG0021 events1 affected10 at risk
INJECTION SITE REACTION	General disorders	MedDRA 21.0	Systematic Assessment	EG00014 events11 affected144 at risk EG00124 events13 affected283 at risk EG0025 events4 affected10 at risk
INJECTION SITE SWELLING	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
MALAISE	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG00121 events15 affected283 at risk EG0020 events0 affected10 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 21.0	Systematic Assessment	EG00030 events26 affected144 at risk EG00196 events70 affected283 at risk EG0020 events0 affected10 at risk
PAIN	General disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected144 at risk EG00120 events16 affected283 at risk EG0020 events0 affected10 at risk
PYREXIA	General disorders	MedDRA 21.0	Systematic Assessment	EG00043 events30 affected144 at risk EG00193 events66 affected283 at risk EG0025 events2 affected10 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected144 at risk EG00115 events9 affected283 at risk EG0022 events1 affected10 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
ANAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0013 events3 affected283 at risk EG0021 events1 affected10 at risk
GASTROINTESTINAL FUNGAL INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
GINGIVITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0013 events3 affected283 at risk EG0021 events1 affected10 at risk
LUNG INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG00111 events11 affected283 at risk EG0022 events2 affected10 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events5 affected144 at risk EG00121 events17 affected283 at risk EG0020 events0 affected10 at risk
ORAL HERPES	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected144 at risk EG00118 events17 affected283 at risk EG0020 events0 affected10 at risk
PERITONITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
PNEUMONIA	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected144 at risk EG00119 events19 affected283 at risk EG0020 events0 affected10 at risk
RASH PUSTULAR	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0014 events4 affected283 at risk EG0021 events1 affected10 at risk
TINEA INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected144 at risk EG0013 events2 affected283 at risk EG0021 events1 affected10 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00015 events13 affected144 at risk EG00129 events25 affected283 at risk EG0024 events4 affected10 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected144 at risk EG00134 events22 affected283 at risk EG0022 events1 affected10 at risk
BITE	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00013 events12 affected144 at risk EG00122 events16 affected283 at risk EG0020 events0 affected10 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected144 at risk EG00154 events33 affected283 at risk EG0020 events0 affected10 at risk
ADENOSINE DEAMINASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0022 events2 affected10 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG00015 events11 affected144 at risk EG00134 events24 affected283 at risk EG0023 events3 affected10 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG00016 events12 affected144 at risk EG00131 events22 affected283 at risk EG0024 events3 affected10 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected144 at risk EG00125 events15 affected283 at risk EG0020 events0 affected10 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected144 at risk EG00128 events21 affected283 at risk EG0026 events4 affected10 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG00013 events8 affected144 at risk EG00115 events13 affected283 at risk EG0022 events2 affected10 at risk
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0018 events7 affected283 at risk EG0027 events4 affected10 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected144 at risk EG00117 events16 affected283 at risk EG0020 events0 affected10 at risk
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected144 at risk EG00111 events7 affected283 at risk EG0022 events2 affected10 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG00112 events7 affected283 at risk EG0022 events1 affected10 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG0009 events3 affected144 at risk EG00124 events13 affected283 at risk EG0021 events1 affected10 at risk
WEIGHT DECREASED	Investigations	MedDRA 21.0	Systematic Assessment	EG00022 events18 affected144 at risk EG00161 events42 affected283 at risk EG0025 events4 affected10 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00029 events26 affected144 at risk EG001101 events78 affected283 at risk EG0027 events6 affected10 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0022 events1 affected10 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected144 at risk EG00114 events12 affected283 at risk EG0021 events1 affected10 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG00116 events15 affected283 at risk EG0021 events1 affected10 at risk
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG00110 events9 affected283 at risk EG0021 events1 affected10 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected144 at risk EG0019 events8 affected283 at risk EG0025 events4 affected10 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00015 events13 affected144 at risk EG00131 events23 affected283 at risk EG0025 events2 affected10 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected144 at risk EG00127 events19 affected283 at risk EG0026 events5 affected10 at risk
HYPOCHLORAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0012 events2 affected283 at risk EG0021 events1 affected10 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00059 events43 affected144 at risk EG001125 events84 affected283 at risk EG00213 events8 affected10 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0007 events5 affected144 at risk EG00128 events24 affected283 at risk EG0020 events0 affected10 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected144 at risk EG00120 events16 affected283 at risk EG0022 events2 affected10 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00023 events17 affected144 at risk EG00146 events36 affected283 at risk EG0022 events2 affected10 at risk
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected144 at risk EG00143 events35 affected283 at risk EG0023 events3 affected10 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0019 events8 affected283 at risk EG0021 events1 affected10 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected144 at risk EG00132 events25 affected283 at risk EG0020 events0 affected10 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0021 events1 affected10 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected144 at risk EG00119 events18 affected283 at risk EG0020 events0 affected10 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG0016 events6 affected283 at risk EG0021 events1 affected10 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00019 events15 affected144 at risk EG00127 events23 affected283 at risk EG0020 events0 affected10 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0012 events2 affected283 at risk EG0021 events1 affected10 at risk
DIZZINESS	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00014 events11 affected144 at risk EG00151 events37 affected283 at risk EG0021 events1 affected10 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected144 at risk EG00113 events11 affected283 at risk EG0021 events1 affected10 at risk
HEADACHE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00013 events12 affected144 at risk EG00138 events34 affected283 at risk EG0022 events1 affected10 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected144 at risk EG00110 events8 affected283 at risk EG0021 events1 affected10 at risk
POOR QUALITY SLEEP	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected144 at risk EG0010 events0 affected283 at risk EG0022 events2 affected10 at risk
INSOMNIA	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00017 events15 affected144 at risk EG00139 events36 affected283 at risk EG0024 events3 affected10 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected144 at risk EG00127 events21 affected283 at risk EG0020 events0 affected10 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00021 events20 affected144 at risk EG00140 events36 affected283 at risk EG0022 events2 affected10 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected144 at risk EG00149 events37 affected283 at risk EG0020 events0 affected10 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected144 at risk EG00130 events24 affected283 at risk EG0020 events0 affected10 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events6 affected144 at risk EG00138 events28 affected283 at risk EG0022 events1 affected10 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected144 at risk EG00129 events27 affected283 at risk EG0020 events0 affected10 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG00120 events17 affected283 at risk EG0021 events1 affected10 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected144 at risk EG00117 events15 affected283 at risk EG0020 events0 affected10 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected144 at risk EG00119 events18 affected283 at risk EG0020 events0 affected10 at risk
PRURIGO	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected144 at risk EG00134 events28 affected283 at risk EG0020 events0 affected10 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected144 at risk EG00140 events31 affected283 at risk EG0023 events3 affected10 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected144 at risk EG0012 events2 affected283 at risk EG0022 events2 affected10 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected144 at risk EG00127 events24 affected283 at risk EG0020 events0 affected10 at risk
AORTIC ARTERIOSCLEROSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0010 events0 affected283 at risk EG0021 events1 affected10 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected144 at risk EG0011 events1 affected283 at risk EG0021 events1 affected10 at risk
HAEMATOMA	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00014 events9 affected144 at risk EG00121 events16 affected283 at risk EG0020 events0 affected10 at risk
HYPERTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00014 events12 affected144 at risk EG00132 events30 affected283 at risk EG0023 events2 affected10 at risk
HYPOTENSION	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected144 at risk EG00131 events23 affected283 at risk EG0020 events0 affected10 at risk

ID	Title	Description
BG000	Group 1: Placebo + Azacitidine 75 mg/m^2	Participants enrolled under original protocol received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
BG001	Group 1: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2	Participants enrolled under original protocol received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
BG002	Group 2: Placebo + Azacitidine 75 mg/m^2	Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
BG003	Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2	Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
BG004	Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2	Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
BG005	Total	Total of all reporting groups

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2	Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).	140	144	111	144	137	144
EG001	Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2	Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).	226	283	242	283	279	283
EG002	Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2	Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).	6	10	7	10	10	10