A Study Comparing Zanubrutinib With Bendamustine Plus Rit... | NCT03336333

ID	Type	Description	Link
2017-001551-31	EudraCT Number
CTR20190416	Registry Identifier	ChinaDrugTrials

Label	Type	Description	Intervention Names
Cohort 1: Bendamustine + Rituximab	Experimental	Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)	Drug: Bendamustine Drug: Rituximab
Cohort 1: Zanubrutinib	Experimental	Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)	Drug: Zanubrutinib
Cohort 1a (China only): Bendamustine + Rituximab	Experimental	Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only)	Drug: Bendamustine Drug: Rituximab
Cohort 1a (China only): Zanubrutinib	Experimental	Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)	Drug: Zanubrutinib
Cohort 2: Zanubrutinib	Experimental	Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)	Drug: Zanubrutinib

Name	Type	Description	Arm Group Labels	Other Names
Zanubrutinib	Drug	Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)	Cohort 1: Zanubrutinib Cohort 1a (China only): Zanubrutinib

Measure	Description	Time Frame
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)	PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).	Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)

Measure	Description	Time Frame
Cohort 1: Overall Response Rate (ORR) Between Treatment Groups as Determined by ICR	ORR in Cohort 1 is defined as the percentage of participants who achieve a complete response, complete response with incomplete bone marrow recovery, partial response, or partial response with lymphocytosis, determined by the ICR.	Up to 5 years

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Augusta University		Augusta	Georgia	30912	United States
Northwestern University

PubMed Identifier	Type	Citation	Retractions
31875923	Result	Mu S, Tang Z, Novotny W, Tawashi M, Li TK, Ou Y, Sahasranaman S. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton's tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2020 Feb;85(2):391-399. doi: 10.1007/s00280-019-04015-w. Epub 2019 Dec 26.
33054121

ID	Title	Description
FG000	Cohort 1: Bendamustine + Rituximab Without Del(17p)	Bendamustine + rituximab in participants with chronic lymphocytic leukemia (CLL) without deletion 17p [del(17p)]; bendamustine 90 milligrams (mg)/m^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m^2 for Cycle 1 and 500 mg/m^2 for Cycles 2 to 6 (each cycle is 28 days)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 10, 2021	Oct 16, 2023

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG00015 events5 affected227 at risk EG0016 events2 affected240 at risk EG0022 events1 affected111 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG00011 events11 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Angina unstable	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0014 events4 affected240 at risk EG0023 events3 affected111 at risk
Bradycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Cardiac failure	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0021 events1 affected111 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Palpitations	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Retinal detachment	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events1 affected240 at risk EG0020 events0 affected111 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Hyperpyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Implant site erosion	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Malaise	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG00019 events17 affected227 at risk EG0012 events2 affected240 at risk EG0023 events2 affected111 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Gallbladder rupture	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Regenerative siderotic hepatic nodule	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Abdominal sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Abscess of salivary gland	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Appendicitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0023 events2 affected111 at risk
Bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Bronchitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0018 events8 affected240 at risk EG0021 events1 affected111 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0017 events7 affected240 at risk EG0021 events1 affected111 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0013 events3 affected240 at risk EG0020 events0 affected111 at risk
Cholecystitis infective	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Chronic sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Disseminated varicella zoster virus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Diverticulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Endocarditis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Erysipelas	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Groin abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
H3N2 influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Hepatitis B reactivation	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Infected skin ulcer	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events1 affected240 at risk EG0020 events0 affected111 at risk
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Intervertebral discitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Neuroborreliosis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Otitis externa	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Otitis media acute	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0008 events7 affected227 at risk EG0015 events4 affected240 at risk EG0026 events6 affected111 at risk
Pneumonia chlamydial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Pneumonia viral	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Postoperative wound infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Respiratory tract infection fungal	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0007 events6 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Sialoadenitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Skin infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Soft tissue infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events1 affected240 at risk EG0020 events0 affected111 at risk
Systemic candida	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Tick-borne fever	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0006 events5 affected227 at risk EG0012 events1 affected240 at risk EG0022 events2 affected111 at risk
Urosepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0022 events2 affected111 at risk
Viral infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Viral pericarditis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Wound infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0024 events3 affected111 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0008 events7 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0021 events1 affected111 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Blood pressure increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
External ear neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0013 events3 affected240 at risk EG0021 events1 affected111 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Lung squamous cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events1 affected240 at risk EG0020 events0 affected111 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0022 events2 affected111 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events1 affected240 at risk EG0020 events0 affected111 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Skin squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Transitional cell carcinoma urethra	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Cerebral infarction	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Encephalopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Facial paralysis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0022 events2 affected111 at risk
Hydrocephalus	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Radial nerve palsy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Confusional state	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Bladder stenosis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0012 events2 affected240 at risk EG0021 events1 affected111 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0022 events2 affected111 at risk
Renal colic	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Renal failure	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Ureteral polyp	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Urinary retention	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0020 events0 affected111 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events2 affected240 at risk EG0022 events2 affected111 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events1 affected240 at risk EG0020 events0 affected111 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0012 events1 affected240 at risk EG0022 events2 affected111 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected240 at risk EG0020 events0 affected111 at risk
Aortic dissection	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Aortic intramural haematoma	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Arteriosclerosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected227 at risk EG0010 events0 affected240 at risk EG0021 events1 affected111 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG00065 events41 affected227 at risk EG00112 events11 affected240 at risk EG0027 events5 affected111 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG00012 events7 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG000233 events101 affected227 at risk EG00162 events30 affected240 at risk EG00228 events13 affected111 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG00062 events30 affected227 at risk EG00115 events8 affected240 at risk EG0024 events4 affected111 at risk
Palpitations	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected227 at risk EG00110 events10 affected240 at risk EG0023 events3 affected111 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0004 events2 affected227 at risk EG00112 events9 affected240 at risk EG0022 events2 affected111 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00013 events12 affected227 at risk EG00116 events11 affected240 at risk EG00210 events9 affected111 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00049 events43 affected227 at risk EG00126 events24 affected240 at risk EG00218 events17 affected111 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00037 events26 affected227 at risk EG00142 events33 affected240 at risk EG00224 events20 affected111 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00010 events9 affected227 at risk EG0013 events3 affected240 at risk EG0020 events0 affected111 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0008 events8 affected227 at risk EG00112 events10 affected240 at risk EG00212 events10 affected111 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected227 at risk EG0012 events2 affected240 at risk EG0022 events2 affected111 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG000107 events74 affected227 at risk EG00130 events24 affected240 at risk EG00226 events18 affected111 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0009 events8 affected227 at risk EG0015 events5 affected240 at risk EG0021 events1 affected111 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00040 events31 affected227 at risk EG00123 events17 affected240 at risk EG0029 events8 affected111 at risk
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG00025 events18 affected227 at risk EG0016 events5 affected240 at risk EG0026 events4 affected111 at risk
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0019 events9 affected240 at risk EG0022 events2 affected111 at risk
Chills	General disorders	MedDRA 24.0	Systematic Assessment	EG00021 events19 affected227 at risk EG0013 events3 affected240 at risk EG0026 events5 affected111 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG00052 events36 affected227 at risk EG00137 events28 affected240 at risk EG00214 events10 affected111 at risk
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG00017 events16 affected227 at risk EG00125 events18 affected240 at risk EG0029 events8 affected111 at risk
Peripheral swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG0007 events6 affected227 at risk EG00111 events9 affected240 at risk EG0024 events4 affected111 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG00069 events46 affected227 at risk EG00115 events15 affected240 at risk EG0027 events6 affected111 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0009 events8 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Bronchitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00017 events15 affected227 at risk EG0016 events6 affected240 at risk EG0023 events3 affected111 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0008 events7 affected227 at risk EG00116 events16 affected240 at risk EG0025 events3 affected111 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG00115 events12 affected240 at risk EG0022 events2 affected111 at risk
Conjunctivitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 events6 affected227 at risk EG0014 events4 affected240 at risk EG0027 events4 affected111 at risk
Herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 events9 affected227 at risk EG0015 events5 affected240 at risk EG0021 events1 affected111 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0006 events4 affected227 at risk EG00111 events8 affected240 at risk EG0026 events6 affected111 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00015 events12 affected227 at risk EG00116 events16 affected240 at risk EG00213 events11 affected111 at risk
Oral herpes	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0008 events7 affected227 at risk EG0013 events3 affected240 at risk EG0022 events2 affected111 at risk
Pharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG0013 events1 affected240 at risk EG0025 events4 affected111 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00014 events13 affected227 at risk EG0019 events8 affected240 at risk EG00211 events8 affected111 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 events8 affected227 at risk EG00115 events7 affected240 at risk EG0026 events5 affected111 at risk
Sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00011 events10 affected227 at risk EG00112 events12 affected240 at risk EG0027 events6 affected111 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00032 events27 affected227 at risk EG00153 events41 affected240 at risk EG00229 events23 affected111 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00028 events16 affected227 at risk EG00129 events16 affected240 at risk EG00211 events9 affected111 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0008 events8 affected227 at risk EG00158 events46 affected240 at risk EG00231 events22 affected111 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG00012 events7 affected227 at risk EG00111 events9 affected240 at risk EG0029 events9 affected111 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG00044 events39 affected227 at risk EG0011 events1 affected240 at risk EG0020 events0 affected111 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0005 events4 affected227 at risk EG0014 events4 affected240 at risk EG0027 events6 affected111 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG00018 events10 affected227 at risk EG0017 events3 affected240 at risk EG0020 events0 affected111 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG00012 events9 affected227 at risk EG0016 events3 affected240 at risk EG0020 events0 affected111 at risk
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG0012 events2 affected240 at risk EG0024 events4 affected111 at risk
Neutrophil count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG00069 events28 affected227 at risk EG00114 events6 affected240 at risk EG00217 events7 affected111 at risk
Platelet count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG00020 events11 affected227 at risk EG0012 events2 affected240 at risk EG00213 events4 affected111 at risk
Weight decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected227 at risk EG0012 events2 affected240 at risk EG0022 events2 affected111 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG00018 events18 affected227 at risk EG00110 events7 affected240 at risk EG0021 events1 affected111 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG00013 events8 affected227 at risk EG0011 events1 affected240 at risk EG0021 events1 affected111 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0006 events4 affected227 at risk EG0015 events4 affected240 at risk EG0027 events6 affected111 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG00013 events9 affected227 at risk EG0017 events6 affected240 at risk EG0022 events2 affected111 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG00026 events12 affected227 at risk EG0015 events4 affected240 at risk EG0023 events3 affected111 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00024 events19 affected227 at risk EG00140 events32 affected240 at risk EG00225 events22 affected111 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00020 events15 affected227 at risk EG00126 events21 affected240 at risk EG00219 events16 affected111 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00010 events9 affected227 at risk EG0012 events1 affected240 at risk EG0021 events1 affected111 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0005 events4 affected227 at risk EG00110 events8 affected240 at risk EG0028 events7 affected111 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0018 events7 affected240 at risk EG0025 events4 affected111 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected227 at risk EG00111 events9 affected240 at risk EG0028 events6 affected111 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0015 events5 affected240 at risk EG0029 events7 affected111 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00013 events12 affected227 at risk EG00123 events15 affected240 at risk EG00211 events10 affected111 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0004 events3 affected227 at risk EG00112 events9 affected240 at risk EG00217 events12 affected111 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00013 events10 affected227 at risk EG00121 events19 affected240 at risk EG00210 events8 affected111 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00019 events17 affected227 at risk EG00131 events26 affected240 at risk EG00214 events11 affected111 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected227 at risk EG0011 events1 affected240 at risk EG0024 events4 affected111 at risk
Sciatica	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0005 events4 affected227 at risk EG0014 events3 affected240 at risk EG0024 events4 affected111 at risk
Insomnia	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG00017 events16 affected227 at risk EG00111 events10 affected240 at risk EG0023 events3 affected111 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0009 events8 affected227 at risk EG0011 events1 affected240 at risk EG0022 events2 affected111 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected227 at risk EG00116 events12 affected240 at risk EG00212 events10 affected111 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected227 at risk EG0013 events3 affected240 at risk EG0024 events4 affected111 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00027 events23 affected227 at risk EG00133 events27 affected240 at risk EG00218 events14 affected111 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00012 events9 affected227 at risk EG0018 events8 affected240 at risk EG00211 events11 affected111 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG00122 events12 affected240 at risk EG0028 events7 affected111 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0006 events6 affected227 at risk EG00111 events10 affected240 at risk EG0023 events3 affected111 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG00110 events9 affected240 at risk EG0026 events6 affected111 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected227 at risk EG0018 events6 affected240 at risk EG0023 events3 affected111 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG0018 events7 affected240 at risk EG0028 events6 affected111 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG00011 events8 affected227 at risk EG0018 events7 affected240 at risk EG0023 events3 affected111 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected227 at risk EG00122 events18 affected240 at risk EG0026 events5 affected111 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG00022 events16 affected227 at risk EG00124 events20 affected240 at risk EG00211 events10 affected111 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG00059 events42 affected227 at risk EG00131 events26 affected240 at risk EG00219 events16 affected111 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG00012 events10 affected227 at risk EG00110 events8 affected240 at risk EG0024 events4 affected111 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected227 at risk EG00112 events9 affected240 at risk EG0025 events5 affected111 at risk
Haematoma	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected227 at risk EG00118 events13 affected240 at risk EG0028 events6 affected111 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG00021 events19 affected227 at risk EG00136 events28 affected240 at risk EG00213 events10 affected111 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG00025 events21 affected227 at risk EG0016 events6 affected240 at risk EG0025 events4 affected111 at risk

ID	Title	Description
BG000	Cohort 1: Bendamustine + Rituximab Without Del(17p)	Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m^2 for Cycle 1 and 500 mg/m^2 for Cycles 2 to 6 (each cycle is 28 days)
BG001	Cohort 1: Zanubrutinib Without Del(17p)	Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
BG002	Cohort 2: Zanubrutinib With Del(17p)	Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: Bendamustine + Rituximab Without Del(17p)	Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m^2 for Cycle 1 and 500 mg/m^2 for Cycles 2 to 6 (each cycle is 28 days)	14	238	113	227	214	227
EG001	Cohort 1: Zanubrutinib Without Del(17p)	Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	16	241	88	240	208	240
EG002	Cohort 2: Zanubrutinib With Del(17p)	Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	8	111	45	111	104	111

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000629551	zanubrutinib
D000069461	Bendamustine Hydrochloride
D000069283	Rituximab
C579720	venetoclax

ID	Term
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins