Safety and Tolerability Study of PCI-32765 in B Cell Lymp... | NCT01109069

NCT01109069

ID	Type	Description	Link
PCI-32765	Other Identifier	Pharmacyclics

Status Module

Name	Class
Janssen Research & Development, LLC	INDUSTRY

Label	Type	Description	Intervention Names
PCI-32765	Experimental		Drug: PCI-32765

Name	Type	Description	Arm Group Labels	Other Names
PCI-32765	Drug	Dose based on parent protocol	PCI-32765

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Adverse Events	Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.	30 days after last dose of study drug, continue up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Progressive Disease (PD)	A progressive disease confirmed by a CT scan.	30 days after last dose of study drug, continue up to 6 months
Death Event	All death events are due to AE, progressive disease, and other reasons.

Eligibility Module

Name	Affiliation	Role
James Dean, MD	Medical Monitor	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States

PubMed Identifier	Type	Citation	Retractions
32209572	Derived	Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum K, Sharman JP, Wierda W, Zhao W, Heerema NA, Luan Y, Liu EA, Dean JP, O'Brien S. Ibrutinib Treatment for First-Line and Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase Ib/II PCYC-1102 Study. Clin Cancer Res. 2020 Aug 1;26(15):3918-3927. doi: 10.1158/1078-0432.CCR-19-2856. Epub 2020 Mar 24.
31196847

Label	URL
Home page of Pharmacyclics	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH	A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 14, 2015	Jan 29, 2020

ID	Title	Description
BG000	A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh	A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg).

Units	Counts
Participants	BG000199

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG00083
>=65 years	BG000

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00065.6± 8.98

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00056
Male	BG000143

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006
Not Hispanic or Latino	BG000192

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001
Asian	BG0002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000199

Estimated creatinine clearance rate (mL/min)

Mean

Standard Deviation

ML/min

Title

Denominators

Categories

Title	Measurements
	BG00085.55± 34.150

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Adverse Events

Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.

Posted

Count of Participants

Participants

30 days after last dose of study drug, continue up to 6 months

ID	Title	Description
OG000	A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH	A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg).

Units	Counts
Participants	OG000199

Title

Denominators

Categories

Title	Measurements
	OG000199

Secondary

Progressive Disease (PD)

A progressive disease confirmed by a CT scan.

Posted

Count of Participants

Participants

30 days after last dose of study drug, continue up to 6 months

ID	Title	Description
OG000	IBRUTINIB/PCI-32765	This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.

Units	Counts
Participants	OG000199

Secondary

Death Event

All death events are due to AE, progressive disease, and other reasons.

Posted

Count of Participants

Participants

30 days after last dose of study drug

ID	Title	Description
OG000	IBRUTINIB/PCI-32765	This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.

Units	Counts
Participants	OG000199

Secondary

Documented Responses

Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.

Posted

Count of Participants

Participants

30 days after last dose of study drug, continue up to 6 months

ID	Title	Description
OG000	IBRUTINIB/PCI-32765	This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 21.0	Systematic Assessment	EG0005 events4 affected199 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG00025 events21 affected199 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Atrial flutter	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Sinus bradycardia	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Bundle branch block left	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Bundle branch block right	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Coronary artery disease	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Palpitations	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pericarditis	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Subendocardial ischaemia	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events1 affected199 at risk
Haematotympanum	Ear and labyrinth disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Uveitis	Eye disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0003 events3 affected199 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pyrexia	General disorders	MedDRA Version 21.0	Systematic Assessment	EG0009 events8 affected199 at risk
Asthenia	General disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Chest pain	General disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Fatigue	General disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pneumonia	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG00061 events32 affected199 at risk
Cellulitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG00016 events13 affected199 at risk
Sepsis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG00012 events11 affected199 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0007 events6 affected199 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0004 events3 affected199 at risk
Gastroenteritis viral	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0004 events3 affected199 at risk
Herpes zoster	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0003 events3 affected199 at risk
Septic shock	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0003 events3 affected199 at risk
Bacteraemia	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Diverticulitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0003 events2 affected199 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Influenza	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0003 events2 affected199 at risk
Localised infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Lung infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0003 events2 affected199 at risk
Urosepsis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Viral infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Acute sinusitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Appendicitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Bronchitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Cellulitis orbital	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Clostridial sepsis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Clostridium difficile infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Dengue fever	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Ear infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Fusarium infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0003 events1 affected199 at risk
Gangrene	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Gastrointestinal infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Klebsiella infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Klebsiella sepsis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Lymphangitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pelvic abscess	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pharyngitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pilonidal cyst	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pneumonia bacterial	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pneumonia fungal	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pneumonia legionella	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pseudomonas infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Sinusitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Staphylococcal infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Vestibular neuronitis	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Wound infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0004 events3 affected199 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Transaminases increased	Investigations	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Diabetic ketosis	Metabolism and nutrition disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0004 events3 affected199 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0003 events3 affected199 at risk
Richter's syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0004 events3 affected199 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Appendix cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Chronic lymphocytic leukaemia transformation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Lung adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Syncope	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0003 events3 affected199 at risk
Headache	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events2 affected199 at risk
Autoimmune neuropathy	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Dizziness	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Embolic stroke	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Encephalopathy	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Ischaemic stroke	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Myelitis transverse	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Optic neuritis	Nervous system disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Mental status changes	Psychiatric disorders	MedDRA Version 21.0	Systematic Assessment	EG0003 events3 affected199 at risk
Confusional state	Psychiatric disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 21.0	Systematic Assessment	EG0004 events4 affected199 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0005 events4 affected199 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0005 events4 affected199 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0002 events1 affected199 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Eosinophilic pustular folliculitis	Skin and subcutaneous tissue disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Hypotension	Vascular disorders	MedDRA Version 21.0	Systematic Assessment	EG0004 events3 affected199 at risk
Aortic aneurysm	Vascular disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Aortic stenosis	Vascular disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Hypertension	Vascular disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk
Orthostatic hypotension	Vascular disorders	MedDRA Version 21.0	Systematic Assessment	EG0001 events1 affected199 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 21.0	Systematic Assessment	EG00024 events21 affected199 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 21.0	Systematic Assessment	EG00023 events10 affected199 at risk
Cataract	Ear and labyrinth disorders	MedDRA Version 21.0	Systematic Assessment	EG00020 events14 affected199 at risk
Diarrohea	Gastrointestinal disorders	MedDRA Version 21.0	Systematic Assessment	EG00010 events9 affected199 at risk
Upper Respiratory Track Infection	Infections and infestations	MedDRA Version 21.0	Systematic Assessment	EG00010 events9 affected199 at risk
Lymphocyte count decreased	Investigations	MedDRA Version 21.0	Systematic Assessment	EG00059 events24 affected199 at risk
Neutrophil Count decreased	Investigations	MedDRA Version 21.0	Systematic Assessment	EG00032 events17 affected199 at risk
White Blood cell count decreased	Investigations	MedDRA Version 21.0	Systematic Assessment	EG00012 events8 affected199 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA Version 21.0	Systematic Assessment	EG00015 events10 affected199 at risk
Hypertension	Vascular disorders	MedDRA Version 21.0	Systematic Assessment	EG000197 events67 affected199 at risk

Ancestor Terms

ID	Term
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
D008223	Lymphoma
D054219	Neoplasms, Plasma Cell
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006474	Hemorrhagic Disorders
D020031	Epstein-Barr Virus Infections
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D014412	Tumor Virus Infections

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D016393	Lymphoma, B-Cell
D008224	Lymphoma, Follicular
D020522	Lymphoma, Mantle-Cell
D008228	Lymphoma, Non-Hodgkin
D008258	Waldenstrom Macroglobulinemia
D002051	Burkitt Lymphoma
D007945	Leukemia, Lymphoid
D015448	Leukemia, B-Cell