A Study to Assess the Clinical Efficacy and Safety of Dar... | NCT02927925

ID	Type	Description	Link
54767414NKT2001	Other Identifier	Janssen Research & Development, LLC

Label	Type	Description	Intervention Names
Daratumumab	Experimental	Participants will receive daratumumab 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity.	Drug: Daratumumab

Name	Type	Description	Arm Group Labels	Other Names
Daratumumab	Drug	Participants will receive daratumumab 16 mg/kg as intravenous infusion.	Daratumumab

Measure	Description	Time Frame
Percentage of Participants With Overall Response	Overall response was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on blinded independent central review (BICR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), where applicable. CR: complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.	Up to 2 years and 11 months

Measure	Description	Time Frame
Percentage of Participants With Complete Response (CR)	CR was defined as the percentage of participants who achieved CR as per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on BICR. CR was a complete disappearance of all evidence of disease.	Up to 2 years and 11 months

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital, Chinese Academy of Medical Sciences		Beijing		100021	China
Beijing Cancer Hospital

PubMed Identifier	Type	Citation	Retractions
38233570	Derived	Qing M, Zhou T, Perova T, Abraham Y, Sweeney C, Krevvata M, Zhang X, Qi M, Gao G, Kim TM, Yao M, Cho SG, Eom HS, Lim ST, Yeh SP, Kwong YL, Yoon DH, Kim JS, Kim WS, Zhou L, Attar R, Verona RI. Immune profiling of patients with extranodal natural killer/T cell lymphoma treated with daratumumab. Ann Hematol. 2024 Jun;103(6):1989-2001. doi: 10.1007/s00277-023-05603-w. Epub 2024 Jan 18.
33588922

ID	Title	Description
FG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 24, 2019	Dec 18, 2020

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

Percentage of Participants With Overall Response

Overall response was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on blinded independent central review (BICR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), where applicable. CR: complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG00032

Title

Denominators

Categories

Title	Measurements
	OG00025.0(11.5 to 43.4)

Secondary

Percentage of Participants With Complete Response (CR)

CR was defined as the percentage of participants who achieved CR as per Revised Criteria for Response Assessment of Hodgkin and non-Hodgkin lymphoma: LUGANO classification based on BICR. CR was a complete disappearance of all evidence of disease.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Progression Free Survival (PFS)

PFS was defined as the duration from the date of the first daratumumab dose to the date of progression/relapse or death, whichever came first. Progressive disease (PD) was defined as any new lesion greater than (>) 1.5 centimeter (cm) in any axis or greater than or equal to (>=) 50 percent (%) increase in previously involved sites.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Median

95% Confidence Interval

days

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Duration of Response (DoR)

DoR was defined as duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD) (or relapse for participants who experienced CR). PD was defined as any new lesion >1.5 cm in any axis or >= 50% increase in previously involved sites.

All treated analysis set included all the participants who have received at least one dose of study drug and had CR or PR.

Posted

Median

95% Confidence Interval

days

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Time to Response

Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR based on BICR) is first documented. CR was defined as complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.

All treated analysis set included all the participants who have received at least one dose of study drug and had CR or PR.

Posted

Median

Full Range

days

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

OS was defined as the duration from the date of the first daratumumab dose to the date of death.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Median

95% Confidence Interval

days

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety and Tolerability

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Change in Vital Signs

Number of participants with clinically significant change in vital signs (blood pressure, temperature, pulse rate, and weight) was reported.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Number of participants with clinically significant ECG abnormalities were reported.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Change in Physical Finding

Number of participants with clinically significant change in physical finding was reported.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Change in Laboratory Parameters

Number of participants with clinically significant change in hematology (WBC, hemoglobin, platelets, neutrophils, and lymphocytes) and biochemistry (alanine transaminase [ALT], aspartate transaminase [AST], sodium, potassium, bilirubin, alkaline phosphatase, calcium laboratory parameters were reported.

All treated analysis set included all the participants who have received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to 2 years and 11 months

ID	Title	Description
OG000	Daratumumab	Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly for 8 weeks, then every 2 weeks for 16 weeks, then every 4 weeks thereafter until study drug discontinuation due to progressive disease (PD), consent withdrawal or unacceptable toxicity (up to 392 Days).

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0009 affected32 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0007 affected32 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0007 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0009 affected32 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Myocarditis	Cardiac disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Pericardial Effusion	Cardiac disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Tachycardia	Cardiac disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Ear Discomfort	Ear and labyrinth disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Steroid Withdrawal Syndrome	Endocrine disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Cataract	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Diplopia	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Eye Swelling	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Periorbital Oedema	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Periorbital Swelling	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Uveitis	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Vision Blurred	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Vitritis	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Anorectal Swelling	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Aphthous Ulcer	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Gingival Pain	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Mouth Ulceration	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0005 affected32 at risk
Proctalgia	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Asthenia	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Chest Discomfort	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Chills	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0008 affected32 at risk
Face Oedema	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Fatigue	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0007 affected32 at risk
Generalised Oedema	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Influenza Like Illness	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Oedema	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Oedema Peripheral	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Pain	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Pyrexia	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG00020 affected32 at risk
Swelling Face	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Immunodeficiency	Immune system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Eye Infection	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Gingivitis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Influenza	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Localised Infection	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Oral Candidiasis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Oropharyngeal Candidiasis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Otitis Media	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Pharyngitis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Pneumonia	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Sinusitis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Skin Infection	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0009 affected32 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0008 affected32 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Blood Chloride Decreased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
C-Reactive Protein Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Influenza B Virus Test Positive	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Interleukin Level Increased	Investigations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0006 affected32 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Paraneoplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Tumour Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Convulsions Local	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Dizziness	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Headache	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0008 affected32 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Limbic Encephalitis	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Lumbosacral Radiculopathy	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Tremor	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Delirium	Psychiatric disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hallucination	Psychiatric disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Insomnia	Psychiatric disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Polyuria	Renal and urinary disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Dry Throat	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Nasal Obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0004 affected32 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0007 affected32 at risk
Skin Haemorrhage	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Hypertension	Vascular disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hypotension	Vascular disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0005 affected32 at risk

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Periorbital Swelling	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Uveitis	Eye disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Death	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Pyrexia	General disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0005 affected32 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Cellulitis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Epstein-Barr Virus Infection	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Hepatitis Infectious Mononucleosis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Oral Candidiasis	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Pneumonia	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Septic Shock	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0003 affected32 at risk
Skin Infection	Infections and infestations	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Headache	Nervous system disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0002 affected32 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Non-systematic Assessment	EG0001 affected32 at risk