Ofatumumab for Patients With Previously Untreated Chronic... | NCT01113632

NCT01113632

Status Module

Sponsor/Collaborators Module

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ofatumumab 1000mg	Experimental	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks	Drug: Ofatumumab
Ofatumumab 2000mg	Experimental	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks	Drug: Ofatumumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ofatumumab	Drug	IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	18 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.	18 months
Number of Complete Responses	The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CD20+ B-cell chronic lymphocytic leukemia (B-CLL) or small lymphocytic lymphoma according to NCI criteria (see Appendix B).
Previously untreated CLL or small lymphocytic lymphoma (SLL).
Patients must require treatment according to NCI-Working Group guidelines (see Appendix C).
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2 (see Appendix A).
Laboratory values as follows ≤7 days of initiation of treatment:
- Creatinine <3.0 mg/dL
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) and alkaline phosphatase (ALP) must be <3 x upper limit of normal (ULN)
- Total bilirubin <1.5 x the institutional ULN
Patients must be hepatitis B sAg negative. Note: Patients who are HepB sAg negative but are HepB cAb positive (regardless of HepB sAb status) will NOT be allowed.
Women of childbearing potential must have a negative serum pregnancy test performed ≤7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
Patients ≤ 65 years of age, or patients 18-64 years of age who have declined fludarabine-based regimens, are eligible.
Patient must be accessible for treatment and follow-up.
Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.

Exclusion Criteria:

Previous therapy for CLL/SLL. (Patients who have received steroids or IVIG for autoimmune complications of CLL are eligible).
Current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease, per assessment by the treating physician).
Active bacterial or viral infection, or infection requiring intravenous antibiotic treatment at the time of accrual.
Central nervous system lymphoma/CLL.
Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (i.e., Richters transformation).
History of other malignancy within 2 years of study entry which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, low grade, early-stage, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast treated with curative intent, are generally eligible. These cases should be discussed with the study chair or study co-chair prior to enrollment.
Patients who are HepB sAg positive and/or HepB cAb positive.
Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
A major surgical procedure, open biopsy, or significant traumatic injury ≤28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study.
Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to visit 1, whichever is longer. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

Contacts/Locations Module

Name	Affiliation	Role
Ian Flinn, M.D.	SCRI Development Innovations, LLC	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Los Robles		Thousand Oaks	California	91360	United States
Florida Cancer Specialists

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
BG001	Ofatumumab 2000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00033 BG00144 BG00277

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00075(50 to 93) BG00169(47 to 88) BG00272(47 to 93)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG00119 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00033 BG00144 BG002

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

Secondary

Progression-free Survival (PFS)

To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.

Posted

Median

95% Confidence Interval

months

18 months

ID	Title	Description
OG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.
OG001	Ofatumumab 2000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Units	Counts
Participants	OG00033 OG00144

Title

Denominators

Categories

Title	Measurements
	OG00019.8(9.7 to NA)Upper bound of the 95% confidence interval cannot be calculated as there is an insufficient number of events for this caluclation OG00132.5(26.6 to NA)Upper bound of the 95% confidence interval cannot be calculated as there is an insufficient number of events for this caluclation

Primary

Overall Response Rate (ORR)

The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

All patients who were evaluable for a response assessment

Posted

Number

participants

18 months

ID	Title	Description
OG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.
OG001	Ofatumumab 2000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Secondary

Number of Complete Responses

The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions

All patients who were evaluable for a response assessment

Posted

Number

participants

18 Months

ID	Title	Description
OG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.
OG001	Ofatumumab 2000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Secondary

Number of Partial Responses

The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions

All patients who were evaluable for a response assessment

Posted

Number

participants

18 Months

ID	Title	Description
OG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.
OG001	Ofatumumab 2000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Secondary

Safety of the Treatment Regimen

Listing of all non-serious Adverse Events ocurring in 5% of patients or more

Posted

Number

participants

18 Months

ID	Title	Description
OG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.
OG001	Ofatumumab 2000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ofatumumab 1000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.			3	33	32	33
EG001	Ofatumumab 2000mg	Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.			2	44	42	44

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Cholesterol high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected33 at risk EG0011 affected44 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Gastrointestinal disorders - Other, hernia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Gastrointestinal disorders - Other, unknown	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected33 at risk EG0011 affected44 at risk
Urticaria	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0010 affected44 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG00012 affected33 at risk EG00121 affected44 at risk
Allergic reaction	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected33 at risk EG00116 affected44 at risk
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected33 at risk EG00113 affected44 at risk
Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected33 at risk EG00114 affected44 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00013 affected33 at risk EG00110 affected44 at risk
Rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected33 at risk EG00116 affected44 at risk
White blood cell decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00010 affected33 at risk EG0019 affected44 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected33 at risk EG00113 affected44 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected33 at risk EG0019 affected44 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0007 affected33 at risk EG00110 affected44 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected33 at risk EG0019 affected44 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG00111 affected44 at risk
Edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected33 at risk EG0016 affected44 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG00111 affected44 at risk
Infections and infestations - Other, unspecified	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0006 affected33 at risk EG0017 affected44 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG00111 affected44 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG00110 affected44 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG0019 affected44 at risk
Psychiatric disorders - Other, mood alteration	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected33 at risk EG0017 affected44 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG0017 affected44 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected33 at risk EG0015 affected44 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected33 at risk EG0014 affected44 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG0015 affected44 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0006 affected33 at risk EG0012 affected44 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0016 affected44 at risk
Oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0017 affected44 at risk
Respiratory, thoracic and mediastinal disorders - Other, unknown	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG0015 affected44 at risk
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0016 affected44 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG0013 affected44 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0014 affected44 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG0013 affected44 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0014 affected44 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0014 affected44 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0014 affected44 at risk
Gastrointestinal disorders - Other, unknown	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG0013 affected44 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG0012 affected44 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG0013 affected44 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG0012 affected44 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0013 affected44 at risk
Flushing	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0014 affected44 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected33 at risk EG0012 affected44 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0013 affected44 at risk
Musculoskeletal and connective tissue disorders - Other, unknown	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0013 affected44 at risk
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG0011 affected44 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected33 at risk EG0015 affected44 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0014 affected44 at risk
Alanine aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0012 affected44 at risk
Blurred vision	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected33 at risk EG0010 affected44 at risk
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0013 affected44 at risk
Chills	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0013 affected44 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0013 affected44 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0013 affected44 at risk
Infusion related reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0013 affected44 at risk
Urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected33 at risk EG0013 affected44 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected33 at risk EG0012 affected44 at risk

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

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
C527517	ofatumumab

Units	Counts
Participants	OG00033 OG00144