Study of Iodine-131 Anti-B1 Antibody for Patients With No... | NCT00996593

Label	Type	Description	Intervention Names
open-label, single arm	Experimental		Biological: Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab)

Name	Type	Description	Arm Group Labels	Other Names
Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab)	Biological	Patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of Anti-B1 Antibody (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Patients will then receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of 35 mg Anti-B1 Antibody containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator	Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).	Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator	CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.	Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator	CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.	Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years
Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to International Working Formulation.
Patients must have evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity with Anti-B1 Antibody or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20 positivity.
Patients must have been treated with at least 4 doses of rituximab at any time and failed to achieve an objective response (CR, CCR, PR) or relapse/progressed during treatment or following the completion of rituximab therapy.
Patients must have a performance status of at least 60% on the Karnofsky Scale and an anticipated survival of at least 3 months.
Patients must have an absolute granulocyte count >1500 cells/mm3 (US) and a platelet count >100,000 cells/mm3 (US) within 14 days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
Patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [ULN]) and hepatic function (defined as total bilirubin <1.5 x ULN and aspartate transaminase [AST] <5 x ULN) within 14 days of study entry.
Patients must have bi-dimensionally measurable disease. At least one lesion must be greater than or equal to 2 x 2 cm (by computed tomography [CT] scan).
Patients must be at least 18 years of age.
Patients must give written informed consent and sign an IRB/EC- approved informed consent form prior to study entry.

Exclusion Criteria

Patients with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrabecular space involved exceeds 10% on a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
Patients who received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (6 weeks of nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids must be discontinued at least 1 week prior to study entry.
Patients with prior hematopoietic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy.
Patients with active obstructive hydronephrosis.
Patients with evidence of active infection requiring intravenous (IV) antibiotics at the time of study entry.
Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
Patients with known HIV infection.
Patients with known brain or leptomeningeal metastases.
Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test within 7 days of study entry and radiolabeled antibody is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy.
Patients with previous allergic reactions to iodine. This does not include reacting to IV iodine-containing contrast materials.
Patients who previously received radioimmunotherapy.
Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with > 3500 cGy.
Patients who are HAMA positive.
Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Label	URL
GSK Clinical Study Register	View source
Horning SJ, Younes, Jain V, Kroll S, Lucas J, Podoloff D, et al. Efficacy and Safety of Tositumomab and Iodine-131 Tositumomab (Bexxar) in B-Cell Lymphoma, Progressive After Rituximab. J Clin Oncol 23:712-719, 2005	View source

ID	Type	URL	Comment
104507	Individual Participant Data Set	View IPD

ID	Title	Description
FG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

ID	Title	Description
BG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

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 Participants (Par.) With Confirmed Response as Assessed by the Investigator

Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).

Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants	OG00034

Title

Denominators

Categories

Title	Measurements
	OG00026

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000						Percentage of participants	65			2-Sided	95	50	80			The estimated value represents the percentage of participants with complete response.	No	Superiority or Other

Primary

Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator

CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Primary

Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator

CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.

ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Primary

Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator

Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.

ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Primary

Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator

Response duration is defined as the time from the first documented response until disease progression.

ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Primary

Duration of Response for Confirmed CR as Assessed by the Investigator

Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.

ITT Exposed Population. Only those participants with confirmed CR and those who experienced progressive disease were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Primary

Duration of Response for CR and CCR as Assessed by the Investigator

Response duration is defined as the time from the first documented response until disease progression.

ITT Exposed Population. Only those participants with confirmed CR + CCR response and those who experienced progressive disease were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Primary

Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator

Response duration is defined as the time from the first documented response until progressive disease.

ITT Exposed Population. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Primary

Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study

Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Primary

Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab

Duration of response is defined as the time from the first documented response to disease progression.

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with a response were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts

Primary

Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study

CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts

Primary

Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab

Duration of response is defined as the time from the first documented response to disease progression.

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts

Primary

Progression-free Survival for Participants With or Without a Prior Response to Rituximab

Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts

Primary

Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator

Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.

ITT Exposed Population. Only those participants who experienced progression were evaluated.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts

Secondary

Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.

ITT Exposed Population

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Secondary

Number of Participants With the Indicated Type of Infection

An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.

ITT Exposed Population

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Secondary

Number of Participants With an Infection for Which Anti-infectives Were Administered

Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.

ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units

Secondary

Number of Participants With Serious Adverse Events (SAE) Related to Study Drug

An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.

ITT Exposed Population. All participants who experienced any SAE were analyzed.

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Secondary

Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations

Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.

ITT Exposed Population

Posted

Median

Full Range

days

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Secondary

Nadir Values for ANC, a Hematologic Parameter

Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.

ITT Exposed Population

Posted

Median

Full Range

cells/millimeters cubed (mm^3)

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Secondary

Nadir Values for Hemoglobin, a Hematologic Parameter

Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.

ITT Exposed Population

Posted

Median

Full Range

G/dL

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Secondary

Nadir Values for Hematologic Parameters Platelets and WBC Count

Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.

ITT Exposed Population

Posted

Median

Full Range

cells/microliter

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Secondary

Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities

Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.

ITT Exposed Population

Posted

Number

participants

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units

Secondary

Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities

ITT Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed.

Posted

Median

Full Range

days

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Primary

Overall Survival

Overall survival is defined as the time from the treatment start date to the date of death from any cause.

ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.

Posted

Median

95% Confidence Interval

months

Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years

ID	Title	Description
OG000	TST and Iodine I 131 TST	Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Malignant hepatobiliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Human anti-mouse antibody positive	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hallucination	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00012 affected40 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00011 affected40 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0004 affected40 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Face oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Ill-defined disorder	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Infusion site erythema	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
ANC <1000 cells/mm^3	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00016 affected40 at risk
WBC < 2000 cells/mm^3	Investigations	MedDRA	Systematic Assessment	EG00015 affected40 at risk
Platelets <50000 cells/mm^3	Investigations	MedDRA	Systematic Assessment	EG00010 affected40 at risk
Hemoglobin <8.0 g/dL	Investigations	MedDRA	Systematic Assessment	EG0005 affected40 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected40 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected40 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Fungal skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected40 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected40 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected40 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0005 affected40 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0005 affected40 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Rash follicular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected40 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Cardiac murmur	Investigations	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Body temperature increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Breath sounds abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Ejection fraction decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Haemoglobin decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Human anti-mouse antibody positive	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Platelet count decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Malignant hepatobiliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected40 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Dissociation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hallucination	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected40 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Hot flush	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Peripheral coldness	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected40 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected40 at risk

ID	Term
D008223	Lymphoma
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