Trial Outcomes & Findings for Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology (NCT NCT00950755)

Last Updated: 2017-01-18

Results Overview

Par. with 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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.

Results posted on

2017-01-18

Participant Flow

Participants (par.) received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases (Ph.): Ph. 1, dosimetric dose; Ph. 2, therapeutic dose. Par. were evaluated until disease progression, they died, or they were on study for 2 years. Par. completing 2 years of study could enter a long-term follow-up study (BEX104528; NCT00240578).

Participant milestones

Participant milestones
Measure	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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Dosimetric and Therapeutic Treatment STARTED	41
Dosimetric and Therapeutic Treatment COMPLETED	0
Dosimetric and Therapeutic Treatment NOT COMPLETED	41
Long-Term Follow-Up STARTED	18
Long-Term Follow-Up COMPLETED	9
Long-Term Follow-Up NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Dosimetric and Therapeutic Treatment Lost to Follow-up	3
Dosimetric and Therapeutic Treatment Received Alternative Therapy	1
Dosimetric and Therapeutic Treatment Progressive Disease	27
Dosimetric and Therapeutic Treatment Death	1
Dosimetric and Therapeutic Treatment Stroke; Difficult to Attend Study Visits	1
Dosimetric and Therapeutic Treatment Participant Moved; Unable to Follow Up	1
Dosimetric and Therapeutic Treatment Rolled Over to Study BEX104528	6
Dosimetric and Therapeutic Treatment Investigator Discretion	1
Long-Term Follow-Up Lost to Follow-up	1
Long-Term Follow-Up Death	8

Baseline Characteristics

Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TST and Iodine I 131 TST n=41 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Age, Continuous	58.2 Years STANDARD_DEVIATION 11.4 • n=5 Participants
Gender Female	21 Participants n=5 Participants
Gender Male	20 Participants n=5 Participants
Race/Ethnicity, Customized White	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.

Population: 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 response were analyzed.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=40 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants (Par.) With Response as Assessed by the Investigator	31 participants

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=35 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With Confirmed Response as Assessed by the Investigator	22 participants

PRIMARY outcome

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

Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. 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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=35 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator	14 participants

PRIMARY outcome

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

Responses had to be confirmed by 2 separate evaluations occurring \>4 weeks apart. 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 (EOD) must be unchanged or decreased upon follow-up evaluations. If the EOD was unchanged or if further decreases occurred for \>=6 months, the participant was reclassified as having a CR.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=35 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator	17 participants

PRIMARY outcome

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

Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Confirmed PR is defined as a \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=35 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator	4 participants

SECONDARY outcome

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

Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Duration of response 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 measurable lesions or the appearance of any new lesion. Individual lesions must be \>2 cm in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=13 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator	46.4 months Interval 15.2 to The upper limit of the 95% confidence interval (CI) was not able to be determined (not reached) because there were not enough events to be able to calculate the upper limit of the 95% CI.

SECONDARY outcome

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

Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. 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 measurable lesions or the appearance of any new lesion. New lesions must be greater than 2 x 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=32 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Time to Progression of Disease or Death as Assessed by the Investigator	12.6 months Interval 6.1 to 29.9

SECONDARY outcome

Population: ITT Exposed Population. Only those participants who experienced treatment failure were evaluated.

Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=33 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Time to Treatment Failure as Assessed by the Investigator	9.5 months Interval 6.0 to 26.9

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=26 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Overall Survival	74.5 months Interval 34.9 to 121.5

SECONDARY outcome

Population: ITT Exposed Population

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 AE 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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=41 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Absolute Neutrophil Count (ANC) <1000 cells/cm^3	18 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants White Blood Cells (WBC) <2000 cells/cm^3	14 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Platelets <50000 cells/cm^3	15 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Diarrhea	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Lethargy	6 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Somnolence	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Thrombocytopenia	11 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Anemia	7 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Pancytopenia	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Fatigue	6 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Herpes Zoster	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Lower Respiratory Tract Infection	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Rhinitis	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Cough	4 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Oropharyngeal Pain	4 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Dyspnea	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Hemoglobin <8.0 grams/deciliter (g/dL)	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Nausea	12 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Constipation	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Vomiting	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Headache	4 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Paraesthesia	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Neutropenia	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Pyrexia	6 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Chills	5 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Pain	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Pneumonia	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Upper Respiratory Tract Infection	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Neutropenic Sepsis	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Respiratory Tract Infection	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Sneezing	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Back pain	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Muscle Spasms	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Myalgia	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Rash	4 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Contusion	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Fall	2 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Hypothyroidism	4 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Decreased Appetite	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Myelodysplastic Syndrome	3 participants
Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants Orthostatic Hypotension	2 participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=13 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Herpes Zoster	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Anemia	6 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Thrombocytopenia	6 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Pancytopenia	2 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Febrile Neutropenia	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Neutropenia	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Lower Respiratory Tract Infection	2 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Pneumonia	2 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Hemophilus Infection	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Herpes Simplex	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Neutropenic Sepsis	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Respiratory Tract Infection	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Myelodysplastic Syndrome	3 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Pyrexia	2 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Hematuria	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Renal Failure Chronic	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Hepatic Failure	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Hypercalcemia	1 participants
Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug Radiculitis Brachial	1 participants

SECONDARY outcome

Population: ITT Exposed Population

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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=41 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With the Indicated Type of Infection Pyelonephritis; n=21	0 participants
Number of Participants With the Indicated Type of Infection Sepsis; n=21	3 participants
Number of Participants With the Indicated Type of Infection Other Infections; n=21	20 participants
Number of Participants With the Indicated Type of Infection Any Infection; n=41	21 participants
Number of Participants With the Indicated Type of Infection No Infection; n=41	20 participants
Number of Participants With the Indicated Type of Infection Meningitis; n=21	0 participants
Number of Participants With the Indicated Type of Infection Pneumonia; n=21	1 participants
Number of Participants With the Indicated Type of Infection Endocarditis/Pericarditis; n=21	0 participants
Number of Participants With the Indicated Type of Infection Peritonitis; n=21	0 participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=21 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants With an Infection for Which Anti-infectives Were Administered Anti-infective Administered	18 participants
Number of Participants With an Infection for Which Anti-infectives Were Administered Anti-infective Not Administered	3 participants

SECONDARY outcome

Population: ITT Exposed Population. The "n" in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity.

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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=41 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities WBC count, n=14	23 days Interval 8.0 to 179.0
Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities ANC, n=18	16 days Interval 5.0 to 179.0
Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities Hemoglobin, n=3	25 days Interval 6.0 to 375.0
Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities Platelets, n=15	28 days Interval 8.0 to 261.0

SECONDARY outcome

Population: ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to nadir and time to recovery to baseline. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).

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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=40 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to nadir ANC, n=40	42.5 days Interval 11.0 to 54.0
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to nadir hemoglobin, n=40	47 days Interval 14.0 to 96.0
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to nadir platelets, n=40	32 days Interval 19.0 to 65.0
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to nadir WBC count, n=40	42.5 days Interval 11.0 to 54.0
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to recovery to baseline ANC, n=35	61 days Interval 54.0 to 85.0
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to recovery to baseline hemoglobin, n=30	61 days Interval 54.0 to 86.0
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to recovery to baseline platelets, n=35	49 days Interval 46.0 to 61.0
Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations Time to recovery to baseline WBC count, n=34	85 days Interval 57.0 to 88.0

SECONDARY outcome

Population: ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each 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 WBC that fights against infection. Platelets and WBCs are types of blood cells.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=40 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Nadir Values for Hematologic Parameters ANC, Platelets, and WBC Count ANC	1.2 1000 cells/millimeters cubed (mm^3) Interval 0.0 to 5.0
Nadir Values for Hematologic Parameters ANC, Platelets, and WBC Count Platelets	78 1000 cells/millimeters cubed (mm^3) Interval 6.0 to 184.0
Nadir Values for Hematologic Parameters ANC, Platelets, and WBC Count WBC count	2.3 1000 cells/millimeters cubed (mm^3) Interval 1.0 to 6.0

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=40 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Nadir Values for Hemoglobin, a Hematologic Parameter	11.3 g/dL Interval 7.0 to 15.0

SECONDARY outcome

Population: ITT Exposed Population

Tositumomab is a murine (mouse) antibody. Participants in this study were evaluated to determine if they developed a human anti-murine antibody (HAMA) immune response after administration of tositumomab and iodine I 131 tositumomab.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=41 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants Who Became Positive or Negative for Human Anti-murine Antibody (HAMA) After Study Treatment Positive	4 participants
Number of Participants Who Became Positive or Negative for Human Anti-murine Antibody (HAMA) After Study Treatment Negative	37 participants

SECONDARY outcome

Population: ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.

Time to HAMA positivity is defined as the time from the first dosimetric dose to the first reported HAMA-positive result for the participant.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=4 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Time to HAMA Positivity From First Dosimetric Dose	112 days Interval 12.0 to 264.0

SECONDARY outcome

Population: ITT Exposed Population. Participants who were evaluable for thyroid function assessment and who had no elevated TSH level or hypothyroidism at baseline were analyzed.

Hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone \[TSH\] in the blood), may result from treatment with radioactive iodine I 131. A thyroid blockade medication was given prior to administration of the study drug and up to 2 weeks after the therapeutic dose to prevent the uptake of I 131 in the thyroid gland. Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the I 131 on thyroid function, such as hypothyroidism.

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=36 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Participants in the Indicated Categories of Thyroid Function Assessment Elevated TSH post therapy	9 participants
Number of Participants in the Indicated Categories of Thyroid Function Assessment Hypothyroidism	3 participants

SECONDARY outcome

Population: ITT Exposed Population. Participants experiencing hypothyroidism were analyzed.

Hypothyroidism is a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone \[TSH\] in the blood).

Outcome measures

Outcome measures
Measure	TST and Iodine I 131 TST n=3 Participants 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Number of Days Each Participant Took to Reach Hypothyroidism After the First Dosimetric Dose Participant Number 19/57	671 days
Number of Days Each Participant Took to Reach Hypothyroidism After the First Dosimetric Dose Participant Number 19/73	192 days
Number of Days Each Participant Took to Reach Hypothyroidism After the First Dosimetric Dose Participant Number 18/68	475 days

Adverse Events

TST and Iodine I 131 TST

Serious events: 13 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TST and Iodine I 131 TST n=41 participants at risk 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Blood and lymphatic system disorders Anemia	14.6% 6/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Thrombocytopenia	14.6% 6/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Pancytopenia	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Febrile Neutropenia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Neutropenia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Lower Respiratory Tract Infection	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Pneumonia	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Hemophilus Infection	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Herpes Simplex	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Herpes Zoster	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Neutropenic Sepsis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Respiratory Tract Infection	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Pyrexia	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Renal and urinary disorders Hematuria	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Renal and urinary disorders Renal Failure Chronic	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Hepatobiliary disorders Hepatic Failure	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Metabolism and nutrition disorders Hypercalcemia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Radiculitis Brachial	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.

Other adverse events

Other adverse events
Measure	TST and Iodine I 131 TST n=41 participants at risk 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 disease progression or 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 (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
Gastrointestinal disorders Nausea	31.7% 13/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Constipation	12.2% 5/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Vomiting	12.2% 5/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Dyspepsia	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Abdominal Discomfort	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Diarrhea	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Abdominal Pain	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Abdominal Pain Upper	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Abdominal Pain Lower	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Aphthous Stomatitis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Cheilosis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Epigastric Discomfort	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Gastrointestinal Disorder	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Gingival Bleeding	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Glossodynia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Melaena	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Gastrointestinal disorders Tongue Coated	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Investigations ANC <1000 cells/cubic millimeters (10^3/mm^3)	43.9% 18/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Investigations Platelets <50000 cells/10^3/mm^3	36.6% 15/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Investigations WBC <2000 cells/10^3/mm^3	34.1% 14/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Investigations Hemoglobin <8.0 g/dL	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Fatigue	19.5% 8/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Chills	12.2% 5/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Pyrexia	12.2% 5/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Edema Peripheral	9.8% 4/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Pain	9.8% 4/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Chest Discomfort	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Chest Pain	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Asthenia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Feeling Cold	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Gait Disturbance	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Ill-defined Disorder	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Influenza Like Illness	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
General disorders Local Swelling	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Back Pain	12.2% 5/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Pain in Extremity	9.8% 4/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Muscle Spasms	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Myalgia	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Musculoskeletal and connective tissue disorders Neck Pain	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Upper Respiratory Tract Infection	14.6% 6/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Herpes Zoster	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Lower Respiratory Tract Infection	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Respiratory Tract Infection	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Rhinitis	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Bronchitis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Folliculitis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Herpes Simplex	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Influenza	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Infusion Site Infection	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Neutropenic Sepsis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Oral Herpes	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Pneumonia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Sinusitis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Urinary Tract Infection	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Infections and infestations Viral Infection	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Headache	17.1% 7/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Lethargy	17.1% 7/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Paraesthesia	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Somnolence	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Ageusia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Dizziness	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Dizziness Postural	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Dysgeusia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Nervous system disorders Post Herpetic Neuralgia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Cough	17.1% 7/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	9.8% 4/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Sneezing	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Reproductive system and breast disorders Productive Cough	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Respiratory, thoracic and mediastinal disorders Wheezing	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Rash	9.8% 4/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Erythema	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Petechiae	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Pruritus	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Decubitus Ulcer	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Night Sweats	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Psoriasis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Subcutaneous Nodule	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Skin and subcutaneous tissue disorders Urticaria	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Thrombocytopenia	17.1% 7/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Anemia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Lymph Node Pain	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Lymphadenitis	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Blood and lymphatic system disorders Neutropenia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Injury, poisoning and procedural complications Contusion	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Injury, poisoning and procedural complications Fall	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Injury, poisoning and procedural complications Muscle Injury	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Injury, poisoning and procedural complications Skeletal Injury	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Endocrine disorders Hypothyroidism	12.2% 5/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Vascular disorders Orthostatic Hypotension	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Vascular disorders Flushing	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Vascular disorders Hypertension	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Metabolism and nutrition disorders Decreased Appetite	7.3% 3/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Renal and urinary disorders Dysuria	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Renal and urinary disorders Nocturia	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Renal and urinary disorders Renal Failure	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Cardiac disorders Palpitations	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Eye disorders Conjunctival Hemorrhage	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Eye disorders Dry Eye	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Psychiatric disorders Insomnia	4.9% 2/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Ear and labyrinth disorders Tinnitus	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.
Immune system disorders Hypersensitivity	2.4% 1/41 • Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER