Trial Outcomes & Findings for A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma (NCT NCT00315731)

NCT ID: NCT00315731

Last Updated: 2017-07-11

Results Overview

Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: 0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)
• Results posted on: 2017-07-11

Participant Flow

Blood pharmacokinetics (the primary objective), biodistribution, and organ dosimetry following a dosimetric dose of tositumomab and fission-derived iodine I-131 tositumomab in this study were compared with results following a dosimetric dose of tositumomab and tellurium-derived iodine I-131 tositumomab in a historical control group (NCT00996996).

Participant milestones

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Overall Study STARTED	15
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Overall Study Lost to Follow-up	1
Overall Study Death	5

Baseline Characteristics

A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=15 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Age, Continuous	58.1 Years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours AUC(0-120)	1.04 %ID.h/mL Interval 0.88 to 1.24	—
Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours AUC(0-168)	1.18 %ID.h/mL Interval 0.98 to 1.43	—
Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours AUC(0-infinity)	1.39 %ID.h/mL Interval 1.1 to 1.75	—

PRIMARY outcome

Timeframe: 0 to 7 days from dosimetric dose (given only once on Day 0)

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Maximum Concentration (Cmax) Values	0.0189 %ID/mL Interval 0.0169 to 0.0211	—

PRIMARY outcome

Timeframe: 0 to 7 days from dosimetric dose (given only once on Day 0)

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Terminal Phase Half-life (t½)	59.5 hours Interval 48.8 to 72.5	—

PRIMARY outcome

Timeframe: 0 to 7 days from dosimetric dose given only once on Day 0

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Clearance (CL) Values	71.9 milliliters per hour (ml/hr) Interval 57.1 to 90.6	—

PRIMARY outcome

Timeframe: 0 to 7 days from dosimetric dose given only once on Day 0

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Volume of Distribution at Steady State (Vss)	6055 milliliters (ml) Interval 5293.0 to 6927.0	—

SECONDARY outcome

Timeframe: 0-120 hours from dosimetric dose (given only once on Day 0)

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Area under the concentration-time curve from time 0 to 120 hours after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab n=22 Participants Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Area Under the Curve (AUC) at 0 to 120 Hours	1.04 %ID.h/mL Interval 0.88 to 1.24	1.07 %ID.h/mL Interval 0.98 to 1.17

SECONDARY outcome

Timeframe: 0-168 h from dosimetric dose (given only once on Day 0)

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Ratio and 90% confidence interval for AUC(0-168) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium-derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab n=22 Participants Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Area Under the Curve (AUC) at 0 to 168 Hours	1.18 %ID.h/mL Interval 0.98 to 1.43	1.24 %ID.h/mL Interval 1.13 to 1.35

SECONDARY outcome

Timeframe: 0 to infinity h from dosimetric dose (given only once on Day 0)

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Ratio and 90% CI for AUC (0 to infinity) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose is given.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab n=22 Participants Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)	1.39 %ID.h/mL Interval 1.1 to 1.75	1.50 %ID.h/mL Interval 1.35 to 1.67

SECONDARY outcome

Timeframe: 0 to 7 days from dosimetric dose (given only once on Day 0)

Population: All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.

Maximum observed concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after the dose.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=11 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab n=22 Participants Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Maximum Concentration (Cmax) Values	0.0189 %ID/mL Interval 0.0169 to 0.0211	0.0193 %ID/mL Interval 0.0176 to 0.0211

SECONDARY outcome

Timeframe: 0 to 7 days from dosimetric dose (given only once on Day 0)

Population: All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).

Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. Assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the total body residence times. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=10 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab n=22 Participants Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Mean Residence Times From Day 0 to Day 7 Kidneys, n=10, 21	1.5 hours Interval 1.2 to 1.7	1.9 hours Interval 1.7 to 2.1
Mean Residence Times From Day 0 to Day 7 Total Body, n=10, 22	87.9 hours Interval 78.8 to 96.9	95.7 hours Interval 90.8 to 100.7
Mean Residence Times From Day 0 to Day 7 Liver, n=10, 22	3.7 hours Interval 3.0 to 4.4	4.7 hours Interval 4.2 to 5.3
Mean Residence Times From Day 0 to Day 7 Lungs, n=9, 22	3.0 hours Interval 2.4 to 3.5	4.3 hours Interval 3.8 to 4.8
Mean Residence Times From Day 0 to Day 7 Spleen, n=10, 22	1.3 hours Interval 1.1 to 1.6	1.8 hours Interval 1.5 to 2.1
Mean Residence Times From Day 0 to Day 7 Urinary Bladder, n=10, 22	1.6 hours Interval 1.5 to 1.7	1.4 hours Interval 1.3 to 1.4
Mean Residence Times From Day 0 to Day 7 Remainder of Body, n=10, 22	76.1 hours Interval 66.9 to 85.4	81.7 hours Interval 77.1 to 86.4

SECONDARY outcome

Timeframe: 0 to 7 days from dosimetric dose

Population: All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).

The radiation absorbed dose to source organs were determined with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software using residence times directly determined by an independent reviewer for kidneys, liver, lungs, spleen, urinary bladder, and total body; the radiation absorbed dose for the remaining target organs was based on a mathematical model used to calculate source organ radiation dose estimates using the same OLINDA/EXM software. OLINDA/EXM is a registered proprietary computer program.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=10 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab n=22 Participants Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Mean Absorbed Dose in the Source Organs and the Target Organs Adrenals	0.25 mGy/MBq Interval 0.23 to 0.28	0.28 mGy/MBq Interval 0.26 to 0.29
Mean Absorbed Dose in the Source Organs and the Target Organs Brain	0.19 mGy/MBq Interval 0.17 to 0.21	0.2 mGy/MBq Interval 0.19 to 0.21
Mean Absorbed Dose in the Source Organs and the Target Organs Liver	0.36 mGy/MBq Interval 0.3 to 0.41	0.45 mGy/MBq Interval 0.4 to 0.49
Mean Absorbed Dose in the Source Organs and the Target Organs Osteogenic Cells	0.44 mGy/MBq Interval 0.4 to 0.49	0.45 mGy/MBq Interval 0.42 to 0.47
Mean Absorbed Dose in the Source Organs and the Target Organs Ovaries	0.25 mGy/MBq Interval 0.22 to 0.27	0.26 mGy/MBq Interval 0.25 to 0.28
Mean Absorbed Dose in the Source Organs and the Target Organs Red Marrow	0.24 mGy/MBq Interval 0.18 to 0.3	0.20 mGy/MBq Interval 0.19 to 0.21
Mean Absorbed Dose in the Source Organs and the Target Organs Spleen	0.79 mGy/MBq Interval 0.5 to 1.08	0.84 mGy/MBq Interval 0.72 to 0.96
Mean Absorbed Dose in the Source Organs and the Target Organs Testes	0.21 mGy/MBq Interval 0.18 to 0.23	0.22 mGy/MBq Interval 0.21 to 0.23
Mean Absorbed Dose in the Source Organs and the Target Organs Thyroid	0.21 mGy/MBq Interval 0.19 to 0.23	0.25 mGy/MBq Interval 0.2 to 0.29
Mean Absorbed Dose in the Source Organs and the Target Organs Upper Large Intestine Wall	0.24 mGy/MBq Interval 0.21 to 0.27	0.26 mGy/MBq Interval 0.26 to 0.27
Mean Absorbed Dose in the Source Organs and the Target Organs Urinary Bladder Wall	0.73 mGy/MBq Interval 0.73 to 0.74	0.66 mGy/MBq Interval 0.66 to 0.69
Mean Absorbed Dose in the Source Organs and the Target Organs Total Body	0.23 mGy/MBq Interval 0.2 to 0.25	0.25 mGy/MBq Interval 0.23 to 0.26
Mean Absorbed Dose in the Source Organs and the Target Organs Breast	0.18 mGy/MBq Interval 0.16 to 0.2	0.2 mGy/MBq Interval 0.19 to 0.21
Mean Absorbed Dose in the Source Organs and the Target Organs Gallbladder Wall	0.26 mGy/MBq Interval 0.23 to 0.28	0.28 mGy/MBq Interval 0.27 to 0.3
Mean Absorbed Dose in the Source Organs and the Target Organs Heart Wall	0.24 mGy/MBq Interval 0.21 to 0.26	0.26 mGy/MBq Interval 0.24 to 0.27
Mean Absorbed Dose in the Source Organs and the Target Organs Kidneys	0.72 mGy/MBq Interval 0.61 to 0.83	0.92 mGy/MBq Interval 0.83 to 1.01
Mean Absorbed Dose in the Source Organs and the Target Organs Lower Large Intestine Wall	0.24 mGy/MBq Interval 0.21 to 0.27	0.26 mGy/MBq Interval 0.24 to 0.27
Mean Absorbed Dose in the Source Organs and the Target Organs Lungs	0.44 mGy/MBq Interval 0.37 to 0.52	0.61 mGy/MBq Interval 0.55 to 0.68
Mean Absorbed Dose in the Source Organs and the Target Organs Muscle	0.21 mGy/MBq Interval 0.18 to 0.23	0.22 mGy/MBq Interval 0.21 to 0.24
Mean Absorbed Dose in the Source Organs and the Target Organs Pancreas	0.26 mGy/MBq Interval 0.24 to 0.29	0.29 mGy/MBq Interval 0.28 to 0.31
Mean Absorbed Dose in the Source Organs and the Target Organs Skin	0.17 mGy/MBq Interval 0.15 to 0.19	0.19 mGy/MBq Interval 0.18 to 0.2
Mean Absorbed Dose in the Source Organs and the Target Organs Small Intestine	0.24 mGy/MBq Interval 0.22 to 0.27	0.26 mGy/MBq Interval 0.25 to 0.27
Mean Absorbed Dose in the Source Organs and the Target Organs Stomach	0.24 mGy/MBq Interval 0.21 to 0.26	0.26 mGy/MBq Interval 0.25 to 0.27
Mean Absorbed Dose in the Source Organs and the Target Organs Thymus	0.22 mGy/MBq Interval 0.19 to 0.24	0.23 mGy/MBq Interval 0.22 to 0.25
Mean Absorbed Dose in the Source Organs and the Target Organs Uterus	0.26 mGy/MBq Interval 0.23 to 0.28	0.27 mGy/MBq Interval 0.27 to 0.28

SECONDARY outcome

Timeframe: 0 to 7 days from dosimetric dose (given only once on Day 0)

Population: All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points.

Expected biodistribution (images): most radioactivity (RA) in blood pool, with uptake in normal liver and spleen less than the heart. Later time points, RA in blood pool decrease and uptake in normal liver and spleen decrease. Images may show uptake by the thyroid gland, kidneys, urinary bladder, and lungs. Altered biodistribution: Blood pool not visualized or diffuse, intense uptake in the liver and/or spleen, or uptake suggestive of urinary obstruction, diffuse lung uptake greater than the blood pool

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=10 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab n=22 Participants Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.	10 participants	22 participants

SECONDARY outcome

Timeframe: From Baseline up to 99 Months

Population: ITT-E Population. The individual categories for confirmed CR, confirmed CRu, etc. counts those participants who had their response confirmed by the exact same response, not those who had their response confirmed by a better response (for example, Cru to CR; PR to CR; PR to CRU; etc.).

Evaluation based on the Int'l Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma (NHL). CR, complete disappearance of all detectable clinical/radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to NHL. CRu, complete response unconfirmed, included complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. PR, >=50% decrease in sum of perpendicular diameters (SPD) of all measurable lesions determined at baseline. SD, less than a PR but not progressive disease (>=50% increase from nadir in SPD for all measurable disease or the appearance of any new lesion that was >=1.4 cm x 1.4 cm by radiographic evaluation or >=1.0 cm by palpation per physical examination).

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=15 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) SD	7 percentage of participants	—
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) Overall response (CR, CRu, or PR)	67 percentage of participants	—
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) CR	33 percentage of participants	—
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) PD	7 percentage of participants	—
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) CRu	7 percentage of participants	—
Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) PR	27 percentage of participants	—

SECONDARY outcome

Timeframe: Week 7 to Week 260 post treatment

Population: ITT-E Population. Only participants who had a response (CR, CRu, or PR) were evaluated.

Duration of response is defined as the time from first documented response (CR, CRu, or PR) until disease progression.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=10 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Duration of Response	NA months The median was not reached using Kaplan-Meier methodology because not enough events were observed.	—

SECONDARY outcome

Timeframe: Week 7 to Week 260 post treatment

Population: ITT-E Population

Progression-free survival, or time to progression, is defined as the time from the dosimetric dose to the first documented disease progression (PD) or death. PD is defined as a >= 50% increase from nadir in the SPPD for all measurable disease.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=15 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Progression-free Survival	59.0 months Interval 10.1 to An upper limit of the 95% confidence interval could not be calculated due to the low number of events.	—

SECONDARY outcome

Timeframe: Week 7 to Week 260 post treatment

Population: ITT-E Population

Time to death is defined as the time from the dosimetric dose to the date of death.

Outcome measures

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=15 Participants Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).	Tellurium-Derived Iodine I-131 Tositumomab Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
Overall Survival	NA months The median was not reached using Kaplan-Meier methodology due to the low number of events.	—

Adverse Events

Tositumomab and Fission-derived Iodine I-131 Tositumomab

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=15 participants at risk Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
General disorders Pyrexia	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of oral cavity	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukemia	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.

Other adverse events

Measure	Tositumomab and Fission-derived Iodine I-131 Tositumomab n=15 participants at risk Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
General disorders Fatigue	40.0% 6/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Pyrexia	33.3% 5/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Chills	26.7% 4/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Axillary pain	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Local swelling	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Pain	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Chest discomfort	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Chest pain	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Mucosal inflammation	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Edema peripheral	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
General disorders Swelling	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 3/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Back pain	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Bone pain	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Muscular weakness	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Pain in extremity	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Bursitis	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Limb discomfort	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Blood and lymphatic system disorders Neutropenia	46.7% 7/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Blood and lymphatic system disorders Thrombocytopenia	40.0% 6/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Blood and lymphatic system disorders Anemia	20.0% 3/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Blood and lymphatic system disorders Leukopenia	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Blood and lymphatic system disorders Lymph node pain	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Nausea	40.0% 6/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Abdominal discomfort	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Diarrhea	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Dry mouth	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Dyspepsia	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Vomiting	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Abdominal distension	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Abdominal pain upper	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Gastrointestinal disorders Constipation	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 3/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Epistaxis	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Dysphonia	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Nasal congestions	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Rhinorhea	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Rash	20.0% 3/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Hyperhidrosis	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Night sweats	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Exfoliative rash	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Petechiae	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Pruritis	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Rash generalized	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Rash pruritic	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Skin exfoliation	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Swelling face	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Skin and subcutaneous tissue disorders Urticaria	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Nervous system disorders Headache	20.0% 3/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Nervous system disorders Dizziness	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Nervous system disorders Dysgeusia	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Nervous system disorders Neuropathy peripheral	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Infections and infestations Hordeolum	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Infections and infestations Sinusitis	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Infections and infestations Upper resp trct infection	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukemia	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/oral cancer	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Endocrine disorders Hypothyroidism	20.0% 3/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Eye disorders Eyelid margin crusting	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Eye disorders Lacrimation increased	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Immune system disorders Hypersensitivity	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Immune system disorders Seasonal allergy	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Metabolism and nutrition disorders Decreased appetite	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Psychiatric disorders Insomnia	13.3% 2/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Psychiatric disorders Depressed mood	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Reproductive system and breast disorders Pelvic discomfort	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Reproductive system and breast disorders Pelvic pain	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Vascular disorders Flushing	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Vascular disorders Hypertension	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Cardiac disorders Tachycardia	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Ear and labyrinth disorders Ear discomfort	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Injury, poisoning and procedural complications Contusion	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Renal and urinary disorders Dysuria	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	6.7% 1/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Investigations Absolute neutrophil count (calc) <1000 cells/millimeter^3	53.3% 8/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Investigations White Blood Cell count <2000 cells/millimeter^3	33.3% 5/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.
Investigations Platelets <50000 cells/millimeter^3	26.7% 4/15 • Serious adverse events (SAEs) and non-serious AEs occurring from the time of enrollment up to 99 months are reported. An on-therapy adverse event (AE) is an AE that occurred from the time of enrollment until 26 weeks after the dosimetric dose (DD) or until administration of subsequent therapy for lymphoma, whichever occurred first. After Week 26, AEs were reported if considered by the investigator to be possibly associated with the iodine I-131 tositumomab DD.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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