Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.

Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.

Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms (by the IWSRC) if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Confirmation of response was carried out by an independent reviewer

Response duration is defined as the time from the first documented response (complete response, complete response unconfirmed, or partial response) until disease progression. Partial response is defined as at least a 50% decrease in the product of two perpendicular diameters of all measurable lesions; no increase in the size of other nodes, liver, or spleen; and no new disease sites.

Time to death is defined as the time from treatment start to the date of death. As a median time to death is not presented for either group, see the outcome measure entitled "Number of Participants Who Had Died by the Month Indicated" for data regarding time to death.

The median time to death could not be calculated for participants in either treatment group; thus, data are shown as the number of participants who had died by the month indicated.

Time to next treatment is defined as time from the date of randomization until the new treatment is needed for NHL. Because too few evaluable participants were enrolled/treated, analysis of the time to next treatment was not conducted as planned.

Hematologic toxicity includes the analysis of hematologic nadir, which is defined as the lowest hematology value within 120 days of study drug administration.

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to nadir is defined as the number of days from the last administration of study drug to nadir.

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to recovery to Baseline grade is defined as the number of days from the last administration of study drug to a post-nadir hematology value of unmaintained Baseline grade or lower.

Duration of Grade 3/4 toxicity is defined as the time between the date of the first Grade 3/4 lab result to the first lab date with a Grade of 0, 1, or 2 result. Laboratory abnormalities will be recorded as AEs using NCI CTCAE, Version 3, if they are associated with clinical squeal and/or require an intervention. Specific AEs not listed in the NCI criteria will be graded as follows: 1. Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities, 2. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities, 3. Severe: An event that prevents normal everyday activities, 4. Life-threatening or debilitating, and 5. Death

Hypothyroidism is defined as elevated Thyroid-Stimulating Hormone (TSH) or current history of using thyroid medication. The frequency of hypothyroidism at study enrollment will be determined, and participants with hypothyroidism at Baseline were excluded from analysis.

An infusion reaction is defined as any adverse event that occured within 24 hours of an infusion. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

The frequency of hospitalizations within 90 days of treatment was summarized. Because too few evaluable participants were enrolled/treated, analysis of the number of hospitalizations was not conducted as planned.

The cumulative incidence of myelodysplasia/leukemia was estimated.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a Grade 4 (life threatening or disabling) non-hematologic laboratory abnormality assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.