Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma

Responders are defined as participants with Complete Response (CR: disappearance of all clinical and radiological evidence of lymphoma), Clinical Complete Response (CCR: all criteria met for CR, except there is a residual nodal mass >15 millimeters), or Partial Response (PR: 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.

Investigator-assessed confirmed CR is defined as the disappearance of all clinical and radiological evidence of lymphoma. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation.

Duration of response is defined as the time from the first documented response to the first documented disease progression. Response is based on objective evaluation, using the guidelines developed by The International Workshop to Standardize Response Criteria, independent of the investigator's evaluation. Disease progression is defined as a 50% increase in the sum of the products of the two perpendicular diameters of all measurable lesions, or the appearance of new lesions.

PFS is defined as the time interval between the date of the DD to the first date at which progressive disease (PD) or death is observed. PD is defined as a 50% increase in the sum of the products of two perpendicular diameters of all measurable lesions, or the appearance of new lesions. Participants with no evidence of PD were censored to the last date of contact; and those who died for any reason in the absense of PD were classified as having experienced PD on the date of death. For non-responders, duration of PFS was recorded as 0. Participants were censored if they withdrew without PD.

An AE is defined as 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 serious adverse event (SAE) is 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 in a child from a parent who was exposed to treatment; or is an SAE based on medical or scientific judgement of the investigator.

Qualty of Life will be asessed utilizing several scales and questionnaires: FACT-G questionnaire was designed to measure multidimensional quality of life (QOL) in participants with cancer. FACT-LymThe FACT-Lym subscale questionnaire is a cancer-specific questionnaire designed to measure multidimensional QOL in participants with lymphoma.

The Resource Utilization Assessment questionnaires are used to assess the resource utilization of the participant and impacted associates (e.g., family members, caregivers) as well as costs involved to treat participants receiving TST and I 131 TST. As an assessment of general health, participants were asked to rate their activity level on average in the last 7 days on an 11-point scale: 0= exhausted in bed all day; 10=normal activity level.

Survival time is defined as the number of weeks from the first study medication administration to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known be alive. If the participant was alive at the time of analysis, then the survival time was censored at the date of last contact.