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NCT00073918 · OUTCOME

Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0

Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2017-08-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
events
Interval / dispersion
Not reported
Time frame
From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years

What was measured

Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%

Analysis population: Number of Grade 3-4 toxicities.

Groups in this outcome

Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0. cyclophosphamide: Given IV etoposide: Given IV iodine I 131 tositumomab: Given IV quality-of-life assessment: Ancillary study peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)111

Reported measurements

Source class 1
Values in events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      111
    units
    Participants
description
Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%
groups
  1. description
    RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0. cyclophosphamide: Given IV etoposide: Given IV iodine I 131 tositumomab: Given IV quality-of-life assessment: Ancillary study peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
    id
    OG000
    title
    Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
param Type
NUMBER
population Description
Number of Grade 3-4 toxicities.
reporting Status
POSTED
time Frame
From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years
title
Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0
type
SECONDARY
unit Of Measure
events

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice