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NCT00057811 · OUTCOME

Toxic Death

Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma · Source last updated 2014-09-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.

Analysis population: Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.

Groups in this outcome

Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)

Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.

Group C (Chemotherapy, Monoclonal Antibody Therapy)

Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.

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

Analysis denominator · Participants

GroupSource count
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)45
Group C (Chemotherapy, Monoclonal Antibody Therapy)40

Reported measurements

Toxic death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)0Not reportedNot reportedNot reportedNot reported
Group C (Chemotherapy, Monoclonal Antibody Therapy)2Not reportedNot reportedNot reportedNot reported
No toxic death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)45Not reportedNot reportedNot reportedNot reported
Group C (Chemotherapy, Monoclonal Antibody Therapy)38Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Toxic death
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        38
    title
    No toxic death
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.
groups
  1. description
    Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
    id
    OG000
    title
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
  2. description
    Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
    id
    OG001
    title
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
param Type
NUMBER
population Description
Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.
reporting Status
POSTED
time Frame
Up to 1 year
title
Toxic Death
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice