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NCT00566696 · OUTCOME

Incidence of Non-hematologic Regimen-related Toxicities

Mismatched Family Member Donor Transplantation for Children and Young Adults With High Risk Hematological Malignancies · Source last updated 2020-04-14

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
100 days post-transplant

What was measured

Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death.

Groups in this outcome

High-Risk Hematologic Malignancies

Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.

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

Analysis denominator · Participants

GroupSource count
High-Risk Hematologic Malignancies31

Reported measurements

Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-Risk Hematologic Malignancies0Not reportedNot reportedNot reportedNot reported
Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-Risk Hematologic Malignancies3.2Not reportedNot reportedNot reportedNot reported
Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-Risk Hematologic Malignancies61.3Not reportedNot reportedNot reportedNot reported
Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-Risk Hematologic Malignancies19.4Not reportedNot reportedNot reportedNot reported
Grade 5
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High-Risk Hematologic Malignancies16.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3.2
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        61.3
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        19.4
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16.1
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death.
groups
  1. description
    Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
    id
    OG000
    title
    High-Risk Hematologic Malignancies
param Type
NUMBER
reporting Status
POSTED
time Frame
100 days post-transplant
title
Incidence of Non-hematologic Regimen-related Toxicities
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice