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NCT00856388 · OUTCOME

Acute GVHD Grade III-IV

Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders · Source last updated 2019-11-13

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
95% Confidence Interval
Time frame
Up to day 100

What was measured

Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.

Analysis population: All treated and eligible patients

Groups in this outcome

Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)

Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.

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 (Reduced Intensity Allogeneic Stem Cell Transplant)61

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)27Not reported1638Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16
        upper Limit
        38
        value
        27
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    units
    Participants
description
Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
    id
    OG000
    title
    Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)
param Type
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
Up to day 100
title
Acute GVHD Grade III-IV
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice