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NCT00309842 · OUTCOME

Number of Participants With Acute Graft-Versus-Host Disease

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases · Source last updated 2020-09-10

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 100

What was measured

Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Groups in this outcome

Unrelated UCBT for Blood Cancers

Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.

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

Analysis denominator · Participants

GroupSource count
Unrelated UCBT for Blood Cancers212

Reported measurements

Grade II-IV
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Unrelated UCBT for Blood Cancers106Not reportedNot reportedNot reportedNot reported
Grade III-IV
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Unrelated UCBT for Blood Cancers49Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
    title
    Grade II-IV
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        49
    title
    Grade III-IV
denoms
  1. counts
    1. group Id
      OG000
      value
      212
    units
    Participants
description
Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
groups
  1. description
    Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    id
    OG000
    title
    Unrelated UCBT for Blood Cancers
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day 100
title
Number of Participants With Acute Graft-Versus-Host Disease
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice