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NCT01408563 · OUTCOME

The Rate of Chronic GVHD

Reduced Intensity Double Umbilical Cord Blood Transplantation · Source last updated 2019-01-23

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
From the time of transplantation until the time of chronic GVHD onset, up to 1 year

What was measured

Chronic Graft Versus Host Disease (GVHD) is assessed using the National Institutes of Health (NIH) consensus criteria.

Analysis population: The two participants found to be ineligible after being consented and registered were excluded from the analysis.

Groups in this outcome

Fludarabine/Melphalan/TBI

All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV

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

Analysis denominator · Participants

GroupSource count
Fludarabine/Melphalan/TBI31

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fludarabine/Melphalan/TBI21Not reported8.137Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.1
        upper Limit
        37
        value
        21
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Chronic Graft Versus Host Disease (GVHD) is assessed using the National Institutes of Health (NIH) consensus criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV
    id
    OG000
    title
    Fludarabine/Melphalan/TBI
param Type
NUMBER
population Description
The two participants found to be ineligible after being consented and registered were excluded from the analysis.
reporting Status
POSTED
time Frame
From the time of transplantation until the time of chronic GVHD onset, up to 1 year
title
The Rate of Chronic GVHD
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice