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NCT00763490 · OUTCOME

Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)

Trial Of Double Umbilical Cord Blood Transplantation · Source last updated 2016-12-23

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 years

What was measured

The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated. Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea).

Groups in this outcome

Double Cord Blood Tranplant

Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.

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

Analysis denominator · Participants

GroupSource count
Double Cord Blood Tranplant20

Reported measurements

Acute GVHD (Grades II-IV)
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Double Cord Blood Tranplant40Not reported1960Not reported
Chronic GVHD
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Double Cord Blood Tranplant35Not reported1665Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19
        upper Limit
        60
        value
        40
    title
    Acute GVHD (Grades II-IV)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16
        upper Limit
        65
        value
        35
    title
    Chronic GVHD
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated. Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea).
dispersion Type
95% Confidence Interval
groups
  1. description
    Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
    id
    OG000
    title
    Double Cord Blood Tranplant
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 5 years
title
Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice