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NCT00506857 · OUTCOME

Number of Participants With Graft Versus Host Disease (GVHD)

Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support · Source last updated 2012-02-28

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
5 years

What was measured

Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status.

Analysis population: Analysis was per protocol for 73 patients out of 80 patients due to 3 early deaths and 4 non engraftments.

Groups in this outcome

Tacrolimus + Methotrexate

Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.

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

Analysis denominator · Participants

GroupSource count
Tacrolimus + Methotrexate73

Reported measurements

Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tacrolimus + Methotrexate18Not reportedNot reportedNot reportedNot reported
Grade 3-4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tacrolimus + Methotrexate8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Grade 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade 3-4
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    units
    Participants
description
Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status.
groups
  1. description
    Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.
    id
    OG000
    title
    Tacrolimus + Methotrexate
param Type
NUMBER
population Description
Analysis was per protocol for 73 patients out of 80 patients due to 3 early deaths and 4 non engraftments.
reporting Status
POSTED
time Frame
5 years
title
Number of Participants With Graft Versus Host Disease (GVHD)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice