Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01158118 · OUTCOME

Rate of Chronic Graft vs. Host Disease (GvHD) (Recipient Only)

Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors · Source last updated 2017-06-05

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 100-1 year

What was measured

Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).

Analysis population: 6 participants are not evaluable for this outcome measure as they came off study prior to the start of chronic GvHD assessments.

Groups in this outcome

Arm 2 - Recipient

Conditioning Regimens * fludarabine and busulfan +/- thymoglobulin * fractionated total body irradiation and cyclophosphamide * busulfan and cyclophosphamide * single dose total body irradiation and cyclophosphamide Day -2 = GvHD prophylaxis Day 0 or +1 = PBSC transplant Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day

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

Analysis denominator · Participants

GroupSource count
Arm 2 - Recipient15

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 2 - Recipient10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
groups
  1. description
    Conditioning Regimens * fludarabine and busulfan +/- thymoglobulin * fractionated total body irradiation and cyclophosphamide * busulfan and cyclophosphamide * single dose total body irradiation and cyclophosphamide Day -2 = GvHD prophylaxis Day 0 or +1 = PBSC transplant Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day
    id
    OG000
    title
    Arm 2 - Recipient
param Type
COUNT_OF_PARTICIPANTS
population Description
6 participants are not evaluable for this outcome measure as they came off study prior to the start of chronic GvHD assessments.
reporting Status
POSTED
time Frame
Day 100-1 year
title
Rate of Chronic Graft vs. Host Disease (GvHD) (Recipient Only)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice