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NCT01158118 · OUTCOME

Rate of Acute 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
Up through Day 100

What was measured

-Incidence and severity of acute GVHD will be assessed based on the Seattle criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).

Analysis population: 3 of the recipients received cells mobilized by 10 mcg/kg of GM-CSF and the 11 recipients received stem cells from donors mobilized with the decreased dose of 5 mcg/kg of GM-CSF.

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 - Recipient21

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 2 - Recipient14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
-Incidence and severity of acute GVHD will be assessed based on the Seattle criteria. 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
3 of the recipients received cells mobilized by 10 mcg/kg of GM-CSF and the 11 recipients received stem cells from donors mobilized with the decreased dose of 5 mcg/kg of GM-CSF.
reporting Status
POSTED
time Frame
Up through Day 100
title
Rate of Acute 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