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NCT02793544 · OUTCOME

Cumulative Incidence of Acute GVHD

HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide · Source last updated 2025-08-06

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
90% Confidence Interval
Time frame
100 days post-transplant

What was measured

Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI. Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.

Groups in this outcome

Myeloablative Conditioning (MAC)

Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan

Reduced Intensity Conditioning (RIC)

Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation

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

Analysis denominator · Participants

GroupSource count
Myeloablative Conditioning (MAC)40
Reduced Intensity Conditioning (RIC)40

Reported measurements

Grades II-IV acute GVHD
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Myeloablative Conditioning (MAC)42.5Not reported29.855.7Not reported
Reduced Intensity Conditioning (RIC)32.5Not reported20.945.3Not reported
Grades III-IV acute GVHD
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Myeloablative Conditioning (MAC)17.5Not reported8.728.5Not reported
Reduced Intensity Conditioning (RIC)0Not reported00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.8
        upper Limit
        55.7
        value
        42.5
      2. group Id
        OG001
        lower Limit
        20.9
        upper Limit
        45.3
        value
        32.5
    title
    Grades II-IV acute GVHD
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.7
        upper Limit
        28.5
        value
        17.5
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    Grades III-IV acute GVHD
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI. Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
    id
    OG000
    title
    Myeloablative Conditioning (MAC)
  2. description
    Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
    id
    OG001
    title
    Reduced Intensity Conditioning (RIC)
param Type
NUMBER
reporting Status
POSTED
time Frame
100 days post-transplant
title
Cumulative Incidence of Acute GVHD
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice