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NCT00800839 · OUTCOME

Cumulative Incidence of Grade III to IV Acute GVHD

Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide · Source last updated 2016-09-19

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

Measure
NUMBER
Unit
percentage of incidence
Interval / dispersion
95% Confidence Interval
Time frame
100 days post transplant

What was measured

Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.

Groups in this outcome

Busulfan + Fludarabine + Cyclophosphamide

Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.

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

Analysis denominator · Participants

GroupSource count
Busulfan + Fludarabine + Cyclophosphamide49

Reported measurements

Source class 1
Values in percentage of incidence · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Busulfan + Fludarabine + Cyclophosphamide22Not reported1338Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13
        upper Limit
        38
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    units
    Participants
description
Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
    id
    OG000
    title
    Busulfan + Fludarabine + Cyclophosphamide
param Type
NUMBER
reporting Status
POSTED
time Frame
100 days post transplant
title
Cumulative Incidence of Grade III to IV Acute GVHD
type
PRIMARY
unit Of Measure
percentage of incidence

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

Preserved source evidence · Not medical advice