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NCT00089141 · OUTCOME

Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy

Mycophenolate Mofetil (MMF) for Treatment of Chronic Graft-versus-host Disease (GVHD) · Source last updated 2013-05-03

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
2 years

What was measured

Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy

Groups in this outcome

Mycophenolate Mofetil

Patients receive oral mycophenolate mofetil 1000 mg twice daily.

Placebo

Patients receive oral placebo twice daily

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

Analysis denominator · Participants

GroupSource count
Mycophenolate Mofetil74
Placebo77

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mycophenolate Mofetil11Not reportedNot reportedNot reportedNot reported
Placebo10Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.7
    ci Pct Value
    95
    ci Upper Limit
    3.7
    estimate Comment
    For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .22
    p Value Comment
    P values are 2 sided and are based on likelihood ratio statistics.
    param Type
    Hazard Ratio (HR)
    param Value
    1.66
    statistical Comment
    Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.7
    ci Pct Value
    95
    ci Upper Limit
    3.7
    estimate Comment
    For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .22
    p Value Comment
    P values are 2 sided and are based on likelihood ratio statistics.
    param Type
    Hazard Ratio (HR)
    param Value
    1.66
    statistical Comment
    Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      77
    units
    Participants
description
Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy
groups
  1. description
    Patients receive oral mycophenolate mofetil 1000 mg twice daily.
    id
    OG000
    title
    Mycophenolate Mofetil
  2. description
    Patients receive oral placebo twice daily
    id
    OG001
    title
    Placebo
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice