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NCT00089141 · OUTCOME

Definitive Absence of Efficacy Success

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

Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy

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 Mofetil45Not reportedNot reportedNot reportedNot reported
Placebo40Not 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
    1.1
    ci Pct Value
    95
    ci Upper Limit
    2.6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .03
    param Type
    Hazard Ratio (HR)
    param Value
    1.65
    statistical Comment
    Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.1
    ci Pct Value
    95
    ci Upper Limit
    2.6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    .03
    param Type
    Hazard Ratio (HR)
    param Value
    1.65
    statistical Comment
    Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        40
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      77
    units
    Participants
description
Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy
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
Definitive Absence of Efficacy Success
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice