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NCT00085709 · OUTCOME

2-year Disease-free Survival (DFS)

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML · Source last updated 2015-09-30

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

Measure
NUMBER
Unit
Percentage of population
Interval / dispersion
95% Confidence Interval
Time frame
After completing any treatment, every 6 months for 2 years, than annually for years 3-5

What was measured

Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.

Analysis population: Eligible patients who completed induction and consolidation therapy

Groups in this outcome

Post-consolidation GO

For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.

Post-consolidation Observation

Patients did not receive any post-consolidation therapy

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

Analysis denominator · Participants

GroupSource count
Post-consolidation GO84
Post-consolidation Observation84

Reported measurements

Source class 1
Values in Percentage of population · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Post-consolidation GO39Not reported2751Not reported
Post-consolidation Observation50Not reported3862Not reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Description
    Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    statistical Comment
    The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    statistical Comment
    The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.
    statistical Method
    Regression, Cox
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27
        upper Limit
        51
        value
        39
      2. group Id
        OG001
        lower Limit
        38
        upper Limit
        62
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    2. group Id
      OG001
      value
      84
    units
    Participants
description
Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.
dispersion Type
95% Confidence Interval
groups
  1. description
    For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
    id
    OG000
    title
    Post-consolidation GO
  2. description
    Patients did not receive any post-consolidation therapy
    id
    OG001
    title
    Post-consolidation Observation
param Type
NUMBER
population Description
Eligible patients who completed induction and consolidation therapy
reporting Status
POSTED
time Frame
After completing any treatment, every 6 months for 2 years, than annually for years 3-5
title
2-year Disease-free Survival (DFS)
type
PRIMARY
unit Of Measure
Percentage of population

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice