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NCT00085709 · OUTCOME

Complete Remission

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
participants
Interval / dispersion
Not reported
Time frame
After induction therapy was completed (1 or 2 months)

Analysis population: Eligible patients who did not withdraw consent

Groups in this outcome

Ara-C+Daunomycin

A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment

Ara-C+Daunomycin+Mylotarg

A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment

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

Analysis denominator · Participants

GroupSource count
Ara-C+Daunomycin296
Ara-C+Daunomycin+Mylotarg300

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ara-C+Daunomycin203Not reportedNot reportedNot reportedNot reported
Ara-C+Daunomycin+Mylotarg207Not reportedNot reportedNot reportedNot 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 alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0025
    statistical Method
    Test of difference of proportions
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0025
    statistical Method
    Test of difference of proportions
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        203
      2. group Id
        OG001
        value
        207
denoms
  1. counts
    1. group Id
      OG000
      value
      296
    2. group Id
      OG001
      value
      300
    units
    Participants
groups
  1. description
    A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
    id
    OG000
    title
    Ara-C+Daunomycin
  2. description
    A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
    id
    OG001
    title
    Ara-C+Daunomycin+Mylotarg
param Type
NUMBER
population Description
Eligible patients who did not withdraw consent
reporting Status
POSTED
time Frame
After induction therapy was completed (1 or 2 months)
title
Complete Remission
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice