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NCT00136084 · OUTCOME

Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.

Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia · Source last updated 2012-12-05

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
Induction II

What was measured

To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy

Analysis population: 30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.

Groups in this outcome

Overall

Post-GO Treatment MRD

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

Analysis denominator · Participants

GroupSource count
Overall30

Reported measurements

Experienced Grade 3 or 4 toxicities
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall27Not reportedNot reportedNot reportedNot reported
Did not experience Grade 3 or 4 toxicities
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall3Not 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
    .735
    ci Pct Value
    95
    ci Upper Limit
    .979
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Binomial proportion
    param Value
    .9
    statistical Method
    Binomial proportion
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    .735
    ci Pct Value
    95
    ci Upper Limit
    .979
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Binomial proportion
    param Value
    .9
    statistical Method
    Binomial proportion
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27
    title
    Experienced Grade 3 or 4 toxicities
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Did not experience Grade 3 or 4 toxicities
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy
groups
  1. description
    Post-GO Treatment MRD
    id
    OG000
    title
    Overall
param Type
NUMBER
population Description
30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.
reporting Status
POSTED
time Frame
Induction II
title
Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice