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NCT00136084 · OUTCOME

Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (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
Consolidation I

What was measured

To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)

Analysis population: Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 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
Overall15

Reported measurements

Negative
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall11Not reportedNot reportedNot reportedNot reported
Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall4Not 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
    .449
    ci Pct Value
    95
    ci Upper Limit
    .922
    group Description
    Estimate of the proportion of negative minimal residual disease.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Binomial proportion
    param Value
    .733
    statistical Method
    Binomial proportion
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    .449
    ci Pct Value
    95
    ci Upper Limit
    .922
    group Description
    Estimate of the proportion of negative minimal residual disease.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Binomial proportion
    param Value
    .733
    statistical Method
    Binomial proportion
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Negative
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)
groups
  1. description
    Post-GO Treatment MRD
    id
    OG000
    title
    Overall
param Type
NUMBER
population Description
Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.
reporting Status
POSTED
time Frame
Consolidation I
title
Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice