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NCT00136084 · OUTCOME

Relationship of Inhibition of DNA Synthesis and Clinical Response

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
MEAN
Unit
Percent inhibition of DNA Synthesis
Interval / dispersion
Standard Error
Time frame
Measurements were assessed in Induction I chemotherapy

What was measured

Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.

Analysis population: Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD.

Groups in this outcome

Overall

17 of the 232 eligible patients

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

Analysis denominator · Participants

GroupSource count
Overall17

Reported measurements

Source class 1
Values in Percent inhibition of DNA Synthesis · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Overall66.712.6Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.0365
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.00873
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2287
    param Type
    Odds Ratio, log
    param Value
    -0.0139
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -0.0365
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.00873
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2287
    param Type
    Odds Ratio, log
    param Value
    -0.0139
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.6
        value
        66.7
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.
dispersion Type
Standard Error
groups
  1. description
    17 of the 232 eligible patients
    id
    OG000
    title
    Overall
param Type
MEAN
population Description
Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD.
reporting Status
POSTED
time Frame
Measurements were assessed in Induction I chemotherapy
title
Relationship of Inhibition of DNA Synthesis and Clinical Response
type
SECONDARY
unit Of Measure
Percent inhibition of DNA Synthesis

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

Preserved source evidence · Not medical advice