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NCT00136084 · OUTCOME

To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy

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

Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.

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. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.

Groups in this outcome

Arm 1: (HDAC)

High-dose Cytarabine (Ara-C) (HDAC)

Arm 2:(LDAC)

Low-dose Cytarabine (Ara-C) (LDAC)

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

Analysis denominator · Participants

GroupSource count
Arm 1: (HDAC)9
Arm 2:(LDAC)12

Reported measurements

Source class 1
Values in Percent Inhibition of DNA Synthesis · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm 1: (HDAC)60.616.0Not reportedNot reportedNot reported
Arm 2:(LDAC)72.815.6Not 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 Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.60
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.60
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.0
        value
        60.6
      2. group Id
        OG001
        spread
        15.6
        value
        72.8
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.
dispersion Type
Standard Error
groups
  1. description
    High-dose Cytarabine (Ara-C) (HDAC)
    id
    OG000
    title
    Arm 1: (HDAC)
  2. description
    Low-dose Cytarabine (Ara-C) (LDAC)
    id
    OG001
    title
    Arm 2:(LDAC)
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. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.
reporting Status
POSTED
time Frame
Measurements were assessed in Induction I chemotherapy
title
To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy
type
SECONDARY
unit Of Measure
Percent Inhibition of DNA Synthesis

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

Preserved source evidence · Not medical advice