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NCT00071799 · OUTCOME

Duration of Any Hematologic Improvement

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care · Source last updated 2019-10-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 (randomization) to 42 months

What was measured

The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.

Analysis population: Intent to treat population. Participants showing hematologic improvement were 48 in azacitidine and 31 in conventional care.

Groups in this outcome

Azacitidine

Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.

Conventional Care

Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)

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

Analysis denominator · Participants

GroupSource count
Azacitidine87
Conventional Care51

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Azacitidine13.57Not reported10.116.3Not reported
Conventional Care5.18Not reported4.19.7Not 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_LEGACY
    p Value
    0.0002
    p Value Comment
    The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    p Value Comment
    The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.1
        upper Limit
        16.3
        value
        13.57
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        9.7
        value
        5.18
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    2. group Id
      OG001
      value
      51
    units
    Participants
description
The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
    id
    OG000
    title
    Azacitidine
  2. description
    Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
    id
    OG001
    title
    Conventional Care
param Type
MEDIAN
population Description
Intent to treat population. Participants showing hematologic improvement were 48 in azacitidine and 31 in conventional care.
reporting Status
POSTED
time Frame
Day 1 (randomization) to 42 months
title
Duration of Any Hematologic Improvement
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice