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NCT00071799 · OUTCOME

Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause

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 time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.

Analysis population: Intent to treat population. The number of participants with disease progression, relapse after remission or death from any cause is 84 for azacitidine and 79 for conventional care. Remaining participants were censored.

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
Azacitidine179
Conventional Care179

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Azacitidine14.13Not reported9.527.6Not reported
Conventional Care8.82Not reported6.412.4Not 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
    0.0466
    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
  2. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.00
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0474
    param Type
    Hazard Ratio (HR)
    param Value
    0.73
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0466
    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
  2. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.00
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0474
    param Type
    Hazard Ratio (HR)
    param Value
    0.73
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.5
        upper Limit
        27.6
        value
        14.13
      2. group Id
        OG001
        lower Limit
        6.4
        upper Limit
        12.4
        value
        8.82
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, 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. The number of participants with disease progression, relapse after remission or death from any cause is 84 for azacitidine and 79 for conventional care. Remaining participants were censored.
reporting Status
POSTED
time Frame
Day 1 (randomization) to 42 months
title
Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice