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NCT00071799 · OUTCOME

Kaplan-Meier Estimates for Median Time to 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
NUMBER
Unit
months
Interval / dispersion
Not reported
Time frame
Day 1 (randomization) to 42 months

What was measured

Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.

Analysis population: Intent to treat population. Includes participants who died and participants who 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: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine24.46Not reportedNot reportedNot reportedNot reported
Conventional Care15.02Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here. Azacitidine: low range of 17.9 months and high range of 'does not exist'. Conventional Care: low range of 9.8 and high range of 17.0 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0001
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.77
    estimate Comment
    Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here. Azacitidine: low range of 17.9 months and high range of 'does not exist'. Conventional Care: low range of 9.8 and high range of 17.0 months.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0001
    statistical Comment
    The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.77
    estimate Comment
    Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24.46
      2. group Id
        OG001
        value
        15.02
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.
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
NUMBER
population Description
Intent to treat population. Includes participants who died and participants who were censored.
reporting Status
POSTED
time Frame
Day 1 (randomization) to 42 months
title
Kaplan-Meier Estimates for Median Time to Death From Any Cause
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice