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NCT00071799 · OUTCOME

Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)

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 transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.

Analysis population: Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.

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
Azacitidine20.66Not reported14.925.5Not reported
Conventional Care15.44Not reported12.422.5Not 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
    0.2555
    p Value 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
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    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
    0.2562
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    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
    0.2555
    p Value 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
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    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
    0.2562
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.9
        upper Limit
        25.5
        value
        20.66
      2. group Id
        OG001
        lower Limit
        12.4
        upper Limit
        22.5
        value
        15.44
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.
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 who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.
reporting Status
POSTED
time Frame
Day 1 (randomization) to 42 months
title
Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice