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NCT03069352 · OUTCOME

Overall Survival (OS) by Mutation Subgroups

A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy · Source last updated 2025-09-30

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
From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.

What was measured

Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. Overall survival was analyzed in participants with the following molecular markers: * Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation * FMS (Feline McDonough Sarcoma)-like tyrosine kinase 3 (FLT3) mutation

Analysis population: The full analysis set; participants in each mutation subgroup

Groups in this outcome

Placebo + Low Dose Cytarabine (LDAC)

Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Venetoclax + Low Dose Cytarabine (LDAC)

Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Placebo + Low Dose Cytarabine (LDAC)68
Venetoclax + Low Dose Cytarabine (LDAC)143

Reported measurements

IDH1/2 mutation

Analysis denominator · Participants

GroupSource count
Placebo + Low Dose Cytarabine (LDAC)12
Venetoclax + Low Dose Cytarabine (LDAC)21
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)9.0Not reported2.2NACould not be calculated due to the low number of events
Venetoclax + Low Dose Cytarabine (LDAC)10.8Not reported4.2NACould not be calculated due to the low number of events
FLT3 mutation

Analysis denominator · Participants

GroupSource count
Placebo + Low Dose Cytarabine (LDAC)9
Venetoclax + Low Dose Cytarabine (LDAC)20
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)9.8Not reported0.9NACould not be calculated due to the low number of events
Venetoclax + Low Dose Cytarabine (LDAC)5.9Not reported1.610.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Could not be calculated due to the low number of events
        group Id
        OG000
        lower Limit
        2.2
        upper Limit
        NA
        value
        9.0
      2. comment
        Could not be calculated due to the low number of events
        group Id
        OG001
        lower Limit
        4.2
        upper Limit
        NA
        value
        10.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    IDH1/2 mutation
  2. categories
    1. measurements
      1. comment
        Could not be calculated due to the low number of events
        group Id
        OG000
        lower Limit
        0.9
        upper Limit
        NA
        value
        9.8
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        10.9
        value
        5.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    FLT3 mutation
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      143
    units
    Participants
description
Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. Overall survival was analyzed in participants with the following molecular markers: * Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation * FMS (Feline McDonough Sarcoma)-like tyrosine kinase 3 (FLT3) mutation
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    OG000
    title
    Placebo + Low Dose Cytarabine (LDAC)
  2. description
    Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    OG001
    title
    Venetoclax + Low Dose Cytarabine (LDAC)
param Type
MEDIAN
population Description
The full analysis set; participants in each mutation subgroup
reporting Status
POSTED
time Frame
From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.
title
Overall Survival (OS) by Mutation Subgroups
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice