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NCT03069352 · OUTCOME

Event-free Survival (EFS)

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

Event-free survival is defined as the time from randomization to the date of progressive disease (PD), confirmed morphologic relapse from CR or CRi, treatment failure (failure to achieve CR, CRi or morphologic leukemia free state (MLFS) after at least 6 cycles of study treatment), or death from any cause, assessed by the investigator according to the modified IWG criteria. PD: * \> 50% increase in marrow blasts (minimum 15% increase required if blasts \< 30% at baseline); or persistent marrow blast \> 70% for ≥ 3 months; without at least a 100% improvement in ANC to an absolute level \> 0.5 × 10⁹/L, and/or platelets to \> 50 × 10⁹/L non-transfused; or * 50% increase in peripheral blasts to \> 25 × 10⁹/L; or * New extramedullary disease Participants with no events prior to the cut-off date were censored at their last assessment date; participants with no events prior to post-treatment therapy initiated before the cut-off date were censored on the start date of post-treatment therapy.

Analysis population: Full analysis set

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

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)2.0Not reported1.63.1Not reported
Venetoclax + Low Dose Cytarabine (LDAC)4.7Not reported3.76.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.416
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.817
    estimate Comment
    The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    param Type
    Hazard Ratio (HR)
    param Value
    0.583
    statistical Comment
    Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.430
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.839
    estimate Comment
    The hazard ratio was estimated using the Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.003
    param Type
    Hazard Ratio (HR)
    param Value
    0.601
    statistical Comment
    Unstratified analysis
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.416
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.817
    estimate Comment
    The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    param Type
    Hazard Ratio (HR)
    param Value
    0.583
    statistical Comment
    Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.430
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.839
    estimate Comment
    The hazard ratio was estimated using the Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.003
    param Type
    Hazard Ratio (HR)
    param Value
    0.601
    statistical Comment
    Unstratified analysis
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.6
        upper Limit
        3.1
        value
        2.0
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        6.4
        value
        4.7
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      143
    units
    Participants
description
Event-free survival is defined as the time from randomization to the date of progressive disease (PD), confirmed morphologic relapse from CR or CRi, treatment failure (failure to achieve CR, CRi or morphologic leukemia free state (MLFS) after at least 6 cycles of study treatment), or death from any cause, assessed by the investigator according to the modified IWG criteria. PD: * \> 50% increase in marrow blasts (minimum 15% increase required if blasts \< 30% at baseline); or persistent marrow blast \> 70% for ≥ 3 months; without at least a 100% improvement in ANC to an absolute level \> 0.5 × 10⁹/L, and/or platelets to \> 50 × 10⁹/L non-transfused; or * 50% increase in peripheral blasts to \> 25 × 10⁹/L; or * New extramedullary disease Participants with no events prior to the cut-off date were censored at their last assessment date; participants with no events prior to post-treatment therapy initiated before the cut-off date were censored on the start date of post-treatment therapy.
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
Full analysis set
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
Event-free Survival (EFS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice