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NCT03069352 · OUTCOME

Percentage of Participants With Post Baseline Platelet Transfusion Independence

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.

What was measured

The post baseline platelet transfusion independence rate was calculated as the percentage of participants who achieved platelet transfusion independence post Baseline. Platelet transfusion independence is defined as a period of at least 56 consecutive days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut--off date, whichever occurred earlier.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)32.4Not reported21.544.8Not reported
Venetoclax + Low Dose Cytarabine (LDAC)47.6Not reported39.156.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    29.0
    estimate Comment
    Treatment difference = Venetoclax - Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.040
    param Type
    Treatment Difference
    param Value
    15.2
    statistical Comment
    Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.039
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Lower Limit
    1.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    29.0
    estimate Comment
    Treatment difference = Venetoclax - Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.040
    param Type
    Treatment Difference
    param Value
    15.2
    statistical Comment
    Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.039
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.5
        upper Limit
        44.8
        value
        32.4
      2. group Id
        OG001
        lower Limit
        39.1
        upper Limit
        56.1
        value
        47.6
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      143
    units
    Participants
description
The post baseline platelet transfusion independence rate was calculated as the percentage of participants who achieved platelet transfusion independence post Baseline. Platelet transfusion independence is defined as a period of at least 56 consecutive days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut--off date, whichever occurred earlier.
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
NUMBER
population Description
Full analysis set
reporting Status
POSTED
time Frame
From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.
title
Percentage of Participants With Post Baseline Platelet Transfusion Independence
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice