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NCT03069352 · OUTCOME

Percentage of Participants With RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline

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 rate of conversion was calculated as the percentage of participants who were post-baseline RBC transfusion independent among participants who had an RBC transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). RBC transfusion independence is defined as a period of at least 56 days with no RBC 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 participants who were RBC transfusion-dependent at Baseline

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)53
Venetoclax + Low Dose Cytarabine (LDAC)104

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Low Dose Cytarabine (LDAC)15.1Not reported6.727.6Not reported
Venetoclax + Low Dose Cytarabine (LDAC)37.5Not reported28.247.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    9.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    35.8
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Treatment Difference
    param Value
    22.4
Complete source fields
analyses
  1. ci Lower Limit
    9.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    35.8
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Treatment Difference
    param Value
    22.4
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.7
        upper Limit
        27.6
        value
        15.1
      2. group Id
        OG001
        lower Limit
        28.2
        upper Limit
        47.5
        value
        37.5
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      104
    units
    Participants
description
The rate of conversion was calculated as the percentage of participants who were post-baseline RBC transfusion independent among participants who had an RBC transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). RBC transfusion independence is defined as a period of at least 56 days with no RBC 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 participants who were RBC transfusion-dependent at Baseline
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 RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice