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NCT02631070 · OUTCOME

Time to Acute Myeloid Leukemia (AML) Progression

A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes · Source last updated 2021-12-17

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 to study completion (up to approximately 57 months)

What was measured

Time to AML progression was defined as the time between randomization date and the first diagnosis of AML as per World Health Organization (WHO) classification of ≥ 20% blasts in peripheral blood or bone marrow. Participants with a diagnosis of AML were considered to have had an event, participants who did not progress to AML at the time of analysis were censored at the last assessment date which did not indicate progression to AML.

Analysis population: All treated participants who progressed to AML

Groups in this outcome

Luspatercept

Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle

Placebo

Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment 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
Luspatercept4
Placebo3

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
LuspaterceptNANot reportedNANAMedian was not estimable due to the insufficient number of events
PlaceboNANot reportedNANAMedian was not estimable due to the insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median was not estimable due to the insufficient number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median was not estimable due to the insufficient number of events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Time to AML progression was defined as the time between randomization date and the first diagnosis of AML as per World Health Organization (WHO) classification of ≥ 20% blasts in peripheral blood or bone marrow. Participants with a diagnosis of AML were considered to have had an event, participants who did not progress to AML at the time of analysis were censored at the last assessment date which did not indicate progression to AML.
dispersion Type
95% Confidence Interval
groups
  1. description
    Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
    id
    OG000
    title
    Luspatercept
  2. description
    Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
All treated participants who progressed to AML
reporting Status
POSTED
time Frame
From randomization to study completion (up to approximately 57 months)
title
Time to Acute Myeloid Leukemia (AML) Progression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice