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NCT03682536 · OUTCOME

Time to Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days)

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
Week 1 through Week 24

What was measured

Time from first dose to first onset of transfusion independence ≥ 84 days.

Analysis population: ITT Population (all randomized participants regardless of whether or not the participant received treatment) who were RBC-TI \>= 12 Weeks (Week 1-24) responders

Groups in this outcome

Luspatercept

Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.

Epoetin Alfa

Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).

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

Analysis denominator · Participants

GroupSource count
Luspatercept124
Epoetin Alfa88

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Luspatercept1.0Not reported1.075.0Not reported
Epoetin Alfa1.0Not reported1.085.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        75.0
        value
        1.0
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        85.0
        value
        1.0
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    2. group Id
      OG001
      value
      88
    units
    Participants
description
Time from first dose to first onset of transfusion independence ≥ 84 days.
dispersion Type
Full Range
groups
  1. description
    Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
    id
    OG000
    title
    Luspatercept
  2. description
    Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
    id
    OG001
    title
    Epoetin Alfa
param Type
MEDIAN
population Description
ITT Population (all randomized participants regardless of whether or not the participant received treatment) who were RBC-TI \>= 12 Weeks (Week 1-24) responders
reporting Status
POSTED
time Frame
Week 1 through Week 24
title
Time to Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice