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NCT03682536 · OUTCOME

The Number of Red Blood Cell (RBC) Units Transfused Within the First 24 Weeks of Treatment

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
MEAN
Unit
RBC units
Interval / dispersion
Standard Deviation
Time frame
Week 1 through Week 24

What was measured

RBC transfusion burden on treatment is defined as total number of packed red blood cell (pRBC) units transfused within the first 24 weeks of treatment since Week 1.

Analysis population: All participants who were randomized and received at least one dose.

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
Luspatercept182
Epoetin Alfa179

Reported measurements

Source class 1
Values in RBC units · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept3.85.90Not reportedNot reportedNot reported
Epoetin Alfa5.26.36Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.90
        value
        3.8
      2. group Id
        OG001
        spread
        6.36
        value
        5.2
denoms
  1. counts
    1. group Id
      OG000
      value
      182
    2. group Id
      OG001
      value
      179
    units
    Participants
description
RBC transfusion burden on treatment is defined as total number of packed red blood cell (pRBC) units transfused within the first 24 weeks of treatment since Week 1.
dispersion Type
Standard Deviation
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
MEAN
population Description
All participants who were randomized and received at least one dose.
reporting Status
POSTED
time Frame
Week 1 through Week 24
title
The Number of Red Blood Cell (RBC) Units Transfused Within the First 24 Weeks of Treatment
type
SECONDARY
unit Of Measure
RBC units

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

Preserved source evidence · Not medical advice