Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02631070 · OUTCOME

Change From Baseline in RBC Units Transfused Over Fixed 16-Week Period

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
MEAN
Unit
Units
Interval / dispersion
Standard Deviation
Time frame
At Baseline (16 weeks prior to first dose of study treatment) and Weeks 9 to 24 or Weeks 33 to 48

What was measured

Mean change in total number of Red Blood Cells (RBC) units transfused over a fixed 16-week period (Week 9-24 or Week 33-48) from the total number of RBC units transfused in the 16 weeks immediately on or prior to first dose of study treatment.

Analysis population: All treated participants with available measurements at the indicated timepoints

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
Luspatercept128
Placebo68

Reported measurements

Weeks 9 to 24

Analysis denominator · Participants

GroupSource count
Luspatercept128
Placebo68
Values in Units · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-3.05.17Not reportedNot reportedNot reported
Placebo0.44.25Not reportedNot reportedNot reported
Weeks 33 to 48

Analysis denominator · Participants

GroupSource count
Luspatercept78
Placebo12
Values in Units · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Luspatercept-4.94.22Not reportedNot reportedNot reported
Placebo-3.97.14Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.17
        value
        -3.0
      2. group Id
        OG001
        spread
        4.25
        value
        0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Weeks 9 to 24
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.22
        value
        -4.9
      2. group Id
        OG001
        spread
        7.14
        value
        -3.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Weeks 33 to 48
denoms
  1. counts
    1. group Id
      OG000
      value
      128
    2. group Id
      OG001
      value
      68
    units
    Participants
description
Mean change in total number of Red Blood Cells (RBC) units transfused over a fixed 16-week period (Week 9-24 or Week 33-48) from the total number of RBC units transfused in the 16 weeks immediately on or prior to first dose of study treatment.
dispersion Type
Standard Deviation
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
MEAN
population Description
All treated participants with available measurements at the indicated timepoints
reporting Status
POSTED
time Frame
At Baseline (16 weeks prior to first dose of study treatment) and Weeks 9 to 24 or Weeks 33 to 48
title
Change From Baseline in RBC Units Transfused Over Fixed 16-Week Period
type
SECONDARY
unit Of Measure
Units

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

Preserved source evidence · Not medical advice