Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02631070 · OUTCOME

Percentage of Participants Who Achieved a Mean Hemoglobin (Hgb) Increase of at Least 1.0 g/dL Over Any Consecutive 56-Day Period in Absence of Red Blood Cells (RBC) Transfusions

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Week 1 though Week 24 and Week 1 through 48

What was measured

A mean hgb increase of ≥ 1.0 g/dL was analyzed as the percentage of participants with a hgb increase ≥ 1.0 g/dL compared with baseline (after applying the 14/3 day rule) that was sustained over any consecutive 56-day (8-week) period in the absence of RBC transfusions during the treatment period. (Week 1 through Week 24 and Week 1 through Week 48).

Analysis population: All treated participants

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
Luspatercept153
Placebo76

Reported measurements

Week 1 Through Week 24
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Luspatercept35.3Not reported27.7543.42Not reported
Placebo7.9Not reported2.9516.40Not reported
Week 1 Through Week 48
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Luspatercept41.2Not reported33.2949.41Not reported
Placebo10.5Not reported4.6619.69Not reported

Source statistical analyses

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

  1. group Description
    Week 1 Through Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
  2. group Description
    Week 1 Through Week 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Week 1 Through Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
  2. group Description
    Week 1 Through Week 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.75
        upper Limit
        43.42
        value
        35.3
      2. group Id
        OG001
        lower Limit
        2.95
        upper Limit
        16.40
        value
        7.9
    title
    Week 1 Through Week 24
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.29
        upper Limit
        49.41
        value
        41.2
      2. group Id
        OG001
        lower Limit
        4.66
        upper Limit
        19.69
        value
        10.5
    title
    Week 1 Through Week 48
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      76
    units
    Participants
description
A mean hgb increase of ≥ 1.0 g/dL was analyzed as the percentage of participants with a hgb increase ≥ 1.0 g/dL compared with baseline (after applying the 14/3 day rule) that was sustained over any consecutive 56-day (8-week) period in the absence of RBC transfusions during the treatment period. (Week 1 through Week 24 and Week 1 through Week 48).
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
NUMBER
population Description
All treated participants
reporting Status
POSTED
time Frame
Week 1 though Week 24 and Week 1 through 48
title
Percentage of Participants Who Achieved a Mean Hemoglobin (Hgb) Increase of at Least 1.0 g/dL Over Any Consecutive 56-Day Period in Absence of Red Blood Cells (RBC) Transfusions
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice