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NCT02631070 · OUTCOME

Percentage of Participants Who Achieved a Hematologic Improvement in Platelet Response (HI-P) Over Any Consecutive 56-day 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Week 1 through Week 24 or Week 1 Through Week 48 of study treatment

What was measured

Percentage of participants who achieved a hematologic improvement platelet response (HI-P) was defined as the percentage of participants meeting the HI-P criteria per the IWG sustained over any consecutive 56-day (8-week) period (Week 1 to Week 24 and Week 1 to Week 48) during the treatment period. HI - P reponse was defined as: * Absolute increase of ≥ 30 X 10\^9/L in platelets for participants starting with \> 20 X 10\^9/L platelets * Increase in platelets from \< 20 X 10\^9/L to \> 20 X 10\^9/L and by at least 100%

Analysis population: All treated participants with available measurements

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
Luspatercept8
Placebo6

Reported measurements

Week 1 Through Week 24
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Luspatercept50.0Not reported15.7084.30Not reported
Placebo33.3Not reported4.3377.72Not reported
Week 1 Through Week 48
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Luspatercept62.5Not reported24.4991.48Not reported
Placebo33.3Not reported4.3377.72Not reported

Source statistical analyses

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

  1. group Description
    Week 1 -24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5479
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Description
    Week 1 - 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2980
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Description
    Week 1 -24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5479
    statistical Method
    Cochran-Mantel-Haenszel
  2. group Description
    Week 1 - 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2980
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.70
        upper Limit
        84.30
        value
        50.0
      2. group Id
        OG001
        lower Limit
        4.33
        upper Limit
        77.72
        value
        33.3
    title
    Week 1 Through Week 24
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.49
        upper Limit
        91.48
        value
        62.5
      2. group Id
        OG001
        lower Limit
        4.33
        upper Limit
        77.72
        value
        33.3
    title
    Week 1 Through Week 48
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Percentage of participants who achieved a hematologic improvement platelet response (HI-P) was defined as the percentage of participants meeting the HI-P criteria per the IWG sustained over any consecutive 56-day (8-week) period (Week 1 to Week 24 and Week 1 to Week 48) during the treatment period. HI - P reponse was defined as: * Absolute increase of ≥ 30 X 10\^9/L in platelets for participants starting with \> 20 X 10\^9/L platelets * Increase in platelets from \< 20 X 10\^9/L to \> 20 X 10\^9/L and by at least 100%
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 with available measurements
reporting Status
POSTED
time Frame
Week 1 through Week 24 or Week 1 Through Week 48 of study treatment
title
Percentage of Participants Who Achieved a Hematologic Improvement in Platelet Response (HI-P) Over Any Consecutive 56-day Period
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice