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NCT02631070 · OUTCOME

Change From Baseline in Mean Daily Dose of Iron Chelation Therapy (ICT)

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
LEAST_SQUARES_MEAN
Unit
mg/day
Interval / dispersion
Standard Error
Time frame
Baseline and Week 9 through Week 24 and Week 33 through Week 48 of study treatment

What was measured

Mean change from baseline in mean daily dose of ICT averaged over Week 9 to Week 24 or Week 33 to Week 48. For each participant, the mean change in daily dose of ICT was calculated as the difference of postbaseline mean daily dose and baseline mean daily dose.

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
Luspatercept128
Placebo68

Reported measurements

Weeks 9-24

Analysis denominator · Participants

GroupSource count
Luspatercept128
Placebo68
Values in mg/day · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Luspatercept10.029.25Not reportedNot reportedNot reported
Placebo51.035.92Not reportedNot reportedNot reported
Weeks 33-48

Analysis denominator · Participants

GroupSource count
Luspatercept78
Placebo12
Values in mg/day · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Luspatercept-148.846.13Not reportedNot reportedNot reported
Placebo-123.892.19Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -120.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    38.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    40.18
    group Description
    Weeks 9 Through 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3087
    param Type
    LS Mean Difference
    param Value
    -41.0
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -210.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    160.8
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    93.42
    group Description
    Weeks 33 Through 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7903
    param Type
    LS Mean Difference
    param Value
    -24.9
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Lower Limit
    -120.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    38.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    40.18
    group Description
    Weeks 9 Through 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3087
    param Type
    LS Mean Difference
    param Value
    -41.0
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -210.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    160.8
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    93.42
    group Description
    Weeks 33 Through 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7903
    param Type
    LS Mean Difference
    param Value
    -24.9
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.25
        value
        10.0
      2. group Id
        OG001
        spread
        35.92
        value
        51.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Weeks 9-24
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.13
        value
        -148.8
      2. group Id
        OG001
        spread
        92.19
        value
        -123.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Weeks 33-48
denoms
  1. counts
    1. group Id
      OG000
      value
      128
    2. group Id
      OG001
      value
      68
    units
    Participants
description
Mean change from baseline in mean daily dose of ICT averaged over Week 9 to Week 24 or Week 33 to Week 48. For each participant, the mean change in daily dose of ICT was calculated as the difference of postbaseline mean daily dose and baseline mean daily dose.
dispersion Type
Standard Error
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
LEAST_SQUARES_MEAN
population Description
All treated participants with available measurements
reporting Status
POSTED
time Frame
Baseline and Week 9 through Week 24 and Week 33 through Week 48 of study treatment
title
Change From Baseline in Mean Daily Dose of Iron Chelation Therapy (ICT)
type
SECONDARY
unit Of Measure
mg/day

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Preserved source evidence · Not medical advice