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NCT02631070 · OUTCOME

Change From Baseline in Mean Serum Ferritin

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
ug/L
Interval / dispersion
Standard Error
Time frame
Baseline and Week 9 through Week 24 and Week 33 through Week 48

What was measured

Mean change from baseline in mean serum ferritin was calculated as the difference of postbaseline mean serum ferritin (averaged over the specified timepoints) and baseline mean serum ferritin.

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
Luspatercept148
Placebo74

Reported measurements

Weeks 9-24

Analysis denominator · Participants

GroupSource count
Luspatercept148
Placebo74
Values in ug/L · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Luspatercept-2.754.05Not reportedNot reportedNot reported
Placebo226.568.02Not reportedNot reportedNot reported
Weeks 33-48

Analysis denominator · Participants

GroupSource count
Luspatercept89
Placebo16
Values in ug/L · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Luspatercept-72.074.76Not reportedNot reportedNot reported
Placebo247.4140.96Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -375.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -82.4
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    74.43
    group Description
    Week 9 Through 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0024
    param Type
    LS Mean Difference
    param Value
    -229.1
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -606.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -32.7
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    144.57
    group Description
    Week 33 Through 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0294
    param Type
    LS Mean Difference
    param Value
    -319.5
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Lower Limit
    -375.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -82.4
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    74.43
    group Description
    Week 9 Through 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0024
    param Type
    LS Mean Difference
    param Value
    -229.1
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -606.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -32.7
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    144.57
    group Description
    Week 33 Through 48
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0294
    param Type
    LS Mean Difference
    param Value
    -319.5
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.05
        value
        -2.7
      2. group Id
        OG001
        spread
        68.02
        value
        226.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        148
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Weeks 9-24
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.76
        value
        -72.0
      2. group Id
        OG001
        spread
        140.96
        value
        247.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    Weeks 33-48
denoms
  1. counts
    1. group Id
      OG000
      value
      148
    2. group Id
      OG001
      value
      74
    units
    Participants
description
Mean change from baseline in mean serum ferritin was calculated as the difference of postbaseline mean serum ferritin (averaged over the specified timepoints) and baseline mean serum ferritin.
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
title
Change From Baseline in Mean Serum Ferritin
type
SECONDARY
unit Of Measure
ug/L

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Preserved source evidence · Not medical advice