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NCT02631070 · FLOW

Participant flow

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.

groups
  1. description
    Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
    id
    FG000
    title
    Luspatercept
  2. description
    Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        13
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        24
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        21
      type
      Transition to rollover protocol
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        76
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        149
      2. group Id
        FG001
        num Subjects
        64
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
229 participants were randomized and treated.
Complete source fields
groups
  1. description
    Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
    id
    FG000
    title
    Luspatercept
  2. description
    Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        13
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        24
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        21
      type
      Transition to rollover protocol
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        76
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        149
      2. group Id
        FG001
        num Subjects
        64
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
229 participants were randomized and treated.

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Preserved source evidence · Not medical advice