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NCT01437787 · FLOW

Participant flow

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis · Source last updated 2026-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Placebo
  2. description
    SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
    id
    FG001
    title
    SAR302503 400 mg
  3. description
    SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
    id
    FG002
    title
    SAR302503 500 mg
  4. description
    At the end of cycle 6, participants were crossed-over to SAR302503 400 mg until disease progression or unacceptable toxicity.
    id
    FG003
    title
    Placebo Then SAR302503 400 mg
  5. description
    At the end of cycle 6, participants were crossed-over to SAR302503 500 mg until disease progression or unacceptable toxicity.
    id
    FG004
    title
    Placebo Then SAR302503 500 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by participant
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Randomized, but not treated
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Poor compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Other than specified
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Participant request
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Study termination by sponsor
    9. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Early crossover
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomization until end of Cycle 6
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        Crossover from placebo
        group Id
        FG003
        num Subjects
        35
      5. comment
        Crossover from placebo
        group Id
        FG004
        num Subjects
        36
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        35
      5. group Id
        FG004
        num Subjects
        36
      type
      NOT COMPLETED
    title
    Crossover After Cycle 6
pre Assignment Details
Of 351 screened participants, 62 were screen failures and 289 were randomized.
recruitment Details
The study was conducted at 101 sites in 25 countries. A total of 351 participants were screened between 22 December 2011 and 24 August 2012.
Complete source fields
groups
  1. description
    Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Placebo
  2. description
    SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
    id
    FG001
    title
    SAR302503 400 mg
  3. description
    SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
    id
    FG002
    title
    SAR302503 500 mg
  4. description
    At the end of cycle 6, participants were crossed-over to SAR302503 400 mg until disease progression or unacceptable toxicity.
    id
    FG003
    title
    Placebo Then SAR302503 400 mg
  5. description
    At the end of cycle 6, participants were crossed-over to SAR302503 500 mg until disease progression or unacceptable toxicity.
    id
    FG004
    title
    Placebo Then SAR302503 500 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by participant
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Randomized, but not treated
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Poor compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Other than specified
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Participant request
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Study termination by sponsor
    9. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Early crossover
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        96
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomization until end of Cycle 6
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        Crossover from placebo
        group Id
        FG003
        num Subjects
        35
      5. comment
        Crossover from placebo
        group Id
        FG004
        num Subjects
        36
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        35
      5. group Id
        FG004
        num Subjects
        36
      type
      NOT COMPLETED
    title
    Crossover After Cycle 6
pre Assignment Details
Of 351 screened participants, 62 were screen failures and 289 were randomized.
recruitment Details
The study was conducted at 101 sites in 25 countries. A total of 351 participants were screened between 22 December 2011 and 24 August 2012.

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Preserved source evidence · Independent clinical review pending · Not medical advice