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NCT01437787 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      96
    2. group Id
      BG001
      value
      96
    3. group Id
      BG002
      value
      97
    4. group Id
      BG003
      value
      289
    units
    Participants
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
    BG000
    title
    Placebo
  2. description
    SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
    id
    BG001
    title
    SAR302503 400 mg
  3. description
    SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
    id
    BG002
    title
    SAR302503 500 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.5
          value
          64.9
        2. group Id
          BG001
          spread
          9.6
          value
          62.9
        3. group Id
          BG002
          spread
          9.3
          value
          64.7
        4. group Id
          BG003
          spread
          9.5
          value
          64.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          119
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          61
        4. group Id
          BG003
          value
          170
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      96
    2. group Id
      BG001
      value
      96
    3. group Id
      BG002
      value
      97
    4. group Id
      BG003
      value
      289
    units
    Participants
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
    BG000
    title
    Placebo
  2. description
    SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
    id
    BG001
    title
    SAR302503 400 mg
  3. description
    SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
    id
    BG002
    title
    SAR302503 500 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.5
          value
          64.9
        2. group Id
          BG001
          spread
          9.6
          value
          62.9
        3. group Id
          BG002
          spread
          9.3
          value
          64.7
        4. group Id
          BG003
          spread
          9.5
          value
          64.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          119
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          61
        4. group Id
          BG003
          value
          170
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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