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NCT02038036 · BASELINE

Baseline characteristics

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. · Source last updated 2021-07-20

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
      74
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      149
    units
    Participants
groups
  1. description
    Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
    id
    BG000
    title
    Ruxolitinib
  2. description
    Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
    id
    BG001
    title
    Best Available Therapy (BAT)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.31
          value
          62.8
        2. group Id
          BG001
          spread
          11.12
          value
          66.0
        3. group Id
          BG002
          spread
          11.29
          value
          64.4
    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
          35
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          86
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          133
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      74
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      149
    units
    Participants
groups
  1. description
    Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
    id
    BG000
    title
    Ruxolitinib
  2. description
    Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
    id
    BG001
    title
    Best Available Therapy (BAT)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.31
          value
          62.8
        2. group Id
          BG001
          spread
          11.12
          value
          66.0
        3. group Id
          BG002
          spread
          11.29
          value
          64.4
    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
          35
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          86
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          133
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice