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NCT01243944 · BASELINE

Baseline characteristics

Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial) · Source last updated 2019-03-06

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
      110
    2. group Id
      BG001
      value
      112
    3. group Id
      BG002
      value
      222
    units
    Participants
groups
  1. description
    Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
    id
    BG000
    title
    Ruxolitinib
  2. description
    Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
    id
    BG001
    title
    Best Available Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.48
          value
          61.1
        2. group Id
          BG001
          spread
          10.25
          value
          59.1
        3. group Id
          BG002
          spread
          10.39
          value
          60.1
    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
          49
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          103
      title
      < 60 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          119
      title
      ≥ 60 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          76
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          146
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          194
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          27
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.09
          value
          76.6
        2. group Id
          BG001
          spread
          17.34
          value
          79.0
        3. group Id
          BG002
          spread
          15.83
          value
          77.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.44
          value
          172.2
        2. group Id
          BG001
          spread
          9.79
          value
          173.3
        3. group Id
          BG002
          spread
          9.14
          value
          172.8
    description
    Height was missing at study entry for one participant in the ruxolitinib arm.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.82
          value
          25.8
        2. group Id
          BG001
          spread
          4.24
          value
          26.1
        3. group Id
          BG002
          spread
          4.03
          value
          25.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          153
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          65
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      2
    description
    Eastern Cooperative Oncology Group (ECOG) - ECOG Status: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    ECOG performance status
    unit Of Measure
    participants
population Description
All enrolled participants, regardless treated or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      110
    2. group Id
      BG001
      value
      112
    3. group Id
      BG002
      value
      222
    units
    Participants
groups
  1. description
    Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
    id
    BG000
    title
    Ruxolitinib
  2. description
    Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
    id
    BG001
    title
    Best Available Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.48
          value
          61.1
        2. group Id
          BG001
          spread
          10.25
          value
          59.1
        3. group Id
          BG002
          spread
          10.39
          value
          60.1
    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
          49
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          103
      title
      < 60 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          119
      title
      ≥ 60 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          76
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          146
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          194
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Black/African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          27
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.09
          value
          76.6
        2. group Id
          BG001
          spread
          17.34
          value
          79.0
        3. group Id
          BG002
          spread
          15.83
          value
          77.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.44
          value
          172.2
        2. group Id
          BG001
          spread
          9.79
          value
          173.3
        3. group Id
          BG002
          spread
          9.14
          value
          172.8
    description
    Height was missing at study entry for one participant in the ruxolitinib arm.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.82
          value
          25.8
        2. group Id
          BG001
          spread
          4.24
          value
          26.1
        3. group Id
          BG002
          spread
          4.03
          value
          25.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          153
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          65
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      2
    description
    Eastern Cooperative Oncology Group (ECOG) - ECOG Status: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    ECOG performance status
    unit Of Measure
    participants
population Description
All enrolled participants, regardless treated or not.

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Preserved source evidence · Not medical advice