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NCT01969838 · BASELINE

Baseline characteristics

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis · Source last updated 2023-05-12

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
      215
    2. group Id
      BG001
      value
      217
    3. group Id
      BG002
      value
      432
    units
    Participants
groups
  1. description
    Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib: Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib: Placebo to match ruxolitinib tablets were administered orally twice daily.
    id
    BG000
    title
    Momelotinib (MMB)
  2. description
    Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib: Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib: Placebo to match momelotinib tablets were administered orally once daily
    id
    BG001
    title
    Ruxolitinib (RUX)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          185
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          247
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          upper Limit
          85
          value
          67
        2. group Id
          BG001
          lower Limit
          25
          upper Limit
          86
          value
          66
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          86
          value
          66
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          188
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          244
        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
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          191
        2. group Id
          BG001
          value
          194
        3. group Id
          BG002
          value
          385
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          37
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          357
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
      title
      Not Permitted
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          105
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          327
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Transfusion Dependent
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          41
        title
        < 100
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          129
        title
        >= 100 and <= 200
      3. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          262
        title
        > 200
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platelet Count (10^9/L)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62.9
          upper Limit
          80.0
          value
          69.3
        2. group Id
          BG001
          lower Limit
          62.5
          upper Limit
          83.4
          value
          71.4
        3. group Id
          BG002
          lower Limit
          62.8
          upper Limit
          82.0
          value
          70.0
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Weight
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          163.0
          upper Limit
          176.0
          value
          170.0
        2. group Id
          BG001
          lower Limit
          162.0
          upper Limit
          177.0
          value
          170.0
        3. group Id
          BG002
          lower Limit
          162.5
          upper Limit
          176.0
          value
          170.0
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Height
    unit Of Measure
    cm
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22.0
          upper Limit
          26.7
          value
          24.6
        2. group Id
          BG001
          lower Limit
          22.3
          upper Limit
          27.5
          value
          24.9
        3. group Id
          BG002
          lower Limit
          22.2
          upper Limit
          27.2
          value
          24.6
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    BMI
    unit Of Measure
    kg/m^2
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          9.1
          upper Limit
          12.0
          value
          10.5
        2. group Id
          BG001
          lower Limit
          9.2
          upper Limit
          11.9
          value
          10.3
        3. group Id
          BG002
          lower Limit
          9.1
          upper Limit
          12.0
          value
          10.4
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Hemoglobin
    unit Of Measure
    g/dL
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      215
    2. group Id
      BG001
      value
      217
    3. group Id
      BG002
      value
      432
    units
    Participants
groups
  1. description
    Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib: Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib: Placebo to match ruxolitinib tablets were administered orally twice daily.
    id
    BG000
    title
    Momelotinib (MMB)
  2. description
    Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib: Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib: Placebo to match momelotinib tablets were administered orally once daily
    id
    BG001
    title
    Ruxolitinib (RUX)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          185
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          247
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          upper Limit
          85
          value
          67
        2. group Id
          BG001
          lower Limit
          25
          upper Limit
          86
          value
          66
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          86
          value
          66
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          188
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          244
        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
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          191
        2. group Id
          BG001
          value
          194
        3. group Id
          BG002
          value
          385
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          37
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          357
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
      title
      Not Permitted
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          105
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          327
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Transfusion Dependent
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          41
        title
        < 100
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          129
        title
        >= 100 and <= 200
      3. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          262
        title
        > 200
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platelet Count (10^9/L)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          62.9
          upper Limit
          80.0
          value
          69.3
        2. group Id
          BG001
          lower Limit
          62.5
          upper Limit
          83.4
          value
          71.4
        3. group Id
          BG002
          lower Limit
          62.8
          upper Limit
          82.0
          value
          70.0
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Weight
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          163.0
          upper Limit
          176.0
          value
          170.0
        2. group Id
          BG001
          lower Limit
          162.0
          upper Limit
          177.0
          value
          170.0
        3. group Id
          BG002
          lower Limit
          162.5
          upper Limit
          176.0
          value
          170.0
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Height
    unit Of Measure
    cm
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22.0
          upper Limit
          26.7
          value
          24.6
        2. group Id
          BG001
          lower Limit
          22.3
          upper Limit
          27.5
          value
          24.9
        3. group Id
          BG002
          lower Limit
          22.2
          upper Limit
          27.2
          value
          24.6
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    BMI
    unit Of Measure
    kg/m^2
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          9.1
          upper Limit
          12.0
          value
          10.5
        2. group Id
          BG001
          lower Limit
          9.2
          upper Limit
          11.9
          value
          10.3
        3. group Id
          BG002
          lower Limit
          9.1
          upper Limit
          12.0
          value
          10.4
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Hemoglobin
    unit Of Measure
    g/dL

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Preserved source evidence · Not medical advice