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NCT01444417 · BASELINE

Baseline characteristics

Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Source last updated 2017-02-09

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
      20
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      62
    units
    Participants
groups
  1. description
    Participants received weekly subcutaneous placebo for 24 weeks.
    id
    BG000
    title
    Placebo
  2. description
    Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
    id
    BG001
    title
    Romiplostim
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.7
          value
          9.4
        2. group Id
          BG001
          spread
          4.1
          value
          9.7
        3. group Id
          BG002
          spread
          4.3
          value
          9.6
    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
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      ≥ 1 - < 6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
      title
      ≥ 6 - < 12 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          23
      title
      ≥ 12 - < 18 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          35
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Multiple
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          41
      title
      White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.3
          value
          19.9
        2. group Id
          BG001
          spread
          10.7
          value
          17.5
        3. group Id
          BG002
          spread
          13.9
          value
          18.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Platelets
    unit Of Measure
    10^9/L
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      62
    units
    Participants
groups
  1. description
    Participants received weekly subcutaneous placebo for 24 weeks.
    id
    BG000
    title
    Placebo
  2. description
    Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
    id
    BG001
    title
    Romiplostim
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.7
          value
          9.4
        2. group Id
          BG001
          spread
          4.1
          value
          9.7
        3. group Id
          BG002
          spread
          4.3
          value
          9.6
    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
          4
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          12
      title
      ≥ 1 - < 6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
      title
      ≥ 6 - < 12 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          23
      title
      ≥ 12 - < 18 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          35
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Multiple
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          41
      title
      White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.3
          value
          19.9
        2. group Id
          BG001
          spread
          10.7
          value
          17.5
        3. group Id
          BG002
          spread
          13.9
          value
          18.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Platelets
    unit Of Measure
    10^9/L

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Preserved source evidence · Not medical advice