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NCT02279173 · BASELINE

Baseline characteristics

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP) · Source last updated 2022-06-23

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
      203
    units
    Participants
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
    id
    BG000
    title
    Romiplostim
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          17
          value
          10.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        title
        ≥ 1 to < 6 years
      2. measurements
        1. group Id
          BG000
          value
          81
        title
        ≥ 6 to < 12 years
      3. measurements
        1. group Id
          BG000
          value
          73
        title
        ≥ 12 to < 18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          100
        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
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Multiple
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          11
        title
        Other, Not Specified
      7. measurements
        1. group Id
          BG000
          value
          164
        title
        White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.5
          upper Limit
          13.8
          value
          1.75
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Years Since ITP Diagnosis
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.6
          upper Limit
          17.3
          value
          5.97
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Age at ITP Diagnosis
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          193
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Splenectomy Done
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.5
          upper Limit
          265.0
          value
          14.00
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Platelet Count
    unit Of Measure
    10⁹ cells/L
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          7
          value
          2.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Number of Prior ITP Treatments
    unit Of Measure
    prior ITP treatments
population Description
All enrolled participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      203
    units
    Participants
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
    id
    BG000
    title
    Romiplostim
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          17
          value
          10.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        title
        ≥ 1 to < 6 years
      2. measurements
        1. group Id
          BG000
          value
          81
        title
        ≥ 6 to < 12 years
      3. measurements
        1. group Id
          BG000
          value
          73
        title
        ≥ 12 to < 18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          100
        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
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Multiple
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          11
        title
        Other, Not Specified
      7. measurements
        1. group Id
          BG000
          value
          164
        title
        White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.5
          upper Limit
          13.8
          value
          1.75
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Years Since ITP Diagnosis
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.6
          upper Limit
          17.3
          value
          5.97
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Age at ITP Diagnosis
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          193
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Splenectomy Done
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.5
          upper Limit
          265.0
          value
          14.00
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Platelet Count
    unit Of Measure
    10⁹ cells/L
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          7
          value
          2.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Number of Prior ITP Treatments
    unit Of Measure
    prior ITP treatments
population Description
All enrolled participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice