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NCT01143038 · BASELINE

Baseline characteristics

Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim · Source last updated 2022-09-21

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
      75
    units
    Participants
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.
    id
    BG000
    title
    Romiplostim
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.7
          value
          44.5
    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
          44
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        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
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Black (or African American)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          72
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Hispanic/Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      title
      Not Hispanic/Latino
    param Type
    NUMBER
    title
    Ethnicity
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          6.6
          value
          2.2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since ITP diagnosis
    unit Of Measure
    months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.80
          value
          19.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Platelet Count at Screening
    unit Of Measure
    x 10^9/L
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      75
    units
    Participants
groups
  1. description
    Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.
    id
    BG000
    title
    Romiplostim
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.7
          value
          44.5
    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
          44
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        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
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Black (or African American)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          72
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Hispanic/Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      title
      Not Hispanic/Latino
    param Type
    NUMBER
    title
    Ethnicity
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          6.6
          value
          2.2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since ITP diagnosis
    unit Of Measure
    months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.80
          value
          19.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Platelet Count at Screening
    unit Of Measure
    x 10^9/L

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Preserved source evidence · Not medical advice