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NCT00789828 · BASELINE

Baseline characteristics

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) · Source last updated 2016-02-03

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
      78
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      117
    units
    Participants
groups
  1. description
    Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
    id
    BG000
    title
    Everolimus (Core Period)
  2. description
    Participants received oral dose of placebo matching to everolimus daily.
    id
    BG001
    title
    Placebo (Core Period)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.9
          value
          10.1
        2. group Id
          BG001
          spread
          7.3
          value
          10.3
        3. group Id
          BG002
          spread
          6.4
          value
          10.2
    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
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
      title
      <3 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          81
      title
      3-18 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
      title
      ≥18 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          50
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          67
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      78
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      117
    units
    Participants
groups
  1. description
    Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
    id
    BG000
    title
    Everolimus (Core Period)
  2. description
    Participants received oral dose of placebo matching to everolimus daily.
    id
    BG001
    title
    Placebo (Core Period)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.9
          value
          10.1
        2. group Id
          BG001
          spread
          7.3
          value
          10.3
        3. group Id
          BG002
          spread
          6.4
          value
          10.2
    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
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
      title
      <3 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          81
      title
      3-18 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          16
      title
      ≥18 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          50
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          67
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice