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NCT01713946 · BASELINE

Baseline characteristics

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures · Source last updated 2018-11-07

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
      117
    2. group Id
      BG001
      value
      130
    3. group Id
      BG002
      value
      119
    4. group Id
      BG003
      value
      366
    units
    Participants
groups
  1. description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
    id
    BG000
    title
    Everolimus LT Target of 3 to 7 ng/mL
  2. description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
    id
    BG001
    title
    Everolimus HT Target of 9 to 15 ng/mL
  3. description
    Participants were randomized to receive placebo dispersible tablets for oral suspension.
    id
    BG002
    title
    Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.2
          upper Limit
          56.3
          value
          9.72
        2. group Id
          BG001
          lower Limit
          2.3
          upper Limit
          50.5
          value
          10.08
        3. group Id
          BG002
          lower Limit
          2.2
          upper Limit
          52.0
          value
          10.34
        4. group Id
          BG003
          lower Limit
          2.2
          upper Limit
          56.3
          value
          10.06
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          104
      title
      < 6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          113
      title
      6 to <12 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          82
      title
      12 to <18 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          67
      title
      18 to <65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          176
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          61
        4. group Id
          BG003
          value
          190
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          237
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          87
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          36
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          22.802
          value
          38.69
        2. group Id
          BG001
          spread
          27.267
          value
          40.75
        3. group Id
          BG002
          spread
          24.923
          value
          40.50
        4. group Id
          BG003
          spread
          25.093
          value
          40.01
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          26.171
          value
          135.65
        2. group Id
          BG001
          spread
          28.234
          value
          136.25
        3. group Id
          BG002
          spread
          27.097
          value
          135.67
        4. group Id
          BG003
          spread
          27.145
          value
          135.87
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.437
          value
          1.18
        2. group Id
          BG001
          spread
          0.501
          value
          1.20
        3. group Id
          BG002
          spread
          0.476
          value
          1.20
        4. group Id
          BG003
          spread
          0.472
          value
          1.20
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Body surface area
    unit Of Measure
    m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.283
          value
          19.29
        2. group Id
          BG001
          spread
          6.233
          value
          19.56
        3. group Id
          BG002
          spread
          5.484
          value
          19.78
        4. group Id
          BG003
          spread
          5.689
          value
          19.55
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Body mass index
    unit Of Measure
    kg/m^2
population Description
Full Analysis Set: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      117
    2. group Id
      BG001
      value
      130
    3. group Id
      BG002
      value
      119
    4. group Id
      BG003
      value
      366
    units
    Participants
groups
  1. description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
    id
    BG000
    title
    Everolimus LT Target of 3 to 7 ng/mL
  2. description
    Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
    id
    BG001
    title
    Everolimus HT Target of 9 to 15 ng/mL
  3. description
    Participants were randomized to receive placebo dispersible tablets for oral suspension.
    id
    BG002
    title
    Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.2
          upper Limit
          56.3
          value
          9.72
        2. group Id
          BG001
          lower Limit
          2.3
          upper Limit
          50.5
          value
          10.08
        3. group Id
          BG002
          lower Limit
          2.2
          upper Limit
          52.0
          value
          10.34
        4. group Id
          BG003
          lower Limit
          2.2
          upper Limit
          56.3
          value
          10.06
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          104
      title
      < 6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          113
      title
      6 to <12 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          82
      title
      12 to <18 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          67
      title
      18 to <65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          176
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          61
        4. group Id
          BG003
          value
          190
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          237
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          87
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          36
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          22.802
          value
          38.69
        2. group Id
          BG001
          spread
          27.267
          value
          40.75
        3. group Id
          BG002
          spread
          24.923
          value
          40.50
        4. group Id
          BG003
          spread
          25.093
          value
          40.01
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          26.171
          value
          135.65
        2. group Id
          BG001
          spread
          28.234
          value
          136.25
        3. group Id
          BG002
          spread
          27.097
          value
          135.67
        4. group Id
          BG003
          spread
          27.145
          value
          135.87
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.437
          value
          1.18
        2. group Id
          BG001
          spread
          0.501
          value
          1.20
        3. group Id
          BG002
          spread
          0.476
          value
          1.20
        4. group Id
          BG003
          spread
          0.472
          value
          1.20
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Body surface area
    unit Of Measure
    m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.283
          value
          19.29
        2. group Id
          BG001
          spread
          6.233
          value
          19.56
        3. group Id
          BG002
          spread
          5.484
          value
          19.78
        4. group Id
          BG003
          spread
          5.689
          value
          19.55
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
    title
    Body mass index
    unit Of Measure
    kg/m^2
population Description
Full Analysis Set: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.

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