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NCT01282424 · BASELINE

Baseline characteristics

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas · Source last updated 2019-07-11

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
      125
    units
    Participants
groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
    id
    BG000
    title
    Idelalisib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          62
    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
          45
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          80
        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
          110
        title
        White/Caucasian
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          8
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          117
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Missing
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      France
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          83
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Poland
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Italy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Score = 60
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Score = 70
      3. measurements
        1. group Id
          BG000
          value
          27
        title
        Score = 80
      4. measurements
        1. group Id
          BG000
          value
          44
        title
        Score = 90
      5. measurements
        1. group Id
          BG000
          value
          46
        title
        Score = 100
    description
    Karnofsky performance status classified participants according to their functional impairment. Scores ranged from 0-100, the lower the score, the worse the survival for most serious illnesses.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        title
        Folicular lymphoma
      2. measurements
        1. group Id
          BG000
          value
          28
        title
        Small lymphocytic lymphoma
      3. measurements
        1. group Id
          BG000
          value
          10
        title
        LPL/WM
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        Marginal zone lymphoma
    description
    LPL/WM: Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Disease History
    unit Of Measure
    Participants
population Description
ITT analysis set included enrolled participants who received at least one dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      125
    units
    Participants
groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
    id
    BG000
    title
    Idelalisib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          62
    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
          45
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          80
        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
          110
        title
        White/Caucasian
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          8
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          117
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Missing
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      France
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          83
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Poland
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Italy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Score = 60
      2. measurements
        1. group Id
          BG000
          value
          6
        title
        Score = 70
      3. measurements
        1. group Id
          BG000
          value
          27
        title
        Score = 80
      4. measurements
        1. group Id
          BG000
          value
          44
        title
        Score = 90
      5. measurements
        1. group Id
          BG000
          value
          46
        title
        Score = 100
    description
    Karnofsky performance status classified participants according to their functional impairment. Scores ranged from 0-100, the lower the score, the worse the survival for most serious illnesses.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        title
        Folicular lymphoma
      2. measurements
        1. group Id
          BG000
          value
          28
        title
        Small lymphocytic lymphoma
      3. measurements
        1. group Id
          BG000
          value
          10
        title
        LPL/WM
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        Marginal zone lymphoma
    description
    LPL/WM: Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Disease History
    unit Of Measure
    Participants
population Description
ITT analysis set included enrolled participants who received at least one dose of study drug.

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Preserved source evidence · Not medical advice