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NCT01732926 · BASELINE

Baseline characteristics

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas · Source last updated 2018-11-16

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
      320
    2. group Id
      BG001
      value
      155
    3. group Id
      BG002
      value
      475
    units
    Participants
groups
  1. description
    Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    BG000
    title
    Idelalisib + Bendamustine + Rituximab
  2. description
    Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    BG001
    title
    Placebo + Bendamustine + Rituximab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.5
          value
          62
        2. group Id
          BG001
          spread
          11.1
          value
          62
        3. group Id
          BG002
          spread
          10.9
          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
          132
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          190
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          285
        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
          26
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          34
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          247
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          369
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          62
      title
      Not Permitted
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          24
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          262
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          391
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          60
      title
      Not Permitted
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          27
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          49
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          53
      title
      United Kingdom
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          32
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          66
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
      title
      Czech Republic
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Sweden
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
      title
      Taiwan
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          36
      title
      Poland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          12
      title
      Korea, Republic of
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          35
      title
      Italy
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Israel
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Intent to Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      320
    2. group Id
      BG001
      value
      155
    3. group Id
      BG002
      value
      475
    units
    Participants
groups
  1. description
    Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    BG000
    title
    Idelalisib + Bendamustine + Rituximab
  2. description
    Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    BG001
    title
    Placebo + Bendamustine + Rituximab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.5
          value
          62
        2. group Id
          BG001
          spread
          11.1
          value
          62
        3. group Id
          BG002
          spread
          10.9
          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
          132
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          190
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          285
        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
          26
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          34
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          247
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          369
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          62
      title
      Not Permitted
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          24
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          262
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          391
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          60
      title
      Not Permitted
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          27
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          49
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          53
      title
      United Kingdom
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          32
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          66
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
      title
      Czech Republic
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Sweden
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
      title
      Taiwan
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          36
      title
      Poland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          12
      title
      Korea, Republic of
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          35
      title
      Italy
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Israel
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Intent to Treat (ITT) Analysis Set: all participants who were randomized regardless of whether they received any study treatment

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

Preserved source evidence · Not medical advice