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NCT03364231 · BASELINE

Baseline characteristics

Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma · Source last updated 2023-06-23

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
      8
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      21
    units
    Participants
groups
  1. description
    Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
    id
    BG000
    title
    MZL: Umbralisib
  2. description
    Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
    id
    BG001
    title
    WM: Umbralisib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.64
          value
          71.9
        2. group Id
          BG001
          spread
          5.78
          value
          67.7
        3. group Id
          BG002
          spread
          6.69
          value
          69.3
    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
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        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
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety population included all enrolled participants who received at least one dose of study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      8
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      21
    units
    Participants
groups
  1. description
    Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
    id
    BG000
    title
    MZL: Umbralisib
  2. description
    Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
    id
    BG001
    title
    WM: Umbralisib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.64
          value
          71.9
        2. group Id
          BG001
          spread
          5.78
          value
          67.7
        3. group Id
          BG002
          spread
          6.69
          value
          69.3
    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
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        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
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety population included all enrolled participants who received at least one dose of study treatment.

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Preserved source evidence · Not medical advice