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NCT02328014 · BASELINE

Baseline characteristics

Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies · Source last updated 2025-12-09

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
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      22
    5. group Id
      BG004
      value
      40
    units
    Participants
groups
  1. description
    Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
    id
    BG000
    title
    Part 1 Cohort 1
  2. description
    Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    BG001
    title
    Part 1 Cohort 2
  3. description
    Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
    id
    BG002
    title
    Part 1 Cohort 3
  4. description
    Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    BG003
    title
    Part 2
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.3
          value
          61.2
        2. group Id
          BG001
          spread
          9.9
          value
          68.0
        3. group Id
          BG002
          spread
          7.9
          value
          62.5
        4. group Id
          BG003
          spread
          9.2
          value
          68.3
        5. group Id
          BG004
          spread
          9.2
          value
          68.3
    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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          24
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          39
      title
      Not Hispanic or Latino
    3. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          34
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          40
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All treated = subjects who receive at least 1 dose of study drug; Efficacy evaluable = all-treated population with one evaluable response assessment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      22
    5. group Id
      BG004
      value
      40
    units
    Participants
groups
  1. description
    Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
    id
    BG000
    title
    Part 1 Cohort 1
  2. description
    Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    BG001
    title
    Part 1 Cohort 2
  3. description
    Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
    id
    BG002
    title
    Part 1 Cohort 3
  4. description
    Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
    id
    BG003
    title
    Part 2
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.3
          value
          61.2
        2. group Id
          BG001
          spread
          9.9
          value
          68.0
        3. group Id
          BG002
          spread
          7.9
          value
          62.5
        4. group Id
          BG003
          spread
          9.2
          value
          68.3
        5. group Id
          BG004
          spread
          9.2
          value
          68.3
    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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          24
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          39
      title
      Not Hispanic or Latino
    3. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          34
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          40
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All treated = subjects who receive at least 1 dose of study drug; Efficacy evaluable = all-treated population with one evaluable response assessment.

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Preserved source evidence · Not medical advice