Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02343120 · BASELINE

Baseline characteristics

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies · Source last updated 2022-04-28

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
      3
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      278
    5. group Id
      BG004
      value
      95
    6. group Id
      BG005
      value
      385
    units
    Participants
groups
  1. description
    Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    BG000
    title
    Part 1: 40 mg QD
  2. description
    Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    BG001
    title
    Part 1: 80 mg QD
  3. description
    Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    BG002
    title
    Part 1: 160 mg QD
  4. description
    Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    BG003
    title
    Part 1 and Part 2: 160 mg BID
  5. description
    Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    BG004
    title
    Part 1 and Part 2: 320 mg QD
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.45
          value
          62.7
        2. group Id
          BG001
          spread
          14.38
          value
          62.3
        3. group Id
          BG002
          spread
          8.88
          value
          72.6
        4. group Id
          BG003
          spread
          11.21
          value
          66.4
        5. group Id
          BG004
          spread
          11.24
          value
          65.8
        6. group Id
          BG005
          spread
          11.19
          value
          66.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          86
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          192
        5. group Id
          BG004
          value
          75
        6. group Id
          BG005
          value
          276
        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
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          205
        5. group Id
          BG004
          value
          87
        6. group Id
          BG005
          value
          303
      title
      White
    2. 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
          47
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          53
      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
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
      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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      Native Hawaiians or other Pacific Islanders
    5. 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
          0
        6. group Id
          BG005
          value
          1
      title
      Multiple
    6. 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
          0
        6. group Id
          BG005
          value
          1
      title
      Not Reported
    7. 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
          18
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          20
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      278
    5. group Id
      BG004
      value
      95
    6. group Id
      BG005
      value
      385
    units
    Participants
groups
  1. description
    Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    BG000
    title
    Part 1: 40 mg QD
  2. description
    Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    BG001
    title
    Part 1: 80 mg QD
  3. description
    Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
    id
    BG002
    title
    Part 1: 160 mg QD
  4. description
    Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    BG003
    title
    Part 1 and Part 2: 160 mg BID
  5. description
    Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up were evaluated. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
    id
    BG004
    title
    Part 1 and Part 2: 320 mg QD
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.45
          value
          62.7
        2. group Id
          BG001
          spread
          14.38
          value
          62.3
        3. group Id
          BG002
          spread
          8.88
          value
          72.6
        4. group Id
          BG003
          spread
          11.21
          value
          66.4
        5. group Id
          BG004
          spread
          11.24
          value
          65.8
        6. group Id
          BG005
          spread
          11.19
          value
          66.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          86
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          192
        5. group Id
          BG004
          value
          75
        6. group Id
          BG005
          value
          276
        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
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          205
        5. group Id
          BG004
          value
          87
        6. group Id
          BG005
          value
          303
      title
      White
    2. 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
          47
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          53
      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
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
      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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
      title
      Native Hawaiians or other Pacific Islanders
    5. 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
          0
        6. group Id
          BG005
          value
          1
      title
      Multiple
    6. 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
          0
        6. group Id
          BG005
          value
          1
      title
      Not Reported
    7. 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
          18
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          20
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who received ≥ 1 dose of study drug

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

Preserved source evidence · Not medical advice