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NCT03734016 · BASELINE

Baseline characteristics

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30

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
      327
    2. group Id
      BG001
      value
      325
    3. group Id
      BG002
      value
      652
    units
    Participants
groups
  1. description
    Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    BG000
    title
    Zanubrutinib
  2. description
    Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    BG001
    title
    Ibrutinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          251
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          401
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          90
          value
          67.0
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          89
          value
          68.0
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          90
          value
          67.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          207
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          445
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          607
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          91
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          265
        3. group Id
          BG002
          value
          526
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Multiple
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        title
        Unknown/Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          94
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
        title
        Australia/New Zealand
      3. measurements
        1. group Id
          BG000
          value
          198
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          389
        title
        Europe
      4. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          111
        title
        North America
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          150
        title
        Del(17p) and/or TP53 mutation
      2. measurements
        1. group Id
          BG000
          value
          251
        2. group Id
          BG001
          value
          250
        3. group Id
          BG002
          value
          501
        title
        Neither Del(17p) nor TP53 mutation
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    Deletion 17p is a chromosomal abnormality that occurs when part or all of the short arm of chromosome 17 is lost. The TP53 gene provides instructions for making a protein called tumor protein p53 (or p53) which acts as a tumor suppressor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Chromosome 17p Deletion (del[17p]) and TP53 Mutation Status
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      327
    2. group Id
      BG001
      value
      325
    3. group Id
      BG002
      value
      652
    units
    Participants
groups
  1. description
    Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    BG000
    title
    Zanubrutinib
  2. description
    Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    BG001
    title
    Ibrutinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          251
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          401
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          90
          value
          67.0
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          89
          value
          68.0
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          90
          value
          67.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          207
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          445
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          607
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          91
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          265
        3. group Id
          BG002
          value
          526
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Multiple
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
        title
        Unknown/Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          94
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
        title
        Australia/New Zealand
      3. measurements
        1. group Id
          BG000
          value
          198
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          389
        title
        Europe
      4. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          111
        title
        North America
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          150
        title
        Del(17p) and/or TP53 mutation
      2. measurements
        1. group Id
          BG000
          value
          251
        2. group Id
          BG001
          value
          250
        3. group Id
          BG002
          value
          501
        title
        Neither Del(17p) nor TP53 mutation
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    Deletion 17p is a chromosomal abnormality that occurs when part or all of the short arm of chromosome 17 is lost. The TP53 gene provides instructions for making a protein called tumor protein p53 (or p53) which acts as a tumor suppressor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Chromosome 17p Deletion (del[17p]) and TP53 Mutation Status
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Analysis Set includes all randomized participants

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Preserved source evidence · Not medical advice