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NCT03206970 · BASELINE

Baseline characteristics

Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL) · Source last updated 2024-10-26

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
      86
    units
    Participants
groups
  1. description
    Zanubrutinib (160 mg) administered BID until Zanubrutinib (160 milligrams \[mg\]) administered orally twice daily (BID) until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
    id
    BG000
    title
    Zanubrutinib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.18
          value
          59.0
    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
          64
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      ≥ 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          67
        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
          86
      title
      Chinese
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
      title
      China
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        MCL Stage I
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        MCL Stage II
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        MCL Stage III
      4. measurements
        1. group Id
          BG000
          value
          64
        title
        MCL Stage IV
    description
    Participants' MCL disease stage at consent date, with higher stages indicating more severe MCL.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mantle Cell Lymphoma (MCL) Disease Stage at Study Entry
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        title
        Relapsed Disease
      2. measurements
        1. group Id
          BG000
          value
          45
        title
        Refractory Disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Grade 2
    description
    Grade 0 = Fully active, able to carry on all pre-disease performance without restriction; Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; Lower grades indicate better outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
population Description
Safety Analysis Set: All participants who received any dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      86
    units
    Participants
groups
  1. description
    Zanubrutinib (160 mg) administered BID until Zanubrutinib (160 milligrams \[mg\]) administered orally twice daily (BID) until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
    id
    BG000
    title
    Zanubrutinib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.18
          value
          59.0
    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
          64
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      ≥ 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          67
        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
          86
      title
      Chinese
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
      title
      China
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        MCL Stage I
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        MCL Stage II
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        MCL Stage III
      4. measurements
        1. group Id
          BG000
          value
          64
        title
        MCL Stage IV
    description
    Participants' MCL disease stage at consent date, with higher stages indicating more severe MCL.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mantle Cell Lymphoma (MCL) Disease Stage at Study Entry
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        title
        Relapsed Disease
      2. measurements
        1. group Id
          BG000
          value
          45
        title
        Refractory Disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Grade 2
    description
    Grade 0 = Fully active, able to carry on all pre-disease performance without restriction; Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; Lower grades indicate better outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
population Description
Safety Analysis Set: All participants who received any dose of study drug.

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

Preserved source evidence · Not medical advice