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NCT03336333 · BASELINE

Baseline characteristics

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL · Source last updated 2026-03-09

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
      238
    2. group Id
      BG001
      value
      241
    3. group Id
      BG002
      value
      111
    4. group Id
      BG003
      value
      590
    units
    Participants
groups
  1. description
    Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)
    id
    BG000
    title
    Cohort 1: Bendamustine + Rituximab Without Del(17p)
  2. description
    Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    BG001
    title
    Cohort 1: Zanubrutinib Without Del(17p)
  3. description
    Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    BG002
    title
    Cohort 2: Zanubrutinib With Del(17p)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. calculate Pct
    false
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          107
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          192
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          483
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          144
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          377
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          211
        2. group Id
          BG001
          value
          218
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          528
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          52
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          221
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          532
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          38
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat analysis set included all enrolled participants who were assigned to a treatment group (as of cut-off date of 07MAY2021)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      238
    2. group Id
      BG001
      value
      241
    3. group Id
      BG002
      value
      111
    4. group Id
      BG003
      value
      590
    units
    Participants
groups
  1. description
    Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)
    id
    BG000
    title
    Cohort 1: Bendamustine + Rituximab Without Del(17p)
  2. description
    Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    BG001
    title
    Cohort 1: Zanubrutinib Without Del(17p)
  3. description
    Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
    id
    BG002
    title
    Cohort 2: Zanubrutinib With Del(17p)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. calculate Pct
    false
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          107
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          192
        2. group Id
          BG001
          value
          196
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          483
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          144
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          377
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          211
        2. group Id
          BG001
          value
          218
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          528
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          52
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          221
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          532
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          38
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat analysis set included all enrolled participants who were assigned to a treatment group (as of cut-off date of 07MAY2021)

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

Preserved source evidence · Not medical advice