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NCT02970318 · BASELINE

Baseline characteristics

A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL · Source last updated 2026-07-24

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
      155
    2. group Id
      BG001
      value
      155
    3. group Id
      BG002
      value
      310
    units
    Participants
groups
  1. description
    Arm A- Acalabrutinib 100 mg BID
    id
    BG000
    title
    Arm A- Acala. 100 mg BID
  2. description
    IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
    id
    BG001
    title
    Arm B: Investigator Choice (IR or BR)-Main Study Period
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          115
      title
      Age < 65 Years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          195
      title
      Age >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          102
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          208
        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
          6
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          276
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          26
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          286
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      New Zealand
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          263
      title
      Europe
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Taiwan, Province Of China
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Hong Kong
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Korea, Republic Of
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Singapore
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants grouped according to assigned treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      155
    2. group Id
      BG001
      value
      155
    3. group Id
      BG002
      value
      310
    units
    Participants
groups
  1. description
    Arm A- Acalabrutinib 100 mg BID
    id
    BG000
    title
    Arm A- Acala. 100 mg BID
  2. description
    IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009
    id
    BG001
    title
    Arm B: Investigator Choice (IR or BR)-Main Study Period
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          115
      title
      Age < 65 Years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          195
      title
      Age >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          102
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          208
        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
          6
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          276
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          26
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          286
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      New Zealand
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          263
      title
      Europe
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Taiwan, Province Of China
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Hong Kong
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Korea, Republic Of
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Singapore
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants grouped according to assigned treatment.

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

Preserved source evidence · Not medical advice