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NCT02165397 · BASELINE

Baseline characteristics

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia · Source last updated 2021-03-03

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
      75
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      31
    4. group Id
      BG003
      value
      181
    units
    Participants
groups
  1. description
    Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
    id
    BG000
    title
    Ibrutinib + Rituximab
  2. description
    Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
    id
    BG001
    title
    Placebo + Rituximab
  3. description
    Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
    id
    BG002
    title
    Open-Label Substudy: Ibrutinib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          72
      title
      < 65 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          109
      title
      >= 65 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          119
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          176
        title
        Not Hispanic or Latino
      3. 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
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          144
        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
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          30
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      75
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      31
    4. group Id
      BG003
      value
      181
    units
    Participants
groups
  1. description
    Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
    id
    BG000
    title
    Ibrutinib + Rituximab
  2. description
    Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
    id
    BG001
    title
    Placebo + Rituximab
  3. description
    Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
    id
    BG002
    title
    Open-Label Substudy: Ibrutinib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          72
      title
      < 65 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          109
      title
      >= 65 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          119
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          176
        title
        Not Hispanic or Latino
      3. 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
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          144
        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
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          30
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice