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NCT01776840 · BASELINE

Baseline characteristics

A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma · Source last updated 2025-07-08

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
      262
    2. group Id
      BG001
      value
      261
    3. group Id
      BG002
      value
      523
    units
    Participants
groups
  1. description
    Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.
    id
    BG000
    title
    Placebo + Bendamustine and Rituximab (BR) (Treatment A)
  2. description
    Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
    id
    BG001
    title
    Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.2
          value
          71.7
        2. group Id
          BG001
          spread
          5.04
          value
          71.8
        3. group Id
          BG002
          spread
          5.12
          value
          71.7
    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
          154
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          316
        title
        70 years and over
      2. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          207
        title
        < 70 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          364
        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
          17
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          35
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          466
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        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
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          89
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          199
        3. group Id
          BG002
          value
          405
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Unknown or Not Reported
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
      title
      BELGIUM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
      title
      BRAZIL
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      CANADA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          57
      title
      CHINA
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
      title
      CZECH REPUBLIC
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
      title
      FRANCE
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
      title
      GERMANY
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      GREECE
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      HUNGARY
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      IRELAND
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      262
    2. group Id
      BG001
      value
      261
    3. group Id
      BG002
      value
      523
    units
    Participants
groups
  1. description
    Participants received 4 capsules of ibrutinib-matching Placebo administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a complete response (CR) or partial response (PR) continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment A up to 100.1 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment A discontinued placebo treatment.
    id
    BG000
    title
    Placebo + Bendamustine and Rituximab (BR) (Treatment A)
  2. description
    Participants received ibrutinib capsules 560 mg (4\*140 mg capsule) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a maximum of 6 cycles of BR background therapy (bendamustine hydrochloride 90 mg/m\^2 IV infusion on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV infusion on Day 1 of each cycle), unless disease progression or unacceptable toxicity prior to Cycle 6. Participants with a CR or PR continued to receive background therapy with rituximab maintenance (375 mg/m\^2 IV infusion) on Day 1 every second cycle starting at Cycle 8 for a maximum of 12 additional doses unless disease progression or unacceptable toxicity. Each cycle was of 28 days. Participants received treatment B up to 117.2 months. After treatment unblinding at the time of the primary analysis, participants randomized to Treatment B continued treatment with ibrutinib at the discretion of the investigator.
    id
    BG001
    title
    Ibrutinib + Bendamustine and Rituximab (BR) (Treatment B)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.2
          value
          71.7
        2. group Id
          BG001
          spread
          5.04
          value
          71.8
        3. group Id
          BG002
          spread
          5.12
          value
          71.7
    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
          154
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          316
        title
        70 years and over
      2. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          207
        title
        < 70 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          364
        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
          17
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          35
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          466
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        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
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          89
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          199
        3. group Id
          BG002
          value
          405
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Unknown or Not Reported
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          31
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
      title
      BELGIUM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
      title
      BRAZIL
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
      title
      CANADA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          57
      title
      CHINA
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
      title
      CZECH REPUBLIC
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
      title
      FRANCE
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
      title
      GERMANY
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      GREECE
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      HUNGARY
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      IRELAND
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice