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NCT01088984 · BASELINE

Baseline characteristics

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia · Source last updated 2016-05-23

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
      11
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      43
    units
    Participants
groups
  1. description
    Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    BG000
    title
    Phase 1: Bendamustine 90 or 120 mg/m^2
  2. description
    Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    BG001
    title
    Phase 2: Bendamustine 120 mg/m^2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.31
          value
          8.7
        2. group Id
          BG001
          spread
          4.93
          value
          9.3
        3. group Id
          BG002
          spread
          4.74
          value
          9.2
    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
          4
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          14
      title
      1 to 6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
      title
      7 to 11 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
      title
      12 to 20 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Includes 5 participants treated with bendamustine at 90 mg/m2 in Phase 1, and 6 participants treated with bendamustine at 120 mg/m2 in Phase 1, and 32 participants treated with the recommended phase II dose (RP2D) of bendamustine (120 mg/m2) in Phase 2.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      11
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      43
    units
    Participants
groups
  1. description
    Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    BG000
    title
    Phase 1: Bendamustine 90 or 120 mg/m^2
  2. description
    Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    BG001
    title
    Phase 2: Bendamustine 120 mg/m^2
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.31
          value
          8.7
        2. group Id
          BG001
          spread
          4.93
          value
          9.3
        3. group Id
          BG002
          spread
          4.74
          value
          9.2
    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
          4
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          14
      title
      1 to 6 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
      title
      7 to 11 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
      title
      12 to 20 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Includes 5 participants treated with bendamustine at 90 mg/m2 in Phase 1, and 6 participants treated with bendamustine at 120 mg/m2 in Phase 1, and 32 participants treated with the recommended phase II dose (RP2D) of bendamustine (120 mg/m2) in Phase 2.

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Preserved source evidence · Not medical advice