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NCT00608907 · BASELINE

Baseline characteristics

An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) · Source last updated 2012-01-30

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
      30
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      61
    units
    Participants
groups
  1. description
    Control arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
    id
    BG000
    title
    VELCADE
  2. description
    Treatment Arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
    id
    BG001
    title
    VELCADE + Rifampicin
  3. description
    Treatment arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
    id
    BG002
    title
    VELCADE + Dexamethasone
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. 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
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          31
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.86
          value
          64.7
        2. group Id
          BG001
          spread
          9.97
          value
          60.2
        3. group Id
          BG002
          spread
          11.72
          value
          62.3
        4. group Id
          BG003
          spread
          10.91
          value
          63.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      30
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      61
    units
    Participants
groups
  1. description
    Control arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
    id
    BG000
    title
    VELCADE
  2. description
    Treatment Arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
    id
    BG001
    title
    VELCADE + Rifampicin
  3. description
    Treatment arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
    id
    BG002
    title
    VELCADE + Dexamethasone
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. 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
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          31
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.86
          value
          64.7
        2. group Id
          BG001
          spread
          9.97
          value
          60.2
        3. group Id
          BG002
          spread
          11.72
          value
          62.3
        4. group Id
          BG003
          spread
          10.91
          value
          63.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice