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NCT00793650 · BASELINE

Baseline characteristics

Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study · Source last updated 2012-08-30

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
      19
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      39
    units
    Participants
groups
  1. description
    All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
    id
    BG000
    title
    Bortezomib Before HD Melphalan
  2. description
    patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
    id
    BG001
    title
    Bortezomib After HD melphalanAll
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          28
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        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
          7.92
          value
          58.32
        2. group Id
          BG001
          spread
          8.05
          value
          58.75
        3. group Id
          BG002
          spread
          7.88
          value
          58.54
    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
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
        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
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          39
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      19
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      39
    units
    Participants
groups
  1. description
    All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
    id
    BG000
    title
    Bortezomib Before HD Melphalan
  2. description
    patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
    id
    BG001
    title
    Bortezomib After HD melphalanAll
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          28
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        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
          7.92
          value
          58.32
        2. group Id
          BG001
          spread
          8.05
          value
          58.75
        3. group Id
          BG002
          spread
          7.88
          value
          58.54
    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
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
        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
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          39
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice