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NCT00784823 · BASELINE

Baseline characteristics

Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma · Source last updated 2022-08-11

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
      6
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      32
    units
    Participants
groups
  1. description
    Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG000
    title
    Phase I Cohort - Bortezomib Dose 1 mg/m2
  2. description
    Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG001
    title
    Phase I Cohort - Bortezomib 1.3 mg/m2
  3. description
    Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG002
    title
    Phase I Cohort - Bortezomib 1.6 mg/m2
  4. description
    Bortezomib 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG003
    title
    Phase II Cohort
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          65
          value
          57
        2. group Id
          BG001
          lower Limit
          55
          upper Limit
          65
          value
          63
        3. group Id
          BG002
          lower Limit
          49
          upper Limit
          61
          value
          58
        4. group Id
          BG003
          lower Limit
          52
          upper Limit
          71
          value
          57
        5. group Id
          BG004
          lower Limit
          49
          upper Limit
          71
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          15
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG004
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
        units
        Participants
      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
      6
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      32
    units
    Participants
groups
  1. description
    Bortezomib at 1 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG000
    title
    Phase I Cohort - Bortezomib Dose 1 mg/m2
  2. description
    Bortezomib at 1.3 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG001
    title
    Phase I Cohort - Bortezomib 1.3 mg/m2
  3. description
    Bortezomib at 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG002
    title
    Phase I Cohort - Bortezomib 1.6 mg/m2
  4. description
    Bortezomib 1.6 mg/m2 on days -4 and -1 before transplantation with melphalan 200 mg/m2 given on day -2.
    id
    BG003
    title
    Phase II Cohort
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          65
          value
          57
        2. group Id
          BG001
          lower Limit
          55
          upper Limit
          65
          value
          63
        3. group Id
          BG002
          lower Limit
          49
          upper Limit
          61
          value
          58
        4. group Id
          BG003
          lower Limit
          52
          upper Limit
          71
          value
          57
        5. group Id
          BG004
          lower Limit
          49
          upper Limit
          71
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          15
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG004
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          32
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice