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NCT00948922 · BASELINE

Baseline characteristics

Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma · Source last updated 2019-09-18

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
      34
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      124
    units
    Participants
groups
  1. description
    Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
    id
    BG000
    title
    A: Allogeneic Stem Cell Transplant
  2. description
    Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
    id
    BG001
    title
    B: Autologous Stem Cell Transplant
  3. description
    Group B Expansion on Bortezomib Maintenance: Autologous Only.
    id
    BG002
    title
    BE: Group B Expansion
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          76
          value
          53.5
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          79
          value
          62
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          78
          value
          62
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          79
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          19
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          104
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          102
        title
        White
      6. 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
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          124
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Baseline: All participants enrolled on study. Adverse Events: All participants who received study treatment. Outcome Measures: All participants evaluable at time of analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      34
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      124
    units
    Participants
groups
  1. description
    Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
    id
    BG000
    title
    A: Allogeneic Stem Cell Transplant
  2. description
    Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
    id
    BG001
    title
    B: Autologous Stem Cell Transplant
  3. description
    Group B Expansion on Bortezomib Maintenance: Autologous Only.
    id
    BG002
    title
    BE: Group B Expansion
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          76
          value
          53.5
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          79
          value
          62
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          78
          value
          62
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          79
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          19
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          104
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          102
        title
        White
      6. 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
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          124
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Baseline: All participants enrolled on study. Adverse Events: All participants who received study treatment. Outcome Measures: All participants evaluable at time of analysis.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice