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NCT01237951 · BASELINE

Baseline characteristics

High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma · Source last updated 2020-05-05

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
      74
    units
    Participants
groups
  1. description
    Patients ages 18-70 with primary refractory or relapsed myeloma, candidates for an autologous SCT (ASCT) who had previously received treatment with bortezomib, an immunomodulatory drug, or both, or who were receiving a salvage ASCT.
    id
    BG000
    title
    Gemcitabine/Busulfan/Melphalan
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.5
          value
          58.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          55
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      1st SCT/salvage SCT
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Poor-risk cytogenetics
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Extramedullary disease
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Double refractory (IMiDs + proteasome inhibitors)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Disease Status: Primary refractory
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Disease Status: Refractory relapse
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Disease Status: Sensitive relapse
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Response at ASCT: Response
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Response at ASCT: Refractory
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      No. prior lines of treatment
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      No. prior lines of treatment > 2
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Post-ASCT maintenance
    param Type
    NUMBER
    title
    Overall study group
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      74
    units
    Participants
groups
  1. description
    Patients ages 18-70 with primary refractory or relapsed myeloma, candidates for an autologous SCT (ASCT) who had previously received treatment with bortezomib, an immunomodulatory drug, or both, or who were receiving a salvage ASCT.
    id
    BG000
    title
    Gemcitabine/Busulfan/Melphalan
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.5
          value
          58.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          55
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      1st SCT/salvage SCT
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Poor-risk cytogenetics
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Extramedullary disease
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Double refractory (IMiDs + proteasome inhibitors)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Disease Status: Primary refractory
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Disease Status: Refractory relapse
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Disease Status: Sensitive relapse
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Response at ASCT: Response
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Response at ASCT: Refractory
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      No. prior lines of treatment
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      No. prior lines of treatment > 2
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Post-ASCT maintenance
    param Type
    NUMBER
    title
    Overall study group
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice