Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00461045 · BASELINE

Baseline characteristics

Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2017-12-19

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
      15
    units
    Participants
groups
  1. description
    Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    id
    BG000
    title
    MRZ 0.5 mg/m^2
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.02
          value
          61.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.152
          value
          170.97
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.825
          value
          77.27
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2629
          value
          1.893
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Potential able to bear children
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Surgically sterile
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Post menopausal
      4. measurements
        1. group Id
          BG000
          value
          10
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Fertility Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          70.0
          upper Limit
          100.0
          value
          87.3
    description
    KPS Score: 100=Normal, no complaints; 90=Able to carry on normal activity, minor signs or symptoms of disease; 80=Normal activity with effort; 70= Unable to carry on normal activity or perform active work, cares for self.
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Karnofsky Performance Status (KPS) Score
    unit Of Measure
    KPS Score
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.79
          value
          5.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Initial Diagnosis
    unit Of Measure
    years
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      1 Relapse
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      2 Relapses
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      3 Relapses
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      >3 Relapses
    param Type
    NUMBER
    title
    Number of Relapses
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    units
    Participants
groups
  1. description
    Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    id
    BG000
    title
    MRZ 0.5 mg/m^2
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.02
          value
          61.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.152
          value
          170.97
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.825
          value
          77.27
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2629
          value
          1.893
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Potential able to bear children
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Surgically sterile
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Post menopausal
      4. measurements
        1. group Id
          BG000
          value
          10
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Fertility Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          70.0
          upper Limit
          100.0
          value
          87.3
    description
    KPS Score: 100=Normal, no complaints; 90=Able to carry on normal activity, minor signs or symptoms of disease; 80=Normal activity with effort; 70= Unable to carry on normal activity or perform active work, cares for self.
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Karnofsky Performance Status (KPS) Score
    unit Of Measure
    KPS Score
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.79
          value
          5.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Initial Diagnosis
    unit Of Measure
    years
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      1 Relapse
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      2 Relapses
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      3 Relapses
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      >3 Relapses
    param Type
    NUMBER
    title
    Number of Relapses
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice