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NCT01159574 · BASELINE

Baseline characteristics

Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma · Source last updated 2019-06-11

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
      120
    units
    Participants
groups
  1. description
    ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day. dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
    id
    BG000
    title
    All Patients
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          87
          value
          63
    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
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          58
        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
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          112
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        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
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          93
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          7
        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
          lower Limit
          6.4
          upper Limit
          14.6
          value
          10.4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Hemoglobin
    unit Of Measure
    g/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          15
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Range of Prior Therapies
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.2
          upper Limit
          40.4
          value
          35
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 microglobulin at baseline (in mg/L)
    unit Of Measure
    mg/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          79
          upper Limit
          1353
          value
          170.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    lactage dehydrogenase at baseline (U/L)
    unit Of Measure
    u/l
population Description
121 subject signed consent; 1 subject was not considered to be evaluable and was not included in any analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      120
    units
    Participants
groups
  1. description
    ClaPd therapy: Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day. dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
    id
    BG000
    title
    All Patients
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          87
          value
          63
    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
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          58
        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
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          112
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        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
          8
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          93
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          7
        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
          lower Limit
          6.4
          upper Limit
          14.6
          value
          10.4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Hemoglobin
    unit Of Measure
    g/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          15
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Range of Prior Therapies
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.2
          upper Limit
          40.4
          value
          35
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 microglobulin at baseline (in mg/L)
    unit Of Measure
    mg/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          79
          upper Limit
          1353
          value
          170.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    lactage dehydrogenase at baseline (U/L)
    unit Of Measure
    u/l
population Description
121 subject signed consent; 1 subject was not considered to be evaluable and was not included in any analysis.

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

Preserved source evidence · Not medical advice