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NCT01380106 · BASELINE

Baseline characteristics

Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma · Source last updated 2021-01-25

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
      16
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      33
    units
    Participants
groups
  1. description
    Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
    id
    BG000
    title
    Lenalidomide 25mg
  2. description
    Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
    id
    BG001
    title
    Lenalidomide 15mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          .47
          upper Limit
          6.9
          value
          3.12
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6.9
          value
          2.74
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          6.9
          value
          2.93
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    M-protein
    unit Of Measure
    g/dL
population Description
33
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      16
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      33
    units
    Participants
groups
  1. description
    Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
    id
    BG000
    title
    Lenalidomide 25mg
  2. description
    Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
    id
    BG001
    title
    Lenalidomide 15mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          26
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          .47
          upper Limit
          6.9
          value
          3.12
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6.9
          value
          2.74
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          6.9
          value
          2.93
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    M-protein
    unit Of Measure
    g/dL
population Description
33

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Preserved source evidence · Not medical advice