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NCT00432458 · BASELINE

Baseline characteristics

Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma · Source last updated 2012-07-04

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
      35
    2. group Id
      BG001
      value
      33
    3. group Id
      BG002
      value
      68
    units
    Participants
groups
  1. description
    Thalidomide (Thal) + Zolendronic acid (ZLD)
    id
    BG000
    title
    Arm I: Thal/ZLD
  2. description
    Zoledronic acid (ZLD)
    id
    BG001
    title
    Arm II: ZLD
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          84
          value
          63
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          80
          value
          63
        3. group Id
          BG002
          lower Limit
          47
          upper Limit
          84
          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
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          41
        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
          35
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          68
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          55
      title
      High (> upper limit of normal)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      title
      Normal (<= upper limit of normal)
    description
    The upper limit of normal for Beta-2 microglobulin was 1.80 mcg/mL.
    param Type
    NUMBER
    title
    Beta-2 Microglobulin
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Present
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          64
      title
      Not Present
    param Type
    NUMBER
    title
    Lytic Bone Lesions
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      High (> 1.0%)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          61
      title
      Low (<= 1.0%)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Not Applicable
    description
    The labeling index indicates how fast the cancer cells are growing. This test is done in specialized labs, using myeloma cells from bone marrow samples. A high labeling index can predict a more rapid accumulation of cancer cells and a worse outlook.
    param Type
    NUMBER
    title
    Bone Marrow Labeling Index
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          32
      title
      < lower limit of normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          36
      title
      >= lower limit of normal
    description
    The lower limit of normal (LLN) is institution specific, typically about 13.5 g/dL for males and 12.0 g/dL for females.
    param Type
    NUMBER
    title
    Anemia
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Not Applicable
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Not Done
    description
    Peripheral blood circulating plasma cells are cells which live outside of the bone marrow.
    param Type
    NUMBER
    title
    Peripheral blood circulating plasma cells
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      35
    2. group Id
      BG001
      value
      33
    3. group Id
      BG002
      value
      68
    units
    Participants
groups
  1. description
    Thalidomide (Thal) + Zolendronic acid (ZLD)
    id
    BG000
    title
    Arm I: Thal/ZLD
  2. description
    Zoledronic acid (ZLD)
    id
    BG001
    title
    Arm II: ZLD
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          84
          value
          63
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          80
          value
          63
        3. group Id
          BG002
          lower Limit
          47
          upper Limit
          84
          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
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          41
        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
          35
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          68
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          55
      title
      High (> upper limit of normal)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      title
      Normal (<= upper limit of normal)
    description
    The upper limit of normal for Beta-2 microglobulin was 1.80 mcg/mL.
    param Type
    NUMBER
    title
    Beta-2 Microglobulin
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      Present
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          64
      title
      Not Present
    param Type
    NUMBER
    title
    Lytic Bone Lesions
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      High (> 1.0%)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          61
      title
      Low (<= 1.0%)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Not Applicable
    description
    The labeling index indicates how fast the cancer cells are growing. This test is done in specialized labs, using myeloma cells from bone marrow samples. A high labeling index can predict a more rapid accumulation of cancer cells and a worse outlook.
    param Type
    NUMBER
    title
    Bone Marrow Labeling Index
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          32
      title
      < lower limit of normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          36
      title
      >= lower limit of normal
    description
    The lower limit of normal (LLN) is institution specific, typically about 13.5 g/dL for males and 12.0 g/dL for females.
    param Type
    NUMBER
    title
    Anemia
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Not Applicable
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Not Done
    description
    Peripheral blood circulating plasma cells are cells which live outside of the bone marrow.
    param Type
    NUMBER
    title
    Peripheral blood circulating plasma cells
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice