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NCT00104104 · BASELINE

Baseline characteristics

A Multiple Myeloma Trial in Patients With Bone Metastases · Source last updated 2011-06-29

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
      88
    2. group Id
      BG001
      value
      88
    3. group Id
      BG002
      value
      176
    units
    Participants
groups
  1. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
    id
    BG000
    title
    15 - Minute Infusion
  2. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
    id
    BG001
    title
    30 - Minute Infusion
  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
          39
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          86
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          90
        title
        >=65 years
    description
    Demographic data is provided for the entire Safety Population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.95
          value
          64.3
        2. group Id
          BG001
          spread
          11.54
          value
          64.0
        3. group Id
          BG002
          spread
          11.7
          value
          64.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          71
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          105
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          139
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          22
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          176
      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
          24.3
          value
          12.5
        2. group Id
          BG001
          spread
          14.1
          value
          9.7
        3. group Id
          BG002
          spread
          19.8
          value
          11.1
    description
    This baseline measurement was based on n=86, 87.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time since diagnosis
    unit Of Measure
    months
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          32.6
          value
          87.3
        2. group Id
          BG001
          spread
          39.5
          value
          89.3
        3. group Id
          BG002
          spread
          36.1
          value
          88.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Calculated creatinine clearance
    unit Of Measure
    mL/min
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      88
    2. group Id
      BG001
      value
      88
    3. group Id
      BG002
      value
      176
    units
    Participants
groups
  1. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
    id
    BG000
    title
    15 - Minute Infusion
  2. description
    Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
    id
    BG001
    title
    30 - Minute Infusion
  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
          39
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          86
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          90
        title
        >=65 years
    description
    Demographic data is provided for the entire Safety Population.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.95
          value
          64.3
        2. group Id
          BG001
          spread
          11.54
          value
          64.0
        3. group Id
          BG002
          spread
          11.7
          value
          64.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          71
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          105
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          139
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          22
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          176
      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
          24.3
          value
          12.5
        2. group Id
          BG001
          spread
          14.1
          value
          9.7
        3. group Id
          BG002
          spread
          19.8
          value
          11.1
    description
    This baseline measurement was based on n=86, 87.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time since diagnosis
    unit Of Measure
    months
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          32.6
          value
          87.3
        2. group Id
          BG001
          spread
          39.5
          value
          89.3
        3. group Id
          BG002
          spread
          36.1
          value
          88.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Calculated creatinine clearance
    unit Of Measure
    mL/min

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Preserved source evidence · Not medical advice