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NCT00104650 · BASELINE

Baseline characteristics

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates · Source last updated 2011-01-24

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
      38
    2. group Id
      BG001
      value
      37
    3. group Id
      BG002
      value
      36
    4. group Id
      BG003
      value
      111
    units
    Participants
groups
  1. description
    Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
    id
    BG000
    title
    Denosumab 180 mg Q4W
  2. description
    Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
    id
    BG001
    title
    Bisphosphonate IV Q4W
  3. description
    Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
    id
    BG002
    title
    Denosumab 180 mg Q12W
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.7
          value
          60.6
        2. group Id
          BG001
          spread
          11.7
          value
          61.6
        3. group Id
          BG002
          spread
          12.7
          value
          65.3
        4. group Id
          BG003
          spread
          11.8
          value
          62.5
    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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          55
        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
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          63
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          44
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          46
      title
      Breast cancer
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          50
      title
      Prostate cancer
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
      title
      Mutiple myeloma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
      title
      Other solid tumor
    param Type
    NUMBER
    title
    Cancer Type Stratification Factor
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          147.20
          value
          149.94
        2. group Id
          BG001
          spread
          176.28
          value
          149.88
        3. group Id
          BG002
          spread
          208.87
          value
          175.15
        4. group Id
          BG003
          spread
          177.11
          value
          158.01
    description
    Corrected for urine creatinine (uNTx/Creatinine)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Urinary N-telopeptide (uNTx) Level
    unit Of Measure
    nmol/mmol
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.18
          value
          1.12
        2. group Id
          BG001
          spread
          1.93
          value
          1.40
        3. group Id
          BG002
          spread
          1.27
          value
          1.34
        4. group Id
          BG003
          spread
          1.48
          value
          1.28
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum C-Telopeptide (CTx)
    unit Of Measure
    ng/mL
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      38
    2. group Id
      BG001
      value
      37
    3. group Id
      BG002
      value
      36
    4. group Id
      BG003
      value
      111
    units
    Participants
groups
  1. description
    Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
    id
    BG000
    title
    Denosumab 180 mg Q4W
  2. description
    Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
    id
    BG001
    title
    Bisphosphonate IV Q4W
  3. description
    Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
    id
    BG002
    title
    Denosumab 180 mg Q12W
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.7
          value
          60.6
        2. group Id
          BG001
          spread
          11.7
          value
          61.6
        3. group Id
          BG002
          spread
          12.7
          value
          65.3
        4. group Id
          BG003
          spread
          11.8
          value
          62.5
    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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          55
        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
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          63
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          44
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          46
      title
      Breast cancer
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          50
      title
      Prostate cancer
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
      title
      Mutiple myeloma
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
      title
      Other solid tumor
    param Type
    NUMBER
    title
    Cancer Type Stratification Factor
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          147.20
          value
          149.94
        2. group Id
          BG001
          spread
          176.28
          value
          149.88
        3. group Id
          BG002
          spread
          208.87
          value
          175.15
        4. group Id
          BG003
          spread
          177.11
          value
          158.01
    description
    Corrected for urine creatinine (uNTx/Creatinine)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Urinary N-telopeptide (uNTx) Level
    unit Of Measure
    nmol/mmol
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.18
          value
          1.12
        2. group Id
          BG001
          spread
          1.93
          value
          1.40
        3. group Id
          BG002
          spread
          1.27
          value
          1.34
        4. group Id
          BG003
          spread
          1.48
          value
          1.28
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum C-Telopeptide (CTx)
    unit Of Measure
    ng/mL

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Preserved source evidence · Not medical advice