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NCT00321620 · BASELINE

Baseline characteristics

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer · Source last updated 2018-08-29

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
      951
    2. group Id
      BG001
      value
      950
    3. group Id
      BG002
      value
      1901
    units
    Participants
groups
  1. description
    Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
    id
    BG000
    title
    Zoledronic Acid
  2. description
    Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
    id
    BG001
    title
    Denosumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          71.0
        2. group Id
          BG001
          spread
          8.7
          value
          70.5
        3. group Id
          BG002
          spread
          8.6
          value
          70.8
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          951
        2. group Id
          BG001
          value
          950
        3. group Id
          BG002
          value
          1901
        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
          810
        2. group Id
          BG001
          value
          829
        3. group Id
          BG002
          value
          1639
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          102
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          48
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          37
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          290
      title
      PSA level < 10 ng/mL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          806
        2. group Id
          BG001
          value
          805
        3. group Id
          BG002
          value
          1611
      title
      PSA level ≥ 10 ng/mL
    param Type
    NUMBER
    title
    Prostate-Specific Antigen (PSA) Stratification Factor
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          231
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          463
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          720
        2. group Id
          BG001
          value
          718
        3. group Id
          BG002
          value
          1438
      title
      No
    param Type
    NUMBER
    title
    Previous Skeletal-Related Event (SRE) Stratification Factor
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          264
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          819
        2. group Id
          BG001
          value
          818
        3. group Id
          BG002
          value
          1637
      title
      No
    description
    Defined as within 6 weeks before randomization
    param Type
    NUMBER
    title
    Current Prostate Cancer Chemotherapy Stratification Factor
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      951
    2. group Id
      BG001
      value
      950
    3. group Id
      BG002
      value
      1901
    units
    Participants
groups
  1. description
    Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
    id
    BG000
    title
    Zoledronic Acid
  2. description
    Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
    id
    BG001
    title
    Denosumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          71.0
        2. group Id
          BG001
          spread
          8.7
          value
          70.5
        3. group Id
          BG002
          spread
          8.6
          value
          70.8
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          951
        2. group Id
          BG001
          value
          950
        3. group Id
          BG002
          value
          1901
        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
          810
        2. group Id
          BG001
          value
          829
        3. group Id
          BG002
          value
          1639
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          102
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          48
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          37
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          290
      title
      PSA level < 10 ng/mL
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          806
        2. group Id
          BG001
          value
          805
        3. group Id
          BG002
          value
          1611
      title
      PSA level ≥ 10 ng/mL
    param Type
    NUMBER
    title
    Prostate-Specific Antigen (PSA) Stratification Factor
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          231
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          463
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          720
        2. group Id
          BG001
          value
          718
        3. group Id
          BG002
          value
          1438
      title
      No
    param Type
    NUMBER
    title
    Previous Skeletal-Related Event (SRE) Stratification Factor
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          264
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          819
        2. group Id
          BG001
          value
          818
        3. group Id
          BG002
          value
          1637
      title
      No
    description
    Defined as within 6 weeks before randomization
    param Type
    NUMBER
    title
    Current Prostate Cancer Chemotherapy Stratification Factor
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice