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NCT00321464 · BASELINE

Baseline characteristics

A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects. · Source last updated 2022-11-08

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
      1020
    2. group Id
      BG001
      value
      1026
    3. group Id
      BG002
      value
      2046
    units
    Participants
groups
  1. description
    Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
    id
    BG000
    title
    Zoledronic Acid
  2. description
    Denomsumab 120 mg subcutaneously with 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
          11.6
          value
          56.6
        2. group Id
          BG001
          spread
          11.5
          value
          56.8
        3. group Id
          BG002
          spread
          11.5
          value
          56.7
    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
          1011
        2. group Id
          BG001
          value
          1018
        3. group Id
          BG002
          value
          2029
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        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
          813
        2. group Id
          BG001
          value
          822
        3. group Id
          BG002
          value
          1635
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          118
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          69
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
      title
      Japanese
    6. 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
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          32
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          373
        2. group Id
          BG001
          value
          378
        3. group Id
          BG002
          value
          751
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          647
        2. group Id
          BG001
          value
          648
        3. group Id
          BG002
          value
          1295
      title
      No
    param Type
    NUMBER
    title
    Previous Skeletal-Related Event Stratification Factor
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          80
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          982
        2. group Id
          BG001
          value
          984
        3. group Id
          BG002
          value
          1966
      title
      No
    param Type
    NUMBER
    title
    Prior Oral Bisphosphonate Use Stratification Factor
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          408
        2. group Id
          BG001
          value
          410
        3. group Id
          BG002
          value
          818
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          612
        2. group Id
          BG001
          value
          616
        3. group Id
          BG002
          value
          1228
      title
      No
    description
    Defined as within 6 weeks before randomization
    param Type
    NUMBER
    title
    Current Chemotherapy Stratification Factor
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          136
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          953
        2. group Id
          BG001
          value
          957
        3. group Id
          BG002
          value
          1910
      title
      No
    description
    Participant located in Japan
    param Type
    NUMBER
    title
    Japan Stratification Factor
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1020
    2. group Id
      BG001
      value
      1026
    3. group Id
      BG002
      value
      2046
    units
    Participants
groups
  1. description
    Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
    id
    BG000
    title
    Zoledronic Acid
  2. description
    Denomsumab 120 mg subcutaneously with 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
          11.6
          value
          56.6
        2. group Id
          BG001
          spread
          11.5
          value
          56.8
        3. group Id
          BG002
          spread
          11.5
          value
          56.7
    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
          1011
        2. group Id
          BG001
          value
          1018
        3. group Id
          BG002
          value
          2029
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
        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
          813
        2. group Id
          BG001
          value
          822
        3. group Id
          BG002
          value
          1635
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          118
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          69
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
      title
      Japanese
    6. 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
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          32
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          373
        2. group Id
          BG001
          value
          378
        3. group Id
          BG002
          value
          751
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          647
        2. group Id
          BG001
          value
          648
        3. group Id
          BG002
          value
          1295
      title
      No
    param Type
    NUMBER
    title
    Previous Skeletal-Related Event Stratification Factor
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          80
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          982
        2. group Id
          BG001
          value
          984
        3. group Id
          BG002
          value
          1966
      title
      No
    param Type
    NUMBER
    title
    Prior Oral Bisphosphonate Use Stratification Factor
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          408
        2. group Id
          BG001
          value
          410
        3. group Id
          BG002
          value
          818
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          612
        2. group Id
          BG001
          value
          616
        3. group Id
          BG002
          value
          1228
      title
      No
    description
    Defined as within 6 weeks before randomization
    param Type
    NUMBER
    title
    Current Chemotherapy Stratification Factor
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          136
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          953
        2. group Id
          BG001
          value
          957
        3. group Id
          BG002
          value
          1910
      title
      No
    description
    Participant located in Japan
    param Type
    NUMBER
    title
    Japan Stratification Factor
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice