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NCT00079001 · BASELINE

Baseline characteristics

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases · Source last updated 2020-05-12

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
      323
    2. group Id
      BG001
      value
      322
    3. group Id
      BG002
      value
      645
    units
    Participants
groups
  1. description
    4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
    id
    BG000
    title
    Zoledronic Acid + Androgen Deprivation Therapy
  2. description
    Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
    id
    BG001
    title
    Placebo + Androgen Deprivation Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          60.0
          upper Limit
          72.5
          value
          66.1
        2. group Id
          BG001
          lower Limit
          60.2
          upper Limit
          73.6
          value
          66.7
        3. group Id
          BG002
          lower Limit
          60.0
          upper Limit
          73.0
          value
          66.3
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    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
          323
        2. group Id
          BG001
          value
          322
        3. group Id
          BG002
          value
          645
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          92
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          256
        3. group Id
          BG002
          value
          517
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          323
        2. group Id
          BG001
          value
          321
        3. group Id
          BG002
          value
          644
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          205
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          410
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          210
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          25
      title
      2
    description
    Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).
    param Type
    NUMBER
    title
    ECOG Performance Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          82
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          281
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          563
      title
      No
    param Type
    NUMBER
    title
    Prior Skeletal Related Event
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      323
    2. group Id
      BG001
      value
      322
    3. group Id
      BG002
      value
      645
    units
    Participants
groups
  1. description
    4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
    id
    BG000
    title
    Zoledronic Acid + Androgen Deprivation Therapy
  2. description
    Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
    id
    BG001
    title
    Placebo + Androgen Deprivation Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          60.0
          upper Limit
          72.5
          value
          66.1
        2. group Id
          BG001
          lower Limit
          60.2
          upper Limit
          73.6
          value
          66.7
        3. group Id
          BG002
          lower Limit
          60.0
          upper Limit
          73.0
          value
          66.3
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    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
          323
        2. group Id
          BG001
          value
          322
        3. group Id
          BG002
          value
          645
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          92
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          256
        3. group Id
          BG002
          value
          517
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          323
        2. group Id
          BG001
          value
          321
        3. group Id
          BG002
          value
          644
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Canada
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          205
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          410
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          210
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          25
      title
      2
    description
    Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).
    param Type
    NUMBER
    title
    ECOG Performance Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          82
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          281
        2. group Id
          BG001
          value
          282
        3. group Id
          BG002
          value
          563
      title
      No
    param Type
    NUMBER
    title
    Prior Skeletal Related Event
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice