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NCT00396279 · BASELINE

Baseline characteristics

Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone · 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
      37
    units
    Participants
groups
  1. description
    Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
    id
    BG000
    title
    Denosumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          33.9
    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
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          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
          27
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Primary unresectable
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Recurrent unresectable
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Recurrent resectable
    param Type
    NUMBER
    title
    Giant Cell Tumor Disease Type
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      0 - Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      1 - Restricted but ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      2 - Ambulatory but unable to work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 - Limited selfcare, confined to bed >50% daytime
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      4 - Completely disabled
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Missing
    description
    0: Fully active, able to carry on all pre-disease performance without restriction; 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.1
          value
          28.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Percent of giant cells in tumor on pre-treatment biopsy
    unit Of Measure
    percentage of giant cells in tumor
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Lower extremities
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Upper extremities
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Pelvis
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Spine
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Pulmonary disease
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Dorsal vertebrae
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Pelvic region
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Location of target lesion
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      37
    units
    Participants
groups
  1. description
    Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
    id
    BG000
    title
    Denosumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          33.9
    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
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          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
          27
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Asian
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Primary unresectable
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Recurrent unresectable
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Recurrent resectable
    param Type
    NUMBER
    title
    Giant Cell Tumor Disease Type
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      0 - Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      1 - Restricted but ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      2 - Ambulatory but unable to work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 - Limited selfcare, confined to bed >50% daytime
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      4 - Completely disabled
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Missing
    description
    0: Fully active, able to carry on all pre-disease performance without restriction; 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.1
          value
          28.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Percent of giant cells in tumor on pre-treatment biopsy
    unit Of Measure
    percentage of giant cells in tumor
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Lower extremities
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Upper extremities
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Pelvis
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Spine
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Pulmonary disease
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Dorsal vertebrae
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Pelvic region
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Location of target lesion
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice