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NCT00896454 · BASELINE

Baseline characteristics

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium · Source last updated 2018-10-17

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
      33
    units
    Participants
groups
  1. description
    Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
    id
    BG000
    title
    Denosumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.8
          value
          60.3
    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
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        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
          23
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          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
          1
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      4
    description
    Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Bladder
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Breast
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Head and neck
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Liver
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Neuroendocrine/carcinoid
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Non-hodgkin's
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Non-small cell lung cancer
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Ovarian
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Renal
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Small cell lung cancer
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Soft tissue sarcoma
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown (primary tumor)
    param Type
    NUMBER
    title
    Primary Tumor Type
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          68.8
          value
          56.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from initial cancer diagnosis to enrollment
    unit Of Measure
    months
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No
    param Type
    NUMBER
    title
    Presence of metastatic disease at enrollment
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      No
    param Type
    NUMBER
    title
    Presence of bone metastatic disease at enrollment
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Fatigue
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Anorexia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Nausea
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Depressed level of consciousness
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Vomiting
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Dry mouth
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Constipation
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Lethargy
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Confusion
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Polyuria
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Abdominal pain
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Decreased mental acuity
    description
    Participants may have had more than one symptom
    param Type
    NUMBER
    title
    Baseline Hypercalcemia of Malignancy (HCM) Symptoms
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.27
          value
          13.89
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Calcium (corrected)
    unit Of Measure
    mg/dL
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      33
    units
    Participants
groups
  1. description
    Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
    id
    BG000
    title
    Denosumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.8
          value
          60.3
    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
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        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
          23
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          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
          1
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      4
    description
    Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Bladder
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Breast
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Head and neck
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Liver
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Neuroendocrine/carcinoid
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Non-hodgkin's
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Non-small cell lung cancer
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Ovarian
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Renal
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Small cell lung cancer
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Soft tissue sarcoma
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown (primary tumor)
    param Type
    NUMBER
    title
    Primary Tumor Type
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          68.8
          value
          56.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from initial cancer diagnosis to enrollment
    unit Of Measure
    months
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No
    param Type
    NUMBER
    title
    Presence of metastatic disease at enrollment
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      No
    param Type
    NUMBER
    title
    Presence of bone metastatic disease at enrollment
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Fatigue
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Anorexia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Nausea
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Depressed level of consciousness
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Vomiting
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Dry mouth
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Constipation
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Lethargy
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Confusion
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Polyuria
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Abdominal pain
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Decreased mental acuity
    description
    Participants may have had more than one symptom
    param Type
    NUMBER
    title
    Baseline Hypercalcemia of Malignancy (HCM) Symptoms
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.27
          value
          13.89
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Calcium (corrected)
    unit Of Measure
    mg/dL

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Preserved source evidence · Not medical advice