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NCT03280264 · BASELINE

Baseline characteristics

Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism · Source last updated 2021-05-27

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
      18
    units
    Participants
groups
  1. description
    KHK7580 was orally administered daily for up to week 52.
    id
    BG000
    title
    KHK7580 (2-24 mg)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.9
          value
          62.2
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        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
          18
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.84
          value
          11.73
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    serum corrected Ca conc.
    unit Of Measure
    mg/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1409.8
          value
          507.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    serum intact Parathyroid Hormone conc.
    unit Of Measure
    pg/mL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
    param Type
    COUNT_OF_PARTICIPANTS
    title
    parathyroid carcinoma
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
    param Type
    NUMBER
    title
    Unable to undergo parathyroidectomy
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
    param Type
    NUMBER
    title
    Relapse after parathyroidectomy
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
    param Type
    NUMBER
    title
    previous cinacalcet use
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
    param Type
    NUMBER
    title
    Pharmacotherapy for primary diseases
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
    param Type
    NUMBER
    title
    parathyroidectomy
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      18
    units
    Participants
groups
  1. description
    KHK7580 was orally administered daily for up to week 52.
    id
    BG000
    title
    KHK7580 (2-24 mg)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.9
          value
          62.2
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        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
          18
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.84
          value
          11.73
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    serum corrected Ca conc.
    unit Of Measure
    mg/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1409.8
          value
          507.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    serum intact Parathyroid Hormone conc.
    unit Of Measure
    pg/mL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
    param Type
    COUNT_OF_PARTICIPANTS
    title
    parathyroid carcinoma
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
    param Type
    NUMBER
    title
    Unable to undergo parathyroidectomy
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
    param Type
    NUMBER
    title
    Relapse after parathyroidectomy
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
    param Type
    NUMBER
    title
    previous cinacalcet use
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
    param Type
    NUMBER
    title
    Pharmacotherapy for primary diseases
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
    param Type
    NUMBER
    title
    parathyroidectomy
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice