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NCT03301857 · BASELINE

Baseline characteristics

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004 · Source last updated 2024-05-20

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
      51
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      85
    units
    Participants
groups
  1. description
    Participants who received denosumab at the conclusion of study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
    id
    BG000
    title
    Exposed to IP
  2. description
    Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
    id
    BG001
    title
    Not Exposed to IP
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.8
          value
          42.4
        2. group Id
          BG001
          spread
          15.1
          value
          46.7
        3. group Id
          BG002
          spread
          13.9
          value
          44.1
    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
          32
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          55
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          30
        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
          13
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          62
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
      title
      Other
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Black (or African American)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Asian
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      51
    2. group Id
      BG001
      value
      34
    3. group Id
      BG002
      value
      85
    units
    Participants
groups
  1. description
    Participants who received denosumab at the conclusion of study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
    id
    BG000
    title
    Exposed to IP
  2. description
    Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
    id
    BG001
    title
    Not Exposed to IP
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.8
          value
          42.4
        2. group Id
          BG001
          spread
          15.1
          value
          46.7
        3. group Id
          BG002
          spread
          13.9
          value
          44.1
    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
          32
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          55
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          30
        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
          13
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          62
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
      title
      Other
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      Black (or African American)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Asian
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.

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

Preserved source evidence · Not medical advice