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NCT02234115 · BASELINE

Baseline characteristics

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma · Source last updated 2019-03-05

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
      137
    units
    Participants
groups
  1. description
    All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
    id
    BG000
    title
    Leuprolide Mesylate 50mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.70
          value
          71.1
    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
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          137
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          73
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          123
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Austria
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Czechia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Taiwan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Slovakia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      title
      Lithuania
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Germany
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      137
    units
    Participants
groups
  1. description
    All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
    id
    BG000
    title
    Leuprolide Mesylate 50mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.70
          value
          71.1
    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
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          137
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          73
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          123
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Austria
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Czechia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Taiwan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Slovakia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          29
      title
      Lithuania
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Germany
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice