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NCT02804750 · BASELINE

Baseline characteristics

Study to Evaluate CORT125134 in Participants With Cushing's Syndrome · Source last updated 2019-10-15

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
      17
    2. group Id
      BG001
      value
      18
    3. group Id
      BG002
      value
      35
    units
    Participants
groups
  1. description
    100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
    id
    BG000
    title
    Group 1: Low-dose Group
  2. description
    250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
    id
    BG001
    title
    Group 2: High-dose Group
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.62
          value
          47.6
        2. group Id
          BG001
          spread
          13.46
          value
          49.5
        3. group Id
          BG002
          spread
          13.37
          value
          48.6
    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
          9
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          32
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          35
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. 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
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Netherlands
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      Italy
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      United Kingdom
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
    description
    Confirmed with a mean systolic blood pressure (BP) of 130-170 mmHg and/or a mean diastolic BP of 85-110 mmHg based on the 24-hour ambulatory BP measurement.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertension
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          28
    description
    Either a fasting glucose \> 126 mg/dL and a 2-hour Oral Glucose Tolerance Test (oGTT) result for plasma glucose ≥ 200 mg/dL at 2 hours (for T2DM), or a 2-hour oGTT result for plasma glucose in the range of ≥ 140 mg/dL to \< 200 mg/dL (for IGT).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Impaired Glucose Tolerance (IGT) / Type-2 Diabetes Mellitus (T2DM)
    unit Of Measure
    Participants
population Description
All enrolled participants who received at least 1 dose of study drug
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      17
    2. group Id
      BG001
      value
      18
    3. group Id
      BG002
      value
      35
    units
    Participants
groups
  1. description
    100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
    id
    BG000
    title
    Group 1: Low-dose Group
  2. description
    250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
    id
    BG001
    title
    Group 2: High-dose Group
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.62
          value
          47.6
        2. group Id
          BG001
          spread
          13.46
          value
          49.5
        3. group Id
          BG002
          spread
          13.37
          value
          48.6
    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
          9
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          32
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          35
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. 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
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Netherlands
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          12
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      Italy
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      United Kingdom
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
    description
    Confirmed with a mean systolic blood pressure (BP) of 130-170 mmHg and/or a mean diastolic BP of 85-110 mmHg based on the 24-hour ambulatory BP measurement.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertension
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          28
    description
    Either a fasting glucose \> 126 mg/dL and a 2-hour Oral Glucose Tolerance Test (oGTT) result for plasma glucose ≥ 200 mg/dL at 2 hours (for T2DM), or a 2-hour oGTT result for plasma glucose in the range of ≥ 140 mg/dL to \< 200 mg/dL (for IGT).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Impaired Glucose Tolerance (IGT) / Type-2 Diabetes Mellitus (T2DM)
    unit Of Measure
    Participants
population Description
All enrolled participants who received at least 1 dose of study drug

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