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NCT02804750 · FLOW

Participant flow

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.

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. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
    id
    FG000
    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. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    id
    FG001
    title
    Group 2: High-dose Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Period 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 2
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        13
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Period 3
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    milestones
    1. achievements
      1. comment
        Per-protocol, Group 1 did not participate in Period 4.
        group Id
        FG000
        num Subjects
        0
      2. comment
        One participant completed Period 3 but did not start Period 4 due to a pre-scheduled surgery.
        group Id
        FG001
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Period 4
recruitment Details
All enrolled participants who received at least 1 dose of study drug
Complete source fields
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. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
    id
    FG000
    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. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
    id
    FG001
    title
    Group 2: High-dose Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        18
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Period 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 2
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        15
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        13
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Period 3
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    milestones
    1. achievements
      1. comment
        Per-protocol, Group 1 did not participate in Period 4.
        group Id
        FG000
        num Subjects
        0
      2. comment
        One participant completed Period 3 but did not start Period 4 due to a pre-scheduled surgery.
        group Id
        FG001
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Period 4
recruitment Details
All enrolled participants who received at least 1 dose of study drug

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Preserved source evidence · Not medical advice