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NCT04421027 · FLOW

Participant flow

A Study of Baricitinib (LY3009104) in Participants With COVID-19 · Source last updated 2022-07-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Placebo tablets administered orally every day (QD) with standard of care.
    id
    FG000
    title
    Placebo + Standard of Care (SOC)
  2. description
    4 milligrams (mg) baricitinib administered orally QD with standard of care.
    id
    FG001
    title
    Baricitinib + SOC
  3. description
    Participants did not receive drug during the Follow-Up Period.
    id
    FG002
    title
    Placebo + SOC Follow-Up
  4. description
    Participants did not receive drug during the Follow-Up Period.
    id
    FG003
    title
    Baricitinib + SOC Follow-Up
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        98
      2. group Id
        FG001
        num Subjects
        61
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other-Unknown
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized Not Dosed
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        761
      2. group Id
        FG001
        num Subjects
        764
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        752
      2. group Id
        FG001
        num Subjects
        750
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        604
      2. group Id
        FG001
        num Subjects
        644
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        157
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        17
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        7
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Deviation
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Still in hospital on ventilator at end of study
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Left message, participant did not call back
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant died
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant was alive but did not respond to calls
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        613
      4. group Id
        FG003
        num Subjects
        645
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        588
      4. comment
        One participants study disposition case report form was not completed, therefore the participant appeared as 'ongoing' at Day 60. The participant completed Day 60 Clinical Status Assessment (CSA) and is considered as completing the study.
        group Id
        FG003
        num Subjects
        615
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Follow-Up Period
Complete source fields
groups
  1. description
    Placebo tablets administered orally every day (QD) with standard of care.
    id
    FG000
    title
    Placebo + Standard of Care (SOC)
  2. description
    4 milligrams (mg) baricitinib administered orally QD with standard of care.
    id
    FG001
    title
    Baricitinib + SOC
  3. description
    Participants did not receive drug during the Follow-Up Period.
    id
    FG002
    title
    Placebo + SOC Follow-Up
  4. description
    Participants did not receive drug during the Follow-Up Period.
    id
    FG003
    title
    Baricitinib + SOC Follow-Up
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        98
      2. group Id
        FG001
        num Subjects
        61
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Other-Unknown
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized Not Dosed
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        761
      2. group Id
        FG001
        num Subjects
        764
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        752
      2. group Id
        FG001
        num Subjects
        750
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        604
      2. group Id
        FG001
        num Subjects
        644
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        157
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        17
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        7
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Deviation
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Still in hospital on ventilator at end of study
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Left message, participant did not call back
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant died
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant was alive but did not respond to calls
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        613
      4. group Id
        FG003
        num Subjects
        645
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        588
      4. comment
        One participants study disposition case report form was not completed, therefore the participant appeared as 'ongoing' at Day 60. The participant completed Day 60 Clinical Status Assessment (CSA) and is considered as completing the study.
        group Id
        FG003
        num Subjects
        615
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        30
      type
      NOT COMPLETED
    title
    Follow-Up Period

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Preserved source evidence · Not medical advice