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NCT04421027 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Other-event reporting threshold
5%

All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Placebo tablets administered orally every day (QD) with standard of care.

135 / 7520 / 752104 / 752
4 Milligrams (mg) Baricitinib

4 milligrams (mg) baricitinib administered orally QD with standard of care.

110 / 7500 / 75065 / 750
Placebo Follow-up

Participants did not receive drug during the Follow-Up Period.

12 / 6130 / 61316 / 613
4mg Baricitinib Follow-up

Participants did not receive drug during the Follow-Up Period.

18 / 6450 / 64518 / 645

Group identifiers: EG000: Placebo · EG001: 4 Milligrams (mg) Baricitinib · EG002: Placebo Follow-up · EG003: 4mg Baricitinib Follow-up

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      752
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      750
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      750
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      752
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      750
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      750
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      750
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      750
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      750
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      750
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      752
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      750
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      613
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      752
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      750
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      613
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      645
      num Events
      1
    term
    Cardio-respiratory arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      750
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Cardiogenic shock
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      752
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      750
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      613
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      645
      num Events
      0
    term
    Cardiopulmonary failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    description
    All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
    event Groups
    1. deaths Num Affected
      104
      deaths Num At Risk
      752
      description
      Placebo tablets administered orally every day (QD) with standard of care.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      752
      serious Num Affected
      135
      serious Num At Risk
      752
      title
      Placebo
    2. deaths Num Affected
      65
      deaths Num At Risk
      750
      description
      4 milligrams (mg) baricitinib administered orally QD with standard of care.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      750
      serious Num Affected
      110
      serious Num At Risk
      750
      title
      4 Milligrams (mg) Baricitinib
    3. deaths Num Affected
      16
      deaths Num At Risk
      613
      description
      Participants did not receive drug during the Follow-Up Period.
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      613
      serious Num Affected
      12
      serious Num At Risk
      613
      title
      Placebo Follow-up
    4. deaths Num Affected
      18
      deaths Num At Risk
      645
      description
      Participants did not receive drug during the Follow-Up Period.
      id
      EG003
      other Num Affected
      0
      other Num At Risk
      645
      serious Num Affected
      18
      serious Num At Risk
      645
      title
      4mg Baricitinib Follow-up
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        752
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        750
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Anaemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        750
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Disseminated intravascular coagulation
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        752
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        750
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Lymphopenia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        750
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Thrombocytopenia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        750
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Acute coronary syndrome
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        750
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Acute myocardial infarction
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        750
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Atrial fibrillation
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        750
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Bradycardia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        752
        num Events
        3
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        750
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        613
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Cardiac arrest
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        752
        num Events
        6
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        750
        num Events
        3
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        613
        num Events
        1
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        645
        num Events
        1
      term
      Cardio-respiratory arrest
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        750
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Cardiogenic shock
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      MedDRA 24.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        752
        num Events
        1
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        750
        num Events
        2
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        613
        num Events
        0
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        645
        num Events
        0
      term
      Cardiopulmonary failure
    time Frame
    Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

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