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NCT04401579 · ADVERSE EVENTS

Adverse events

Adaptive COVID-19 Treatment Trial 2 (ACTT-2) · Source last updated 2022-03-14

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
Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Other-event reporting threshold
5%

Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Remdesivir Plus Baricitinib

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.

88 / 507147 / 50724 / 515
Remdesivir Plus Placebo

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.

109 / 509164 / 50937 / 518

Group identifiers: EG000: Remdesivir Plus Baricitinib · EG001: Remdesivir Plus Placebo

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      507
      num Events
      30
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      509
      num Events
      38
    term
    Respiratory failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      507
      num Events
      18
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      509
      num Events
      16
    term
    Acute respiratory failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      507
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      509
      num Events
      11
    term
    Acute kidney injury
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      507
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      509
      num Events
      10
    term
    Acute respiratory distress syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      507
      num Events
      4
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      509
      num Events
      8
    term
    Septic shock
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      507
      num Events
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      509
      num Events
      5
    term
    Hypotension
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      507
      num Events
      8
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      509
      num Events
      7
    term
    Respiratory distress
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      507
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      509
      num Events
      8
    term
    Pneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      507
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      509
      num Events
      6
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      507
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      509
      num Events
      1
    term
    Pulmonary embolism
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      507
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      509
      num Events
      4
    term
    Hypoxia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      507
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      509
      num Events
      4
    term
    Shock

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      507
      num Events
      52
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      509
      num Events
      46
    term
    Glomerular filtration rate decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      507
      num Events
      34
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      509
      num Events
      47
    term
    Hyperglycaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      507
      num Events
      32
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      509
      num Events
      32
    term
    Haemoglobin decreased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      507
      num Events
      28
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      509
      num Events
      36
    term
    Lymphocyte count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      507
      num Events
      28
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      509
      num Events
      40
    term
    Anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      507
      num Events
      26
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      509
      num Events
      28
    term
    Blood glucose increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      507
      num Events
      17
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      509
      num Events
      28
    term
    Acute kidney injury
Complete source fields
description
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
event Groups
  1. deaths Num Affected
    24
    deaths Num At Risk
    515
    description
    200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
    id
    EG000
    other Num Affected
    147
    other Num At Risk
    507
    serious Num Affected
    88
    serious Num At Risk
    507
    title
    Remdesivir Plus Baricitinib
  2. deaths Num Affected
    37
    deaths Num At Risk
    518
    description
    200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
    id
    EG001
    other Num Affected
    164
    other Num At Risk
    509
    serious Num Affected
    109
    serious Num At Risk
    509
    title
    Remdesivir Plus Placebo
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      507
      num Events
      52
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      509
      num Events
      46
    term
    Glomerular filtration rate decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      507
      num Events
      34
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      509
      num Events
      47
    term
    Hyperglycaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      507
      num Events
      32
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      509
      num Events
      32
    term
    Haemoglobin decreased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      507
      num Events
      28
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      509
      num Events
      36
    term
    Lymphocyte count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      507
      num Events
      28
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      509
      num Events
      40
    term
    Anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      507
      num Events
      26
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      509
      num Events
      28
    term
    Blood glucose increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      507
      num Events
      17
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      509
      num Events
      28
    term
    Acute kidney injury
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      507
      num Events
      30
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      509
      num Events
      38
    term
    Respiratory failure
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      507
      num Events
      18
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      509
      num Events
      16
    term
    Acute respiratory failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      507
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      509
      num Events
      11
    term
    Acute kidney injury
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      507
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      509
      num Events
      10
    term
    Acute respiratory distress syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      507
      num Events
      4
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      509
      num Events
      8
    term
    Septic shock
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      507
      num Events
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      509
      num Events
      5
    term
    Hypotension
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      507
      num Events
      8
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      509
      num Events
      7
    term
    Respiratory distress
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      507
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      509
      num Events
      8
    term
    Pneumonia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      507
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      509
      num Events
      6
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      507
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      509
      num Events
      1
    term
    Pulmonary embolism
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      507
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      509
      num Events
      4
    term
    Hypoxia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      507
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      509
      num Events
      4
    term
    Shock
time Frame
Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.

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