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NCT01721044 · ADVERSE EVENTS

Adverse events

A Moderate to Severe Rheumatoid Arthritis Study · Source last updated 2019-09-18

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
Not reported
Other-event reporting threshold
2%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo -Treatment Period

Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

14 / 17679 / 176Not reported / Not reported
Baricitinib 2 mg - Treatment Period

Baricitinib 2mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

8 / 174105 / 174Not reported / Not reported
Baricitinib 4 mg - Treatment Period

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

19 / 177102 / 177Not reported / Not reported
Rescue Period

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

2 / 1276 / 127Not reported / Not reported
Placebo - Follow Up Period

No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.

1 / 192 / 19Not reported / Not reported
Baricitinib 2 mg - Follow Up Period

No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.

1 / 94 / 9Not reported / Not reported
Baricitinib 4 mg - Follow Up Period

No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.

0 / 201 / 20Not reported / Not reported

Group identifiers: EG000: Placebo -Treatment Period · EG001: Baricitinib 2 mg - Treatment Period · EG002: Baricitinib 4 mg - Treatment Period · EG003: Rescue Period · EG004: Placebo - Follow Up Period · EG005: Baricitinib 2 mg - Follow Up Period · EG006: Baricitinib 4 mg - Follow Up Period

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 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Haemorrhagic anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      177
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Motion sickness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Vertigo positional
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diverticulum intestinal haemorrhagic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Inguinal hernia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      174
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Oral disorder

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      174
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Episcleritis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      174
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      174
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      174
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      176
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      174
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      177
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      174
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      174
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      177
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      176
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      174
      num Events
      9
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      177
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      174
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      176
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      174
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Fatigue
Complete source fields
event Groups
  1. description
    Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    EG000
    other Num Affected
    79
    other Num At Risk
    176
    serious Num Affected
    14
    serious Num At Risk
    176
    title
    Placebo -Treatment Period
  2. description
    Baricitinib 2mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    174
    serious Num Affected
    8
    serious Num At Risk
    174
    title
    Baricitinib 2 mg - Treatment Period
  3. description
    Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    EG002
    other Num Affected
    102
    other Num At Risk
    177
    serious Num Affected
    19
    serious Num At Risk
    177
    title
    Baricitinib 4 mg - Treatment Period
  4. description
    Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    127
    serious Num Affected
    2
    serious Num At Risk
    127
    title
    Rescue Period
  5. description
    No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    19
    serious Num Affected
    1
    serious Num At Risk
    19
    title
    Placebo - Follow Up Period
  6. description
    No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    9
    serious Num Affected
    1
    serious Num At Risk
    9
    title
    Baricitinib 2 mg - Follow Up Period
  7. description
    No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    20
    serious Num Affected
    0
    serious Num At Risk
    20
    title
    Baricitinib 4 mg - Follow Up Period
frequency Threshold
2
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      174
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      19
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Episcleritis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      174
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      174
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      174
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      176
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      174
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      177
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      174
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      176
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      174
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      177
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      176
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      174
      num Events
      9
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      177
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      176
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      174
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      176
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      174
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Haemorrhagic anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      177
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      176
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Motion sickness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Vertigo positional
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Diverticulum intestinal haemorrhagic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      174
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Inguinal hernia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      176
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      174
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      127
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      19
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    Oral disorder

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Preserved source evidence · Not medical advice