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NCT03570749 · ADVERSE EVENTS

Adverse events

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata · Source last updated 2026-04-16

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
Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
Other-event reporting threshold
5%

(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo Phase 2

\- Week 0 to Week 200: Participants received three placebo tablets administered orally QD.

0 / 2812 / 280 / 28
2 mg Baricitinib Phase 2

\- Week 0 to Week 200: Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.

0 / 2721 / 270 / 27
4 mg Baricitinib Phase 2

\- Week 0 to Week 200: Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.

2 / 2719 / 270 / 27
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg)

Participants who received Baricitinib in any of the three treatment arms \[1 mg/4 mg arm (1 mg until Week 12, then 4 mg until Week 200), 2 mg arm, or 4 mg arm\], plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 200) of Phase 2 were grouped in this arm.

3 / 10679 / 1060 / 106
Placebo Phase 3

* Week 0 to Week 52: Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same placebo or switched to either 2 mg or 4 mg Baricitinib dose administered orally QD (Period 2).

3 / 18937 / 1890 / 189
2 mg Baricitinib Phase 3

* Week 0 to Week 52: Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 2 mg dose or switched to an uptitrated 4 mg Baricitinib dose administered orally QD (Period 2).

7 / 18358 / 1830 / 183
4 mg Baricitinib Phase 3

* Week 0 to Week 52: Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 4 mg dose or switched to a downtitrated 2 mg Baricitinib dose, or receive placebo tablets matched to Baricitinib administered orally QD (Period 2).

16 / 280126 / 2800 / 280
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg)

Participants who received Baricitinib in any of 2 mg arm or the 4 mg arm, plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 248) of Phase 3 were grouped in this arm.

40 / 619275 / 6190 / 619
4 mg Baricitinib Phase 3 Open-Label Addendum

Week 0 to Week 52: Participants who received one 4 mg Baricitinib tablet administered orally QD.

1 / 1913 / 190 / 19

Group identifiers: EG000: Placebo Phase 2 · EG001: 2 mg Baricitinib Phase 2 · EG002: 4 mg Baricitinib Phase 2 · EG003: All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg) · EG004: Placebo Phase 3 · EG005: 2 mg Baricitinib Phase 3 · EG006: 4 mg Baricitinib Phase 3 · EG007: All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg) · EG008: 4 mg Baricitinib Phase 3 Open-Label Addendum

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Ventricular tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Inappropriate antidiuretic hormone secretion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Food poisoning
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Gastric stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Obstruction gastric
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Peptic ulcer haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Asthenia

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
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      27
      num Events
      2
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      106
      num Events
      16
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      189
      num Events
      4
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      183
      num Events
      18
    7. group Id
      EG006
      num Affected
      46
      num At Risk
      280
      num Events
      50
    8. group Id
      EG007
      num Affected
      130
      num At Risk
      619
      num Events
      139
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Covid-19
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      27
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      106
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      189
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      183
      num Events
      3
    7. group Id
      EG006
      num Affected
      15
      num At Risk
      280
      num Events
      20
    8. group Id
      EG007
      num Affected
      20
      num At Risk
      619
      num Events
      25
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      27
      num Events
      3
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      106
      num Events
      17
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      189
      num Events
      13
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      183
      num Events
      15
    7. group Id
      EG006
      num Affected
      28
      num At Risk
      280
      num Events
      36
    8. group Id
      EG007
      num Affected
      48
      num At Risk
      619
      num Events
      62
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      27
      num Events
      8
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      27
      num Events
      8
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      106
      num Events
      38
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      189
      num Events
      17
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      183
      num Events
      24
    7. group Id
      EG006
      num Affected
      28
      num At Risk
      280
      num Events
      47
    8. group Id
      EG007
      num Affected
      63
      num At Risk
      619
      num Events
      99
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      19
      num Events
      4
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      27
      num Events
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      106
      num Events
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      189
      num Events
      8
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      183
      num Events
      7
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      280
      num Events
      21
    8. group Id
      EG007
      num Affected
      30
      num At Risk
      619
      num Events
      46
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      189
      num Events
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      183
      num Events
      4
    7. group Id
      EG006
      num Affected
      29
      num At Risk
      280
      num Events
      47
    8. group Id
      EG007
      num Affected
      42
      num At Risk
      619
      num Events
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Blood creatine phosphokinase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      189
      num Events
      13
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      183
      num Events
      12
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      280
      num Events
      37
    8. group Id
      EG007
      num Affected
      38
      num At Risk
      619
      num Events
      58
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      27
      num Events
      3
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      106
      num Events
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      189
      num Events
      1
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      183
      num Events
      13
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      280
      num Events
      21
    8. group Id
      EG007
      num Affected
      49
      num At Risk
      619
      num Events
      52
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      19
      num Events
      4
    term
    Acne
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      27
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      106
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      27
      num Events
      4
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      106
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      106
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      27
      num Events
      1
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      106
      num Events
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Herpes zoster
Complete source fields
description
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    28
    description
    \- Week 0 to Week 200: Participants received three placebo tablets administered orally QD.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    28
    serious Num Affected
    0
    serious Num At Risk
    28
    title
    Placebo Phase 2
  2. deaths Num Affected
    0
    deaths Num At Risk
    27
    description
    \- Week 0 to Week 200: Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
    id
    EG001
    other Num Affected
    21
    other Num At Risk
    27
    serious Num Affected
    0
    serious Num At Risk
    27
    title
    2 mg Baricitinib Phase 2
  3. deaths Num Affected
    0
    deaths Num At Risk
    27
    description
    \- Week 0 to Week 200: Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
    id
    EG002
    other Num Affected
    19
    other Num At Risk
    27
    serious Num Affected
    2
    serious Num At Risk
    27
    title
    4 mg Baricitinib Phase 2
  4. deaths Num Affected
    0
    deaths Num At Risk
    106
    description
    Participants who received Baricitinib in any of the three treatment arms \[1 mg/4 mg arm (1 mg until Week 12, then 4 mg until Week 200), 2 mg arm, or 4 mg arm\], plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 200) of Phase 2 were grouped in this arm.
    id
    EG003
    other Num Affected
    79
    other Num At Risk
    106
    serious Num Affected
    3
    serious Num At Risk
    106
    title
    All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg)
  5. deaths Num Affected
    0
    deaths Num At Risk
    189
    description
    * Week 0 to Week 52: Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same placebo or switched to either 2 mg or 4 mg Baricitinib dose administered orally QD (Period 2).
    id
    EG004
    other Num Affected
    37
    other Num At Risk
    189
    serious Num Affected
    3
    serious Num At Risk
    189
    title
    Placebo Phase 3
  6. deaths Num Affected
    0
    deaths Num At Risk
    183
    description
    * Week 0 to Week 52: Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 2 mg dose or switched to an uptitrated 4 mg Baricitinib dose administered orally QD (Period 2).
    id
    EG005
    other Num Affected
    58
    other Num At Risk
    183
    serious Num Affected
    7
    serious Num At Risk
    183
    title
    2 mg Baricitinib Phase 3
  7. deaths Num Affected
    0
    deaths Num At Risk
    280
    description
    * Week 0 to Week 52: Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind (Period 1). * Week 52 to Week 248: Participants continued to receive the same 4 mg dose or switched to a downtitrated 2 mg Baricitinib dose, or receive placebo tablets matched to Baricitinib administered orally QD (Period 2).
    id
    EG006
    other Num Affected
    126
    other Num At Risk
    280
    serious Num Affected
    16
    serious Num At Risk
    280
    title
    4 mg Baricitinib Phase 3
  8. deaths Num Affected
    0
    deaths Num At Risk
    619
    description
    Participants who received Baricitinib in any of 2 mg arm or the 4 mg arm, plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 248) of Phase 3 were grouped in this arm.
    id
    EG007
    other Num Affected
    275
    other Num At Risk
    619
    serious Num Affected
    40
    serious Num At Risk
    619
    title
    All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg)
  9. deaths Num Affected
    0
    deaths Num At Risk
    19
    description
    Week 0 to Week 52: Participants who received one 4 mg Baricitinib tablet administered orally QD.
    id
    EG008
    other Num Affected
    13
    other Num At Risk
    19
    serious Num Affected
    1
    serious Num At Risk
    19
    title
    4 mg Baricitinib Phase 3 Open-Label Addendum
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      27
      num Events
      2
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      106
      num Events
      16
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      189
      num Events
      4
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      183
      num Events
      18
    7. group Id
      EG006
      num Affected
      46
      num At Risk
      280
      num Events
      50
    8. group Id
      EG007
      num Affected
      130
      num At Risk
      619
      num Events
      139
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Covid-19
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      27
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      106
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      189
      num Events
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      183
      num Events
      3
    7. group Id
      EG006
      num Affected
      15
      num At Risk
      280
      num Events
      20
    8. group Id
      EG007
      num Affected
      20
      num At Risk
      619
      num Events
      25
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      27
      num Events
      3
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      106
      num Events
      17
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      189
      num Events
      13
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      183
      num Events
      15
    7. group Id
      EG006
      num Affected
      28
      num At Risk
      280
      num Events
      36
    8. group Id
      EG007
      num Affected
      48
      num At Risk
      619
      num Events
      62
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      27
      num Events
      8
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      27
      num Events
      8
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      106
      num Events
      38
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      189
      num Events
      17
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      183
      num Events
      24
    7. group Id
      EG006
      num Affected
      28
      num At Risk
      280
      num Events
      47
    8. group Id
      EG007
      num Affected
      63
      num At Risk
      619
      num Events
      99
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      19
      num Events
      4
    term
    Upper respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      27
      num Events
      1
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      106
      num Events
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      189
      num Events
      8
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      183
      num Events
      7
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      280
      num Events
      21
    8. group Id
      EG007
      num Affected
      30
      num At Risk
      619
      num Events
      46
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      189
      num Events
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      183
      num Events
      4
    7. group Id
      EG006
      num Affected
      29
      num At Risk
      280
      num Events
      47
    8. group Id
      EG007
      num Affected
      42
      num At Risk
      619
      num Events
      64
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Blood creatine phosphokinase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      189
      num Events
      13
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      183
      num Events
      12
    7. group Id
      EG006
      num Affected
      20
      num At Risk
      280
      num Events
      37
    8. group Id
      EG007
      num Affected
      38
      num At Risk
      619
      num Events
      58
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      27
      num Events
      3
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      106
      num Events
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      189
      num Events
      1
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      183
      num Events
      13
    7. group Id
      EG006
      num Affected
      19
      num At Risk
      280
      num Events
      21
    8. group Id
      EG007
      num Affected
      49
      num At Risk
      619
      num Events
      52
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      19
      num Events
      4
    term
    Acne
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      27
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      106
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      27
      num Events
      4
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      106
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      106
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      27
      num Events
      1
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      106
      num Events
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      619
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Herpes zoster
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Cardiac failure congestive
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Ventricular tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Inappropriate antidiuretic hormone secretion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      280
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Food poisoning
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Gastric stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Obstruction gastric
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      183
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Peptic ulcer haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      27
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      106
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      189
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      183
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      280
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      619
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      19
      num Events
      0
    term
    Asthenia
time Frame
Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)

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