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NCT03899259 · ADVERSE EVENTS

Adverse events

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata · Source last updated 2026-04-07

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

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

Collection time frame
Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately).
Other-event reporting threshold
5%

(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) 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

* 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 / 17144 / 1710 / 171
2 mg Baricitinib

* 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).

5 / 17385 / 1730 / 173
4 mg Baricitinib

* 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 / 258133 / 2580 / 258
All Baricitinib- Extended

* The extended safety population (All Baricitinib- Extended) included participants who were continuously treated from baseline with baricitinib 2 mg, baricitinib 4 mg, or placebo and were censored at the time of any dose change or after the permanent study drug discontinuation, whichever occurred earlier. * In addition, the population included an "All Baricitinib" group, including all participants who received at least one dose of baricitinib (2 mg or 4 mg) at any time during the treatment period.

34 / 578321 / 5780 / 578

Group identifiers: EG000: Placebo · EG001: 2 mg Baricitinib · EG002: 4 mg Baricitinib · EG003: All Baricitinib- Extended

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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Lymphadenopathy
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Aortic valve incompetence
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      173
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Glaucoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Keratitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Flatulence
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Inguinal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      578
      num Events
      0
    term
    Strangulated umbilical hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      173
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      258
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      578
      num Events
      3
    term
    Cholecystitis acute
  10. 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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      578
      num Events
      2
    term
    Appendicitis
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Appendicitis perforated
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Covid-19

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
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      173
      num Events
      20
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      258
      num Events
      52
    4. group Id
      EG003
      num Affected
      148
      num At Risk
      578
      num Events
      178
    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
      8
      num At Risk
      171
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      173
      num Events
      12
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      258
      num Events
      43
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      578
      num Events
      80
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      171
      num Events
      16
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      173
      num Events
      29
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      258
      num Events
      45
    4. group Id
      EG003
      num Affected
      77
      num At Risk
      578
      num Events
      107
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      171
      num Events
      4
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      173
      num Events
      24
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      258
      num Events
      29
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      578
      num Events
      84
    term
    Urinary tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      171
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      173
      num Events
      7
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      258
      num Events
      14
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      578
      num Events
      23
    term
    Blood cholesterol increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      173
      num Events
      5
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      258
      num Events
      25
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      578
      num Events
      49
    term
    Blood creatine phosphokinase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      173
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      258
      num Events
      5
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      578
      num Events
      21
    term
    Weight increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      171
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      173
      num Events
      10
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      258
      num Events
      12
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      578
      num Events
      40
    term
    Hypercholesterolaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      171
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      173
      num Events
      4
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      258
      num Events
      15
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      578
      num Events
      29
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      171
      num Events
      12
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      173
      num Events
      37
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      258
      num Events
      45
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      578
      num Events
      119
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      171
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      173
      num Events
      5
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      258
      num Events
      16
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      578
      num Events
      36
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      171
      num Events
      4
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      173
      num Events
      13
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      258
      num Events
      17
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      578
      num Events
      44
    term
    Acne
Complete source fields
description
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-252) 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
    171
    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
    EG000
    other Num Affected
    44
    other Num At Risk
    171
    serious Num Affected
    3
    serious Num At Risk
    171
    title
    Placebo
  2. deaths Num Affected
    0
    deaths Num At Risk
    173
    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
    EG001
    other Num Affected
    85
    other Num At Risk
    173
    serious Num Affected
    5
    serious Num At Risk
    173
    title
    2 mg Baricitinib
  3. deaths Num Affected
    0
    deaths Num At Risk
    258
    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
    EG002
    other Num Affected
    133
    other Num At Risk
    258
    serious Num Affected
    16
    serious Num At Risk
    258
    title
    4 mg Baricitinib
  4. deaths Num Affected
    0
    deaths Num At Risk
    578
    description
    * The extended safety population (All Baricitinib- Extended) included participants who were continuously treated from baseline with baricitinib 2 mg, baricitinib 4 mg, or placebo and were censored at the time of any dose change or after the permanent study drug discontinuation, whichever occurred earlier. * In addition, the population included an "All Baricitinib" group, including all participants who received at least one dose of baricitinib (2 mg or 4 mg) at any time during the treatment period.
    id
    EG003
    other Num Affected
    321
    other Num At Risk
    578
    serious Num Affected
    34
    serious Num At Risk
    578
    title
    All Baricitinib- Extended
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
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      173
      num Events
      20
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      258
      num Events
      52
    4. group Id
      EG003
      num Affected
      148
      num At Risk
      578
      num Events
      178
    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
      8
      num At Risk
      171
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      173
      num Events
      12
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      258
      num Events
      43
    4. group Id
      EG003
      num Affected
      54
      num At Risk
      578
      num Events
      80
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      171
      num Events
      16
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      173
      num Events
      29
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      258
      num Events
      45
    4. group Id
      EG003
      num Affected
      77
      num At Risk
      578
      num Events
      107
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      171
      num Events
      4
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      173
      num Events
      24
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      258
      num Events
      29
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      578
      num Events
      84
    term
    Urinary tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      171
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      173
      num Events
      7
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      258
      num Events
      14
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      578
      num Events
      23
    term
    Blood cholesterol increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      173
      num Events
      5
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      258
      num Events
      25
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      578
      num Events
      49
    term
    Blood creatine phosphokinase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      173
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      258
      num Events
      5
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      578
      num Events
      21
    term
    Weight increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      171
      num Events
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      173
      num Events
      10
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      258
      num Events
      12
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      578
      num Events
      40
    term
    Hypercholesterolaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      171
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      173
      num Events
      4
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      258
      num Events
      15
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      578
      num Events
      29
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      171
      num Events
      12
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      173
      num Events
      37
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      258
      num Events
      45
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      578
      num Events
      119
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      171
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      173
      num Events
      5
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      258
      num Events
      16
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      578
      num Events
      36
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      171
      num Events
      4
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      173
      num Events
      13
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      258
      num Events
      17
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      578
      num Events
      44
    term
    Acne
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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Lymphadenopathy
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Aortic valve incompetence
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      173
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Cardiac failure congestive
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Glaucoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Keratitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Flatulence
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Inguinal hernia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      578
      num Events
      0
    term
    Strangulated umbilical hernia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      171
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      173
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      258
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      578
      num Events
      3
    term
    Cholecystitis acute
  10. 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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      578
      num Events
      2
    term
    Appendicitis
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      258
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Appendicitis perforated
  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
      171
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      173
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      258
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      578
      num Events
      1
    term
    Covid-19
time Frame
Baseline up to end of follow up (up to 252 weeks). (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within Period 2 (Week 52 to Week 248) it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately).

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Preserved source evidence · Not medical advice