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NCT02346240 · ADVERSE EVENTS

Adverse events

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) · Source last updated 2021-07-16

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
Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144.
Other-event reporting threshold
5%

At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo Q2W (SS) Wk 0-48

This arm consisted of all participants who received Placebo (PBO) at any time in the study (Week 0 to Week 48). Only 2 participants received PBO from Week 16 to Week 48. Participants formed the Safety Set (SS).

8 / 12842 / 1280 / 128
Etanercept (SS) Wk 0-12

This arm consisted of all participants who received Etanercept at any time in the study (Week 0 to Week 12). Participants formed the SS.

1 / 16837 / 1680 / 168
CZP 200 mg Q2W (SS) Wk 0-144

This arm consisted of all participants who received CZP 200 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.

34 / 373139 / 3732 / 373
CZP 400 mg Q2W (SS) Wk 0-144

This arm consisted of all participants who received CZP 400 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.

51 / 412158 / 4121 / 412
CZP 400mg Q4W (SS) Wk 16-48

This arm consisted of all participants who received CZP 400 mg Q4W at any time in the study (Week 16 to Week 48). Participants formed the SS.

5 / 4411 / 440 / 44

Group identifiers: EG000: Placebo Q2W (SS) Wk 0-48 · EG001: Etanercept (SS) Wk 0-12 · EG002: CZP 200 mg Q2W (SS) Wk 0-144 · EG003: CZP 400 mg Q2W (SS) Wk 0-144 · EG004: CZP 400mg Q4W (SS) Wk 16-48

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Intracardiac mass
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Coronary artery disease
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Cardiac failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Acute myocardial infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Angina pectoris
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Vestibular disorder
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Tympanic membrane perforation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Cataract
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Retinal detachment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Large intestine polyp
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Crohn's disease

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      128
      num Events
      16
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      168
      num Events
      14
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      373
      num Events
      81
    4. group Id
      EG003
      num Affected
      66
      num At Risk
      412
      num Events
      83
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      3
    term
    Nasopharyngitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      128
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      168
      num Events
      14
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      373
      num Events
      55
    4. group Id
      EG003
      num Affected
      45
      num At Risk
      412
      num Events
      64
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      3
    term
    Upper respiratory tract infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      168
      num Events
      4
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      373
      num Events
      34
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      412
      num Events
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      44
      num Events
      4
    term
    Viral upper respiratory tract infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      168
      num Events
      2
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      373
      num Events
      10
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      412
      num Events
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      5
    term
    Blood creatine phosphokinase increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      168
      num Events
      3
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      373
      num Events
      17
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      412
      num Events
      20
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      3
    term
    Arthralgia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      128
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
      num Events
      1
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      373
      num Events
      10
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      412
      num Events
      23
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Psoriasis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      128
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      168
      num Events
      4
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      373
      num Events
      19
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      412
      num Events
      24
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Hypertension
Complete source fields
description
At Week 16, only 2 participants continued PBO until Week 48 (no patient received PBO post Week 48) and all ETN-randomized participants switched to PBO (24) or CZP (135), leading to a significantly lower exposure in PBO/ETN arms than in CZP arms.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    128
    description
    This arm consisted of all participants who received Placebo (PBO) at any time in the study (Week 0 to Week 48). Only 2 participants received PBO from Week 16 to Week 48. Participants formed the Safety Set (SS).
    id
    EG000
    other Num Affected
    42
    other Num At Risk
    128
    serious Num Affected
    8
    serious Num At Risk
    128
    title
    Placebo Q2W (SS) Wk 0-48
  2. deaths Num Affected
    0
    deaths Num At Risk
    168
    description
    This arm consisted of all participants who received Etanercept at any time in the study (Week 0 to Week 12). Participants formed the SS.
    id
    EG001
    other Num Affected
    37
    other Num At Risk
    168
    serious Num Affected
    1
    serious Num At Risk
    168
    title
    Etanercept (SS) Wk 0-12
  3. deaths Num Affected
    2
    deaths Num At Risk
    373
    description
    This arm consisted of all participants who received CZP 200 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.
    id
    EG002
    other Num Affected
    139
    other Num At Risk
    373
    serious Num Affected
    34
    serious Num At Risk
    373
    title
    CZP 200 mg Q2W (SS) Wk 0-144
  4. deaths Num Affected
    1
    deaths Num At Risk
    412
    description
    This arm consisted of all participants who received CZP 400 mg Q2W at any time in the study (Week 0 to Week 144). Participants formed the SS.
    id
    EG003
    other Num Affected
    158
    other Num At Risk
    412
    serious Num Affected
    51
    serious Num At Risk
    412
    title
    CZP 400 mg Q2W (SS) Wk 0-144
  5. deaths Num Affected
    0
    deaths Num At Risk
    44
    description
    This arm consisted of all participants who received CZP 400 mg Q4W at any time in the study (Week 16 to Week 48). Participants formed the SS.
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    44
    serious Num Affected
    5
    serious Num At Risk
    44
    title
    CZP 400mg Q4W (SS) Wk 16-48
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      128
      num Events
      16
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      168
      num Events
      14
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      373
      num Events
      81
    4. group Id
      EG003
      num Affected
      66
      num At Risk
      412
      num Events
      83
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      3
    term
    Nasopharyngitis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      128
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      168
      num Events
      14
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      373
      num Events
      55
    4. group Id
      EG003
      num Affected
      45
      num At Risk
      412
      num Events
      64
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      3
    term
    Upper respiratory tract infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      168
      num Events
      4
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      373
      num Events
      34
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      412
      num Events
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      44
      num Events
      4
    term
    Viral upper respiratory tract infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      128
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      168
      num Events
      2
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      373
      num Events
      10
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      412
      num Events
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      5
    term
    Blood creatine phosphokinase increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      168
      num Events
      3
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      373
      num Events
      17
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      412
      num Events
      20
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      44
      num Events
      3
    term
    Arthralgia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      128
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
      num Events
      1
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      373
      num Events
      10
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      412
      num Events
      23
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Psoriasis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      128
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      168
      num Events
      4
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      373
      num Events
      19
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      412
      num Events
      24
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Hypertension
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Intracardiac mass
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Coronary artery disease
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Cardiac failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Acute myocardial infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Angina pectoris
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Vestibular disorder
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Tympanic membrane perforation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Cataract
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Retinal detachment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      373
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      412
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Large intestine polyp
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      373
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      412
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      44
      num Events
      0
    term
    Crohn's disease
time Frame
Adverse Events (AEs) were collected from Baseline (Week 0) until Week 144.

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Preserved source evidence · Not medical advice