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NCT01550003 · ADVERSE EVENTS

Adverse events

Pediatric Arthritis Study of Certolizumab Pegol · Source last updated 2024-10-23

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
From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
Other-event reporting threshold
5%

TEAEs were defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Any CZP Dose - Weight Group: 10 - <20 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

5 / 1816 / 180 / 18
Any CZP Dose - Weight Group: 20 - <40 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

20 / 6359 / 630 / 63
Any CZP Dose - Weight Group: >=40 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

21 / 11298 / 1123 / 112

Group identifiers: EG000: Any CZP Dose - Weight Group: 10 - <20 kg · EG001: Any CZP Dose - Weight Group: 20 - <40 kg · EG002: Any CZP Dose - Weight Group: >=40 kg

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
      num Events
      2
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Lymphadenopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Adrenal suppression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Crohn's disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Dysphagia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Gastrointestinal motility disorder
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Ileus
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Inflammatory bowel disease
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Pyrexia

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      63
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      112
      num Events
      4
    term
    Lymphadenopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      112
      num Events
      7
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Lichen spinulosus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Ear pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Middle ear effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Conjunctivitis allergic
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Uveitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Iritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Hypermetropia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Ocular hyperaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      63
      num Events
      8
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      112
      num Events
      22
    term
    Vomiting
Complete source fields
description
TEAEs were defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    18
    serious Num Affected
    5
    serious Num At Risk
    18
    title
    Any CZP Dose - Weight Group: 10 - <20 kg
  2. deaths Num Affected
    0
    deaths Num At Risk
    63
    description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    EG001
    other Num Affected
    59
    other Num At Risk
    63
    serious Num Affected
    20
    serious Num At Risk
    63
    title
    Any CZP Dose - Weight Group: 20 - <40 kg
  3. deaths Num Affected
    3
    deaths Num At Risk
    112
    description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    EG002
    other Num Affected
    98
    other Num At Risk
    112
    serious Num Affected
    21
    serious Num At Risk
    112
    title
    Any CZP Dose - Weight Group: >=40 kg
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      63
      num Events
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      112
      num Events
      4
    term
    Lymphadenopathy
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      112
      num Events
      7
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Lichen spinulosus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Ear pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Middle ear effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Conjunctivitis allergic
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Uveitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Iritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Hypermetropia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Ocular hyperaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
      num Events
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      63
      num Events
      8
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      112
      num Events
      22
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      112
      num Events
      2
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Leukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Lymphadenopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Adrenal suppression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Crohn's disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Dysphagia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Gastrointestinal motility disorder
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Ileus
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Inflammatory bowel disease
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Pyrexia
time Frame
From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice