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NCT03493451 · ADVERSE EVENTS

Adverse events

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms · Source last updated 2024-10-26

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
Up to approximately 3 years and 1 week
Other-event reporting threshold
3%

Adverse events were graded by the investigators using Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: ENKTL

Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

9 / 2221 / 2211 / 22
Cohort 2: PTCL-NOS, AITL, and ALCL

Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

21 / 4439 / 4426 / 44
Cohort 3: MF and SS

Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

5 / 1110 / 113 / 11

Group identifiers: EG000: Cohort 1: ENKTL · EG001: Cohort 2: PTCL-NOS, AITL, and ALCL · EG002: Cohort 3: MF and SS

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Intussusception
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lower gastrointestinal haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Nausea

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      22
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymph node pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      44
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Conduction disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Extrasystoles
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Deafness
Complete source fields
description
Adverse events were graded by the investigators using Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    22
    description
    Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    9
    serious Num At Risk
    22
    title
    Cohort 1: ENKTL
  2. deaths Num Affected
    26
    deaths Num At Risk
    44
    description
    Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    44
    serious Num Affected
    21
    serious Num At Risk
    44
    title
    Cohort 2: PTCL-NOS, AITL, and ALCL
  3. deaths Num Affected
    3
    deaths Num At Risk
    11
    description
    Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Cohort 3: MF and SS
frequency Threshold
3
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      22
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymph node pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      44
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Conduction disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Extrasystoles
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Deafness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Intussusception
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Lower gastrointestinal haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Nausea
time Frame
Up to approximately 3 years and 1 week

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Preserved source evidence · Not medical advice