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NCT04971226 · ADVERSE EVENTS

Adverse events

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP · Source last updated 2026-08-28

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) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until data cut-off on 28-Nov-2023 (approx. 2 years).
Other-event reporting threshold
5%

Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Asciminib (All Asciminib)

Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.

22 / 200177 / 2000 / 200
Imatinib

Patients took on ongoing basis the Investigator selected TKI (imatinib).

12 / 9989 / 990 / 99
2nd Generation TKI

Patients took on ongoing basis the 2nd Generation investigator selected TKIs (nilotinib, or dasatinib, or bosutinib)

20 / 102100 / 1020 / 102
All Comparators

Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)

32 / 201189 / 2010 / 201

Group identifiers: EG000: Asciminib (All Asciminib) · EG001: Imatinib · EG002: 2nd Generation TKI · EG003: All Comparators

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Epiretinal membrane
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Constipation

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      49
      num At Risk
      201
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      201
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      201
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      201
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      201
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      201
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      201
    term
    Eyelid oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      201
    term
    Periorbital oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      201
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      201
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      201
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      201
    term
    Dyspepsia
Complete source fields
description
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    200
    description
    Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.
    id
    EG000
    other Num Affected
    177
    other Num At Risk
    200
    serious Num Affected
    22
    serious Num At Risk
    200
    title
    Asciminib (All Asciminib)
  2. deaths Num Affected
    0
    deaths Num At Risk
    99
    description
    Patients took on ongoing basis the Investigator selected TKI (imatinib).
    id
    EG001
    other Num Affected
    89
    other Num At Risk
    99
    serious Num Affected
    12
    serious Num At Risk
    99
    title
    Imatinib
  3. deaths Num Affected
    0
    deaths Num At Risk
    102
    description
    Patients took on ongoing basis the 2nd Generation investigator selected TKIs (nilotinib, or dasatinib, or bosutinib)
    id
    EG002
    other Num Affected
    100
    other Num At Risk
    102
    serious Num Affected
    20
    serious Num At Risk
    102
    title
    2nd Generation TKI
  4. deaths Num Affected
    0
    deaths Num At Risk
    201
    description
    Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib)
    id
    EG003
    other Num Affected
    189
    other Num At Risk
    201
    serious Num Affected
    32
    serious Num At Risk
    201
    title
    All Comparators
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      49
      num At Risk
      201
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      201
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      201
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      201
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      201
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      201
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      201
    term
    Eyelid oedema
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      201
    term
    Periorbital oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      201
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      201
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      201
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      201
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Epiretinal membrane
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      201
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      200
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      102
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      201
    term
    Constipation
time Frame
Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until data cut-off on 28-Nov-2023 (approx. 2 years).

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

Preserved source evidence · Not medical advice