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NCT02467270 · ADVERSE EVENTS

Adverse events

Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses · Source last updated 2026-03-17

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 first dose up to 30 days after last dose of the study drug (up to approximately 9.8 years)
Other-event reporting threshold
5%

All Cause Mortality: All randomized participants were assessed for all-cause mortality. Serious and Non-serious adverse events: Safety Population included all participants who received at least 1 dose of study drug and were assessed for serious and non-serious adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Period: Cohort A: Ponatinib 45 mg

Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

38 / 9493 / 9419 / 94
Treatment Period: Cohort B: Ponatinib 30 mg

Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

33 / 9490 / 9416 / 95
Treatment Period: Cohort C: Ponatinib 15 mg

Participants received ponatinib 15 mg orally once daily in each 28-day cycle.

39 / 9490 / 9414 / 94
Close-out Period: Cohort A: Ponatinib 45 mg

Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

1 / 2719 / 270 / 27
Close-out Period: Cohort B: Ponatinib 30 mg

Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.

3 / 1716 / 170 / 17
Close-out Period: Cohort C: Ponatinib 15 mg

Participants received ponatinib 15 mg orally once daily in each 28-day cycle.

0 / 1713 / 170 / 17

Group identifiers: EG000: Treatment Period: Cohort A: Ponatinib 45 mg · EG001: Treatment Period: Cohort B: Ponatinib 30 mg · EG002: Treatment Period: Cohort C: Ponatinib 15 mg · EG003: Close-out Period: Cohort A: Ponatinib 45 mg · EG004: Close-out Period: Cohort B: Ponatinib 30 mg · EG005: Close-out Period: Cohort C: Ponatinib 15 mg

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute hepatic failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Adenocarcinoma gastric
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Adenocarcinoma of colon
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Age-related macular degeneration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Alcoholic pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Angina pectoris

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      17
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Amylase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic arteriosclerosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic dilatation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic valve stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Arteriosclerosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    term
    Aspartate aminotransferase increased
Complete source fields
description
All Cause Mortality: All randomized participants were assessed for all-cause mortality. Serious and Non-serious adverse events: Safety Population included all participants who received at least 1 dose of study drug and were assessed for serious and non-serious adverse events.
event Groups
  1. deaths Num Affected
    19
    deaths Num At Risk
    94
    description
    Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    EG000
    other Num Affected
    93
    other Num At Risk
    94
    serious Num Affected
    38
    serious Num At Risk
    94
    title
    Treatment Period: Cohort A: Ponatinib 45 mg
  2. deaths Num Affected
    16
    deaths Num At Risk
    95
    description
    Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    EG001
    other Num Affected
    90
    other Num At Risk
    94
    serious Num Affected
    33
    serious Num At Risk
    94
    title
    Treatment Period: Cohort B: Ponatinib 30 mg
  3. deaths Num Affected
    14
    deaths Num At Risk
    94
    description
    Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
    id
    EG002
    other Num Affected
    90
    other Num At Risk
    94
    serious Num Affected
    39
    serious Num At Risk
    94
    title
    Treatment Period: Cohort C: Ponatinib 15 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    27
    description
    Participants received ponatinib 45 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    EG003
    other Num Affected
    19
    other Num At Risk
    27
    serious Num Affected
    1
    serious Num At Risk
    27
    title
    Close-out Period: Cohort A: Ponatinib 45 mg
  5. deaths Num Affected
    0
    deaths Num At Risk
    17
    description
    Participants received ponatinib 30 mg orally once daily in each 28-day cycle until achievement of ≤1% BCR-ABL1IS. Once ≤1% BCR-ABL1IS was achieved, participants received reduced dose of ponatinib 15 mg orally once daily.
    id
    EG004
    other Num Affected
    16
    other Num At Risk
    17
    serious Num Affected
    3
    serious Num At Risk
    17
    title
    Close-out Period: Cohort B: Ponatinib 30 mg
  6. deaths Num Affected
    0
    deaths Num At Risk
    17
    description
    Participants received ponatinib 15 mg orally once daily in each 28-day cycle.
    id
    EG005
    other Num Affected
    13
    other Num At Risk
    17
    serious Num Affected
    0
    serious Num At Risk
    17
    title
    Close-out Period: Cohort C: Ponatinib 15 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      17
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Amylase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic arteriosclerosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic dilatation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic valve stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Arteriosclerosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    term
    Aspartate aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute hepatic failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute kidney injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Adenocarcinoma gastric
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Adenocarcinoma of colon
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Age-related macular degeneration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Alcoholic pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      94
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      94
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      27
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Angina pectoris
time Frame
From first dose up to 30 days after last dose of the study drug (up to approximately 9.8 years)

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Preserved source evidence · Not medical advice