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NCT03106779 · ADVERSE EVENTS

Adverse events

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs · Source last updated 2026-08-18

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) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.
Other-event reporting threshold
5%

Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
On-treatment Period Asciminib

On-treatment period of asciminib was from first day of exposure to asciminib to 30 days after the last exposure to asciminib.

34 / 156130 / 1565 / 156
On-treatment Period Bosutinib

On-treatment period Bosutinib was from first day of exposure to bosutinib to either 30 days after the last exposure to bosutinib or the day before the first administration of asciminib, whichever came first.

20 / 7672 / 761 / 76
On-treatment Period: Switched From Bosutinib to Asciminib

On-treatment switch from bosutinib to asciminib period was from the first day of exposure to asciminib, from switching from bosutinib to asciminib, to 30 days after the last exposure to asciminib, after the switch.

2 / 2520 / 250 / 25
Post-treatment Period Asciminib

Post-treatment period of asciminib started from Day 31 (31st day) of last exposure to asciminib until maximum of approx. 7 years.

1 / 1357 / 13511 / 135
Post-treatment Period Bosutinib

Post-treatment period started either from Day 31 (31st day) of last exposure to bosutinib or from first administration of asciminib (participants switching to asciminib) whichever came first, until maximum of approx. 7 years

0 / 613 / 618 / 61
Post-treatment Period: Switched From Bosutinib to Asciminib

Post-treatment switch from bosutinib to asciminib period started from the day after last exposure to asciminib for people who switched over to asciminib, until end of study or discontinuation from study.

0 / 240 / 243 / 24

Group identifiers: EG000: On-treatment Period Asciminib · EG001: On-treatment Period Bosutinib · EG002: On-treatment Period: Switched From Bosutinib to Asciminib · EG003: Post-treatment Period Asciminib · EG004: Post-treatment Period Bosutinib · EG005: Post-treatment Period: Switched From Bosutinib to Asciminib

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 (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Angina unstable
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Ventricular tachycardia

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 (26.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Fatigue
Complete source fields
description
Adverse Event (AE) is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after participant's signed informed consent has been obtained.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    156
    description
    On-treatment period of asciminib was from first day of exposure to asciminib to 30 days after the last exposure to asciminib.
    id
    EG000
    other Num Affected
    130
    other Num At Risk
    156
    serious Num Affected
    34
    serious Num At Risk
    156
    title
    On-treatment Period Asciminib
  2. deaths Num Affected
    1
    deaths Num At Risk
    76
    description
    On-treatment period Bosutinib was from first day of exposure to bosutinib to either 30 days after the last exposure to bosutinib or the day before the first administration of asciminib, whichever came first.
    id
    EG001
    other Num Affected
    72
    other Num At Risk
    76
    serious Num Affected
    20
    serious Num At Risk
    76
    title
    On-treatment Period Bosutinib
  3. deaths Num Affected
    0
    deaths Num At Risk
    25
    description
    On-treatment switch from bosutinib to asciminib period was from the first day of exposure to asciminib, from switching from bosutinib to asciminib, to 30 days after the last exposure to asciminib, after the switch.
    id
    EG002
    other Num Affected
    20
    other Num At Risk
    25
    serious Num Affected
    2
    serious Num At Risk
    25
    title
    On-treatment Period: Switched From Bosutinib to Asciminib
  4. deaths Num Affected
    11
    deaths Num At Risk
    135
    description
    Post-treatment period of asciminib started from Day 31 (31st day) of last exposure to asciminib until maximum of approx. 7 years.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    135
    serious Num Affected
    1
    serious Num At Risk
    135
    title
    Post-treatment Period Asciminib
  5. deaths Num Affected
    8
    deaths Num At Risk
    61
    description
    Post-treatment period started either from Day 31 (31st day) of last exposure to bosutinib or from first administration of asciminib (participants switching to asciminib) whichever came first, until maximum of approx. 7 years
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    61
    serious Num Affected
    0
    serious Num At Risk
    61
    title
    Post-treatment Period Bosutinib
  6. deaths Num Affected
    3
    deaths Num At Risk
    24
    description
    Post-treatment switch from bosutinib to asciminib period started from the day after last exposure to asciminib for people who switched over to asciminib, until end of study or discontinuation from study.
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    24
    serious Num Affected
    0
    serious Num At Risk
    24
    title
    Post-treatment Period: Switched From Bosutinib to Asciminib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Angina unstable
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      76
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      135
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Ventricular tachycardia
time Frame
Adverse events (AEs) & on-treatment deaths were collected from the first dose of study treatment up to 30 days after last dose of study medication. The maximum duration of treatment exposure was 256.3 weeks for asciminib, and 239.3 weeks for bosutinib.

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