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NCT02130557 · ADVERSE EVENTS

Adverse events

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia · Source last updated 2021-05-18

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
From first dose of drug up to 28 days after last dose (up to Month 60)
Other-event reporting threshold
5%

All-cause mortality: The total number of deaths occurred during study (from randomization and up to month 60) are reported for all randomized participants, not only for treated participants, and included deaths which occurred after 28 days post last study drug dose. Serious AEs and other AEs: Analysis performed on safety population. The safety population included all participants, regardless of Philadelphia chromosome or transcript status, who received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bosutinib

Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.

98 / 268264 / 26814 / 268
Imatinib

Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.

68 / 265260 / 26514 / 268

Group identifiers: EG000: Bosutinib · EG001: Imatinib

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      265
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Agranulocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Haemolysis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Haemolytic anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Myocardial ischaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Cardiac failure acute
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Coronary artery disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Pericarditis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      265
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      265
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      265
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      265
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      265
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      265
    term
    Periorbital oedema
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      265
    term
    Eyelid oedema
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      265
    term
    Conjunctival haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      265
    term
    Dry eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      265
    term
    Lacrimation increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      265
    term
    Vision blurred
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      201
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      265
    term
    Diarrhoea
Complete source fields
description
All-cause mortality: The total number of deaths occurred during study (from randomization and up to month 60) are reported for all randomized participants, not only for treated participants, and included deaths which occurred after 28 days post last study drug dose. Serious AEs and other AEs: Analysis performed on safety population. The safety population included all participants, regardless of Philadelphia chromosome or transcript status, who received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    14
    deaths Num At Risk
    268
    description
    Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    EG000
    other Num Affected
    264
    other Num At Risk
    268
    serious Num Affected
    98
    serious Num At Risk
    268
    title
    Bosutinib
  2. deaths Num Affected
    14
    deaths Num At Risk
    268
    description
    Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    EG001
    other Num Affected
    260
    other Num At Risk
    265
    serious Num Affected
    68
    serious Num At Risk
    265
    title
    Imatinib
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      265
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      265
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      265
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      265
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      265
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      265
    term
    Periorbital oedema
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      265
    term
    Eyelid oedema
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      265
    term
    Conjunctival haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      265
    term
    Dry eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      265
    term
    Lacrimation increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      265
    term
    Vision blurred
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      201
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      265
    term
    Diarrhoea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      265
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Agranulocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Haemolysis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Haemolytic anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Myocardial ischaemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Cardiac failure acute
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Coronary artery disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Pericarditis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      268
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Angina pectoris
time Frame
From first dose of drug up to 28 days after last dose (up to Month 60)

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