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NCT01883362 · ADVERSE EVENTS

Adverse events

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML · Source last updated 2021-03-17

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
Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
Other-event reporting threshold
5%

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

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Standard of Care With Midostaurin

Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).

9 / 3028 / 301 / 30
Standard of Care

Patients received standard of care alone in the post SCT setting

15 / 3026 / 300 / 30
ALL Patients

ALL Patients combined

24 / 6054 / 601 / 60

Group identifiers: EG000: Standard of Care With Midostaurin · EG001: Standard of Care · EG002: ALL Patients

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 (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Arteriosclerosis coronary artery
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Myocarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Pericarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      60
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Gastritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Lower gastrointestinal haemorrhage

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 (16.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      60
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      60
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      60
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      60
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Cushingoid
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      60
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Lacrimation increased
Complete source fields
description
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    30
    description
    Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    30
    serious Num Affected
    9
    serious Num At Risk
    30
    title
    Standard of Care With Midostaurin
  2. deaths Num Affected
    0
    deaths Num At Risk
    30
    description
    Patients received standard of care alone in the post SCT setting
    id
    EG001
    other Num Affected
    26
    other Num At Risk
    30
    serious Num Affected
    15
    serious Num At Risk
    30
    title
    Standard of Care
  3. deaths Num Affected
    1
    deaths Num At Risk
    60
    description
    ALL Patients combined
    id
    EG002
    other Num Affected
    54
    other Num At Risk
    60
    serious Num Affected
    24
    serious Num At Risk
    60
    title
    ALL Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      60
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      60
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      60
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      60
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Cushingoid
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      60
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Lacrimation increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      60
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Arteriosclerosis coronary artery
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Myocarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Pericarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      60
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Gastritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
    term
    Lower gastrointestinal haemorrhage
time Frame
Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).

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Preserved source evidence · Not medical advice