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NCT01460160 · ADVERSE EVENTS

Adverse events

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia · Source last updated 2021-12-08

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
All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dasatinib Cohort

Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.

101 / 106106 / 10621 / 106

Group identifiers: EG000: Dasatinib Cohort

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
    20.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      106
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    FEBRILE BONE MARROW APLASIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      106
    term
    FEBRILE NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    HAEMORRHAGIC ANAEMIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      106
    term
    LEUKOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    LYMPHATIC DISORDER
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      106
    term
    NEUTROPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      106
    term
    PANCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      106
    term
    THROMBOCYTOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    CARDIAC ARREST
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    CARDIAC FAILURE

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
    20.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      106
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      106
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      106
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      106
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      106
    term
    PERICARDIAL EFFUSION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      106
    term
    SINUS TACHYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      106
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      106
    term
    EAR PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    EYE PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      106
    term
    OCULAR HYPERAEMIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      106
    term
    PERIORBITAL OEDEMA
Complete source fields
event Groups
  1. deaths Num Affected
    21
    deaths Num At Risk
    106
    description
    Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
    id
    EG000
    other Num Affected
    106
    other Num At Risk
    106
    serious Num Affected
    101
    serious Num At Risk
    106
    title
    Dasatinib Cohort
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      106
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      106
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      106
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      106
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      106
    term
    PERICARDIAL EFFUSION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      106
    term
    SINUS TACHYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      106
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      106
    term
    EAR PAIN
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    EYE PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      106
    term
    OCULAR HYPERAEMIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      106
    term
    PERIORBITAL OEDEMA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      106
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    FEBRILE BONE MARROW APLASIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      106
    term
    FEBRILE NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    HAEMORRHAGIC ANAEMIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      106
    term
    LEUKOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    LYMPHATIC DISORDER
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      106
    term
    NEUTROPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      106
    term
    PANCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      106
    term
    THROMBOCYTOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    CARDIAC ARREST
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    CARDIAC FAILURE
time Frame
All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)

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