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NCT00306202 · ADVERSE EVENTS

Adverse events

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia · Source last updated 2021-02-26

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 to 100 days post last dose
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.

8 / 1716 / 17Not reported / Not reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose

Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.

14 / 1716 / 17Not reported / Not reported
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.

22 / 2424 / 24Not reported / Not reported

Group identifiers: EG000: Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose · EG001: Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose · EG002: Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose

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
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Ascites
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Enterocolitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Lower gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Pancreatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Stomatitis

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
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    term
    Splenomegaly
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Ear discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Middle ear effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Chalazion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Dacryoadenitis acquired
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Erythema of eyelid
Complete source fields
event Groups
  1. description
    Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    17
    serious Num Affected
    8
    serious Num At Risk
    17
    title
    Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
  2. description
    Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    17
    serious Num Affected
    14
    serious Num At Risk
    17
    title
    Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
  3. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
    id
    EG002
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    22
    serious Num At Risk
    24
    title
    Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    term
    Splenomegaly
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Ear discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Middle ear effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Chalazion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Dacryoadenitis acquired
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Erythema of eyelid
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Ascites
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Enterocolitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Ileus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Lower gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    term
    Pancreatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    term
    Stomatitis
time Frame
From first dose to 100 days post last dose

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Preserved source evidence · Not medical advice