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NCT00558519 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2026-04-29

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Pediatric Regimen)

Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.

134 / 295268 / 295105 / 295

Group identifiers: EG000: Treatment (Pediatric Regimen)

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 09
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      295
      num Events
      4
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      295
      num Events
      84
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      128
      num At Risk
      295
      num Events
      209
    term
    Hemoglobin decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Lymphatic disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      295
      num Events
      4
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Cardiac disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Cardiac pain

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 09
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      295
      num Events
      10
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      2
    term
    Bone marrow hypocellular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      295
      num Events
      14
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      295
      num Events
      181
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      259
      num At Risk
      295
      num Events
      1235
    term
    Hemoglobin decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Hemolysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      295
      num Events
      5
    term
    Lymphatic disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Thrombotic microangiopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      295
      num Events
      4
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      295
      num Events
      7
    term
    Atrial tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      295
      num Events
      7
    term
    Cardiac disorder
Complete source fields
event Groups
  1. deaths Num Affected
    105
    deaths Num At Risk
    295
    description
    Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.
    id
    EG000
    other Num Affected
    268
    other Num At Risk
    295
    serious Num Affected
    134
    serious Num At Risk
    295
    title
    Treatment (Pediatric Regimen)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      295
      num Events
      10
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      2
    term
    Bone marrow hypocellular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      295
      num Events
      14
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      295
      num Events
      181
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      259
      num At Risk
      295
      num Events
      1235
    term
    Hemoglobin decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Hemolysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      295
      num Events
      5
    term
    Lymphatic disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Thrombotic microangiopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      295
      num Events
      4
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      295
      num Events
      7
    term
    Atrial tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      295
      num Events
      7
    term
    Cardiac disorder
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      295
      num Events
      4
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      295
      num Events
      84
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      128
      num At Risk
      295
      num Events
      209
    term
    Hemoglobin decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Lymphatic disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Arrhythmia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      295
      num Events
      4
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      295
      num Events
      3
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
      num Events
      2
    term
    Atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Cardiac disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 09
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
      num Events
      1
    term
    Cardiac pain

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