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NCT00026312 · ADVERSE EVENTS

Adverse events

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma · Source last updated 2026-03-05

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%

Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.

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

Randomized to Regimen A - RA Only

10 / 11292 / 112Not reported / Not reported
Regimen B

Regimen B - RA + Immunotherapy

785 / 13281244 / 1328Not reported / Not reported

Group identifiers: EG000: Regimen A · EG001: Regimen B

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      1328
      num Events
      49
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1328
      num Events
      4
    term
    Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1328
      num Events
      2
    term
    Hemolysis
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1328
      num Events
      2
    term
    Hemolytic uremic syndrome
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      2
    term
    Atrial fibrillation
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Cardiac arrest
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      1328
      num Events
      5
    term
    Cardiac disorders - Other specify
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Heart failure
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      1328
      num Events
      7
    term
    Left ventricular systolic dysfunction
  12. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Pericardial effusion

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      112
      num Events
      47
    2. group Id
      EG001
      num Affected
      428
      num At Risk
      1328
      num Events
      962
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      1328
      num Events
      24
    term
    Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      1328
      num Events
      23
    term
    Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Hemolytic uremic syndrome
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Atrial fibrillation
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      1328
      num Events
      49
    term
    Cardiac disorders - Other specify
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1328
      num Events
      2
    term
    Chest pain - cardiac
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Conduction disorder
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Heart failure
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Left ventricular systolic dysfunction
  12. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Mobitz type I
Complete source fields
description
Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
event Groups
  1. description
    Randomized to Regimen A - RA Only
    id
    EG000
    other Num Affected
    92
    other Num At Risk
    112
    serious Num Affected
    10
    serious Num At Risk
    112
    title
    Regimen A
  2. description
    Regimen B - RA + Immunotherapy
    id
    EG001
    other Num Affected
    1244
    other Num At Risk
    1328
    serious Num Affected
    785
    serious Num At Risk
    1328
    title
    Regimen B
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      112
      num Events
      47
    2. group Id
      EG001
      num Affected
      428
      num At Risk
      1328
      num Events
      962
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      1328
      num Events
      24
    term
    Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      1328
      num Events
      23
    term
    Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Hemolytic uremic syndrome
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Atrial fibrillation
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      1328
      num Events
      49
    term
    Cardiac disorders - Other specify
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1328
      num Events
      2
    term
    Chest pain - cardiac
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Conduction disorder
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Heart failure
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Left ventricular systolic dysfunction
  12. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      1
    term
    Mobitz type I
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      1328
      num Events
      49
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1328
      num Events
      4
    term
    Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1328
      num Events
      2
    term
    Hemolysis
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1328
      num Events
      2
    term
    Hemolytic uremic syndrome
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1328
      num Events
      2
    term
    Atrial fibrillation
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Cardiac arrest
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      1328
      num Events
      5
    term
    Cardiac disorders - Other specify
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Heart failure
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      1328
      num Events
      7
    term
    Left ventricular systolic dysfunction
  12. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1328
      num Events
      3
    term
    Pericardial effusion

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