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NCT02395666 · ADVERSE EVENTS

Adverse events

Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission · Source last updated 2024-08-06

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
Through study completion plus 30 days, an average of 2 years.
Other-event reporting threshold
4%

All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Study Subjects

All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.

23 / 14041 / 1400 / 140

Group identifiers: EG000: All Study Subjects

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
    notes
    All Unrelated
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      140
      num Events
      8
    term
    Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All Unrelated
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      3
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All Unrelated
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      3
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Hyponatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Benign vascular lesion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Eye swelling result of brain mass that has been confirmed as metastatic recurrent neuroblastoma. Unrelated
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Swelling of Eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Possibly related
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Hypoglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Possibly related
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Urticaria
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Respiratory Disorder

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      140
      num Events
      11
    term
    Neutrophil count decrease
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      140
      num Events
      6
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      140
      num Events
      14
    term
    ALT elevation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      140
      num Events
      10
    term
    AST elevation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      140
      num Events
      9
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      140
      num Events
      9
    term
    Hearing Loss
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      140
      num Events
      6
    term
    Otitis Media
Complete source fields
description
All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    140
    description
    All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    140
    serious Num Affected
    23
    serious Num At Risk
    140
    title
    All Study Subjects
frequency Threshold
4
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      140
      num Events
      11
    term
    Neutrophil count decrease
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      140
      num Events
      6
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      140
      num Events
      14
    term
    ALT elevation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      140
      num Events
      10
    term
    AST elevation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      140
      num Events
      9
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      140
      num Events
      9
    term
    Hearing Loss
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      140
      num Events
      6
    term
    Otitis Media
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All Unrelated
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      140
      num Events
      8
    term
    Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All Unrelated
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      3
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All Unrelated
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      3
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Hyponatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Benign vascular lesion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Eye swelling result of brain mass that has been confirmed as metastatic recurrent neuroblastoma. Unrelated
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Swelling of Eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Possibly related
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Hypoglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Possibly related
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Urticaria
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Unrelated
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    term
    Respiratory Disorder
time Frame
Through study completion plus 30 days, an average of 2 years.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice