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NCT02177838 · ADVERSE EVENTS

Adverse events

Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer · Source last updated 2021-04-21

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 patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Cetuximab, Cisplatin, EBRT)

Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies

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Group identifiers: EG000: Treatment (Cetuximab, Cisplatin, EBRT)

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Dysphagia

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
      num Events
      3
    term
    Dry mouth
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      7
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    White blood cell count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      7
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Dehydration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neck pain
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      4
    term
    Dysgeusia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Headache
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Pain
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    8
    description
    Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    1
    serious Num At Risk
    8
    title
    Treatment (Cetuximab, Cisplatin, EBRT)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
      num Events
      3
    term
    Dry mouth
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      7
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    White blood cell count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      8
      num Events
      7
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Dehydration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neck pain
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      4
    term
    Dysgeusia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Headache
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    term
    Pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Dysphagia
time Frame
All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.

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Preserved source evidence · Not medical advice