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NCT00084318 · ADVERSE EVENTS

Adverse events

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck · Source last updated 2018-12-12

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
5%

Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
RT+Cisplatin+Cetuximab

Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.

42 / 9797 / 97Not reported / Not reported
RT+Docetaxel+Cetuximab

Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.

56 / 106105 / 106Not reported / Not reported

Group identifiers: EG000: RT+Cisplatin+Cetuximab · EG001: RT+Docetaxel+Cetuximab

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Cardiac general - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Cardio-respiratory arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Myocardial ischemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Supraventricular arrhythmia NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Hearing impaired
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Hypothyroidism
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Conjunctivitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Abdominal pain NOS

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    term
    Blood/bone marrow - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      106
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    term
    Auditory/ear - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      106
    term
    Hearing impaired
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      106
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      106
    term
    Abdominal pain NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      106
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      106
    term
    Diarrhea NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      106
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      106
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      106
    term
    Dysphagia
Complete source fields
description
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
event Groups
  1. description
    Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
    id
    EG000
    other Num Affected
    97
    other Num At Risk
    97
    serious Num Affected
    42
    serious Num At Risk
    97
    title
    RT+Cisplatin+Cetuximab
  2. description
    Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    106
    serious Num Affected
    56
    serious Num At Risk
    106
    title
    RT+Docetaxel+Cetuximab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    term
    Blood/bone marrow - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      106
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    term
    Auditory/ear - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      106
    term
    Hearing impaired
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      106
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      106
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      106
    term
    Abdominal pain NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      106
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      106
    term
    Diarrhea NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      106
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      106
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      106
    term
    Dysphagia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Cardiac general - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Cardio-respiratory arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Myocardial ischemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Supraventricular arrhythmia NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Hearing impaired
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Hypothyroidism
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Conjunctivitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Abdominal pain NOS

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