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NCT00265941 · ADVERSE EVENTS

Adverse events

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2022-06-14

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%

Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

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

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin

208 / 447442 / 447Not reported / Not reported
RT + Cisplatin + Cetuximab

Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab

237 / 444433 / 444Not reported / Not reported

Group identifiers: EG000: RT + Cisplatin · EG001: RT + Cisplatin + 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
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      444
    term
    Blood/bone marrow - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      444
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      444
    term
    Hemoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      444
    term
    Hemolysis NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Arrhythmia NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Atrial flutter
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Cardiac general - Other
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      444
    term
    Cor pulmonale NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      444
    term
    Left ventricular failure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      444
    term
    Myocardial ischemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Sinus arrhythmia

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
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      444
    term
    Blood/bone marrow - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      262
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      250
      num At Risk
      444
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      444
    term
    Ear pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      127
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      444
    term
    Hearing impaired
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      444
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      444
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      444
    term
    Abdominal pain NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      170
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      146
      num At Risk
      444
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      444
    term
    Diarrhea NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      352
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      344
      num At Risk
      444
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      444
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      431
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      415
      num At Risk
      444
    term
    Dysphagia
Complete source fields
description
Randomized eligible patients with follow-up data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
event Groups
  1. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
    id
    EG000
    other Num Affected
    442
    other Num At Risk
    447
    serious Num Affected
    208
    serious Num At Risk
    447
    title
    RT + Cisplatin
  2. description
    Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
    id
    EG001
    other Num Affected
    433
    other Num At Risk
    444
    serious Num Affected
    237
    serious Num At Risk
    444
    title
    RT + Cisplatin + Cetuximab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      444
    term
    Blood/bone marrow - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      262
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      250
      num At Risk
      444
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      444
    term
    Ear pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      127
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      444
    term
    Hearing impaired
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      444
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      444
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      444
    term
    Abdominal pain NOS
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      170
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      146
      num At Risk
      444
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      444
    term
    Diarrhea NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      352
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      344
      num At Risk
      444
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      444
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      431
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      415
      num At Risk
      444
    term
    Dysphagia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      444
    term
    Blood/bone marrow - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      444
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      444
    term
    Hemoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      444
    term
    Hemolysis NOS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Arrhythmia NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Atrial flutter
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Cardiac general - Other
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      444
    term
    Cor pulmonale NOS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      444
    term
    Left ventricular failure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      444
    term
    Myocardial ischemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      447
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      444
    term
    Sinus arrhythmia

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