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NCT01302834 · ADVERSE EVENTS

Adverse events

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer · Source last updated 2026-07-20

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
From randomization to last follow-up. Maximum follow-up was 7.4 years.
Other-event reporting threshold
5%

Eligible patients who started treatment are included. Patients 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
IMRT + Cisplatin

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

177 / 398398 / 39864 / 406
IMRT + Cetuximab

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

115 / 394393 / 39486 / 399

Group identifiers: EG000: IMRT + Cisplatin · EG001: IMRT + 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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Spleen disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Acute coronary syndrome
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Aortic valve disease
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      394
    term
    Atrial fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      394
    term
    Cardiac arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Cardiac disorders - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Chest pain - cardiac
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Left ventricular systolic dysfunction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      394
    term
    Myocardial infarction

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      118
      num At Risk
      394
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      394
    term
    Ear pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      192
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      394
    term
    Hearing impaired
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      394
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      394
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      394
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      394
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      240
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      214
      num At Risk
      394
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      394
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      376
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      372
      num At Risk
      394
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      394
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      371
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      351
      num At Risk
      394
    term
    Dysphagia
Complete source fields
description
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event
event Groups
  1. deaths Num Affected
    64
    deaths Num At Risk
    406
    description
    Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
    id
    EG000
    other Num Affected
    398
    other Num At Risk
    398
    serious Num Affected
    177
    serious Num At Risk
    398
    title
    IMRT + Cisplatin
  2. deaths Num Affected
    86
    deaths Num At Risk
    399
    description
    Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
    id
    EG001
    other Num Affected
    393
    other Num At Risk
    394
    serious Num Affected
    115
    serious Num At Risk
    394
    title
    IMRT + Cetuximab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      118
      num At Risk
      394
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      394
    term
    Ear pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      192
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      394
    term
    Hearing impaired
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      394
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      394
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      394
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      394
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      240
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      214
      num At Risk
      394
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      394
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      376
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      372
      num At Risk
      394
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      394
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      371
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      351
      num At Risk
      394
    term
    Dysphagia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Spleen disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Acute coronary syndrome
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Aortic valve disease
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      394
    term
    Atrial fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      394
    term
    Cardiac arrest
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Cardiac disorders - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Chest pain - cardiac
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Left ventricular systolic dysfunction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      398
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      394
    term
    Myocardial infarction
time Frame
From randomization to last follow-up. Maximum follow-up was 7.4 years.

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