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NCT02254278 · ADVERSE EVENTS

Adverse events

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer · Source last updated 2026-05-22

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
Weekly during treatment, at 1 and 3 months after end of treatment, then every 3 months from end of treatment for 2 years, every 6 months from end of treatment for 3 years, then annually until study completion. Maximum follow-up at time of reporting was 4.1 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
IMRT 6 Weeks + Cisplatin

Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy

31 / 152152 / 1526 / 152
IMRT 5 Weeks

IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy

11 / 147147 / 1476 / 147

Group identifiers: EG000: IMRT 6 Weeks + Cisplatin · EG001: IMRT 5 Weeks

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    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
      4
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Febrile neutropenia
  3. 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
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Heart failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Retinal detachment
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      147
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      147
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Esophagitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      147
    term
    Gastrointestinal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Oral pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Fever
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Flu like symptoms

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
      92
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      147
    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
      8
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      147
    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
      43
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      147
    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
      65
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      147
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      147
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      147
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      147
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      142
      num At Risk
      147
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      147
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      124
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      147
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      147
    term
    Gastroesophageal reflux disease
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      147
    term
    Gastrointestinal disorders - Other
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    152
    description
    Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks IMRT 6 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    id
    EG000
    other Num Affected
    152
    other Num At Risk
    152
    serious Num Affected
    31
    serious Num At Risk
    152
    title
    IMRT 6 Weeks + Cisplatin
  2. deaths Num Affected
    6
    deaths Num At Risk
    147
    description
    IMRT 5 weeks: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    id
    EG001
    other Num Affected
    147
    other Num At Risk
    147
    serious Num Affected
    11
    serious Num At Risk
    147
    title
    IMRT 5 Weeks
frequency Threshold
5
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
      92
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      147
    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
      8
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      147
    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
      43
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      147
    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
      65
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      147
    term
    Tinnitus
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      147
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      147
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      147
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      142
      num At Risk
      147
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      147
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      124
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      147
    term
    Dysphagia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      147
    term
    Gastroesophageal reflux disease
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      147
    term
    Gastrointestinal disorders - Other
serious 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
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    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
      4
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Febrile neutropenia
  3. 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
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Heart failure
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Retinal detachment
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      147
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      147
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Esophagitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      147
    term
    Gastrointestinal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Oral pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Fever
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      152
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      147
    term
    Flu like symptoms
time Frame
Weekly during treatment, at 1 and 3 months after end of treatment, then every 3 months from end of treatment for 2 years, every 6 months from end of treatment for 3 years, then annually until study completion. Maximum follow-up at time of reporting was 4.1 years.

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