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NCT00820248 · ADVERSE EVENTS

Adverse events

Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer · Source last updated 2023-08-22

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
6.2 years
Other-event reporting threshold
5%

Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.

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

Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy

0 / 156156 / 15643 / 160
Panitumumab

Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy

0 / 159159 / 15932 / 160

Group identifiers: EG000: Cisplatin · EG001: Panitumumab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    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
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        25
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        159
      term
      Hearing (monitoring program)
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        50
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        20
        num At Risk
        159
      term
      Hearing (without monitoring program)
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        8
        num At Risk
        159
      term
      Pain External ear
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        24
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        29
        num At Risk
        159
      term
      Pain Middle ear
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        98
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        18
        num At Risk
        159
      term
      Tinnitus
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        21
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        22
        num At Risk
        159
      term
      Hypothyroidism
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        159
      term
      Dry eye
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        159
      term
      Chelitis
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        123
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        113
        num At Risk
        159
      term
      Constipation
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        29
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        40
        num At Risk
        159
      term
      Diarrhea
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        141
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        146
        num At Risk
        159
      term
      Dry mouth
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        144
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        150
        num At Risk
        159
      term
      Dysphagia
    Complete source fields
    description
    Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
    event Groups
    1. deaths Num Affected
      43
      deaths Num At Risk
      160
      description
      Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. cisplatin: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
      id
      EG000
      other Num Affected
      156
      other Num At Risk
      156
      serious Num Affected
      0
      serious Num At Risk
      156
      title
      Cisplatin
    2. deaths Num Affected
      32
      deaths Num At Risk
      160
      description
      Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. panitumumab: Given IV 3-dimensional conformal radiation therapy: Patients undergo radiotherapy accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy intensity-modulated radiation therapy: Patients undergo radiotherapy
      id
      EG001
      other Num Affected
      159
      other Num At Risk
      159
      serious Num Affected
      0
      serious Num At Risk
      159
      title
      Panitumumab
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        25
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        159
      term
      Hearing (monitoring program)
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        50
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        20
        num At Risk
        159
      term
      Hearing (without monitoring program)
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        8
        num At Risk
        159
      term
      Pain External ear
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        24
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        29
        num At Risk
        159
      term
      Pain Middle ear
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        98
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        18
        num At Risk
        159
      term
      Tinnitus
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        21
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        22
        num At Risk
        159
      term
      Hypothyroidism
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        159
      term
      Dry eye
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        159
      term
      Chelitis
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        123
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        113
        num At Risk
        159
      term
      Constipation
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        29
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        40
        num At Risk
        159
      term
      Diarrhea
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        141
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        146
        num At Risk
        159
      term
      Dry mouth
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        144
        num At Risk
        156
      2. group Id
        EG001
        num Affected
        150
        num At Risk
        159
      term
      Dysphagia
    time Frame
    6.2 years

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice