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NCT00608205 · ADVERSE EVENTS

Adverse events

Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2020-08-06

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
Adverse event data was collected over a 2 year period from study start.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Radiation With Concurrent Cisplatin

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

7 / 3535 / 35Not reported / Not reported
Arm B: Radiation With Concurrent 5-FU and Cisplatin

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

14 / 3434 / 34Not reported / Not reported

Group identifiers: EG000: Arm A: Radiation With Concurrent Cisplatin · EG001: Arm B: Radiation With Concurrent 5-FU and Cisplatin

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
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Anorexia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Aspiration
  4. 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
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      34
    term
    Cardiac
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Cranial Neuropathy/ Hearing and Balance
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    term
    Dehydration
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Dizziness
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      34
    term
    Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Fracture
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Hypoalbuminemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Hypocalcemia

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
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Cranial Neuropathy/ Hearing and Balance
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      34
    term
    Dysphagia (difficulty swallowing)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      34
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Increased Creatinine
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      34
    term
    Mucositis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      34
    term
    Mucositis/Dysphagia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      34
    term
    Nausea/Vomiting
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      34
    term
    Neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      34
    term
    Skin Toxicity from Radiation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      34
    term
    Stomatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      34
    term
    Thrombocytopenia
Complete source fields
event Groups
  1. description
    Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
    id
    EG000
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    7
    serious Num At Risk
    35
    title
    Arm A: Radiation With Concurrent Cisplatin
  2. description
    Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
    id
    EG001
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    14
    serious Num At Risk
    34
    title
    Arm B: Radiation With Concurrent 5-FU and Cisplatin
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Cranial Neuropathy/ Hearing and Balance
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      34
    term
    Dysphagia (difficulty swallowing)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      34
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Increased Creatinine
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      34
    term
    Mucositis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      34
    term
    Mucositis/Dysphagia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      34
    term
    Nausea/Vomiting
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      34
    term
    Neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      34
    term
    Skin Toxicity from Radiation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      34
    term
    Stomatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      34
    term
    Thrombocytopenia
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
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Anorexia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Aspiration
  4. 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
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      34
    term
    Cardiac
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Cranial Neuropathy/ Hearing and Balance
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      34
    term
    Dehydration
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
    term
    Diarrhea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Dizziness
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      34
    term
    Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Fracture
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Hypoalbuminemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
    term
    Hypocalcemia
time Frame
Adverse event data was collected over a 2 year period from study start.

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