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NCT00047008 · ADVERSE EVENTS

Adverse events

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer · Source last updated 2023-07-07

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%

Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).

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

Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.

293 / 361360 / 361Not reported / Not reported
Accelerated Fractionation RT + Cisplatin

Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.

279 / 360356 / 360Not reported / Not reported

Group identifiers: EG000: Standard Fractionation RT + Cisplatin · EG001: Accelerated Fractionation RT + 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
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      360
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      360
    term
    Hemoglobin decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Lymphatics-Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      360
    term
    Packed red blood cell transfusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Circulatory or cardiac-Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      360
    term
    Myocardial ischaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Palpitations
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Supraventricular arrhythmia NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Hearing impaired
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Endocrine-Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      360
    term
    Diarrhea NOS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Dyspepsia

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
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      325
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      301
      num At Risk
      360
    term
    Hemoglobin decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      360
    term
    Hearing impaired
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      360
    term
    Hearing-Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      360
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      360
    term
    Diarrhea NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      360
    term
    Dry mouth
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      360
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      360
    term
    Esophageal spasm
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      360
    term
    Esophagitis NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      145
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      360
    term
    Late RT Toxicity: Esophagus: NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      161
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      360
    term
    Late RT Toxicity: Larynx: NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      143
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      360
    term
    Late RT Toxicity: Mucous Membrane: NOS
Complete source fields
description
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
event Groups
  1. description
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    id
    EG000
    other Num Affected
    360
    other Num At Risk
    361
    serious Num Affected
    293
    serious Num At Risk
    361
    title
    Standard Fractionation RT + Cisplatin
  2. description
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    id
    EG001
    other Num Affected
    356
    other Num At Risk
    360
    serious Num Affected
    279
    serious Num At Risk
    360
    title
    Accelerated Fractionation RT + Cisplatin
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      325
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      301
      num At Risk
      360
    term
    Hemoglobin decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      360
    term
    Hearing impaired
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      360
    term
    Hearing-Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      360
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      360
    term
    Diarrhea NOS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      360
    term
    Dry mouth
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      360
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      360
    term
    Esophageal spasm
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      360
    term
    Esophagitis NOS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      145
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      360
    term
    Late RT Toxicity: Esophagus: NOS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      161
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      360
    term
    Late RT Toxicity: Larynx: NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      143
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      360
    term
    Late RT Toxicity: Mucous Membrane: NOS
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      360
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      360
    term
    Hemoglobin decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Lymphatics-Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      360
    term
    Packed red blood cell transfusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Circulatory or cardiac-Other
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      360
    term
    Myocardial ischaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Palpitations
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Supraventricular arrhythmia NOS
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Hearing impaired
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Endocrine-Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      360
    term
    Diarrhea NOS
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      360
    term
    Dyspepsia

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