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NCT00057785 · ADVERSE EVENTS

Adverse events

Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer · Source last updated 2017-02-17

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 nonserious adverse events (AE).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
IMRT +/- Chemotherapy

Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

55 / 6868 / 68Not reported / Not reported

Group identifiers: EG000: IMRT +/- Chemotherapy

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Febrile neutropenia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      68
    term
    Hemoglobin decreased
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    term
    Packed red blood cell transfusion
  4. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Edema NOS
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Left ventricular failure
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Sinus tachycardia
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Supraventricular arrhythmia NOS
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Ventricular arrhythmia NOS
  9. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    term
    Hearing impaired
  10. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Hearing-Other
  11. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
    term
    Otitis externa (exc boil of meatus) NOS
  12. organ System
    Endocrine disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
    term
    Endocrine-Other

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    term
    Hematologic-Other
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      68
    term
    Hemoglobin decreased
  3. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      68
    term
    Edema NOS
  4. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    term
    Earache
  5. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      68
    term
    Hearing impaired
  6. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      68
    term
    Hearing-Other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      68
    term
    Late RT toxicity: Auditory/hearing: NOS
  8. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    term
    Otitis media serous NOS
  9. organ System
    Endocrine disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      68
    term
    Hypothyroidism
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      68
    term
    Constipation
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      68
    term
    Diarrhea NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      68
    term
    Dry mouth
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 nonserious adverse events (AE).
event Groups
  1. description
    Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
    id
    EG000
    other Num Affected
    68
    other Num At Risk
    68
    serious Num Affected
    55
    serious Num At Risk
    68
    title
    IMRT +/- Chemotherapy
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    term
    Hematologic-Other
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      68
    term
    Hemoglobin decreased
  3. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      68
    term
    Edema NOS
  4. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    term
    Earache
  5. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      68
    term
    Hearing impaired
  6. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      68
    term
    Hearing-Other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    RTOG/EORTC Late Tox.
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      68
    term
    Late RT toxicity: Auditory/hearing: NOS
  8. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      68
    term
    Otitis media serous NOS
  9. organ System
    Endocrine disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      68
    term
    Hypothyroidism
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      68
    term
    Constipation
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      68
    term
    Diarrhea NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      68
    term
    Dry mouth
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Febrile neutropenia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      68
    term
    Hemoglobin decreased
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      68
    term
    Packed red blood cell transfusion
  4. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Edema NOS
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Left ventricular failure
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Sinus tachycardia
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Supraventricular arrhythmia NOS
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    term
    Ventricular arrhythmia NOS
  9. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
    term
    Hearing impaired
  10. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    term
    Hearing-Other
  11. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
    term
    Otitis externa (exc boil of meatus) NOS
  12. organ System
    Endocrine disorders
    source Vocabulary
    CTC (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
    term
    Endocrine-Other

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Preserved source evidence · Not medical advice