Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00274937 · ADVERSE EVENTS

Adverse events

Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer · Source last updated 2022-10-25

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)

Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before. amifostine trihydrate: Given subcutaneously fluorouracil: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies radiation therapy: Undergo radiotherapy

79 / 11136 / 111Not reported / Not reported

Group identifiers: EG000: Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      111
    term
    Abdominal infection
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      111
    term
    Abdominal pain
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Acidosis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Activated partial thromboplastin time prolonged
  5. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      111
    term
    Acute kidney injury
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      111
    term
    Alanine aminotransferase increased
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Allergic reaction
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    term
    Anemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      111
    term
    Anorexia
  10. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Anxiety
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Apnea
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Aspartate aminotransferase increased

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Constipation
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Diarrhea
  3. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Dizziness
  4. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Dysgeusia
  5. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Ear and labyrinth disorders - Other, specify
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Ear pain
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Esophageal pain
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      111
    term
    Fever
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Gastrointestinal disorders - Other, specify
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Headache
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      111
    term
    Hearing impaired
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Hyperglycemia
Complete source fields
event Groups
  1. description
    Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before. amifostine trihydrate: Given subcutaneously fluorouracil: Given IV cisplatin: Given IV laboratory biomarker analysis: Correlative studies radiation therapy: Undergo radiotherapy
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    111
    serious Num Affected
    79
    serious Num At Risk
    111
    title
    Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Constipation
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Diarrhea
  3. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Dizziness
  4. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Dysgeusia
  5. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Ear and labyrinth disorders - Other, specify
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Ear pain
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Esophageal pain
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      111
    term
    Fever
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Gastrointestinal disorders - Other, specify
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Headache
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      111
    term
    Hearing impaired
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Hyperglycemia
serious Events
  1. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      111
    term
    Abdominal infection
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      111
    term
    Abdominal pain
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Acidosis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Activated partial thromboplastin time prolonged
  5. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      111
    term
    Acute kidney injury
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      111
    term
    Alanine aminotransferase increased
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Allergic reaction
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      111
    term
    Anemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      111
    term
    Anorexia
  10. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Anxiety
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Apnea
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      111
    term
    Aspartate aminotransferase increased

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

Preserved source evidence · Not medical advice