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NCT00721513 · ADVERSE EVENTS

Adverse events

Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer · Source last updated 2020-04-07

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
Up to 2 years after completion of treatment
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
TPFChemotherapy + Concomitant Cetuximab & RT

Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy cetuximab cisplatin docetaxel fluorouracil computed tomography positron emission tomography quality-of-life assessment 3-dimensional conformal radiation therapy intensity-modulated radiation therapy

20 / 2020 / 201 / 20

Group identifiers: EG000: TPFChemotherapy + Concomitant Cetuximab & RT

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    term
    Low WBC
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    low Platelets
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Low Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
      num Events
      9
    term
    Low ANC
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Weight loss
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    hyperglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    hypocalcemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    hypomagnesemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    hyponatremia

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
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Low WBC
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      20
      num Events
      14
    term
    low Platelets
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Low Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      20
      num Events
      18
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      20
      num Events
      15
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Gastrointestinal - Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
      num Events
      9
    term
    Alkaline phosphatase
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Proteinuria
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    term
    Dyspnea
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    20
    description
    Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy cetuximab cisplatin docetaxel fluorouracil computed tomography positron emission tomography quality-of-life assessment 3-dimensional conformal radiation therapy intensity-modulated radiation therapy
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    20
    serious Num At Risk
    20
    title
    TPFChemotherapy + Concomitant Cetuximab & RT
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Low WBC
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      20
      num Events
      14
    term
    low Platelets
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Low Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      20
      num Events
      18
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      20
      num Events
      15
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Gastrointestinal - Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
      num Events
      9
    term
    Alkaline phosphatase
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Creatinine
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Proteinuria
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    term
    Dyspnea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    term
    Low WBC
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    low Platelets
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    term
    Low Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      4
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
      num Events
      9
    term
    Low ANC
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Weight loss
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    hyperglycemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    hypocalcemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    hypomagnesemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      13
    term
    hyponatremia
time Frame
Up to 2 years after completion of treatment

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Preserved source evidence · Not medical advice