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NCT00248560 · ADVERSE EVENTS

Adverse events

Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer · Source last updated 2019-03-05

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Gemcitabine, Docetaxel

Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.

25 / 3633 / 36Not reported / Not reported

Group identifiers: EG000: Gemcitabine, Docetaxel

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      36
      num Events
      13
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      36
      num Events
      10
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      36
      num Events
      10
    term
    Hyponatremia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Dyspnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Febrile Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Fluid Retention

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
      num Events
      6
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      36
      num Events
      19
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      36
      num Events
      6
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      36
      num Events
      9
    term
    Hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      36
      num Events
      8
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      36
      num Events
      15
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
      num Events
      4
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Fluid Retention
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Mucositis
Complete source fields
event Groups
  1. description
    Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    36
    serious Num Affected
    25
    serious Num At Risk
    36
    title
    Gemcitabine, Docetaxel
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
      num Events
      6
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      36
      num Events
      19
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      36
      num Events
      6
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      36
      num Events
      9
    term
    Hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      36
      num Events
      8
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      36
      num Events
      15
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
      num Events
      4
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Fluid Retention
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Mucositis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      36
      num Events
      13
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      36
      num Events
      10
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      36
      num Events
      10
    term
    Hyponatremia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Dyspnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Febrile Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Fluid Retention

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