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NCT00639769 · ADVERSE EVENTS

Adverse events

Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer · Source last updated 2012-09-14

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
Therapeutic Intervention

Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2

27 / 400 / 40Not reported / Not reported

Group identifiers: EG000: Therapeutic Intervention

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal distention
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal pain
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Anorexia
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Aspiration pneumonia
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Chills
  6. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cholelithiasis
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Creatinine increased
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      13
    term
    Dehydration
  9. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Depressed level of consciouness
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
      num Events
      11
    term
    Diarrhea
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dysphagia - esophageal (related to radiation)
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Dysphagia, esophagitis, odynophagai

Other reported adverse events

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

    Complete source fields
    event Groups
    1. description
      Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      40
      serious Num Affected
      27
      serious Num At Risk
      40
      title
      Therapeutic Intervention
    frequency Threshold
    5
    serious Events
    1. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      term
      Abdominal distention
    2. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      term
      Abdominal pain
    3. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        40
        num Events
        2
      term
      Anorexia
    4. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      term
      Aspiration pneumonia
    5. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      term
      Chills
    6. organ System
      Hepatobiliary disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      term
      Cholelithiasis
    7. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        40
        num Events
        2
      term
      Creatinine increased
    8. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        13
        num At Risk
        40
        num Events
        13
      term
      Dehydration
    9. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      term
      Depressed level of consciouness
    10. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        40
        num Events
        11
      term
      Diarrhea
    11. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        40
        num Events
        1
      term
      Dysphagia - esophageal (related to radiation)
    12. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        40
        num Events
        3
      term
      Dysphagia, esophagitis, odynophagai

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    Preserved source evidence · Not medical advice