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NCT00509002 · ADVERSE EVENTS

Adverse events

Iressa Study in Patients With Salivary Gland Cancer · Source last updated 2017-11-24

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
Adverse events collected every four weeks during treatment at regular assessment, participation expected up to 12 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Gefitinib

Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.

0 / 3737 / 37Not reported / Not reported

Group identifiers: EG000: Gefitinib

Serious adverse events

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

    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 (3.0)
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        37
        num Events
        11
      term
      Anorexia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        30
        num At Risk
        37
        num Events
        30
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        37
        num Events
        8
      term
      Dry skin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        15
        num At Risk
        37
        num Events
        16
      term
      Fatigue
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        37
        num Events
        8
      term
      Rash/desquamation
    Complete source fields
    event Groups
    1. description
      Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
      id
      EG000
      other Num Affected
      37
      other Num At Risk
      37
      serious Num Affected
      0
      serious Num At Risk
      37
      title
      Gefitinib
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        37
        num Events
        11
      term
      Anorexia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        30
        num At Risk
        37
        num Events
        30
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        37
        num Events
        8
      term
      Dry skin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        15
        num At Risk
        37
        num Events
        16
      term
      Fatigue
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        37
        num Events
        8
      term
      Rash/desquamation
    time Frame
    Adverse events collected every four weeks during treatment at regular assessment, participation expected up to 12 months.

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

    Preserved source evidence · Not medical advice