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NCT02388932 · ADVERSE EVENTS

Adverse events

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer · Source last updated 2019-01-24

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 were collected from start of treatment to end of study (over a period of approximately 6 months).
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (SBRT)

Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Stereotactic Body Radiation Therapy: Undergo SBRT Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT Quality-of-Life Assessment: Ancillary studies

0 / 31 / 33 / 3

Group identifiers: EG000: Treatment (SBRT)

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
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      pain
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Fatigue
    Complete source fields
    event Groups
    1. deaths Num Affected
      3
      deaths Num At Risk
      3
      description
      Patients undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Stereotactic Body Radiation Therapy: Undergo SBRT Positron Emission Tomography: Undergo PET/CT Computed Tomography: Undergo PET/CT Quality-of-Life Assessment: Ancillary studies
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      Treatment (SBRT)
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      pain
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      term
      Fatigue
    time Frame
    Adverse events were collected from start of treatment to end of study (over a period of approximately 6 months).

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

    Preserved source evidence · Not medical advice