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NCT01059357 · ADVERSE EVENTS

Adverse events

Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System · Source last updated 2018-11-16

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 6 months
Other-event reporting threshold
2%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Transoral Robotic Surgery (TORS)

Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System

0 / 547 / 540 / 54

Group identifiers: EG000: Transoral Robotic Surgery (TORS)

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
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        54
      term
      Blood loss
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        54
      term
      Chipped tooth
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        54
      term
      Pneumonia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        54
      term
      Postoperative bleeding
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      54
      description
      Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System Da Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System
      id
      EG000
      other Num Affected
      7
      other Num At Risk
      54
      serious Num Affected
      0
      serious Num At Risk
      54
      title
      Transoral Robotic Surgery (TORS)
    frequency Threshold
    2
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        54
      term
      Blood loss
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        54
      term
      Chipped tooth
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        54
      term
      Pneumonia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        54
      term
      Postoperative bleeding
    time Frame
    up to 6 months

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

    Preserved source evidence · Not medical advice