Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02926573 · ADVERSE EVENTS

Adverse events

Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients · Source last updated 2018-08-08

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 the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Gabapentin

Gabapentin liquid by mouth or per Tube 300mg twice a day

0 / 5546 / 550 / 55
Placebo

Placebo liquid by mouth or Per Tube twice a day

0 / 5550 / 551 / 55

Group identifiers: EG000: Gabapentin · EG001: Placebo

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
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Acidosis
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Acute kidney injury
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Acute renal failure
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        55
      term
      Agitation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Airway bleed
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Airway edema
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        55
      term
      Alkalosis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        55
      term
      Allergic contact dermatitis
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        32
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        35
        num At Risk
        55
      term
      Anemia
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        55
      term
      Anxiety
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        55
      term
      Aspiration
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        55
      term
      Atrial fibrillation
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      55
      description
      Gabapentin liquid by mouth or per Tube 300mg twice a day
      id
      EG000
      other Num Affected
      46
      other Num At Risk
      55
      serious Num Affected
      0
      serious Num At Risk
      55
      title
      Gabapentin
    2. deaths Num Affected
      1
      deaths Num At Risk
      55
      description
      Placebo liquid by mouth or Per Tube twice a day
      id
      EG001
      other Num Affected
      50
      other Num At Risk
      55
      serious Num Affected
      0
      serious Num At Risk
      55
      title
      Placebo
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Acidosis
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Acute kidney injury
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Acute renal failure
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        55
      term
      Agitation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Airway bleed
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        55
      term
      Airway edema
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        55
      term
      Alkalosis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        55
      term
      Allergic contact dermatitis
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        32
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        35
        num At Risk
        55
      term
      Anemia
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        55
      term
      Anxiety
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        55
      term
      Aspiration
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        55
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        55
      term
      Atrial fibrillation
    time Frame
    Adverse events were collected from the day of surgery to the end of the study which is post-operative day 3 or sooner if discharge is sooner than post-operative day 3.

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

    Preserved source evidence · Not medical advice