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NCT02084134 · ADVERSE EVENTS

Adverse events

Peri-Operative Steroid Management in Patients · Source last updated 2018-04-11

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
2%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Steroid Treatment Arm

Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg hydrocortisone: 100mg at the time of surgery dexamethasone: 0.5mg every 6 hours for a total of four doses

0 / 230 / 23Not reported / Not reported
Non-steroid Treatment

Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).

1 / 200 / 20Not reported / Not reported

Group identifiers: EG000: Steroid Treatment Arm · EG001: Non-steroid Treatment

Serious adverse events

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

  1. notes
    One patient in non-steroid group died from meningitis which was not felt to be related to the study.
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Death

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
      Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg hydrocortisone: 100mg at the time of surgery dexamethasone: 0.5mg every 6 hours for a total of four doses
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      23
      serious Num Affected
      0
      serious Num At Risk
      23
      title
      Steroid Treatment Arm
    2. description
      Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      20
      serious Num Affected
      1
      serious Num At Risk
      20
      title
      Non-steroid Treatment
    frequency Threshold
    2
    serious Events
    1. notes
      One patient in non-steroid group died from meningitis which was not felt to be related to the study.
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        23
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        20
        num Events
        1
      term
      Death

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

    Preserved source evidence · Not medical advice