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Simple Bone Cyst in Kids

Adverse Event Reporting

An adverse event (AE) is defined as any untoward medical occurrence in a trial patient administered a treatment, which does not necessarily have a causal relationship. An event can be any observed or reported unfavorable and unintended sign, symptom or disease.

Data regarding AEs are collected and reported to ensure safety of all subjects enrolled. All new events, as well as those that worsen in intensity or frequency relative to baseline, following treatment until 30 days afterwards, must be recorded in the source documents and case report forms. At minimum, the following information should be included:

  • Medical diagnosis (if not available, a description of each sign or symptom characterizing the AE)
  • Onset date
  • Seriousness, expectedness, severity, and attribution
  • Resolution date
  • Actions taken
  • Outcome

Unexpected and Serious Adverse Events

An unexpected AE is one for which the nature or severity of the event is not consistent with known side effects of the intervention.

A serious AE is any untoward medical occurrence that:

  • Results in death
  • Is life threatening (patient was at risk of death at the time of the event and not one which hypothetically might have caused death if it were more severe)
  • Requires in-patient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly or birth defect
  • Other important medical events that may jeopardize the patient or require intervention to prevent one of the other outcomes listed above

All serious, unexpected AEs must be reported to SickKids and the appropriate governing bodies (local REB) within 24 hours of learning about the event. If full information is not known, it may be provided at a later time in a follow up report. All serious AEs must be followed until resolution or stabilization.