Term | Definition |
---|---|
Adverse event (AE) | Any untoward medical occurrence in a trial participant |
Serious adverse event (SAE) | An AE which is serious, defined as any untoward medical occurrence or effect that: • Results in death • Is life-threatening* • Requires hospitalisation or prolongation of existing inpatients’ hospitalisation** • Results in persistent or significant disability or incapacity • Is a congenital anomaly/birth defect • Is otherwise considered medically significant by the investigator*** |
Related AE/SAE | An AE or SAE which is related to a research procedure |
Unexpected AE/SAE | An AE or SAE which has not been pre-specified as expected |
Notable event | An event of particular interest that does not necessarily meet the criteria for seriousness but requires expedited reporting as per the protocol |