Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs

Table 3 Adverse event definitions

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

^*The term life-threatening in the definition of a serious event refers to an event in which the patient is at risk of death at the time of the event; it does not refer to an event that hypothetically might cause death if it were more severe, for example, a silent myocardial infarction
^**Hospitalisation is defined as an inpatient admission, regardless of length of stay, even if the hospitalisation is a precautionary measure for continued observation. Hospitalisations for a pre-existing condition, that has not worsened or for an elective procedure do not constitute an SAE
^***Other important medical events that may not result in death, be life-threatening, or require hospitalisation may be considered a serious adverse event/experience when, based upon appropriate medical judgement, they may jeopardise the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition

ISSN: 1745-6215