Table 2 Event recording
Event | If the event is thought to be an adverse reaction | If the event is not thought to be an adverse reaction |
|---|---|---|
Lidocaine toxicity within 2 h of infusion | Record on adverse event log (SARa if meets criteria for serious) | n/a |
Transient events common after surgery (listed in the protocol as: pyrexia; anorexia, nausea, vomiting, constipation, pain; raised inflammatory markers; minor wound infections; dizziness; transient biochemical derangement e.g. hypokalaemia, hyponatraemia, hypomagnesaemia, hypophosphataemia, hypocalcaemia; transient self-limiting confusional state) | Record on adverse event log | Recorded on adverse event log |
Complications of surgery Clavien-Dindo grade 1/2 | Record on adverse event log | Recorded on adverse event log |
Complications of surgery Clavien-Dindo grade 3+ | Record as SAR/SUSAR; report to sponsor within 24 h of becoming aware | Record as outcome data on CRFb |
Prolongation of admission for social reasons | n/a | Record as outcome data on CRF |
Death | Record as SAR/SUSAR; report to sponsor within 24 h of becoming aware | Record as SAE; report to sponsor within 24 h of becoming aware |