Serious adverse events/reactions (SAE/SAR) and suspected unexpected serious adverse reactions (SUSARs)
EVENT
The principal investigator and other investigators will record, evaluate, and report all SAEs and SUSARs throughout the trial. Patients will therefore be followed for late-onset SAEs until completion of the trial (1 year). The sponsor of the trial will be registered in the EudraVigilance system prior to initiation of the trial and is responsible for reporting any SUSARs to the EudraVigilance system and the ethics committee as soon as possible, at latest 7 days following awareness of event if life-threatening. If the SUSAR is not life-threating, the event will be reported at latest 15 days following awareness of the event.