Safety
death
ADVERSE EVENTS, EVENT
Since EnGraft is a phase-IV clinical trial using marketed IMPs within their licensed indication (LTx), there is no additional risk expected for randomised patients.All adverse events and reactions will be documented in the eCRF and will be classified as serious or non-serious and IMP-related or not IMP-related by the investigator. All adverse events (AE) must be recorded in the eCRF database as soon as possible, but within 10 days of awareness. Serious adverse events (SAE) must additionally be reported on a SAE report form to the sponsor within 24 h of awareness. In the case that a SAE is classified as a SUSAR, the sponsor will report all relevant information concerning this SUSAR to the national competent authority, lead ethics committee, chief investigator and principal investigators at all participating trial centres within 15 days after sponsor awareness, in case of fatal or life-threatening SUSARs within 7 days after sponsor awareness. The report should contain date of onset of the event, outcome, date and cause of death (for fatal outcome), dosing of IMPs at the time of the event and the assessment of the causal relationship to all IMPs.