Adverse event reporting and harms {22}
TSC
ADVERSE EVENTS, ADVERSE EVENT, EVENTS
Even though they are unlikely in this study, adverse events will be immediately reported to the TSC if classified as Related and Unsuspected Serious Adverse Events (RUSAEs), i.e. events that are unexpected in severity and seriousness and suspected to be related to the study intervention. The TSC will then report the case to the DMC with a tailored action plan.