Adverse events (AEs) and serious adverse events (SAEs)
death
ADVERSE EVENTS, EVENTS
All adverse events reported spontaneously by the subject or observed by the investigator or his staff will be recorded.The investigator will report all SAEs to the sponsor without undue delay after obtaining knowledge of the events. The sponsor will report the SAEs through the Dutch web portal ToetsingOnline to the accredited METC that approved the protocol (MEC-U), within 7 days of first knowledge for SAEs that result in death or are life-threatening followed by a period of a maximum of 8 days to complete the initial preliminary report. All other SAEs will be reported within a period of a maximum of 15 days after the sponsor has first knowledge of the serious adverse events.