The Sponsor who is non-commercial and not Marketing Authorization Holder (MAH) for any of the Investigational Medicinal Products (IMPs) will report all relevant information about a suspected unexpected serious adverse reaction (SUSAR) which occurs during the course of a clinical trial and is fatal or life-threatening as soon as possible to competent authority (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), the relevant Ethics Committees, the investigators and the manufacturers of the study drugs. This needs to be done not later than 7 days after the Sponsor was first aware of the reaction. Any additional relevant information should be sent within 8 days of the report.