Listed Side Effect

An Adverse Event is considered “listed” if it is described in the product’s Company Core Safety Information (CCSI) or if the events are symptomatically and physio-pathologically similar to the event described in the CCSI or the Drug Company Safety Information (DCSI). Adverse events not described in the CCSI or DCSI or differing in nature or of greater severity from the CCSI or DCSI, are considered “unlisted”. In cases where it is unclear whether or not a reported event is listed, the event will be considered unlisted.