The seriousness of events described in spontaneous ICSRs does not obviously relate to the probability that they are causally related with the medicine. However, it may impact the patient and public health importance should they later prove to be related. This reason is a rationale for prioritising assessment of serious events. Complementary to the creation of a list of DMEs and in addition to the use of lists of IMEs, a simple approach to such prioritisation is to highlight new ICSRs in which a death is reported and to give separate counts of those ICSRs for each DEC. It should be appreciated that this may be a rather imprecise criterion and prioritising all ICSRs with reported death may result in many false positive signals. Hence it is considered that further methodological research may be required in this area.