It is true that the structure and definitions provided in the ICH E3 Guideline could result in deaths appearing in Section 12.3.1.2 (as per E3 numbering), Other Serious Adverse Events, if an event terminated with, or was associated with, a subject’s death.
However, this should not result in double- or mis-counting of deaths. Although deaths may or may not be included in the listing for Section
12.3.1.2, all deaths should be captured in the listing for Section 12.3.1.1. That is, any subject death reported under Section 12.3.1.2 as an “other serious adverse event” with a fatal outcome would also have been captured under deaths in Section 12.3.1.1.
