SAEs by organ group (e.g. MedDRA)

[aghaynes]

From ST:
I came across this guideline: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf

Maybe worth having a look to see whether some guidance can be derived in how safety information could (should?) be presented in the Annual Safety Report (if not already considered anyways, I have not checked …). For example:

Section 4.8.b provides guidance on how Adverse (Drug) Reactions should be tabulated. I think this could be helpful and extended to (Serious) Adverse Events. E.g. the ordering (although I acknowledge that this might be challenging given that we usually do not have MedRA codes but might still be good as a guidance) and the clustering according to incidence proportion groups (very common, common, …).
Section 4.8.Further guidance … might also be informative.