We have seen older APSs that present AE rates (in copy or in the form of a table) using a higher incidence threshold than what is used in the PM. For example, the PM's AE table shows all AEs that occurred in >1% of patients, but in the APS, the table only includes the AEs that occurred in >5% of patients.
Does the PAAB allow this in newer APSs?
On one hand, we understand that this shortens the list of AEs, which could be contentious. On the other hand, the presentation is still accurate and clear if it discloses the threshold that is used (e.g., AEs that occurred in >5% of patients).