Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Presenting AE rates using a higher incidence threshold than what is used in the PM
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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).
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Hello @dmauri
PAAB will generally consider alternate cut offs from the TMA if it does not appear to be minimizing the risks of the product. The alternate cut-offs should not remove pertinent ADRs/safety information that would otherwise be important to the product and within the therapeutic landscape. The TMA should also not have other safety considerations that would preclude the higher percentage cutoff.
