Hello,
The Product Monograph for a drug I work on is being updated. Specifically, there is adverse event information being added from a Dose Regimen study (which doesn't have a placebo arm). This data will be presented separately from the adverse event information from the placebo-controlled studies. My question is: what implications will this have for safety claims in promotional pieces? If we were to make a claim of "demonstrated safety profile", would we necessarily need to include the most common AEs from BOTH the placebo-controlled and Dose Regimen studies?