206 - Under what circumstances would it be acceptable to claim that two arms of a clinical trial have similar side effect profiles? Does it only relate to the type of most commonly reported adverse drug reactions in each arm or must the incidence also be comparable?

  • Broad comparative claims relating to side effect profile are only considered when they appear explicitly in the Product Monograph. When based on a study, a safety comparison would be subject to all PAAB code requirements (including limitation to specific adverse events defined a priori with corresponding statistical analysis).