324 - Dear PAAB, what difference does it make when we combine data from duifferent sections of the TMA (PM). i.e can we put data from the clinical trial section and the adverse event section together since the adverse events are from the clinical trials?

  • In general, clinical trial data and its related adverse events from the same trial may be presented together when taken from the TMA. However, adverse events that are from combined clinical trials may not be presented such that it appears to come from the single source. It should be clearly labeled and appear distinct from the single clinical trial data.