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Frequency, severity, and causality
A label groups adverse events by how often they occurred in trials, not by how alarming they sound. Common and mild is a different clinical situation from rare and serious, and both appear in the same list.
Causality is also graded: an event recorded during a trial is not necessarily caused by the intervention. Placebo-arm rates are the reference point.
Fig. 02 / Molecular pathway02
Where post-marketing data comes in
Rare events often surface only after approval, through spontaneous reporting systems and observational studies. These systems detect signals; they rarely establish incidence on their own.
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