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An adverse event is any untoward medical occurrence in a participant who received the study drug, whether or not it’s caused by the drug. What matters for reporting is that the event happened during the study and has raised a concern about safety or relatedness.

Because of that, an event occurring during the study can be reported as an adverse event, and if it’s serious and unexpected, it may trigger expedited reporting. If there’s a reasonable possibility the event is drug-related, it influences how we classify and prioritize the signal, but it doesn’t determine whether the event is an adverse event at all.

The Investigator’s Brochure lists events that are expected and their frequencies, but merely being listed does not disqualify an event from being an adverse event. Listing in the IB shows prior knowledge of expected effects, not a rule that excludes reporting.