Serious Adverse Events & SAE Reconciliation

• Adverse event (AE): any untoward medical occurrence in a participant, whether or not related to the study drug. • Serious adverse event (SAE): an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect, or is another important medical event. • 'Serious' (outcome-based) is different from 'severe' (intensity). A severe headache can be non-serious.