2.5. Safety analysis
death, bleeding, congenital anomaly, blood loss, thrombotic
THROMBOEMBOLIC EVENT, BLEEDING, ADVERSE EVENTS, BLOOD LOSS, EVENT, EVENTS, COMPLICATIONS
The safety of avatrombopag was assessed by recording adverse events (AEs). These were reported by the patient or, when appropriate, by a caregiver, surrogate, or the patient’s legally authorized representative, and/or collected from data recorded in the patient’s medical record. The severity of each AE was recorded, with mild AEs defined as transient, requiring minimal treatment or intervention and not interfering with daily living; moderate AEs defined as being alleviated with specific therapeutic intervention causing some impairment to daily activities and discomfort but posing no significant or permanent risk of harm; and serious AEs defined as AEs resulting in death, a threat to life, hospitalization (even if admitted and discharged on the same day, although an emergency room attendance that did not result in admission was not included), or prolongation of existing hospitalization, a persistent or significant disability, a congenital anomaly, or a requirement for medical or surgical intervention to prevent any of the aforementioned criteria.AEs were deemed to be treatment-emergent AEs (TEAEs) or serious TEAEs when the time course between the administration of avatrombopag and the occurrence or worsening of the AE was consistent with a causal relationship and no other cause (concomitant drugs, therapies, complications, etc) could be identified. The AEs of special interest were defined as thromboembolic events (any thrombotic or embolic event, whether arterial or venous) and bleeding events (any clinically significant blood loss).