Definition of Serious Adverse Event/Reaction


Serious Adverse Event/Reaction means an Adverse Event/Reaction that (i) results in death; (ii) is life-threatening; that is, an event where the patient and/or clinical investigation subject was at risk of death at the time of the event and not an event that, hypothetically, might have caused death if it had been more severe; (iii) requires hospitalization or prolongation of existing hospitalization; (iv) results in persistent or significant disability or incapacity; (v) is a congenital anomaly or birth defect in the fetus/child, fetal death, spontaneous abortion and serious adverse reactions in the neonate; (vi) involves suspected infection via a Licensed Product of an infectious agent or (vii) may not be immediately life-threatening or result in death or hospitalization and may jeopardize the subject or require medical or surgical intervention to prevent one of the outcomes listed in (i) - (vi). For the avoidance of doubt, a "Serious Adverse Event/Reaction" includes all occurrences which would be regarded as "serious adverse drug reactions" under Applicable Law of the applicable country in the Territory.
Sample 1