2.8.2. Definition of serious adverse events.
ADVERSE EVENTS, EVENTS, DISEASES
Serious adverse events refer to any of the following among the above events.DeathClinical conditions that might lead to deathClinical conditions that require hospitalization for treatment or prolong the duration of hospitalizationDisabilityClinical conditions that might lead to disabilitySerious medical conditions comparable to 1) to 5)Congenital diseases or anomalies in later generations