bn:17382856n
Noun Concept
Categories: Drug safety, Clinical research, Pharmaceutical industry
EN
serious adverse event  serious adverse events  serious adverse reactions
EN
A serious adverse event in human drug trials is defined as any untoward medical occurrence that at any dose Results in death Is life-threatening Requires inpatient hospitalization or causes prolongation of existing hospitalization Results in persistent or significant disability/incapacity May have caused a congenital anomaly/birth defect Requires intervention to prevent permanent impairment or damageThe term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Wikipedia
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EN
A serious adverse event in human drug trials is defined as any untoward medical occurrence that at any dose Results in death Is life-threatening Requires inpatient hospitalization or causes prolongation of existing hospitalization Results in persistent or significant disability/incapacity May have caused a congenital anomaly/birth defect Requires intervention to prevent permanent impairment or damageThe term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Wikipedia
Untoward medical occurrence in human medical trials that is sufficiently serious and meeting criteria such as resulting in death, life-threatening situation, inpatient hospitalization, disability or incapacity, birth defect, or permanent impairment Wikidata