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An Entity of Type : prov:Entity, within Data Space : webisadb.webdatacommons.org associated with source dataset(s)

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  • Adverse Event Reporting (AER) would be created only for serious adverse events which is defined as an experience that resulted in (A) Death(B) A life-threatening condition(C) An inpatient hospitalization or prolongation of hospitalization(D) A persistent or significant disability or incapacity(E) A congenital anomaly, birth defect, or other effect on pregnancy, including premature labor or low bir
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