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Serious Adverse Event

   Also found in: Acronyms, Wikipedia 0.01 sec.
Serious Adverse Event
Any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect


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There were 121 (15A[cedilla]7%) serious adverse events in the nadroparin group and 67 (17A[cedilla]6%) serious adverse events in the placebo group.
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a "responsible person" is required to Submit to FDA within 15 days any serious adverse event it receives in association with its products.
Overdoses and seizures were the most common serious adverse events associated with diacetylmorphine.
 
 
 
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