ABSTRACT
Bullets to Remember DMCs use clinical data to separate signal from noise, that is, to differentiate
adverse events associated with the study drug from those with other etiologies. A serious adverse event (SAE) is any untoward medical occurrence that, at
any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
