Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events

摘要

Potential concealment of AEs by NAEs. Negatively adjudicated events may conceal potentially reportable AEs if the event leads to hospitalization, death, or severe illness and is not attributable to the disease process the trial intervention is seeking to prevent. AE, adverse event; NAE, negatively adjudicated event