Table 5.

Example analysis by seriousness models

Model inputs	Model outputs
Narrative: patient was hospitalized for arrhythmia and passed away 3 days later from cardiac arrest AE: arrhythmia MedDRA® PT: arrhythmia; LLT: arrhythmia AE: cardiac arrest MedDRA® PT: cardiac arrest; LLT: cardiac arrest	Binary seriousness classifier  AE: arrhythmia = serious  AE: cardiac arrest = serious  Case = serious
	Seriousness category classifier  AE: arrhythmia = hospitalization, IME  AE: cardiac arrest = death
	Annotator  Patient was hospitalized for arrhythmia and passed away 3 days later from cardiac arrest

AE adverse event, LLT lowest level term, MedDRA^® Medical Dictionary for Regulatory Activities, PT preferred term, IME important medical event