Long-term adverse event profile from four completed trials of oral eliglustat in adults with Gaucher disease type 1

Table 3 Treatment-related serious adverse events

Trial	Patient	Preferred Term	Severity	Action Taken	Outcome	Relatedness^a Subcategory
Phase 2 (N = 26)	1	Ventricular tachycardia	Mild	Patient withdrawn	Recovered	Possible
ENGAGE (N = 40)	2	Atrioventricular block	Mild	Drug adjusted^b	Recovered	Probable
ENGAGE (N = 40)	2	Atrioventricular block second degree	Mild	Drug adjusted^b	Recovered	Probable
ENCORE (N = 157)	3	Neuropathy peripheral	Moderate	Drug interrupted	Recovered	Possible
ENCORE (N = 157)	4	Intestinal obstruction	Severe	Drug interrupted	Recovered	Possible
EDGE (N = 170)	6	Syncope	Moderate	None	Recovered	Possible
		Muscular weakness	Moderate	None	Not Recovered	Possible
	7	Arrhythmia	Moderate	Patient withdrawn	Recovered	Probable
	5	Syncope	Severe	Drug interrupted	Recovered	Possible
	8	Syncope	Severe	Drug adjusted^b	Recovered	Definite

ISSN: 1750-1172