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Table 3 Treatment-related serious adverse events

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

Trial Patient Preferred Term Severity Action Taken Outcome Relatednessa Subcategory
Phase 2 (N = 26) 1 Ventricular tachycardia Mild Patient withdrawn Recovered Possible
ENGAGE (N = 40) 2 Atrioventricular block Mild Drug adjustedb Recovered Probable
Atrioventricular block second degree Mild Drug adjustedb Recovered Probable
ENCORE (N = 157) 3 Neuropathy peripheral Moderate Drug interrupted Recovered Possible
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7 Arrhythmia Moderate Patient withdrawn Recovered Probable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 adjustedb Recovered Definite
  1. aRelatedness to eliglustat was as determined by the investigator;
  2. b Eliglustat dosage was decreased from 150 mg BID to 50 mg BID