Table 4.
Summary of AEs
| Patients (N = 157) | |
|---|---|
| Any patient with an AE, n (%)* | 147 (94) |
| Severity by event, number of events (%)* | |
| Mild | 1592 (74) |
| Moderate | 502 (23) |
| Severe | 62 (3) |
| Patients reporting at least 1 related AE, n (%) | 84 (54) |
| Patients reporting at least 1 serious AE, n (%) | 27 (17) |
| Patients with an AE leading to withdrawal, n (%) | 12 (8) |
| Deaths | 0 |
| Related AEs by patient in ≥5% of patients, n (%)† | 81 (53) |
| Abdominal pain upper | 11 (7) |
| Arthralgia | 9 (6) |
| Dyspepsia | 9 (6) |
| Fatigue | 8 (5) |
| Gastritis | 8 (5) |
| Diarrhea | 8 (5) |
| Nerve conduction studies abnormal | 8 (5) |
*
Regardless of relationship to eliglustat.
†
Considered by investigator to be possibly, probably, or definitely related to eliglustat. Two related AEs in 2 patients were considered serious and possibly related to eliglustat (neither led to trial withdrawal): 1 peripheral neuropathy (moderate), 1 bowel obstruction from Meckel diverticulum (severe).