Table 2.
AEs Reported in the Open-Label Extension Study (Interim Analysis)
| DS n=264 | LGS n=366 | |
|---|---|---|
| All-causality AEs, n (%) | 246 (93.2) | 337 (92.1) |
| AEs leading to withdrawal, n (%) | 19 (7.2) | 35 (9.6) |
| AEs reported in >10% of patients, n (%) | ||
| Diarrhea | 91 (34.5) | 98 (26.8) |
| Pyrexia | 72 (27.3) | 69 (18.3) |
| Decreased appetite | 67 (25.4) | 65 (17.8) |
| Somnolence | 65 (24.6) | 86 (23.5) |
| Nasopharyngitis | 41 (15.5) | |
| Convulsion | 40 (15.2) | 78 (21.3) |
| Vomiting | 37 (14.0) | |
| Upper respiratory tract infection | 36 (13.6) | 53 (14.5) |
| Status epilepticus | 29 (11.0) | |
| Fatigue | 27 (10.2) | |
| SAEs, n (%) | 77 (29.2) | 94 (25.7) |
| SAEs reported in >1% patients, n (%) | ||
| Status epilepticus | 29 (11.0) | 26 (7.1) |
| Convulsion | 13 (4.9) | 20 (5.5) |
| Pyrexia | 10 (3.8) | |
| Pneumonia | 7 (2.7) | 9 (2.5) |
| AST increased | 5 (1.9) | 6 (1.6) |
| ALT increased | 6 (1.6) | |
| Hepatic enzyme increased | 4 (1.1) | |
| Pneumonia aspiration | 6 (1.6) | |
| Dehydration | 4 (1.5) | |
| Influenza | 4 (1.5) | |
| GTCSs | 4 (1.5) | |
| Diarrhea | 3 (1.1) |