TABLE 4.
Trial EP0092 incidence of overall TEAEs and most common TEAEs with onset during the treatment period (safety set)
| Placebo (n = 55) | PSL 100 mg b.i.d. (n = 60) | PSL 200 mg b.i.d. (n = 57) | PSL 400 mg b.i.d. (n = 59) | All PSL patients (n = 176) | |
|---|---|---|---|---|---|
| Any TEAEs, n (%) | 37 (67.3) | 48 (80.0) | 45 (78.9) | 49 (83.1) | 142 (80.7) |
| Drug‐related TEAEs | 15 (27.3) | 30 (50.0) | 31 (54.4) | 43 (72.9) | 104 (59.1) |
| Serious TEAEs | 3 (5.5) | 0 | 1 (1.8) | 5 (8.5) | 6 (3.4) |
| Severe TEAEs | 2 (3.6) | 4 (6.7) | 4 (7.0) | 3 (5.1) | 11 (6.3) |
| Discontinuations due to TEAEs | 2 (3.6) | 6 (10.0) | 6 (10.5) | 12 (20.3) | 24 (13.6) |
| Deaths | 0 | 0 | 0 | 0 | 0 |
| TEAEs a reported by ≥5% of all patients on placebo or PSL, n (%) | |||||
| Somnolence | 2 (3.6) | 10 (16.7) | 19 (33.3) | 20 (33.9) | 49 (27.8) |
| Dizziness | 4 (7.3) | 14 (23.3) | 10 (17.5) | 18 (30.5) | 42 (23.9) |
| Fatigue | 4 (7.3) | 5 (8.3) | 7 (12.3) | 14 (23.7) | 26 (14.8) |
| Headache | 8 (14.5) | 10 (16.7) | 9 (15.8) | 5 (8.5) | 24 (13.6) |
| Asthenia | 2 (3.6) | 6 (10.0) | 3 (5.3) | 2 (3.4) | 11 (6.3) |
| Insomnia | 0 | 1 (1.7) | 5 (8.8) | 4 (6.8) | 10 (5.7) |
| Irritability | 3 (5.5) | 4 (6.7) | 3 (5.3) | 3 (5.1) | 10 (5.7) |
| Memory impairment | 1 (1.8) | 0 | 3 (5.3) | 6 (10.2) | 9 (5.1) |
| Nasopharyngitis | 4 (7.3) | 1 (1.7) | 4 (7.0) | 1 (1.7) | 6 (3.4) |
| Nausea | 3 (5.5) | 1 (1.7) | 3 (5.3) | 1 (1.7) | 5 (2.8) |
| Contusion | 3 (5.5) | 1 (1.7) | 2 (3.5) | 1 (1.7) | 4 (2.3) |
| Diarrhea | 3 (5.5) | 1 (1.7) | 0 | 2 (3.4) | 3 (1.7) |
Abbreviations: b.i.d., twice daily; PSL, padsevonil; TEAE, treatment‐emergent adverse event.
a
Medical Dictionary for Regulatory Activities Version 22.1 Preferred Term.