TABLE 2.
Trial EP0091 incidence of overall TEAEs and most common TEAEs with onset during the treatment period (safety set)
| Placebo (n = 83) | PSL 50 mg b.i.d. (n = 81) | PSL 100 mg b.i.d. (n = 83) | PSL 200 mg b.i.d. (n = 82) | PSL 400 mg b.i.d. (n = 81) | All PSL patients (n = 327) | |
|---|---|---|---|---|---|---|
| Any TEAEs, n (%) | 65 (78.3) | 67 (82.7) | 65 (78.3) | 61 (74.4) | 73 (90.1) | 266 (81.3) |
| Drug‐related TEAEs | 36 (43.4) | 47 (58.0) | 49 (59.0) | 50 (61.0) | 65 (80.2) | 211 (64.5) |
| Serious TEAEs | 3 (3.6) | 5 (6.2) | 4 (4.8) | 3 (3.7) | 5 (6.2) | 17 (5.2) |
| Severe TEAEs | 7 (8.4) | 6 (7.4) | 6 (7.2) | 7 (8.5) | 7 (8.6) | 26 (8.0) |
| Discontinuations due to TEAEs | 7 (8.4) | 6 (7.4) | 10 (12.0) | 15 (18.3) | 21 (25.9) | 52 (15.9) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs a reported by ≥5% of all patients on placebo or PSL, n (%) | ||||||
| Somnolence | 10 (12.0) | 19 (23.5) | 24 (28.9) | 25 (30.5) | 30 (37.0) | 98 (30.0) |
| Dizziness | 9 (10.8) | 18 (22.2) | 23 (27.7) | 19 (23.2) | 28 (34.6) | 88 (26.9) |
| Fatigue | 10 (12.0) | 20 (24.7) | 12 (14.5) | 14 (17.1) | 20 (24.7) | 66 (20.2) |
| Headache | 10 (12.0) | 17 (21.0) | 9 (10.8) | 15 (18.3) | 9 (11.1) | 50 (15.3) |
| Nasopharyngitis | 5 (6.0) | 5 (6.2) | 9 (10.8) | 7 (8.5) | 5 (6.2) | 26 (8.0) |
| Memory impairment | 1 (1.2) | 3 (3.7) | 1 (1.2) | 8 (9.8) | 14 (17.3) | 26 (8.0) |
| Nausea | 7 (8.4) | 4 (4.9) | 7 (8.4) | 2 (2.4) | 7 (8.6) | 20 (6.1) |
| Diarrhea | 3 (3.6) | 6 (7.4) | 3 (3.6) | 5 (6.1) | 4 (4.9) | 18 (5.5) |
| Tremor | 0 | 5 (6.2) | 2 (2.4) | 6 (7.3) | 5 (6.2) | 18 (5.5) |
| Irritability | 8 (9.6) | 4 (4.9) | 7 (8.4) | 1 (1.2) | 5 (6.2) | 17 (5.2) |
| Vertigo | 7 (8.4) | 3 (3.7) | 2 (2.4) | 3 (3.7) | 4 (4.9) | 12 (3.7) |
Abbreviations: b.i.d., twice daily; PSL, padsevonil; TEAE, treatment‐emergent adverse event.
a
Medical Dictionary for Regulatory Activities Version 22.1 Preferred Term.