TABLE 3.
Incidence of TEAEs with onset during the treatment period by number of concomitant ASMs (safety set)
| One concomitant ASM | Two concomitant ASMs | |||
|---|---|---|---|---|
| Placebo, n = 95 | BRV 50–200 mg/day, n = 181 | Placebo, n = 331 | BRV 50–200 mg/day, n = 557 | |
| Any TEAEs | 57 (60.0) | 123 (68.0) | 201 (60.7) | 370 (66.4) |
| Drug‐related TEAEs | 31 (32.6) | 75 (41.4) | 100 (30.2) | 231 (41.5) |
| Discontinuation due to TEAEs | 2 (2.1) | 12 (6.6) | 15 (4.5) | 30 (5.4) |
| Serious TEAEs | 1 (1.1) | 4 (2.2) | 8 (2.4) | 11 (2.0) |
| Severe TEAEs | 4 (4.2) | 14 (7.7) | 10 (3.0) | 24 (4.3) |
| Deaths | 0 | 4 (2.2) | 3 (.9) | 4 (.7) |
| Incidence of the most common TEAEs a , b | ||||
| Somnolence | 6 (6.3) | 29 (16.0) | 30 (9.1) | 86 (15.4) |
| Headache | 9 (9.5) | 21 (11.6) | 34 (10.3) | 48 (8.6) |
| Fatigue | 4 (4.2) | 11 (6.1) | 12 (3.6) | 49 (8.8) |
| Dizziness | 5 (5.3) | 17 (9.4) | 23 (6.9) | 67 (12.0) |
| Incidence of TEAEs a , c classified as psychiatric disorders d | ||||
| Insomnia | 0 | 4 (2.2) | 3 (.9) | 14 (2.5) |
| Anxiety | 0 | 2 (1.1) | 5 (1.5) | 11 (2.0) |
| Depression | 0 | 1 (.6) | 2 (.6) | 11 (2.0) |
| Incidence of TEAEs a , c potentially associated with behavioral disorders e | ||||
| Irritability | 3 (3.2) | 4 (2.2) | 2 (.6) | 21 (3.8) |
Note: Data are presented as n (%) of patients.
Abbreviations: ASM, antiseizure medication; BRV, brivaracetam; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment‐emergent adverse event.
a
MedDRA (v15.0) preferred terms.
b
Reported by ≥5% of all patients randomized to BRV.
c
Reported by ≥1% of all patients randomized to BRV.
d
MedDRA system organ class.
e
MedDRA preferred terms selected by medical review.