Table 2.
Incidence of treatment-emergent adverse events (TEAEs) with onset during the treatment period by specific concomitant antiseizure medication (ASM) at trial drug initiation (safety population)
| Concomitant ASM | CBZ | LTG | VPA | OXC | TPM | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| PBO | BRV | PBO | BRV | PBO | BRV | PBO | BRV | PBO | BRV | |
| n | 183 | 315 | 120 | 201 | 93 | 182 | 64 | 137 | 84 | 89 |
| Any TEAEs, n (%) | 121 (66.1) | 199 (63.2) | 80 (66.7) | 138 (68.7) | 50 (53.8) | 112 (61.5) | 36 (56.3) | 102 (74.5) | 51 (60.7) | 62 (69.7) |
| Drug-related TEAEs, n (%) | 60 (32.8) | 116 (36.8) | 36 (30.0) | 88 (43.8) | 26 (28.0) | 64 (35.2) | 19 (29.7) | 66 (48.2) | 25 (29.8) | 43 (48.3) |
| Discontinuation due to TEAEs, n (%) | 8 (4.4) | 9 (2.9) | 6 (5.0) | 16 (8.0) | 3 (3.2) | 12 (6.6) | 3 (4.7) | 10 (7.3) | 3 (3.6) | 8 (9.0) |
| Serious TEAEs, n (%) | 6 (3.3) | 5 (1.6) | 2 (1.7) | 7 (3.5) | 3 (3.2) | 5 (2.7) | 2 (3.1) | 3 (2.2) | 2 (2.4) | 2 (2.2) |
| Severe TEAEs, n (%) | 7 (3.8) | 10 (3.2) | 3 (2.5) | 12 (6.0) | 3 (3.2) | 6 (3.3) | 2 (3.1) | 9 (6.6) | 3 (3.6) | 5 (5.6) |
| Deaths, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Incidence of the most common TEAEsa in ≥ 10% of patients in any subgroup, n (%) | ||||||||||
| Somnolence | 17 (9.3) | 51 (16.2) | 11 (9.2) | 27 (13.4) | 7 (7.5) | 18 (9.9) | 6 (9.4) | 27 (19.7) | 9 (10.7) | 20 (22.5) |
| Dizziness | 10 (5.5) | 34 (10.8) | 8 (6.7) | 24 (11.9) | 5 (5.4) | 13 (7.1) | 7 (10.9) | 16 (11.7) | 8 (9.5) | 9 (10.1) |
| Headache | 21 (11.5) | 24 (7.6) | 12 (10.0) | 17 (8.5) | 4 (4.3) | 11 (6.0) | 4 (6.3) | 21 (15.3) | 7 (8.3) | 5 (5.6) |
| Fatigue | 5 (2.7) | 18 (5.7) | 2 (1.7) | 17 (8.5) | 1 (1.1) | 7 (3.8) | 1 (1.6) | 15 (10.9) | 3 (3.6) | 7 (7.9) |
| Nasopharyngitis | 6 (3.3) | 14 (4.4) | 2 (1.7) | 7 (3.5) | 2 (2.2) | 5 (2.7) | 3 (4.7) | 3 (2.2) | 2 (2.4) | 2 (2.2) |
| Concomitant ASM | PHT | LCM | CLB | PHB | ||||
|---|---|---|---|---|---|---|---|---|
| PBO | BRV | PBO | BRV | PBO | BRV | PBO | BRV | |
| n | 46 | 74 | 36 | 72 | 35 | 60 | 22 | 60 |
| Any TEAEs, n (%) | 25 (54.3) | 45 (60.8) | 23 (63.9) | 53 (73.6) | 20 (57.1) | 39 (65.0) | 13 (59.1) | 40 (66.7) |
| Drug-related TEAEs, n (%) | 11 (23.9) | 33 (44.6) | 10 (27.8) | 33 (45.8) | 13 (37.1) | 27 (45.0) | 6 (27.3) | 26 (43.3) |
| Discontinuation due to TEAEs, n (%) | 1 (2.2) | 8 (10.8) | 1 (2.8) | 4 (5.6) | 2 (5.7) | 3 (5.0) | 0 | 8 (13.3) |
| Serious TEAEs, n (%) | 2 (4.3) | 2 (2.7) | 0 | 2 (2.8) | 2 (5.7) | 3 (5.0) | 1 (4.5) | 3 (5.0) |
| Severe TEAEs, n (%) | 3 (6.5) | 4 (5.4) | 1 (2.8) | 4 (5.6) | 1 (2.9) | 3 (5.0) | 2 (9.1) | 7 (11.7) |
| Deaths, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Incidence of the most common TEAEsa in ≥ 10% of patients in any subgroup, n (%) | ||||||||
| Somnolence | 3 (6.5) | 8 (10.8) | 4 (11.1) | 12 (16.7) | 2 (5.7) | 9 (15.0) | 1 (4.5) | 10 (16.7) |
| Dizziness | 4 (8.7) | 9 (12.2) | 3 (8.3) | 9 (12.5) | 1 (2.9) | 4 (6.7) | 1 (4.5) | 6 (10.0) |
| Headache | 2 (4.3) | 5 (6.8) | 6 (16.7) | 6 (8.3) | 2 (5.7) | 6 (10.0) | 5 (22.7) | 9 (15.0) |
| Fatigue | 4 (8.7) | 9 (12.2) | 4 (11.1) | 13 (18.1) | 1 (2.9) | 2 (3.3) | 0 | 7 (11.7) |
| Nasopharyngitis | 1 (2.2) | 3 (4.1) | 4 (11.1) | 3 (4.2) | 0 | 3 (5.0) | 2 (9.1) | 2 (3.3) |
Data are presented as n (%) of patients. BRV denotes BRV 50–200 mg/day
ASM antiseizure medication, BRV brivaracetam, CBZ carbamazepine, CLB clobazam, LCM lacosamide, LTG lamotrigine, MedDRA Medical Dictionary for Regulatory Activities, OXC oxcarbazepine, PBO placebo, PHB phenobarbital, PHT phenytoin, TPM topiramate, TEAE treatment-emergent adverse event, VPA valproate
aMedDRA (version 15.0) preferred terms