Table 3 Overall adverse events
Characteristic | Open-label phase | Double-blind phase | |
|---|---|---|---|
Lamotrigine N = 420 | Lamotrigine N = 131 | Placebo N = 133 | |
Any AE | 177 (42.1) | 41 (31.3) | 47 (35.3) |
TEAEs related to study treatment | 111 (26.4) | 19 (14.5) | 20 (15.0) |
AEs leading to discontinuation of study treatment | 40 (9.5) | 5 (3.8) | 5 (3.8) |
Any TEAE adverse eventsa | 177 (42.1) | 40 (30.5) | 44 (33.1) |
 Rash | 20 (4.8) | 2 (1.5) | 2 (1.5) |
 Headache | 18 (4.3) | 4 (3.1) | 2 (1.5) |
 Dizziness | 17 (4.0) | 2 (1.5) | 1 (0.8) |
 Constipation | 15 (3.6) | - | 1 (0.8) |
 Fatigue | 15 (3.6) | - | 2 (1.5) |
 Nasopharyngitis | 14 (3.3) | 3 (2.3) | 4 (3.0) |
 Somnolence | 10 (2.4) | 1 (0.8) | 1 (0.8) |
 Hepatic function abnormal | 9 (2.1) | - | 1 (0.8) |
 Upper respiratory tract infection | 9 (2.1) | 2 (1.5) | 4 (3.0) |
 Urinary tract infection | 3 (0.7) | 3 (2.3) | 3 (2.3) |
 Nausea | 6 (1.4) | 3 (2.3) | 1 (0.8) |
 Poor quality sleep | 5 (1.2) | 1 (0.8) | 3 (2.3) |
 Weight decreased | 1 (0.2) | 3 (2.3) | 1 (0.8) |
Serious adverse events | |||
 Any serious adverse events | 12 (2.9) | 2 (1.5) | 3 (2.3) |
 Mania | 5 (1.2) | – | 2 (1.5) |
 Rash | 2 (0.5) | – | – |
 Bipolar disorder | 1 (0.2) | – | – |
 Ankle fracture | 1 (0.2) | – | – |
 Face injury | 1 (0.2) | – | – |
 Head injury | 1 (0.2) | – | – |
 Intentional product misuse | 1 (0.2) | – | – |
 Hepatic function abnormal | 1 (0.2) | – | – |
 Suicide attempt | – | 1 (0.8) | – |
 Brain stem infarction | – | 1 (0.8) | – |
 Concussion | – | – | 1 (0.8) |
 Contusion | – | – | 1 (0.8) |
 Laceration | – | – | 1 (0.8) |