Incidence rates of AEs in monotherapy and polytherapy LTG users in RCTs
| Adverse event | Monotherapy n=340 (%) | Polytherapy n=253 (%) | p Value |
|---|---|---|---|
| Rash | 18 (5.3) | 21(8.3) | 0.09 |
| Headache | 16 (4.7) | 20 (7.9) | 0.02* |
| Nasopharyngitis | 13 (3.8) | 14 (5.5) | 0.33 |
| Somnolence | 5 (1.5) | 47 (18.6) | <0.001* |
| Abdominal pain | 5 (1.5) | 13 (5.1) | 0.01* |
| Dizziness | 4 (1.2) | 27 (10.7) | <0.001* |
| Nausea | 3 (0.9) | 11 (4.3) | 0.01* |
| Increased seizure | 1 (0.3) | 0 (0) | 1.00 |
| Vomiting | 0 (0) | 22 (8.7) | <0.001* |
| Fever | 0 (0) | 16 (6.3) | <0.001* |
| Ear infection | 0 (0) | 9 (3.6) | <0.001* |
| Cough | 0 (0) | 2 (0.7) | 0.18 |
| Others | 65 (19.1) | 111 (43.9) | – |
| Total | 127 | 313 | – |
*significant
%, incidence rate; n, number of patients.
AEs, adverse events; LTG, lamotrigine; RCT, randomised controlled trial.