Table 4. Adverse events and discontinuation profiles in treatment groups by age.
| Total (n=220) | Group A (n=129) | Group B (n=91) | p | |
|---|---|---|---|---|
| Discontinuation | 65 (29.5) | 34 (26.4) | 31 (34.1) | 0.022* |
| Adverse events | 39 (17.7) | 15 (11.6) | 24 (26.4) | |
| Lack of efficacy | 21 (9.5) | 16 (12.4) | 5 (5.5) | |
| Loss to follow-up | 5 (2.3) | 3 (2.3) | 2 (2.2) | |
| Patients with adverse events | 88 (40.0) | 45 (34.9) | 43 (47.3) | 0.088 |
| Dose when adverse event occurred, mg | 5.3±3.2 | 4.8±2.8 | 5.8±3.5 | 0.155 |
| Adverse events | 88 (40.0) | 45 (34.9) | 43 (47.3) | |
| Somnolence | 37 (42.1) | 24 (53.3) | 13 (30.2) | 0.048* |
| Dizziness | 19 (21.6) | 6 (13.3) | 13 (30.2) | 0.096 |
| Ataxia | 18 (20.5) | 6 (13.3) | 12 (27.9) | 0.153 |
| Violence | 18 (20.5) | 10 (22.2) | 8 (18.6) | 0.876 |
| Anger | 14 (15.9) | 7 (15.6) | 7 (16.3) | 1.000 |
| Worsening of seizure | 7 (8.0) | 4 (8.9) | 3 (7.0) | 1.000 |
| Insomnia | 5 (5.7) | 3 (6.7) | 2 (4.7) | 1.000 |
| Headache | 3 (3.4) | 1 (2.2) | 2 (4.7) | 0.968 |
| Depression | 3 (3.4) | 2 (4.4) | 1 (2.3) | 1.000 |
| Low appetite | 2 (2.3) | 0 (0.0) | 2 (4.7) | 0.454 |
| Cognitive decline | 2 (2.3) | 1 (2.2) | 1 (2.3) | 1.000 |
| Nausea/vomiting | 1 (1.1) | 0 (0.0) | 1 (2.3) | 0.982 |
| Suicide attempt† | 1 (1.1) | 1 (2.2) | 0 (0.0) | 1.000 |
Data are n (%) or mean±SD values.
*p<0.05, †Unsuccessful suicide attempt in a patient who had a psychiatric history.