Adverse drug reactions | At the first follow-up (n, %) | At the 12-months follow-up (n, %) |
---|---|---|
Any TEAEs | 44 (41.9) | 28 (34.2) |
Most frequent TEAEs (≥ 5% of patients) | ||
Dizziness | 24 (22.9) | 18 (18.3) |
Somnolence | 24 (22.9) | 17 (20.7) |
Nausea/vomiting | 6 (5.7) | 3 (3.7) |
TEAEs leading to dose adjustment | ||
Dizziness | 2 (1.9) | 2 (2.4) |
Nausea/vomiting | 2 (1.9) | 1 (1.2) |
Psychiatric | 1 (0.9) | 1 (1.2) |
Double vision | 1 (0.9) | 0 (0) |