Table 2 Treatment-emergent adverse events (safety population; N [%]; incidence ≥ 5%)
Adverse event | Most recent or current episode of bipolar I disorder | ||
|---|---|---|---|
All patients (n = 199) | Depressed episode (n = 117) | Non-Depressed episode (n = 82) | |
At least one adverse event | 169 (84.9%) | 96 (82.1) | 73 (89.0%) |
Akathisia | 61 (30.7%) | 40 (34.2%) | 21 (25.6%) |
Nasopharyngitis | 53 (26.6%) | 24 (20.5%) | 29 (35.4%) |
Nausea | 24 (12.1%) | 12 (10.3%) | 12 (14.6%) |
Somnolence | 24 (12.1%) | 10 (8.5%) | 14 (17.1%) |
Weight increased | 17 (8.5%) | 8 (6.8%) | 9 (11.0%) |
Headache | 16 (8.0%) | 7 (6.0%) | 9 (11.0%) |
Parkinsonism | 15 (7.5%) | 10 (8.5%) | 5 (6.1%) |
Disease progression | 13 (6.5%) | 9 (7.7%) | 4 (4.9%) |
Vomiting | 13 (6.5%) | 8 (6.8%) | 5 (6.1%) |
Diarrhoea | 10 (5.0%) | 4 (3.4%) | 6 (7.3%) |
Dystonia | 10 (5.0%) | 5 (4.3%) | 5 (6.1%) |