Table 4.
Incidence of adverse events (≥ 5% in either of the studies)
| System organ class Preferred term (adverse events) |
BNS01 study | BNS02 study | ||
|---|---|---|---|---|
| N = 321 | N = 61 | |||
| n | (%) | n | (%) | |
| Extrapyramidal system | 115 | 35.8 | 32 | 52.5 |
| Akathisia | 62 | 19.3 | 21 | 34.4 |
| Tremor | 61 | 19.0 | 17 | 27.9 |
| Bradykinesia | 49 | 15.3 | 10 | 16.4 |
| Dyslalia | 33 | 10.3 | 4 | 6.6 |
| Salivary hypersecretion | 29 | 9.0 | 8 | 13.1 |
| Gait abnormal | 26 | 8.1 | 5 | 8.2 |
| Dyskinesia | 21 | 6.5 | 6 | 9.8 |
| Musculoskeletal stiffness | 20 | 6.2 | 4 | 6.6 |
| Dystonia | 12 | 3.7 | 6 | 9.8 |
| Psychoneurologic system | ||||
| Insomnia | 119 | 37.1 | 31 | 50.8 |
| Somnolence | 84 | 26.2 | 24 | 39.3 |
| Headache | 79 | 24.6 | 12 | 19.7 |
| Anxiety | 75 | 23.4 | 27 | 44.3 |
| Nervousness | 64 | 19.9 | 14 | 23.0 |
| Depression | 34 | 10.6 | 16 | 26.2 |
| Delusion | 8 | 2.5 | 4 | 6.6 |
| General symptom | ||||
| Malaise | 71 | 22.1 | 13 | 21.3 |
| Dizziness | 66 | 20.6 | 13 | 21.3 |
| Feeling hot | 41 | 12.8 | 6 | 9.8 |
| Asthenia | 38 | 11.8 | 10 | 16.4 |
| Circulatory system | ||||
| Tachycardia | 26 | 8.1 | 7 | 11.5 |
| Digestive system | ||||
| Constipation | 75 | 23.4 | 12 | 19.7 |
| Diarrhea | 63 | 19.6 | 11 | 18.0 |
| Nausea | 62 | 19.3 | 8 | 13.1 |
| Anorexia | 53 | 16.5 | 9 | 14.8 |
| Thirst | 50 | 15.6 | 15 | 24.6 |
| Abdominal pain | 41 | 12.8 | 8 | 13.1 |
| Increased appetite | 21 | 6.5 | 5 | 8.2 |
| Toothache | 21 | 6.5 | 2 | 3.3 |
| Vomiting | 18 | 5.6 | 2 | 3.3 |
| Endocrine system | ||||
| Menstrual disorder | 8 | 2.5 | 5 | 8.2 |
| Others | ||||
| Nasopharyngitis | 116 | 36.1 | 17 | 27.9 |
| Hyperprolactinemia | 95 | 29.6 | 21 | 34.4 |
| Back pain | 39 | 12.1 | 1 | 1.6 |
| Pyrexia | 38 | 11.8 | 2 | 3.3 |
| Hypertriglyceridemia | 36 | 11.2 | 5 | 8.2 |
| Creatine phosphokinase increased | 34 | 10.6 | 6 | 9.8 |
| Eczema | 31 | 9.7 | 1 | 1.6 |
| Pharyngitis | 28 | 8.7 | 4 | 6.6 |
| ALT (GPT) increased | 28 | 8.7 | 3 | 4.9 |
| Rhinitis | 27 | 8.4 | 6 | 9.8 |
| Chest pain | 24 | 7.5 | 4 | 6.6 |
| Upper respiratory tract infection | 23 | 7.2 | 5 | 8.2 |
| Weight increased | 23 | 7.2 | 5 | 8.2 |
| Arthralgia | 22 | 6.9 | 1 | 1.6 |
| Gamma-glutamyltransferase increased | 21 | 6.5 | 2 | 3.3 |
| Hypotension | 21 | 6.5 | 4 | 6.6 |
| Fungal skin infection | 20 | 6.2 | 3 | 4.9 |
| Pain | 19 | 5.9 | 0 | 0.0 |
| Purpura | 18 | 5.6 | 1 | 1.6 |
| Cough | 18 | 5.6 | 2 | 3.3 |
| Hypertension | 18 | 5.6 | 1 | 1.6 |
| AST (GOT) increased | 17 | 5.3 | 3 | 4.9 |
| Conjunctivitis | 16 | 5.0 | 0 | 0.0 |
| Accommodation disorder | 12 | 3.7 | 9 | 14.8 |
| White blood cell count increased | 10 | 3.1 | 8 | 13.1 |
| Extrapyramidal adverse drug reactions | 115 | 35.8 | 32 | 52.5 |