Table 4 Most common ADR and ADR of interest in medium to high dose group
Medium to high dose group (N = 364) | ||||||
|---|---|---|---|---|---|---|
Mild | Moderate | Severe | ||||
Patients, n (%) | Events | Patients, n (%) | Events | Patients, n (%) | Events | |
Totala | 69 (19.0) | 205 | 31 (8.5) | 86 | 3 (0.8) | 7 |
Symptoms in the neuron system | ||||||
Akathisia | 64 (17.6) | 65 | 24 (6.6) | 24 | 2 (0.5) | 2 |
Tremor | 43 (11.8) | 45 | 12 (3.3) | 12 | 0 (0) | 0 |
Dystonia | 13 (3.6) | 13 | 12 (3.3) | 13 | 1 (0.3) | 1 |
Parkinsonism | 12 (3.3) | 13 | 8 (2.2) | 8 | 1 (0.3) | 1 |
Examines | ||||||
Weight gain | 10 (2.7) | 10 | 3 (0.8) | 3 | 0 (0) | 0 |
Hyperprolactin | 6 (1.6) | 6 | 1 (0.3) | 1 | 1 (0.3) | 1 |
Increased heart rate | 1 (0.3) | 1 | 4 (1.1) | 4 | 0 (0) | 0 |
Elevated transaminases | 5 (1.4) | 5 | 0 (0) | 0 | 0 (0) | 0 |
Elevated blood glucose | 2 (0.5) | 2 | 0 (0) | 0 | 1 (0.3) | 1 |
Hepatobiliary diseases | ||||||
Abnormal liver function | 8 (2.2) | 8 | 1 (0.3) | 1 | 0 (0) | 0 |
Gastrointestinal diseases | 5 (1.4) | 6 | 3 (0.8) | 3 | 0 (0) | 0 |
Eye diseases | 4 (1.1) | 6 | 1 (0.3) | 1 | 0 (0) | 0 |
Mental illness | 1 (0.3) | 1 | 2 (0.5) | 2 | 0 (0) | 0 |
Reproductive system and breast diseases | 1 (0.3) | 1 | 2 (0.5) | 2 | 0 (0) | 0 |
Metabolic and nutritional diseases | ||||||
Hyperlipidemia | 2 (0.5) | 2 | 0 (0) | 0 | 0 (0) | 0 |
Skin and subcutaneous tissue diseases | 2 (0.5) | 2 | 0 (0) | 0 | 0 (0) | 0 |
Systemic disease and administration site reactions | 2 (0.5) | 2 | 0 (0) | 0 | 0 (0) | 0 |