Table 3 Common AEs and ADRs
5 mg (n = 15) | 10 mg (n = 73) | 20 mg (n = 73) | Total (n = 161) | |
|---|---|---|---|---|
Patients with at least 1 AE, n (%) | 11 (73.3) | 64 (87.7) | 67 (91.8) | 142 (88.2) |
Total number of AEs, n | 23 | 165 | 223 | 411 |
AEs with an incidence of more than 5 % | ||||
Nasopharyngitis | 3 (20.0) | 31 (42.5) | 29 (39.7) | 63 (39.1) |
Somnolence | - | 9 (12.3) | 18 (24.7) | 27 (16.8) |
Worsening of schizophreniaa | 2 (13.3) | 4 (5.5) | 11 (15.1) | 17 (10.6) |
Headache | - | 5 (6.8) | 7 (9.6) | 12 (7.5) |
Insomnia associated with worsening schizophreniab | - | 3 (4.1) | 9 (12.3) | 12 (7.5) |
Patients with at least 1 ADR, n (%) | 2 (13.3) | 35 (47.9) | 41 (56.2) | 78 (48.4) |
Total number of ADRs, n | 2 | 56 | 81 | 139 |
ADRs with an incidence of more than 2 % | ||||
Somnolence | - | 8 (11.0) | 18 (24.7) | 26 (16.1) |
Worsening of schizophreniaa | 1 (6.7) | 4 (5.5) | 7 (9.6) | 12 (7.5) |
Insomnia associated with worsening schizophreniab | 2 (2.7) | 4 (5.5) | 6 (3.7) | |
Parkinsonism | 1 (6.7) | 4 (5.5) | - | 5 (3.1) |
Headache | - | 1 (1.4) | 3 (4.1) | 4 (2.5) |
Akathisia | - | 1 (1.4) | 3 (4.1) | 4 (2.5) |