Table 4.
Placebo group (n = 177) | Quetiapine XR 300 mg group (n = 179) | Quetiapine XR 150 mg group (n = 74) | ||||
---|---|---|---|---|---|---|
Patients n (%) | Number of AEs | Patients n (%) | Number of AEs | Patients n (%) | Number of AEs | |
AEs | 81 (45.8) | 155 | 149 (83.2) | 432 | 55 (74.3) | 144 |
Drug-related AEs | 52 (29.4) | 88 | 133 (74.3) | 331 | 50 (67.6) | 107 |
Deaths | 1 (0.6) | 0 | 0 | 0 | 0 | 0 |
SAEs | 2 (1.1) | 2 | 0 | 0 | 1 (1.4) | 1 |
Drug-related SAEs | 0 | 0 | 0 | 0 | 0 | 0 |
AEs leading to discontinuation | 16 (9.0) | 17 | 27 (15.1) | 35 | 6 (8.1) | 8 |
Drug-related AEs leading to discontinuation | 11 (6.2) | 12 | 23 (12.8) | 30 | 5 (6.8) | 7 |
Patients (n) | Patients (%) | Patients (n) | Patients (%) | Patients (n) | Patients (%) | |
GI disorders | 22 | 12.4 | 34 | 19.0 | 15 | 20.3 |
Constipation | 3 | 1.7 | 14 | 7.8 | 10 | 13.5 |
General disorders and administration site conditions | 10 | 5.6 | 61 | 34.1 | 12 | 16.2 |
Malaise | 2 | 1.1 | 16 | 8.9 | 3 | 4.1 |
Thirst | 5 | 2.8 | 50 | 27.9 | 9 | 12.2 |
Infections and infestations | 22 | 12.4 | 38 | 21.2 | 15 | 20.3 |
Nasopharyngitis | 19 | 10.7 | 26 | 14.5 | 12 | 16.2 |
Investigations | 16 | 9.0 | 41 | 22.9 | 15 | 20.3 |
ALT increased | 0 | 0 | 8 | 4.5 | 4 | 5.4 |
AST increased | 1 | 0.6 | 2 | 1.1 | 4 | 5.4 |
Blood creatine phosphokinase increased | 1 | 0.6 | 5 | 2.8 | 7 | 9.5 |
Blood prolactin increased | 5 | 2.8 | 13 | 7.3 | 4 | 5.4 |
Nervous systems disorders | 17 | 9.6 | 95 | 53.1 | 29 | 39.2 |
Akathisia | 4 | 2.3 | 15 | 8.4 | 7 | 9.5 |
Dizziness | 1 | 0.6 | 5 | 2.8 | 4 | 5.4 |
Somnolence | 4 | 2.3 | 80 | 44.7 | 26 | 35.1 |
Psychiatric disorders | 20 | 11.3 | 12 | 6.7 | 2 | 2.7 |
Depression | 10 | 5.6 | 4 | 2.2 | 1 | 1.4 |
AEs adverse events, SAEs serious adverse events, GI gastrointestinal, ALT alanine aminotransferase, AST aspartate aminotransferase