AE categorya | Quetiapine | Placebo | Lithium | Paroxetine | ||||
---|---|---|---|---|---|---|---|---|
BPI (n = 1217) | BPII (n = 632) | BPI (n = 500) | BPII (n = 242) | BPI (n = 87) | BPII (n = 49) | BPI (n = 76) | BPII (n = 45) | |
Any AE, n (%) | 933 (76.7) | 471 (74.5) | 362 (72.4) | 161 (66.5) | 47 (54.0) | 32 (65.3) | 54 (71.1) | 30 (66.7) |
Any AE leading to discontinuation of treatment, n (%) | 120 (9.9) | 90 (14.2) | 19 (3.8) | 10 (4.1) | 5 (5.7) | 5 (10.2) | 9 (11.8) | 2 (4.4) |
Any SAE (including outcome of death), n (%) | 46 (3.8) | 8 (1.3) | 24 (4.8) | 2 (0.8) | 2 (2.3) | 1 (2.0) | 8 (10.5) | 1 (2.2) |
Any SAE leading to discontinuation of treatment, n (%) | 30 (2.5) | 4 (0.6) | 13 (2.6) | 1 (0.4) | 2 (2.3) | 0 (0.0) | 5 (6.6) | 0 (0.0) |
Any other significant AEb, n (%) | 17 (1.4) | 12 (1.9) | 5 (1.0) | 1 (0.4) | 3 (3.4) | 0 (0.0) | 1 (1.3) | 1 (2.2) |