Table 6 Adverse events summary from the double-blind period
PP | Paliperidone ER | PP placebo | Paliperidone ER placebo | |
|---|---|---|---|---|
(n= 193) | (n= 104) | (n= 192) | (n= 101) | |
All TEAEs, n (%) | 83 (43.0) | 36 (34.6) | 84 (43.8) | 41 (40.6) |
≥1 serious TEAE | 8 (4.2) | 8 (7.7) | 23 (12.0) | 16 (15.8) |
TEAE leading to discontinuation | 3 (1.6) | 3 (2.9) | 1 (0.5) | 1 (1.0) |
EPS-related AEs | 11 (5.7) | 7 (6.7) | 3 (1.6) | 3 (3.0) |
Prolactin-related AEs | 4 (2.1) | 3 (2.9) | 3 (1.6) | 0 |
Weight increase ≥7% | 44 (23.4) | 19 (19.6) | 24 (13.0) | 11 (11.7) |