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) |
AE adverse event, EPS extrapyramidal symptoms, ER extended release, PP paliperidone palmitate, TEAE treatment-emergent AE.