Skip to main content

Advertisement

Table 6 Adverse events summary from the double-blind period

From: Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies

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