Table 5.
Treatment-emergent EPS, as assessed by rating scale scores, in double-blind phase (safety analysis set)
| Paliperidone LAI (n = 1293) n (%) |
Oral paliperidone (n = 963) n (%) |
LAI-PBO (n = 510) n (%) |
Oral-PBO (n = 355) n (%) |
|
|---|---|---|---|---|
| Parkinsonisma | 91 (7) | 110 (11) | 36 (7) | 32 (9) |
| Akathisiab | 55 (4) | 66 (7) | 23 (5) | 22 (6) |
| Dyskinesiac | 43 (3) | 24 (2) | 17 (3) | 17 (5) |
Notes: Percentages are calculated based on number of patients in the safety analysis set per treatment group.
Percentage of patients with SAS total score .0.3 at endpoint. Total score was defined as (sum of items score)/(number of items)
percentage of patients with BARS global clinical rating score ≥2 at endpoint
percentage of patients with a score ≥3 on any of the first seven items or a score ≥2 on two or more of any of the first seven items of AIMS at endpoint.
Abbreviations: AIMS, Abnormal Involuntary Movement Scale; BARS, Barnes Akathisia Rating Scale; CI, confidence interval; EPS, extrapyramidal symptoms; ER, extended-release; LAI, long-acting injectable; LAI-PBO, placebo group in LAI studies; LS Mean Diff, difference of least square means; Oral-PBO, placebo group in oral paliperidone studies; SAS, Simpson Angus Scale.