Table 6.
Incidence of spontaneously reported EPS-related treatment-emergent adverse events: pooled LAI versus oral (safety analysis set)
| Paliperidone LAIa (n = 1293) n (%) |
Oral paliperidone (n = 963)b n (%) |
LAI-PBOa (n = 510) n (%) |
Oral-PBO (n = 355)b n (%) |
|
|---|---|---|---|---|
| Overall | 138 (10.7) | 191 (19.8) | 46 (9) | 39 (11) |
| Dystonia | 12 (0.9) | 30 (3.1) | 1 (0.2) | 4 (1.1) |
| Day 1–8 | 8 (0.6) | 26 (2.7) | 0 | 2 (0.6) |
| Day 9–36 | 1 (0.1) | 9 (0.9) | 0 | 2 (0.6) |
| Day 37–64 | 3 (0.2) | 1 (0.1) | 1 (0.2) | 0 |
| Day >64 | 0 | NA | 0 | NA |
| Parkinsonism | 62 (4.8) | 50 (5.2) | 17 (3.3) | 8 (2.3) |
| Day 1–8 | 29 (2.2) | 24 (2.5) | 9 (1.8) | 4 (1.1) |
| Day 9–36 | 24 (1.9) | 28 (2.9) | 6 (1.2) | 4 (1.1) |
| Day 37–64 | 9 (0.7) | 4 (0.4) | 2 (0.4) | 0 |
| Day >64 | 3 (0.2) | NA | 0 | NA |
| Tremor | 24 (1.9) | 32 (3.3) | 13 (2.5) | 12 (3.4) |
| Day 1–8 | 12 (0.9) | 14 (1.5) | 7 (1.4) | 4 (1.1) |
| Day 9–36 | 10 (0.8) | 15 (1.6) | 5 (1.0) | 8 (2.3) |
| Day 37–64 | 1 (0.1) | 5 (0.5) | 1 (0.2) | 2 (0.6) |
| Day >64 | 1 (0.1) | NA | 1 (0.2) | NA |
| Dyskinesia | 17 (1.3) | 60 (6.2) | 5 (1.0) | 12 (3.4) |
| Day 1–8 | 6 (0.5) | 33 (3.4) | 3 (0.6) | 7 (2.0) |
| Day 9–36 | 9 (0.7) | 32 (3.3) | 1 (0.2) | 7 (2.0) |
| Day 37–64 | 1 (0.1) | 1 (0.1) | 1 (0.2) | 0 |
| Day >64 | 2 (0.2) | NA | 0 | NA |
| Hyperkinesia | 42 (3.2) | 9 (0.9) | 17 (3.3) | 5 (1.4) |
| Day 1–8 | 26 (2.0) | 7 (0.7) | 10 (2.0) | 1 (0.3) |
| Day 9–36 | 15 (1.2) | 4 (0.4) | 6 (1.2) | 4 (1.1) |
| Day 37–64 | 4 (0.3) | 0 | 1 (0.2) | 0 |
| Day >64 | 2 (0.2) | NA | 0 | NA |
Notes: Data for EPS-related TEAE were collected continuously during the studies. Time intervals shown were arbitrarily chosen to construct a frequency distribution.
For three LAI studies, data were collected through day 92; for one LAI study data were collected through day 64
for all oral studies, data were collected through day 43; zero means no AE with onset in this time interval.
Abbreviations: AE, adverse event; EPS, extrapyramidal symptoms; ER, extended-release; LAI, long-acting injectable; LAI-PBO, placebo group in LAI studies; NA, not assessed in this time interval; Oral-PBO, placebo group in oral paliperidone studies; TEAE, treatment-emergent adverse event.