Table 3.
Treatment-emergent adverse events (AEs)
| Adverse events, n (%) | Placebo, n = 83 | Paliperidone palmitate | ||
|---|---|---|---|---|
| 234/39 mg, n = 72 | 234/156 mg, n = 72 | 234/234 mg, n = 85 | ||
| Patients with ≥1 AE | 57 (68.7) | 49 (68.1) | 53 (73.6) | 55 (64.7) |
| Discontinuation due to AEs | 7 (8.4) | 6 (8.3) | 7 (9.7) | 5 (5.9) |
| Most common AEs* | ||||
| Insomnia | 13 (15.7) | 8 (11.1) | 5 (6.9) | 10 (11.8) |
| Headache | 7 (8.4) | 11 (15.3) | 9 (12.5) | 6 (7.1) |
| Schizophrenia exacerbation | 8 (9.6) | 6 (8.3) | 10 (13.9) | 4 (4.7) |
| Injection site pain | 5 (6.0) | 10 (13.9) | 2 (2.8) | 7 (8.2) |
| Anxiety | 6 (7.2) | 3 (4.2) | 5 (6.9) | 7 (8.2) |
| Agitation | 8 (9.6) | 8 (11.1) | 2 (2.8) | 2 (2.4) |
| Akathisia | 5 (6.0) | 1 (1.4) | 5 (6.9) | 5 (5.9) |
| Psychotic disorder | 6 (7.2) | 3 (4.2) | 4 (5.6) | 2 (2.4) |
| Dizziness | 1 (1.2) | 1 (1.4) | 5 (6.9) | 3 (3.5) |
| Upper respiratory tract infection | 1 (1.2) | 0 | 1 (1.4) | 5 (5.9) |
| Constipation | 3 (3.6) | 2 (2.8) | 4 (5.6) | 0 |
| Patients with ≥1 EPS-related AE | 7 (8.4) | 5 (6.9) | 9 (12.5) | 10 (11.8) |
Each paliperidone palmitate subject received 234 mg of paliperidone palmitate on day 1 and then their assigned dose day 8 and monthly thereafter.
*Defined as ≥5% in any one group.
EPS = extrapyramidal symptom.