Table 3 Treatment-emergent adverse events (AEs)
Adverse events, n (%) | Placebo, n = 83 | Paliperidone palmitate | ||
|---|---|---|---|---|
| Â | Â | 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) |