Table 3.
Incidence of treatment-emergent adverse events occurring in ≥5% of patients in any treatment group in the safety analysis set (Meltzer et al 2006)
| Placebo – (n = 355) n (%) | Paliperidone ER 3 mg (n = 127) n (%) | Paliperidone ER 6 mg (n = 235) n (%) | Paliperidone ER 9 mg (n = 246) n (%) | Paliperidone ER 12 mg (n = 242) n (%) | Paliperidone ER 15 mg (n = 113) n (%) | |
|---|---|---|---|---|---|---|
| TEAEs in total | 235 (66) | 91 (72) | 156 (66) | 171 (70) | 184 (76) | 87 (77) |
| Nervous system disorders | ||||||
| Headache | 42 (12) | 14 (11) | 29 (12) | 34 (14) | 35 (14) | 20 (18) |
| Akathisia | 14 (4) | 5 (4) | 7 (3) | 20 (8) | 23 (10) | 11 (10) |
| Extrapyramidal disorder | 8 (2) | 6 (5) | 5 (2) | 17 (7) | 18 (7) | 9 (8) |
| Somnolence | 12 (3) | 6 (5) | 8 (3) | 17 (7) | 11 (5) | 7 (6) |
| Dizziness | 14 (4) | 7 (6) | 11 (5) | 11 (4) | 12 (5) | 7 (6) |
| Sedation | 13 (4) | 1 (1) | 12 (5) | 8 (3) | 15 (6) | 2 (2) |
| Psychiatric disorders | ||||||
| Insomnia | 51 (4) | 14 (11) | 29 (12) | 35 (14) | 26 (11) | 14 (12) |
| Anxiety | 29 (8) | 12 (9) | 16 (7) | 14 (6) | 11 (5) | 9 (8) |
| Agitation | 28 (8) | 7 (6) | 17 (7) | 13 (5) | 13 (5) | 3 (3) |
| Psychotic disorders | 16 (5) | 5 (4) | 6 (3) | 7 (3) | 4 (2) | 4 (4) |
| Gastrointestinal disorders | ||||||
| Nausea | 19 (5) | 8 (6) | 9 (4) | 10 (4) | 10 (4) | 2 (2) |
| Vomiting | 17 (5) | 2 (2) | 6 (3) | 9 (4) | 12 (5) | 8 (7) |
| Constipation | 20 (6) | 7 (6) | 8 (3) | 7 (3) | 7 (3) | 4 (4) |
| Dyspepsia | 14 (4) | 3 (2) | 6 (3) | 5 (2) | 12 (5) | 6 (5) |
| Cardiac disorders | ||||||
| Tachycardia | 10 (3) | 3 (2) | 17 (7) | 18 (7) | 18 (7) | 2 (2) |
| Sinus tachycardia | 15 (4) | 11 (9) | 9 (4) | 10 (4) | 17 (7) | 8 (7) |
| Investigations | ||||||
| Electrocardiogram QT corrected interval prolonged | 9 (3) | 4 (3) | 9 (4) | 7 (3) | 12 (5) | 4 (4) |
Abbreviations: ER, extended release; TEAE, treatment-emergent adverse event.