Table 4.
Incidence of common TEAS occurring in ≥10% of subjects receiving paliperidone ER or placebo (path analysis ITT population; n = 1274)
| Adverse event | Paliperidone ER daily dose
|
||||||
|---|---|---|---|---|---|---|---|
| 3 mg (n = 120) n (%) | 6 mg (n = 224) n (%) | 9 mg (n = 243) n (%) | 12 mg (n = 238) n (%) | 15 mg (n = 112) n (%) | Combined (n = 937) n (%) | Placebo (n = 337) n (%) | |
| Headache | 14 (12) | 25 (11) | 34 (14) | 34 (14) | 20 (18) | 127 (14) | 41(12) |
| Insomnia | 14 (12) | 27 (12) | 35 (14) | 26 (11) | 14 (13) | 116 (12) | 50 (15) |
| Akathisia | 5 (4) | 7 (3) | 19 (8) | 23 (10) | 11 (10) | 65 (7) | 14 (4) |
| Anxiety | 12 (10) | 16 (7) | 14 (6) | 11 (5) | 9 (8) | 62 (7) | 27 (8) |
Abbreviations: ER, extended-release; ITT, intent-to-treat; TEAS, treatment-emergent adverse events.