Table 3.
Treatment-emergent adverse events among early-stage subjects for those events with an incidence >5%.
| Adverse event | Aripiprazole (N = 237) |
Haloperidol (N = 123) |
P-value | ||
|---|---|---|---|---|---|
| N | % | N | % | ||
| Asthenia | 12 | 5.1 | 6 | 4.9 | 0.939 |
| Headache | 18 | 7.6 | 12 | 9.8 | 0.482 |
| Dyspepsia | 12 | 5.1 | 4 | 3.3 | 0.429 |
| Nausea | 15 | 6.3 | 5 | 4.1 | 0.374 |
| Vomiting | 17 | 7.2 | 7 | 5.7 | 0.593 |
| Weight gain (i.e., ≥7%) | 18 | 7.6 | 5 | 4.1 | 0.194 |
| Agitation | 11 | 4.6 | 7 | 5.7 | 0.665 |
| Akathisia | 33 | 13.9 | 27 | 22.0 | 0.053 |
| Anxiety | 37 | 15.6 | 15 | 12.2 | 0.382 |
| Dystonia | 4 | 1.7 | 10 | 8.1 | 0.007 |
| Extrapyramidal syndrome | 28 | 11.8 | 49 | 39.8 | 0.000 |
| Insomnia | 42 | 17.7 | 23 | 18.7 | 0.819 |
| Nervousness | 10 | 4.2 | 8 | 6.5 | 0.346 |
| Psychosis | 28 | 11.8 | 18 | 14.6 | 0.447 |
| Salivation increased | 7 | 3.0 | 7 | 5.7 | 0.251 |
| Somnolence | 14 | 5.9 | 9 | 7.3 | 0.604 |
| Tremor | 6 | 2.5 | 9 | 7.3 | 0.031 |