Table 1.
Pooled Adverse Event Rates from Two Double-Blind, Placebo-Controlled Studies of Buspirone in Children and Adolescents with Generalized Anxiety Disorder
| Adverse events, frequency (%) | Buspirone n = 334 | Placebo n = 225 | Significance |
|---|---|---|---|
| Headache | 29 (9%) | 23 (10%) | χ2 = 0.22, p = 0.641 |
| Asthenia | 10 (3%) | 8 (4%) | χ2 = 0.02, p = 0.876 |
| Accidental injury | 7 (2%) | 7 (3%) | χ2 = 0.23, p = 0.633 |
| Nausea | 16 (5%) | 10 (4%) | χ2<0.01, p = 1 |
| Dyspepsia | 13 (4%) | 12 (5%) | χ2 = 0.36, p = 0.549 |
| Diarrhea | 5 (1.5%) | 7 (3%) | χ2 = 0.36, p = 0.546 |
| Vomiting | 6 (2%) | 7 (3%) | χ2 = 0.53, p = 0.468 |
| Lightheadedness | 34 (10%) | 5 (2%) | χ2 = 11.9,p< 0.001 |
| Somnolence | 14 (4%) | 4 (2%) | χ2 = 1.8, p = 0.180 |
| Insomnia | 5 (1.5%) | 7 (3%) | χ2 = 0.99, p = 0.320 |
| Nervousness | 5 (1.5%) | 3 (1%) | χ2<0.01, p = 1 |
| Upper respiratory tract infection | 5 (1.5%) | 5 (2%) | χ2 = 0.10, p = 0.757 |
| Rhinitis | 5 (1.5%) | 3 (1%) | χ2<0.01, p = 1 |
| Discontinuation secondary to an adverse event | 15 (5%) | 1 (<1%) | χ2 = 6.53,p = 0.011 |
Bold text reflects statistically significant differences.