Table 3. AEs Occurring in >2 Subjects Receiving Any Dose of ABT-894.
| Placebo |
ABT-894 |
Atomoxetine | |||||
|---|---|---|---|---|---|---|---|
| (n=225) | 1 mg QD (n=46) | 2 mg QD (n=42) | 4 mg QD (n=40) | 4 mg BID (n=46) | Total (n=174) | 40 mg BID (n=50) | |
| Any AE, n (%) | 126 (56%) | 32 (69.6%) | 26 (61.9%) | 26 (65.0%) | 25 (54.3%) | 109 (62.6%) | 41 (82.0%) |
| AEs occurring in >2 subjects receiving any dose of ABT-894, n (%) | |||||||
| Nausea | 5 (2.2%) | 2 (4.3%) | 6 (14.3%) | 9 (22.5%) | 4 (8.7%) | 21 (12.1%) | 10 (20.0%) |
| Headache | 23 (10.2%) | 4 (8.7%) | 5 (11.9%) | 5 (12.5%) | 4 (8.7%) | 18 (10.3%) | 7 (14.0%) |
| Dizziness | 6 (2.7%) | 2 (4.3%) | 4 (9.5%) | 4 (10.0%) | 1 (2.2%) | 11 (6.3%) | 4 (8.0%) |
| Insomniaa | 15 (6.7%) | 2 (4.3%) | 4 (9.5%) | 3 (7.5%) | 1 (2.2%) | 10 (5.7%) | 8 (16.0%) |
| Fatigue | 11 (4.9%) | 2 (4.3%) | 1 (2.4%) | 2 (5.0%) | 4 (8.7%) | 9 (5.2%) | 6 (12.0%) |
| Somnolence | 7 (3.1%) | 6 (13.0%) | 0 | 0 | 2 (4.3%) | 8 (4.6%) | 4 (8.0%) |
| Upper respiratory tract infection | 6 (2.7%) | 1 (2.2%) | 3 (7.1%) | 3 (7.5%) | 0 | 7 (4.0%) | 2 (4.0%) |
| Diarrhea | 5 (2.2%) | 0 | 2 (4.8%) | 3 (7.5%) | 1 (2.2%) | 6 (3.4%) | 1 (2.0%) |
| Vomiting | 1 (0.4%) | 0 | 1 (2.4%) | 4 (10.0%) | 1 (2.2%) | 6 (3.4%) | 1 (2.0%) |
| Muscle strain | 1 (0.4%) | 3 (6.5%) | 0 | 0 | 0 | 3 (1.7%) | 0 |
| Nasal congestion | 0 | 0 | 0 | 0 | 3 (6.5%) | 3 (1.7%) | 2 (4.0%) |
a
Includes insomnia, initial insomnia, middle insomnia, and sleep disorder.