Table 2. Summary of Adverse Events.
| Placebo n=144 | ABT-126 25 mg n=66 | ABT-126 50 mg n=151 | ABT-126 75 mg n=70 | |
|---|---|---|---|---|
| Number of subjects (%) | ||||
| Any AE | 71 (49.3) | 32 (48.5) | 73 (48.3) | 39 (55.7) |
| Discontinued due to an AE | 5 (3.5) | 3 (4.5) | 8 (5.3) | 1 (1.4) |
| Severe AE | 5 (3.5) | 1 (1.5) | 5 (3.3) | 3 (4.3) |
| Serious AE | 4 (2.8) | 1 (1.5) | 4 (2.6) | 3 (4.3) |
| Adverse events reported by ⩾3% of ABT-126-treated subjectsa by MedDRA preferred term | ||||
| Headache | 12 (8.3) | 2 (3.0) | 16 (10.6) | 5 (7.1) |
| Nasopharyngitis | 4 (2.8) | 6 (9.1) | 6 (4.0) | 3 (4.3) |
| Diarrhea | 5 (3.5) | 4 (6.1) | 6 (4.0) | 3 (4.3) |
| Insomnia | 2 (1.4) | 4 (6.1) | 4 (2.6) | 5 (7.1)b |
| Constipation | 2 (1.4) | 2 (3.0) | 8 (5.3) | 2 (2.9) |
| Dizziness | 3 (2.1) | 3 (4.5) | 4 (2.6) | 3 (4.3) |
| Nausea | 5 (3.5) | 2 (3.0) | 4 (2.6) | 3 (4.3) |
| Somnolence | 3 (2.1) | 1 (1.5) | 7 (4.6) | 1 (1.4) |
Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.
a
All ABT-126 treatment groups combined.
b
P<0.05 vs placebo.