Table 2.
Patients with treatment-emergent AEs during the 6-week postrandomization treatment period in the analysis population
| Placebo + ADT (n=148), n (%) | BUP/SAM 2 mg/2 mg + ADT (n=147), n (%) | |
|---|---|---|
| Any AE | 51 (34.5) | 63 (42.9) |
| Any serious AE | 1 (0.7) | 0 |
| AE leading to study discontinuation | 2 (1.4) | 2 (1.4) |
| Common AEs (≥2% in any treatment group) | ||
| Nausea | 1 (0.7) | 13 (8.8) |
| Headache | 5 (3.4) | 6 (4.1) |
| Blood creatine phosphokinase increased | 0 | 4 (2.7) |
| Fatigue | 3 (2.0) | 4 (2.7) |
| Upper respiratory tract infection | 3 (2.0) | 4 (2.7) |
| Vomiting | 2 (1.4) | 4 (2.7) |
| Constipation | 1 (0.7) | 3 (2.0) |
| Dry mouth | 2 (1.4) | 3 (2.0) |
| Hypertension | 2 (1.4) | 3 (2.0) |
| Muscle spasms | 0 | 3 (2.0) |
| Nasopharyngitis | 3 (2.0) | 3 (2.0) |
| Diarrhea | 3 (2.0) | 1 (0.7) |
| Dizziness | 3 (2.0) | 1 (0.7) |
Abbreviations: ADT, antidepressant therapy; AEs, adverse events; BUP, buprenorphine; SAM, samidorphan.