Table 3.
Safety events among patients in the pooled analysis of FORWARD-4 and FORWARD-5
| Event, n (%) | Stage 1 | Stage 2 | ||
|---|---|---|---|---|
| Placebo + ADT (n = 545) | BUP/SAM (2 mg/2 mg) + ADT (n = 123) | Placebo + ADT (n = 118) | BUP/SAM (2 mg/2 mg) + ADT (n = 119) | |
| Any AE | 293 (53.8) | 83 (67.5) | 54 (45.8) | 54 (45.4) |
| Any SAE | 2 (0.4) | 2 (1.6) | 1 (0.8) | 0 |
| AE leading to study discontinuation | 12 (2.2) | 18 (14.6) | 2 (1.7) | 3 (2.5) |
| Common AEsa | ||||
| Nausea | 37 (6.8) | 34 (27.6) | 2 (1.7) | 13 (10.9) |
| Constipation | 13 (2.4) | 15 (12.2) | 1 (0.8) | 6 (5.0) |
| Dizziness | 21 (3.9) | 15 (12.2) | 2 (1.7) | 4 (3.4) |
| Vomiting | 11 (2.0) | 12 (9.8) | 1 (0.8) | 5 (4.2) |
| Headache | 44 (8.1) | 10 (8.1) | 5 (4.2) | 4 (3.4) |
| Somnolence | 19 (3.5) | 9 (7.3) | 1 (0.8) | 0 |
| Fatigue | 6 (1.1) | 9 (7.3) | 2 (1.7) | 4 (3.4) |
| Sedation | 4 (0.7) | 8 (6.5) | 0 | 0 |
| Any AESI of abuse potential | 43 (7.9) | 30 (24.4) | 3 (2.5) | 4 (3.4) |
| Euphoria related | ||||
| Feeling abnormal | 1 (0.2) | 2 (1.6) | 0 | 0 |
| Euphoric mood | 0 | 1 (0.8) | 0 | 0 |
| Feeling of relaxation | 0 | 1 (0.8) | 0 | 0 |
| Nonspecific | ||||
| Dizziness | 21 (3.9) | 15 (12.2) | 2 (1.7) | 4 (3.4) |
| Somnolence | 19 (3.5) | 9 (7.3) | 1 (0.8) | 0 |
| Sedation | 4 (0.7) | 8 (6.5) | 0 | 0 |
| Disturbance in attention | 1 (0.2) | 0 | 0 | 0 |
ADT antidepressant therapy; AE adverse event; BUP buprenorphine; SAE serious adverse events; SAM samidorphan
aOccurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment groups