Table 3.
Adverse events to evaluate for abuse potential
| Patients with event, n (%) | No prior exposure to BUP/SAM (n = 929) | Prior exposure to BUP/SAM (n = 556) | All patients (N = 1485) |
|---|---|---|---|
| Any AESI to evaluate abuse potential | 248 (26.7) | 73 (13.1) | 321 (21.6) |
| Euphoria related | 16 (1.7) | 2 (0.4) | 18 (1.2) |
| Feeling abnormal | 7 (0.8) | 2 (0.4) | 9 (0.6) |
| Euphoric mood | 6 (0.6) | 0 | 6 (0.4) |
| Feeling drunk | 2 (0.2) | 0 | 2 (0.1) |
| Hallucination, auditory | 1 (0.1) | 0 | 1 (0.1) |
| Abuse behavior | 0 | 0 | 0 |
| Abuse potential nonspecific | 242 (26.0) | 73 (13.1) | 315 (21.2) |
| Dizziness | 116 (12.5) | 34 (6.1) | 150 (10.1) |
| Somnolence | 100 (10.8) | 24 (4.3) | 124 (8.4) |
| Sedation | 51 (5.5) | 15 (2.7) | 66 (4.4) |
| Disturbance in attention | 9 (1.0) | 4 (0.7) | 13 (0.9) |
| Confusional state | 2 (0.2) | 0 | 2 (0.1) |
| Cognitive disorder | 0 | 1 (0.2) | 1 (0.1) |
| Disorientation | 1 (0.1) | 0 | 1 (0.1) |
| Dissociation | 1 (0.1) | 0 | 1 (0.1) |
| Mood swings | 1 (0.1) | 0 | 1 (0.1) |
| Paranoia | 1 (0.1) | 0 | 1 (0.1) |
Adverse events were coded by preferred terms and system organ class using the Medical Dictionary for Regulatory Activities, version 19.0. A full list of preferred terms evaluated are in the Supplementary Materials
AESI adverse event of special interest, BUP buprenorphine, SAM samidorphan