Table 2.
Summary of adverse events
| Patients with event, n (%) | No prior exposure to BUP/SAM (n = 929) | Prior exposure to BUP/SAM (n = 556) | All patients (N = 1485) |
|---|---|---|---|
| Any AE | 730 (78.6) | 394 (70.9) | 1124 (75.7) |
| Any SAE | 33 (3.6) | 14 (2.5) | 47 (3.2) |
| Common SAEs (≥2 patients in any treatment group) | |||
| Depression | 2 (0.2) | 1 (0.2) | 3 (0.2) |
| Suicidal ideation | 3 (0.3) | 0 | 3 (0.2) |
| Colitis | 2 (0.2) | 0 | 2 (0.1) |
| Sepsis | 2 (0.2) | 0 | 2 (0.1) |
| Pneumonia | 2 (0.2) | 0 | 2 (0.1) |
| Uterine leiomyoma | 2 (0.2) | 0 | 2 (0.1) |
| Myocardial infarction | 1 (0.1) | 1 (0.2) | 2 (0.1) |
| AE leading to study discontinuation | 122 (13.1) | 32 (5.8) | 154 (10.4) |
| Common AEs (≥5% in any treatment group) | |||
| Nausea | 234 (25.2) | 88 (15.8) | 322 (21.7) |
| Headache | 103 (11.1) | 53 (9.5) | 156 (10.5) |
| Constipation | 112 (12.1) | 39 (7.0) | 151 (10.2) |
| Dizziness | 116 (12.5) | 34 (6.1) | 150 (10.1) |
| Somnolence | 100 (10.8) | 24 (4.3) | 124 (8.4) |
| Vomiting | 83 (8.9) | 33 (5.9) | 116 (7.8) |
| Dry mouth | 66 (7.1) | 21 (3.8) | 87 (5.9) |
| Fatigue | 62 (6.7) | 23 (4.1) | 85 (5.7) |
| Upper respiratory tract infection | 50 (5.4) | 33 (5.9) | 83 (5.6) |
| Insomnia | 55 (5.9) | 26 (4.7) | 81 (5.5) |
| Nasopharyngitis | 46 (5.0) | 34 (6.1) | 80 (5.4) |
| Sedation | 51 (5.5) | 15 (2.7) | 66 (4.4) |
| Hyperhidrosis | 48 (5.2) | 9 (1.6) | 57 (3.8) |
AEs were coded by preferred terms and system organ class using the Medical Dictionary for Regulatory Activities, version 19.0
AE adverse event, BUP buprenorphine, SAE serious adverse event, SAM samidorphan