Table 5.
Safety events (full analysis set).
| Safety event | SoC (n = 156) | BUP-XR (n = 158) |
|---|---|---|
| Treatment-emergent adverse events | ||
| Number of participants reporting | 67 (42.9) | 128 (81.0) |
| Number of adverse events | 133 | 450 |
| Type of adverse event—numbera | ||
| Drug administration (pain and pruritis) | 4 (3.0) | 121 (26.9) |
| Gastrointestinal disorders | 13 (9.8) | 61 (13.6) |
| Nervous system disorders | 2 (1.5) | 42 (9.3) |
| Psychiatric disorders | 20 (15.0) | 32 (7.1) |
| Infections and infestations | 38 (28.6) | 34 (7.6) |
| Musculoskeletal and connective tissue disorders | 9 (6.8) | 35 (7.8) |
| Injury, poisoning, and procedural complications | 13 (9.7) | 22 (4.9) |
| Skin and subcutaneous tissue disorders | 5 (3.8) | 24 (5.3) |
| Unintentional drug poisoning adverse events | ||
| Total number of participants reporting | 3 (2.3) | 3 (0.7) |
| Drug class—benzodiazepines | 0 (−) | 1 (0.2) |
| Drug class—not known | 3 (2.3) | 2 (0.4) |
| Treatment-emergent serious adverse events | ||
| Total number of participants reporting | 18 (11.5) | 11 (7.0) |
| Total number of serious adverse events | 26 | 14 |
| Type of serious adverse event—number | ||
| Infections and infestations | 0 (−) | 1 (7.1) |
| Neoplasms benign, malignant and unspecified | 0 (−) | 1 (7.1) |
| Immune system disorders | 1 (3.9) | 0 (−) |
| Psychiatric disorders | 2 (7.7) | 2 (14.3) |
| Nervous system disorders | 6 (23.1) | 1 (7.1)b |
| Vascular disorders | 1 (3.9) | 1 (7.1) |
| Gastrointestinal disorders | 2 (7.7) | 0 (−) |
| Hepatobiliary disorders | 0 (−) | 2 (14.3) |
| Skin and subcutaneous tissue disorders | 1 (3.9) | 0 (−) |
| Musculoskeletal and connective tissue | 1 (3.9) | 0 (−) |
| Renal and urinary disorders | 0 (−) | 1 (7.1) |
| Pregnancy, puerperium and perinatal | 1 (3.9) | 1 (7.1) |
| Injury, poisoning and procedural complication | 7 (26.9) | 1 (7.1) |
| Surgical and medical procedures | 0 (−) | 1 (7.1) |
| Social circumstances | 1 (3.9) | 0 (−) |
| Inconclusive by Coroner | 1 (3.9)b | 0 (−) |
| Unintentional drug poisoning serious adverse eventsc | ||
| Total number of participants reporting | 2 (7.7) | 2 (14.3) |
| Drug class—opioids | 1 (3.9) | 1 (7.1) |
| Drug class—benzodiazepines | 1 (3.9) | 0 (−) |
| Drug class/type—benzodiazepines and cocaine | 0 (−) | 1 (7.1) |
Data are number (%); Appendix I, Supplementary Table S1.4, page 5) shows all adverse events.
BUP-XR, extended-release buprenorphine; SoC, standard-of-care.
a
Reported in at least 5% of participants.
b
Participant died.
c
All discharged after hospital treatment.