Safety analyses
treatment-emergent adverse, OI, TEAEs
HEPATIC DISORDERS
Safety data were analyzed for both BUP-XR maintenance dose groups (100 mg and 300 mg) within OI and NIO separately using the safety analysis set (participants who received at least one maintenance dose). The percentage of participants (incidence proportion) reporting treatment-emergent adverse events (TEAEs) was summarized by BUP-XR injection (1–6), where the denominator was the number of participants receiving that injection. The percentage of participants (incidence proportion) with TEAEs was also summarized separately for the treatment initiation (the first and second 300-mg injections) and maintenance dosing periods, where the denominator was the number of participants who received at least 1 injection during the corresponding period and was the same for both initiation and maintenance dose periods. During the initiation period, almost all participants had 2 BUP-XR injections of 300 mg (except one opioid-injecting participant in the 300-/100-mg group with one 300-mg injection). Analyses were repeated for serious/severe TEAEs and TEAEs of special interest, including injection site reactions, signs and symptoms associated with opioid withdrawal, and hepatic disorders, and for participants meeting the following liver enzyme criteria: elevated alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN], aspartate aminotransferase [AST] > 3 × ULN, or ALT and AST > 3 × ULN at the same time.