Table 3 Incidence proportion (in %) for TEAEs and elevated liver laboratory tests by initiation vs. maintenance dosing period in injecting users and non-injecting participants (Before vs. after the 3rd injection)
| Â | Initiation period | Maintenance dose period | ||||
|---|---|---|---|---|---|---|
Maintenance dose groups | BUP-XR 300/300Â mg | BUP-XR 300/100Â mg | Placeboa | BUP-XR 300/300Â mg | BUP-XR 300/100Â mg | Placeboa |
Opioid-injecting participants | (N = 63) | (N = 66) | (N = 27) | (N = 63) | (N = 66) | (N = 27) |
Participants with any TEAEs | 31 (49.2) | 44 (66.7) | 13 (48.1) | 38 (60.3) | 44 (66.7) | 10 (37.0) |
With treatment-related TEAEs | 17 (27.0) | 14 (21.2) | 4 (14.8) | 16 (25.4) | 12 (18.2) | 0 |
With serious TEAEs | 1 (1.6) | 0 | 1 (3.7) | 3 (4.8) | 1 (1.5) | 3 (11.1) |
With severe TEAEs | 2 (3.2) | 0 | 1 (3.7) | 1 (1.6) | 4 (6.1) | 1 (3.7) |
With TEAE leading to treatment discontinuation | 0 | 0 | 0 | 1 (1.6) | 1 (1.5) | 1 (3.7) |
Participants with TEAEs of special interest | ||||||
Injection site reactions | 6 (9.5) | 7 (10.6) | 2 (7.4) | 10 (15.9) | 5 (7.6) | 0 |
Hepatic disorders | 3 (4.8) | 3 (4.5) | 0 | 5 (7.9) | 6 (9.1) | 0 |
Opioid withdrawal signs and symptoms | 16 (25.4) | 17 (25.8) | 5 (18.5) | 12 (19.0) | 16 (24.2) | 6 (22.2) |
Central nervous system depression | 2 (3.2) | 6 (9.1) | 0 | 1 (1.6) | 2 (3.0) | 1 (3.7) |
Elevated liver laboratory tests | ||||||
ALT > 3 × ULN | 8 (12.7) | 2 (3.0) | 1 (3.7) | 9 (14.3) | 5 (7.6) | 0 |
AST > 3 × ULN | 8 (12.7) | 4 (6.1) | 1 (3.7) | 9 (14.3) | 8 (12.1) | 0 |
ALT & AST ≥ 3 × ULN | 4 (6.3) | 1 (1.5) | 1 (3.7) | 5 (7.9) | 3 (4.5) | 0 |
Non-injecting opioid participants | (N = 92) | (N = 90) | (N = 22) | (N = 92) | (N = 90) | (N = 22) |
Participants with any TEAEs | 50 (54.3) | 55 (61.1) | 12 (54.5) | 50 (54.3) | 50 (55.6) | 11 (50.0) |
With treatment-related TEAEs | 22 (23.9) | 25 (27.8) | 5 (22.7) | 19 (20.7) | 16 (17.8) | 5 (22.7) |
With serious TEAEs | 0 | 1 (1.1) | 1 (4.5) | 2 (2.2) | 2 (2.2) | 0 |
With severe TEAEs | 4 (4.3) | 5 (5.6) | 1 (4.5) | 4 (4.3) | 5 (5.6) | 0 |
With TEAE leading to treatment discontinuation | 2 (2.2) | 1 (1.1) | 0 | 2 (2.2) | 1 (1.1) | 0 |
Participants with TEAEs of special interest | ||||||
Injection site reactions | 9 (9.8) | 9 (10.0) | 4 (18.2) | 13 (14.1) | 8 (8.9) | 1 (4.5) |
Hepatic disorders | 0 | 1 (1.1) | 1 (4.5) | 4 (4.3) | 3 (3.3) | 0 |
Opioid withdrawal signs and symptoms | 20 (21.7) | 22 (24.4) | 7 (31.8) | 14 (15.2) | 13 (14.4) | 6 (27.3) |
Central nervous system depression | 6 (6.5) | 7 (7.8) | 2 (9.1) | 1 (1.1) | 5 (5.6) | 0 |
Elevated liver laboratory tests | ||||||
ALT > 3 × ULN | 6 (6.5) | 0 | 0 | 5 (5.4) | 2 (2.2) | 0 |
AST > 3 × ULN | 3 (3.3) | 2 (2.2) | 0 | 6 (6.5) | 4 (4.4) | 0 |
ALT & AST ≥ 3 × ULN | 3 (3.3) | 0 | 0 | 3 (3.3) | 2 (2.2) | 0 |