Table 4 AE incidence and most common TEAEs in all dosed participants in studies 1 and 2
AE, n (%) | Study 1 (2 tablets IR/ER HB/APAP) | Study 2 (3 tablets IR/ER HB/APAP) | ||||||
|---|---|---|---|---|---|---|---|---|
High-fat meal | Low-fat meal | Fasted | Overall | High-fat meal | Low-fat meal | Fasted | Overall | |
n = 43 | n = 42 | n = 45 | n = 48 | n = 24 | n = 25 | n = 28 | n = 30 | |
≥1 TEAE | 15 (34.9) | 11 (26.2) | 15 (33.3) | 26 (54.2) | 6 (25.0) | 6 (24.0) | 9 (32.1) | 15 (50.0) |
≥1 SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
≥1 severe TEAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Treatment-related TEAEs | 13 (30.2) | 10 (23.8) | 13 (28.9) | 24 (50.0) | 6 (25.0) | 5 (20.0) | 9 (32.1) | 15 (50.0) |
TEAEs leading to study discontinuation | 2 (4.7) | 2 (4.8) | 3 (6.7) | 7 (14.6) | 3 (12.5) | 1 (4.0) | 4 (14.3) | 8 (26.7) |
Most common TEAEsa | ||||||||
Nausea | 4 (9.3) | 3 (7.1) | 7 (15.6) | 12 (25.0) | 4 (16.7) | 3 (12.0) | 6 (21.4) | 11 (36.7) |
Vomiting | 2 (4.7) | 2 (4.8) | 2 (4.4) | 6 (12.5) | 3 (12.5) | 1 (4.0) | 4 (14.3) | 8 (26.7) |
Dizziness | 3 (7.0) | 4 (9.5) | 7 (15.6) | 10 (20.8) | 3 (12.5) | 1 (4.0) | 4 (14.3) | 6 (20.0) |
Headache | 4 (9.3) | 2 (4.8) | 2 (4.4) | 6 (12.5) | 2 (8.3) | 0 | 0 | 2 (6.7) |
Feeling hot | 0 | 0 | 1 (2.2) | 1 (2.1) | 0 | 1 (4.0) | 2 (7.1) | 3 (10.0) |
Pruritus | 1 (2.3) | 0 | 1 (2.2) | 2 (4.2) | 2 (8.3) | 0 | 1 (3.6) | 3 (10.0) |