Table 5. Subjects with values ≥ 1.5 ULN during in-house phase and RR with LCL and UCL limit of 95% confidence interval.
| Total (n = 496) | Active (n = 370) | Placebo (n = 126) | RR [LCL – UCL] (> 1: placebo better < 1: active better) | |
|---|---|---|---|---|
| Amylase | 6 (1.2%) | 4 (1.1%) | 2 (1.6%) | 0.7 [0.1 – 3.7] |
| Lipase | 33 (6.7%) | 28 (7.6%) | 5 (4.0%) | 1.9 [0.8 – 4.8] |
| Creatine kinase | 25 (5.0%) | 16 (4.3%) | 9 (7.1%) | 0.6 [0.3 – 1.3] |
| ALT | 23 (4.6%) | 18 (4.9%) | 5 (4.0%) | 1.2 [0.5 – 3.2] |
| AST | 5 (1.0%) | 5 (1.4%) | 0 | 3.4 [0.2 – 61.9] |
| GLDH | 33 (6.7%) | 28 (7.6%) | 5 (4.0%) | 1.9 [0.8 – 4.8] |
| Bilirubin | 3 (0.6%) | 2 (0.5%) | 1 (0.8%) | 0.7 [0.1 – 7.4] |
| AP | 0 | 0 | 0 | |
| GGT | 2 (0.4%) | 2 (0.5%) | 0 | 1.4 [0.1 – 30.0] |
| Creatinine | 0 | 0 | 0 |
ULN = upper limit of normal; RR = relative risk; LCL = lower limit of 95% confidence interval; UCL = upper limit of 95% confidence interval.