Table 5. Adverse events (n = 74 procedures).
SIF-Y0004 (n = 51) | SIF-H290S (n = 23) | P value | |
Pancreatitis, n (%) | 4 (7.8) | 1 (4.3) | > 0.99 |
Cholangitis, n (%) | 1 (2.0) | 1 (4.3) | 0.53 |
Intestinal perforation, n (%) | 0 (0) | 1 (4.3) | 0.31 |
Total, n (%) | 5 (9.8) | 3 (13.0) | 0.70 |