Table 3.
Adverse Events
| SPS (n = 527) (%) | MLC (n = 1,940) (%) | CLC (n = 114,356) (%) | |
|---|---|---|---|
| Procedure related | |||
| Bile duct fistula | 0 (0.0) | 0 (0.0) | 7 (0.0) |
| Bile duct obstruction | 2 (0.4) | 2 (0.1) | 195 (0.2) |
| Bile duct perforation | 0 (0.0) | 0 (0.0) | 6 (0.0) |
| Systemic adverse events | |||
| Cerebrovascular accident | 0 (0.0) | 1 (0.1) | 43 (0.0) |
| Acute myocardial infarction | 0 (0.0) | 2 (0.1) | 37 (0.0) |
| Transient ischemic attack | 0 (0.0) | 2 (0.1) | 46 (0.0) |
| Other embolism | 0 (0.0) | 3 (0.2) | 120 (0.1) |
| Pneumothorax | 0 (0.0) | 0 (0.0) | 16 (0.0) |
| Pulmonary embolism | 1 (0.2) | 3 (0.2) | 95 (0.1) |
| Other adverse events | |||
| Abdominal rigidity/tenderness | 0 (0.0) | 0 (0.0) | 114 (0.1) |
| Digestive system complications | 8 (1.5) | 15 (0.8) | 735 (0.6) |
| Gastroparesis paralytic ileus | 4 (0.8) | 7 (0.4) | 438 (0.4) |
| Nausea and vomiting | 45 (8.5) | 86 (4.4) | 4,874 (4.3) |
| Operative complication | 19 (3.6) | 30 (1.6) | 2,006 (1.8) |
| Peritonitis (not specified) | 1 (0.2) | 3 (0.2) | 103 (0.1) |
| Death | |||
| Death during procedure | 0 (0.0) | 0 (0.0) | 2 (0.0) |
| Death after procedure | 0 (0.0) | 2 (0.1) | 35 (0.0) |
| Hemorrhage/bleeding | |||
| Minor bleeding | 0 (0.0) | 0 (0.0) | 9 (0.0) |
| Major bleeding | 0 (0.0) | 0 (0.0) | 20 (0.0) |
| Any one or more adverse event | 62 (11.8) | 123 (6.3) | 7,307 (6.4) |