Table 4.
Most common serious adverse events
| Serious adverse event | ITT patients, n (%) |
|---|---|
| Band slippage | 21 (6.9) |
| Erosion into gastrointestinal tract | 4 (1.3) |
| Port displacement | 3 (1.0) |
| Catheter-related complication | 14 (4.6) |
| Gastric dilationa | 7 (2.3) |
| Vomitingb | 5 (1.6) |
| Hiatal herniac | 5 (1.6) |
ITT = intent-to-treat.
a
Gastric dilation was synonymous with pouch dilation, pouch enlargement, or prolapsed pouch.
b
Vomiting was defined as a forcible loss of stomach contents deemed related to the study device.
c
Hiatal hernia was defined as a protrusion of the upper stomach through the diaphragm into the chest cavity.