Table 2.
Safety events by high- and low-level terms.
| High level term | Low level term | Number Of Events | Subjects With Events | Overall % (n = 92) | Month 3% (n = 92) | Month 3 Adjusted %a | Month 24 Adjusted %a | 95% LB | 95% UB |
|---|---|---|---|---|---|---|---|---|---|
| Hernia Recurrence | 3 | 3 | 3.3% | 0.0% | 0.0% | 2.6% | 0.7% | 10.1% | |
| Adjacent Recurrence | 3 | 3 | 3.3% | 0.0% | 0.0% | 2.6% | 0.7% | 10.1% | |
| SSO | 48 | 35 | 38.0% | 34.8% | 36.8% | 40.7% | 31.2% | 52.0% | |
| Seroma | 12 | 12 | 13.0% | 10.9% | 11.6% | 14.4% | 8.4% | 24.1% | |
| Seroma (requiring intervention) | 3 | 3 | 3.3% | 3.3% | 3.5% | 3.5% | 1.2% | 10.5% | |
| Hematoma | 4 | 4 | 4.3% | 4.3% | 4.7% | 4.7% | 1.8% | 12.0% | |
| Wound Dehiscence | 1 | 1 | 1.1% | 1.1% | 1.2% | 1.2% | 0.2% | 8.1% | |
| Skin Necrosis | 1 | 1 | 1.1% | 1.1% | 1.2% | 1.2% | 0.2% | 8.0% | |
| Fistulae | 2 | 2 | 2.2% | 2.2% | 2.3% | 2.3% | 0.6% | 9.0% | |
| Surgical site infection (SSI) | 25 | 19 | 20.7% | 16.3% | 17.3% | 23.3% | 15.4% | 34.3% | |
| Superficial Infection | 11 | 11 | 12.0% | 9.8% | 10.6% | 14.0% | 7.9% | 24.2% | |
| Deep/Abscess Infection | 14 | 9 | 9.8% | 6.5% | 8.0% | 10.6% | 5.6% | 19.4% | |
| Organ Space Infection | 0 | 0 | 0.0% | 0.0% | – | – | – | – | |
| Complications | 11 | 11 | 12.0% | 10.9% | 11.5% | 12.7% | 7.3% | 21.8% | |
| Bowel Obstruction | 1 | 1 | 1.1% | 1.1% | 1.2% | 1.2% | 0.2% | 8.0% | |
| Ileus | 8 | 8 | 8.7% | 8.7% | 9.1% | 9.1% | 4.7% | 17.4% | |
| Any other non-surgery or Hernia-related complications | 2 | 2 | 2.2% | 1.1% | 1.2% | 2.5% | 0.6% | 9.6% | |
| Mesh Removal | 3 | 3 | 3.3% | 2.2% | 2.3% | 3.6% | 1.2% | 10.7% | |
| Full | 2 | 2 | 2.2% | 1.1% | 1.1% | 2.4% | 0.6% | 9.3% | |
| Partial | 1 | 1 | 1.1% | 1.1% | 1.2% | 1.2% | 0.2% | 8.1% | |
a
Kaplan Meier estimates censored at day 90 (3 months) 730 (24 months).