Table 3.
Adverse Events (AEs) in the Coil and Device Closure Groups
| AEs | Total (n=496) | Coil (n=158) | Device (n=338) | P Value |
|---|---|---|---|---|
| Any AE, n (%) | 46 (9) | 21 (13) | 25 (7) | 0.02 |
| Any high‐severity AE (levels 3, 4, 5), n (%) | 11 (2) | 2 (1) | 9 (3) | 1.0 |
| Any coil‐ or device‐related AE, n (%) | 24 (5) | 17 (10) | 7 (2) | <0.001 |
| Embolization* | 11 (2) | 8 (5) | 3 (<1) | 0.003 |
| Malposition* | 13 (3) | 9 (6) | 4 (1) | |
| Highest‐severity AE, n (%) | 0.04 | |||
| 0—no AE | 450 (91) | 137 (87) | 313 (93) | |
| 1—very minor | 5 (<1) | 1 (<1) | 4 (<1) | |
| 2—minor | 30 (6) | 18 (11) | 12 (4) | |
| 3—moderate | 9 (2) | 1 (<1) | 8 (2) | |
| 4—major | 2 (<1) | 1 (1) | 1 (<1) | |
*
Embolization and malposition are subcategories and included in the total of any coil‐ or device‐related AE.