TABLE 5.
Incidence of adverse events, Study 1
| MFU-V (N=14) | SHAM (N=11) | N/A* (N=14) | TOTAL (N=14) | |
|---|---|---|---|---|
| Overall, N (%) | 13 (92.9) | 1 (9.1) | 3 (21.4) | 14 (100.0) |
| • After 1st treatment | 12 (85.7) | 1 (9.1) | 1 (7.1) | 13 (92.9) |
| • After 2nd treatment† | 7 (53.8) | - | 3 (23.1) | 9 (69.2) |
| Severity, N (%) | ||||
| • Mild | 12 (85.7) | 1 (9.1) | 3 (21.4) | 13 (92.9) |
| • Moderate | 2 (14.3) | - | 1 (7.1) | 3 (21.4) |
| • Severe | 1 (7.1) | - | - | 1 (7.1) |
| Related to Device, N (%) | ||||
| • Unrelated/unlikely | 1 (7.1) | - | 3 (21.4) | 3 (21.4) |
| • Possibly | 13 (92.9) | - | 1 (7.1) | 14 (100.0) |
| • Probably | 1 (7.1) | - | - | 1 (7.1) |
| Related to Procedure, N (%) | ||||
| • Unrelated/unlikely | 1 (7.1) | - | 3 (21.4) | 3 (21.4) |
| • Possibly | 1 (7.1) | - | - | 1 (7.1) |
| • Probably | 13 (92.9) | 1 (9.1) | 1 (7.1) | 14 (100.0) |
*
Not specific to MFU-V or sham treatment;
†
For MFU-V, N/A, and total columns, N=13; for sham, N=10