TABLE 6.
Reported adverse events, Study 1
| ADVERSE EVENT, N (%)† | MFU-V (N=14) | SHAM (N=11) | N/A* (N=14) | TOTAL (N=14) |
|---|---|---|---|---|
| Arm paresthesia | 1 (7.1) | - | - | 1 (7.1) |
| Axilla bruising | 4 (28.6) | 1 (9.1) | - | 5 (35.7) |
| Axilla folliculitis | 1 (7.1) | - | - | 1 (7.1) |
| Axilla paresthesia | 2 (14.3) | - | - | 2 (14.3) |
| Axilla redness | 1 (7.1) | - | - | 1 (7.1) |
| Axilla tenderness/soreness | 12 (85.7) | - | 1 (7.1) | 13 (92.9) |
| Bowel preparation for colonoscopy | - | - | 1 (7.1) | 1 (7.1) |
| Mechanical fall while jogging | - | - | 1 (7.1) | 1 (7.1) |
| Sinusitis | - | - | 1 (7.1) | 1 (7.1) |
*
Not specific to MFU-V or sham.
†
For active, N/A, and total columns, N=13; for sham, N=10