Table 3 Summary of device-related adverse events (AEs) while using ProVate
Adverse Event | FAS (111 confirmed/reconfirmed participants, 51 with device-related AEs) | PP (94 completed usage cycles, 44 with device-related AEs) | ||||
|---|---|---|---|---|---|---|
Number of device-related AEs | Number of participants with device-related AEs | % of device-related AEs within FAS | Number of device-related AEs | Number of participants with device-related AEs | % of device-related AEs within PP | |
Anticipated AEs | ||||||
Spotting | 26 | 20 | 18.02 | 23 | 18 | 19.15 |
Discomfort | 21 | 16 | 14.41 | 16 | 12 | 12.77 |
Pain | 9 | 8 | 7.21 | 6 | 6 | 6.38 |
Mild Pain | 7 | 6 | 5.41 | 7 | 6 | 6.38 |
Vaginal wall trauma | 7 | 4 | 3.60 | 7 | 4 | 4.26 |
De-Novo SUI | 2 | 2 | 1.80 | 1 | 1 | 1.06 |
Vaginal irritation | 2 | 2 | 1.80 | 2 | 2 | 2.13 |
Substantial discomfort | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Odor | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
UTI | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Presumptive UTI | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Local vaginal pressure | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Vaginal pain | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Non-anticipated AEs | ||||||
Pressure on urinary bladder | 2 | 2 | 1.80 | 1 | 1 | 1.06 |
Vaginal burning sensation | 2 | 1 | 0.90 | 2 | 1 | 1.06 |
Lower extremities pains | 1 | 1 | 0.90 | . | . | . |
Poor urinary stream | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Asymptomatic Bacteriuria | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Difficulty emptying bladder | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Frequent urination | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Vaginal discharge with odor | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Vulvo-vaginal burning | 1 | 1 | 0.90 | 1 | 1 | 1.06 |
Total | 91 | 51 | 45.95% | 77 | 44 | 46.81% |