Table 5.
Summaries of all the AEs reported during the study of safety population (N = 252)
| Adverse Events | N | % |
|---|---|---|
| Nausea | 4 | 1.6 |
| Device expulsion | 3 | 1.2 |
| Pyrexia | 3 | 1.2 |
| Urinary tract infection | 2 | 0.8 |
| Weight increased | 3 | 1.2 |
| Dysuria | 2 | 0.8 |
| Breast discomfort | 2 | 0.8 |
| Menorrhagia | 3 | 1.2 |
| Metrorrhagia | 3 | 1.2 |
| Vaginal discharge | 6 | 2.4 |
| Vaginal bleeding/spotting | 13 | 5.2 |
| Vulvovaginal pain | 2 | 0.8 |
| Vulvovaginal pruritus | 7 | 2.8 |
Denominator is the number of subjects in the safety population