Table 5.
Treatment-emergent adverse events observed in at least 1% of patients
| TEAE (MedDRA PT) | N | % |
|---|---|---|
| Any TEAE | 407 | 45.9 |
| Vaginal hemorrhage | 95 | 10.7 |
| Metrorrhagia | 75 | 8.5 |
| Amenorrhea | 65 | 7.3 |
| Weight increased | 41 | 4.6 |
| Menstruation irregular | 39 | 4.4 |
| Headache | 33 | 3.7 |
| Acne | 23 | 2.6 |
| Alopecia | 23 | 2.6 |
| Depression | 16 | 1.8 |
| Menorrhagia | 16 | 1.8 |
| Insomnia | 13 | 1.5 |
| Abdominal pain | 12 | 1.4 |
| Dizziness | 12 | 1.4 |
| Uterine hemorrhage | 10 | 1.1 |
| Breast tenderness | 9 | 1 |
MedDRA Medical Dictionary for Regulatory Activities, PT preferred term, TEAE Treatment-emergent adverse event