Table 3.
Number of Participants With Treatment‐Emergent Vilaprisan‐Related Adverse Events by Primary System Organ Class and Preferred Term
| Primary SOC PT MedDRA version 21.1 | Total N = 12 (100.0%) |
|---|---|
| Subjects with at least 1 such AE | 9 (75.0) |
| Gastrointestinal disorders | 4 (33.3) |
| Abdominal distention | 3 (25.0) |
| Abdominal pain | 1 (8.3) |
| Epigastric discomfort | 1 (8.3) |
| General disorders and administration site conditions | 2 (16.7) |
| Fatigue | 2 (16.7) |
| Investigations | 8 (66.7) |
| Alanine aminotransferase increased | 1 (8.3) |
| Aspartate aminotransferase increased | 1 (8.3) |
| Blood triglycerides increased | 6 (50.0) |
| Ultrasound of uterus abnormal | 1 (8.3) |
| Nervous system disorders | 1 (8.3) |
| Headache | 1 (8.3) |
| Reproductive system and breast disorders | 1 (8.3) |
| Cervical cyst | 1 (8.3) |
| Hydrometra | 1 (8.3) |
| Ovarian cyst | 1 (8.3) |
| Pelvic fluid collection | 1 (8.3) |
| Postmenopausal hemorrhage | 1 (8.3) |
| Skin and subcutaneous tissue disorders | 1 (8.3) |
| Eczema | 1 (8.3) |
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class.
Data are presented as n (%). Data are based on the Safety Analysis Set. AEs are sorted in alphabetical order by primary SOC and PT.