Table 4.
TEAEs occurring in ≥1% of women, study drug-related TEAEs occurring in ≥0.5% of women and TE-SAEs reported during the study by primary system organ class and preferred term in the safety analysis set (n=954)
| TEAEs, n (%) | Study drug-related TEAEs, n (%) | TE-SAEs, n (%) | |
|---|---|---|---|
| Total | 457 (47.9) | 155 (16.2) | 13 (1.4) |
| Gastrointestinal disorders | |||
| Diarrhea | 10 (1.0) | – | – |
| Infections and infestations | |||
| Nasopharyngitis | 44 (4.6) | – | – |
| Pharyngitis | 14 (1.5) | – | – |
| Upper respiratory tract infection | 82 (8.6) | – | – |
| Vaginal infection | 17 (1.8) | – | – |
| Vulvovaginal candidiasis | 31 (3.2) | 5 (0.5) | – |
| Investigations–increases in | |||
| Alanine aminotransferase | 12 (1.3) | 8 (0.8) | – |
| Fibrin D dimera | 11 (1.2) | – | – |
| Aspartate aminotransferase | – | 5 (0.5) | – |
| Bodyweight | – | 6 (0.6) | – |
| Nervous system disorders | |||
| Dizziness | 15 (1.6) | 6 (0.6) | – |
| Headache | 27 (2.8) | 9 (0.9) | – |
| Hypoesthesia | – | – | 1 (0.1) |
| Reproductive system and breast disorders | |||
| Amenorrhea | 10 (1.0) | 10 (1.0) | – |
| Breast hyperplasia | 19 (2.0) | 11 (1.2) | – |
| Breast pain | 14 (1.5) | 12 (1.3) | – |
| Cervical dysplasia | 19 (2.0) | 5 (0.5) | – |
| Vaginal hemorrhage | 11 (1.2) | 10 (1.0) | 1 (0.1) |
| Breast engorgement | – | 5 (0.5) | – |
| Skin and subcutaneous tissue disorders | |||
| Acne | 17 (1.8) | 10 (1.0) | – |
| Psychiatric disorders | |||
| Libido decreased | – | 5 (0.5) | – |
| Ear and labyrinth disorders | |||
| Deafness unilateral | – | – | 1 (0.1) |
| Hepatobiliary disorders | |||
| Cholecystitis | – | – | 1 (0.1) |
| Hepatitis cholestatic | – | – | 1 (0.1) |
| Injury, poisoning and procedural complications | |||
| Ankle fracture | – | – | 1 (0.1) |
| Neoplasms benign, malignant and unspecified | |||
| Brain neoplasm benign | – | – | 1 (0.1) |
| Fibroadenoma of breast | – | – | 1 (0.1) |
| Papillary thyroid cancer | – | – | 1 (0.1) |
| Tubular breast carcinoma | – | – | 1 (0.1) |
| Pregnancy, puerperium and perinatal conditions | |||
| Imminent abortion | – | – | 1 (0.1) |
| Renal and urinary disorders | |||
| Calculus ureteric | – | – | 1 (0.1) |
| Respiratory, thoracic and mediastinal disorders | |||
| Vocal cord polyp | – | – | 1 (0.1) |
Note:
a
Measured in women from mainland China and Hong Kong only.
Abbreviations: TEAEs, treatment-emergent adverse events; TE-SAEs, treatment-emergent serious adverse events.