TABLE 2.
AEs.
| 200 mg BID (n = 10) | 300 mg BID (n = 10) | 400 mg BID (n = 10) | 500 mg BID (n = 10) | SHR7280 total (n = 40) | Placebo (n = 8) | |
|---|---|---|---|---|---|---|
| Any AE | 9 (90.0) | 10 (100) | 10 (100) | 10 (100) | 39 (97.5) | 7 (87.5) |
| Reproductive system and breast disorders | ||||||
| Oligomenorrhoea | 8 (80.0) | 10 (100) | 10 (100) | 10 (100) | 38 (95.0) | 0 |
| Heavy menstrual bleeding | 1 (10.0) | 2 (20.0) | 0 | 1 (10.0) | 4 (10.0) | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 2 (20.0) | 3 (30.0) | 0 | 3 (30.0) | 8 (20.0) | 2 (25.0) |
| Urine leukocyte esterase positive | 2 (20.0) | 2 (20.0) | 2 (20.0) | 2 (20.0) | 8 (20.0) | 2 (25.0) |
| Neutrophil count decreased | 0 | 2 (20.0) | 3 (30.0) | 2 (20.0) | 7 (17.5) | 0 |
| Blood thyroid stimulating hormone increased | 1 (10.0) | 1 (10.0) | 4 (40.0) | 0 | 6 (15.0) | 0 |
| White blood cell count decreased | 0 | 1 (10.0) | 2 (20.0) | 2 (20.0) | 5 (12.5) | 0 |
| White blood cells urine positive | 1 (10.0) | 1 (10.0) | 2 (20.0) | 0 | 4 (10.0) | 1 (12.5) |
| Estradiol decreased | 2 (20.0) | 1 (10.0) | 0 | 1 (10.0) | 4 (10.0) | 0 |
| Thyroxine free decreased | 2 (20.0) | 1 (10.0) | 0 | 1 (10.0) | 4 (10.0) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 2 (20.0) | 2 (20.0) | 1 (10.0) | 0 | 5 (12.5) | 4 (50.0) |
| Diarrhea | 2 (20.0) | 1 (10.0) | 1 (10.0) | 0 | 4 (10.0) | 1 (12.5) |
| Infections and infestations | ||||||
| Bacterial vulvovaginitis | 0 | 3 (30.0) | 0 | 2 (20.0) | 5 (12.5) | 0 |
| Asymptomatic bacteriuria | 2 (20.0) | 2 (20.0) | 0 | 0 | 4 (10.0) | 3 (37.5) |
| Blood and lymphatic system disorders | ||||||
| Anemia | 1 (10.0) | 1 (10.0) | 2 (20.0) | 0 | 4 (10.0) | 0 |
Data are n (%). AEs occurred in ≥10% of total participants who received SHR7280 are listed.