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. 2022 Nov 23;13:1027648. doi: 10.3389/fphar.2022.1027648

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.