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. 2021 Sep 17;65(10):e01220-21. doi: 10.1128/AAC.01220-21

TABLE 2.

Summary of adverse events after the administration of GST-HG141, according to each dose cohort (n = 92)a

Preferred term SAD
MAD
50 mg (N = 8), n (%) 100 mg (N = 8), n (%) 200 mg (N = 8), n (%) 300 mg, fasted (N = 16), n (%) 300 mg, fed (N = 16), n (%) 300 mg, overall (N = 16), n (%) 400 mg (N = 8), n (%) 500 mg (N = 8), n (%) Placebo (N = 12), n (%) 100 mg BID (N = 10), n (%) 200 mg BID (N = 10), n (%) Placebo (N = 4), n (%)
Over with TEAE 0 2 (25.0) 0 0 2 (12.5) 2 (12.5) 6 (75.0) 2 (25.0) 4 (33.3) 2 (20.0) 3 (30.0) 2 (50.0)
Serum creatinine increased 0 0 0 0 0 0 2 (25.0) 0 0 0 1 (10.0) 0
ALT increased 0 0 0 0 0 0 1 (12.5) 0 0 0 0 0
AST increased 0 0 0 0 0 0 1 (12.5) 0 0 1 (10.0) 0 0
CK increased 0 0 0 0 0 0 1 (12.5) 0 0 1 (10.0) 1 (10.0) 0
CK-MB increased 0 0 0 0 0 0 0 0 0 1 (10.0) 0 0
Serum bilirubin increased 0 0 0 0 0 0 1 (12.5) 0 0 0 0 1 (25.0)
Hypertriglyceridemia 0 0 0 0 0 0 0 1 (12.5) 0 0 1 (10.0) 0
Hypoalbuminemia 0 0 0 0 0 0 0 0 2 (16.7) 0 0 0
Hyperuricaemia 0 0 0 0 0 0 0 0 0 1 (10.0) 0 0
Neutrophil count increased 0 0 0 0 1 (6.3) 1 (6.3) 0 0 0 0 0 0
Neutrophil count decreased 0 1 (12.5) 0 0 0 0 0 0 0 0 1 (10.0) 0
Lymphocyte count decreased 0 0 0 0 1 (6.3) 1 (6.3) 0 0 0 0 0 0
WBC count increased 0 0 0 0 1 (6.3) 1 (6.3) 0 0 0 0 0 0
WBC count decreased 0 1 (12.5) 0 0 0 0 0 0 0 0 1 (10.0) 0
Urinary RBC positive 0 1 (12.5) 0 0 0 0 0 0 0 0 0 0
Urinary sediments positive 0 0 0 0 0 0 0 0 1 (8.3) 0 0 0
Urinary tract infection 0 0 0 0 0 0 3 (37.5) 1 (12.5) 1 (8.3) 0 0 1 (25.0)
Upper respiratory infection 0 0 0 0 0 0 1 (12.5) 0 0 0 0 0
Cough 0 0 0 0 1 (6.3) 1 (6.3) 0 0 0 0 0 0
Colporrhagia 0 0 0 0 0 0 0 0 0 1 (10.0) 0 0
Myalgia 0 0 0 0 0 0 0 0 0 1 (10.0) 0 0
a

N, number of subjects analyzed; n, number of subjects. TEAE, treatment-emergent AE; WBC, white blood cell; RBC, red blood cell.