Table 2 Treatment-related adverse events with incidence ≥ 10%
Preferred term | GFH018 5 mg BID 14d-on/14d-off (N = 4) n (%) | GFH018 10 mg BID 14d-on/14d-off (N = 3) n (%) | GFH018 20 mg BID 14d-on/14d-off (N = 4) n (%) | GFH018 30 mg BID 14d-on/14d-off (N = 7) n (%) | GFH018 40 mg BID 14d-on/14d-off (N = 4) n (%) | GFH018 50 mg BID 14d-on/14d-off (N = 4) n (%) | GFH018 65 mg BID 14d-on/14d-off (N = 6) n (%) | GFH018 85 mg BID 7d-on/7d-off (N = 6) n (%) | GFH018 85 mg BID 14d-on/14d-off (N = 12) n (%) | Total (N = 50) n (%) |
|---|---|---|---|---|---|---|---|---|---|---|
At least one TRAE | 4 (100%) | 3 (100%) | 4 (100%) | 7 (100%) | 4 (100%) | 2 (50.0%) | 5 (83.3%) | 3 (50.0%) | 11 (91.7%) | 43 (86.0%) |
AST increased | 0 | 0 | 0 | 2 (28.6%) | 0 | 1 (25.0%) | 2 (33.3%) | 0 | 4 (33.3%) | 9 (18.0%) |
Proteinuria | 0 | 0 | 2 (50.0%) | 3 (42.9%) | 0 | 0 | 1 (16.7%) | 0 | 1 (8.3%) | 7 (14.0%) |
Anemia | 0 | 1 (33.3%) | 0 | 0 | 0 | 0 | 2 (33.3%) | 1 (16.7%) | 3 (25.0%) | 7 (14.0%) |
Protein urine present | 1 (25.0%) | 1 (33.3%) | 1 (25.0%) | 0 | 0 | 1 (25.0%) | 0 | 1 (16.7%) | 1 (8.3%) | 6 (12.0%) |
Lymphocyte count decreased | 1 (25.0%) | 0 | 0 | 1 (14.3%) | 0 | 0 | 0 | 2 (33.3%) | 2 (16.7%) | 6 (12.0%) |
ALT increased | 0 | 1 (33.3%) | 0 | 2 (28.6%) | 0 | 1 (25.0%) | 0 | 0 | 2 (16.7%) | 6 (12.0%) |
GGT increased | 0 | 2 (66.7%) | 0 | 0 | 0 | 1 (25.0%) | 0 | 0 | 2 (16.7%) | 5 (10.0%) |
ALP increased | 0 | 1 (33.3%) | 0 | 0 | 1 (25.0%) | 1 (25.0%) | 0 | 1 (16.7%) | 1 (8.3%) | 5 (10.0%) |
LDH increased | 0 | 1 (33.3%) | 0 | 1 (14.3%) | 1 (25.0%) | 0 | 0 | 0 | 2 (16.7%) | 5 (10.0%) |