Table 2 Safety and adverse events.
From: Phase 1 study of GSK3368715, a type I PRMT inhibitor, in patients with advanced solid tumors
Preferred term | GSK3368715 dose | |||
---|---|---|---|---|
50 mg (n = 3) | 100 mg (n = 16) | 200 mg (n = 12) | Total (N = 31) | |
Any AEa | 3 (100) | 15 (94) | 12 (100) | 30 (97) |
>10% of participants, n (%) | ||||
Nausea | 2 (67) | 3 (19) | 4 (33) | 9 (29) |
Anemia | 1 (33) | 6 (38)b | 2 (17) | 9 (29) |
Fatigue | 1 (33) | 6 (38) | 1 (8) | 8 (26) |
Diarrhea | 1 (33) | 5 (31)b | 1 (8) | 7 (23) |
Vomiting | 2 (67) | 2 (13) | 3 (25) | 7 (23) |
Pyrexia | 1 (33) | 5 (31) | 0 | 6 (19) |
Pulmonary embolism | 0 | 2 (13)c | 3 (25)f | 5 (16) |
Neutrophil count decreased | 0 | 1 (6)d,e | 3 (25) | 4 (13) |
Dyspnea | 1 (33) | 2 (13) | 1 (8) | 4 (13) |
GSK3368715-related AEs by maximum grade, n (%) | ||||
Grade 3 | 4 (13) | |||
Aortic thrombosis | 0 | 0 | 1 (8)b,g | |
Deep vein thrombosis | 0 | 0 | 1 (8) | |
Atrial fibrillation | 0 | 0 | 1 (8)g | |
Neutrophil count decreased | 0 | 1 (6)e | 0 | |
Grade 4 | 2 (6) | |||
Platelet count decreased | 0 | 0 | 1 (8)b,g | |
Lymphocyte count decreased | 0 | 0 | 1 (8)b |