Table 2.
Safety and adverse events.
| 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 | |
AE adverse event.
aIncludes all AEs and all grades.
bLed to dose interruption in 1 participant.
cLed to permanent discontinuation in 1 participant.
dPossibly study drug related.
eLed to a dose reduction.
fFatal in 1 participant.
gCategorized as dose-limiting toxicity.