Table 3.
TRAEs of any grade and grade ≥3 occurring across all treatment groups.
| Study INCB 54329-101 (n = 69) |
Study INCB 57643-101 (n = 134) |
|||
|---|---|---|---|---|
| Any gradea | Grade ≥3 | Any gradea | Grade ≥3 | |
| TRAEs, n (%) | 54 (78) | 16 (23) | 115 (86) | 48 (36) |
| Nausea | 24 (35) | 1 (1) | 40 (30) | 2 (2) |
| Thrombocytopeniab | 23 (33) | 9 (13) | 43 (32) | 24 (18) |
| Fatigue | 20 (29) | 0 (0) | 40 (30) | 1 (1) |
| Decreased appetite | 18 (26) | 0 (0) | 30 (22) | 0 (0) |
| Diarrhea | 12 (17) | 0 (0) | 21 (16) | 2 (2) |
| Dysgeusia | 9 (13) | 0 (0) | 22 (16) | 0 (0) |
| Anemia | 7 (10) | 4 (6) | 19 (14) | 14 (10) |
| Vomiting | 7 (10) | 1 (1) | 21 (16) | 2 (2) |
| Hyperglycemia | 3 (4)c | 2 (3) | 18 (13) | 4 (3) |
a
TRAEs that occurred in ≥10% of patients in either study.
b
MedDRA preferred terms of Thrombocytopenia and Platelet counts decreased were combined for this analysis.
c
Although this TRAE occurred in <10% of patients in Study INCB 54329-101, it is listed because it occurred in ≥10% of patients in Study INCB 57643-101.