Table 2.
Most common TRAEs (in >10% of patients) and grade ≥3 TRAEs--combination cohorts
| MedDRA preferred term, n (%) | N = 23 |
|
|---|---|---|
| Any grade | Grade ≥3 | |
| Any TRAE | 18 (78.3) | 7 (30.4)∗ |
| Increased ALT | 8 (34.8) | 5 (21.7) |
| Increased AST | 8 (34.8) | 4 (17.4) |
| Fatigue | 5 (21.7) | 0 |
| Nausea | 5 (21.7) | 0 |
| Decreased appetite | 3 (13.0) | 0 |
| Diarrhea | 3 (13.0) | 1 (4.3) |
| Headache | 3 (13.0) | 0 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities.
∗One grade 5 TRAE (7.5 mg/kg combination cohort) of pneumonia was reported that was also confounded with the progression of underlying AML.