Table 2.
Safety outcomes, including most common TEAEs.
| Parameter, n (%) | Concurrent cohort (n = 22) | Delayed cohort (dose-finding part only) (n = 10) | ||
|---|---|---|---|---|
| All grade | Grade 3/4 | All grade | Grade 3/4 | |
| Patients with ≥1 TEAE | 22 (100.0) | 20 (90.9) | 10 (100.0) | 10 (100.0) |
| Patients with ≥1 serious TEAE | 8 (36.4) | 6 (27.3) | 3 (30.0) | 2 (20.0) |
| Most common TEAEsa | ||||
| Vomiting | 13 (59.1) | 3 (13.6) | 3 (30.0) | 0 |
| Anemia | 13 (59.1) | 10 (45.5) | 7 (70.0) | 4 (40.0) |
| Neutropenia | 11 (50.0) | 9 (40.9) | 5 (50.0) | 5 (50.0) |
| Thrombocytopenia | 8 (36.4) | 2 (9.1) | 2 (20.0) | 1 (10.0) |
| Neutrophil count decreased | 6 (27.3) | 6 (27.3) | 3 (30.0) | 2 (20.0) |
| Hypokalemia | 5 (22.7) | 3 (13.6) | 1 (10.0) | 1 (10.0) |
| WBC count decreased | 5 (22.7) | 3 (13.6) | 1 (10.0) | 0 |
| Pneumonia | 3 (13.6) | 2 (9.1) | – | – |
| Hyponatremia | 2 (9.1) | 2 (9.1) | 1 (10.0) | 0 |
NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; TEAE, treatment-emergent adverse event; WBC, white blood cell. TEAEs presented by preferred term and most severe NCI-CTCAE grade.
a
Grade ≥3 TEAEs reported in >5% of patients in the concurrent cohort, presented in descending order of incidence of all-grade TEAEs in the concurrent cohort.