Grade 3/4 adverse events at least possibly related to the study treatment in ≥5% of patients in the phase 2 portion
| Adverse event . | Arm B (N = 35) [N (%)] . | Arm C (N = 33) [N (%)] . | P value* . | Arm D (N = 17) [N (%)] . |
|---|---|---|---|---|
| Anemia | 4 (11.4) | 8 (24.2) | .211 | 1 (5.9) |
| Febrile neutropenia | 4 (11.4) | 4 (12.1) | 1.000 | — |
| Fatigue | 3 (8.6) | 4 (12.1) | .705 | — |
| Flu-like symptoms | — | — | — | 1 (5.9) |
| Lung infection | 4 (11.4) | 3 (9.1) | 1.000 | 1 (5.9) |
| Sepsis | — | 3 (9.1) | .109 | — |
| Upper respiratory infection | — | 2 (6.1) | .232 | — |
| Lymphopenia | 4 (11.4) | 3 (9.1) | 1.000 | 2 (11.8) |
| Neutropenia | 11 (31.4) | 17 (51.5) | .139 | 4 (23.5) |
| Thrombocytopenia | 2 (5.7) | 5 (15.2) | .252 | — |
| Leukopenia | 5 (14.3) | 4 (12.1) | 1.000 | 1 (5.9) |
| Hyperglycemia | — | 2 (6.1) | .232 | — |
| Hyponatremia | — | 2 (6.1) | .232 | — |
| Hypophosphatemia | — | — | — | 1 (5.9) |
| Hypoxia | — | — | — | 1 (5.9) |
| Confusion | — | 2 (6.1) | .232 | — |
| Pneumonitis | — | 3 (9.1) | .109 | — |
| Thromboembolic event | — | 2 (6.1) | .232 | — |
| Adverse event . | Arm B (N = 35) [N (%)] . | Arm C (N = 33) [N (%)] . | P value* . | Arm D (N = 17) [N (%)] . |
|---|---|---|---|---|
| Anemia | 4 (11.4) | 8 (24.2) | .211 | 1 (5.9) |
| Febrile neutropenia | 4 (11.4) | 4 (12.1) | 1.000 | — |
| Fatigue | 3 (8.6) | 4 (12.1) | .705 | — |
| Flu-like symptoms | — | — | — | 1 (5.9) |
| Lung infection | 4 (11.4) | 3 (9.1) | 1.000 | 1 (5.9) |
| Sepsis | — | 3 (9.1) | .109 | — |
| Upper respiratory infection | — | 2 (6.1) | .232 | — |
| Lymphopenia | 4 (11.4) | 3 (9.1) | 1.000 | 2 (11.8) |
| Neutropenia | 11 (31.4) | 17 (51.5) | .139 | 4 (23.5) |
| Thrombocytopenia | 2 (5.7) | 5 (15.2) | .252 | — |
| Leukopenia | 5 (14.3) | 4 (12.1) | 1.000 | 1 (5.9) |
| Hyperglycemia | — | 2 (6.1) | .232 | — |
| Hyponatremia | — | 2 (6.1) | .232 | — |
| Hypophosphatemia | — | — | — | 1 (5.9) |
| Hypoxia | — | — | — | 1 (5.9) |
| Confusion | — | 2 (6.1) | .232 | — |
| Pneumonitis | — | 3 (9.1) | .109 | — |
| Thromboembolic event | — | 2 (6.1) | .232 | — |
Comparing arm B to arm C using Fisher’s exact test.