Table 5. Tolerability and safety of study therapy at/above the RP2D.
| Parameter | Grade 3-4 n (% cycles) |
Grade 5 n (% cycles) |
|---|---|---|
|
| ||
| Bacteremia | 18 (30.0%) | - |
| Catheter-related infection | 2 (3.3%) | - |
| Disseminated fungal infection | - | 1 (1.7%) |
| Pneumonia, sinusitis | 19 (31.7%) | 1 (1.7%) |
| Neutropenic fever | 47 (78.3%) | - |
| Sepsis | 17 (28.3%) | - |
| Soft-tissue infection | 4 (6.7%) | - |
| Other infection | 4 (6.7%) | - |
|
| ||
| Atrial tachycardia | 2 (3.3%) | - |
| Cardiac arrest | - | 1 (1.7%) |
| Cardiomyopathy | 2 (3.3%) | - |
| Hypotension | 4 (6.7%) | - |
|
| ||
| Multi-system organ failure | 1 (1.7%) | 2 (3.3%) |
| Hypoxia | 10 (16.7%) | - |
| Respiratory failure | 7 (11.7%) | 4 (6.7%) |
|
| ||
| Nausea/vomiting | 4 (6.7%) | - |
| Mucositis | 14 (23.3%) | - |
| Esophagitis | 3 (5.0%) | - |
| Abdominal pain | 2 (3.3%) | - |
| Diarrhea | 5 (8.3%) | - |
| Anorexia | 6 (10.0%) | - |
|
| ||
| Acute kidney injury | 1 (1.7%) | - |
| ALT or AST elevation | 4 (6.7%) | - |
| Bilirubin elevation | 2 (3.3%) | - |
| Cardiac troponin elevation | 2 (3.3%) | - |
| Hypokalemia, hyponatremia, hypophosphatemia | 14 (23.3%) | - |
| Tumor lysis | 2 (3.3%) | - |
|
| ||
| Intracranial hemorrhage | - | 1 (1.7%) |
| Syncope | 2 (3.3%) | - |
|
| ||
| Fall | 2 (3.3%) | - |
| Rash | 2 (3.3%) | - |
Table summarizing grade 3-5 non-hematologic adverse effects considered as definitively, probably, or possibly related to study treatment by the investigator that were experienced by the 46 patients treated at/above the R2PD over 60 treatment cycles