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