Table 2.
Adverse events deemed possibly, probably, and definitely related to the study drug. Grade 1 and 2 events with fever that 3 occurrences not shown. Dose-limiting toxicities denoted with an asterisk.
| Grade | Grade | |||||
|---|---|---|---|---|---|---|
| CTCAE term | 1/2 | 3/4 | CTCAE term | 1/2 | 3/4 | |
| Metabolic/laboratory | Hematologic | |||||
| Hypoalbuminemia* | 8 | 1 | Thrombocytopenia | 7 | 2 | |
| AST elevation* | 8 | 1 | Neutropenia | 6 | 2 | |
| Hyperkalemia* | 7 | 1 | Leukocytosis | 6 | 2 | |
| ALT elevation* | 6 | 1 | Lymphopenia | 5 | 2 | |
| Hyperbilirubinemia | 5 | 1 | Anemia | 8 | 1 | |
| Hypophosphatemia | 4 | 1 | ||||
| Hyponatremia | 3 | 1 | Other | |||
| Hyperuricemia | 2 | 1 | Infection without neutropenia* | 4 | 1 | |
| Hypokalemia | 2 | 1 | Hypotension | 4 | 1 | |
| Acidosis* | 0 | 1 | Diarrhea | 4 | 1 | |
| Cardiac troponin I elevation | 0 | 1 | Vomiting | 3 | 1 | |
| Renal failure | 0 | 1 | Infection with neutropenia | 1 | 1 | |
| Creatinine elevation | 8 | 0 | GI perforation (jejunum)* | 0 | 1 | |
| Hypocalcemia | 5 | 0 | Febrile neutropenia | 0 | 1 | |
| Hypernatremia | 5 | 0 | GI hemorrhage (rectum) | 0 | 1 | |
| Hypercalcemia | 4 | 0 | Syncope | 0 | 1 | |
| CPK elevation | 4 | 0 | Tumor lysis syndrome* | 0 | 1 | |
| Alkaline phosphatase elevation | 4 | 0 | Fatigue | 7 | 0 | |
| Low serum bicarbonate | 4 | 0 | Anorexia | 5 | 0 | |
| Hypomagnesemia | 3 | 0 | Fever (non-neutropenic) | 5 | 0 | |
| Hyperglycemia | 3 | 0 | Nausea | 5 | 0 | |
| Sinus tachycardia | 3 | 0 | ||||
| Bone pain | 3 | 0 | ||||