Table 2.
Adverse events | Cycle 1 n = 20 |
Cycle 2 n = 10 |
Cycle 3 n = 6 |
|||
---|---|---|---|---|---|---|
All (%) | Grade ≥3 | All (%) | Grade ≥3 | All (%) | Grade ≥3 | |
Cardiovascular | ||||||
Hypertension | 1 (5) | − | − | − | 1 (17) | − |
Hypotension | 6 (30) | 1 | 2 (20) | − | − | − |
Sinus Tachycardia | 2 (10) | − | − | − | − | − |
Constitutional | ||||||
Cytokine release sy | 2 (10) | − | − | − | 1 (17) | 1 |
Dehydration | 1 (5) | 1 | 1 (10) | − | − | − |
Fatigue | 6 (30) | 2 | 2 (20) | 1 | 1 (17) | 1 |
Gastrointestinal | ||||||
Anorexia | 1 (5) | − | − | − | 1 (17) | − |
Diarrhea | 14 (70) | 1 | 7 (70) | 1 | 2 (33) | − |
Nausea | 8 (40) | 1 | 3 (30) | − | 1 (17) | − |
Stomatitis | 1 (5) | − | 1 (10) | 1 | − | − |
Vomiting | 9 (45) | − | 2 (20) | − | 2 (33) | − |
Hepatic | ||||||
Hyperbilirubinemia | 2 (10) | − | 1 (10) | − | − | − |
Increased ALT | 4 (20) | − | 1 (10) | − | 1 (17) | − |
Increased AST | 8 (40) | 3 | 1 (10) | − | − | − |
Infections | ||||||
Bacteremia | 2 (10) | 2 | − | − | − | − |
Pneumonia | 2 (10) | 2 | 1 (10) | − | − | − |
Metabolic and electrolyte abnormalities | ||||||
Hyperglycemia | 4 (20) | 2 | − | − | − | − |
Hyperkalemia | 3 (15) | 2 | 1 (10) | − | − | − |
Hyperphosphatemia | 5 (25) | 1 | 1 (10) | − | − | − |
Hypoalbuminemia | 4 (20) | − | 1 (10) | − | − | − |
Hypocalcemia | 6 (30) | 1 | − | − | − | − |
Hypokalemia | 2 (10) | − | − | − | − | − |
Hyponatremia | 2 (10) | 1 | − | − | − | − |
Increased LDH | 2 (10) | 2 | − | − | − | − |
Tumor lysis sy | 3 (15) | 3 | − | − | − | − |
Neurology | ||||||
Syncope | 1 (5) | 1 | 1 (10) | 1 | − | − |
Renal | ||||||
Acute renal failure | 2 (10) | 2 | − | − | − | − |
Increased creatinine | 3 (15) | 1 | − | − | − | − |