Table 3.
Instances of toxicities possibly, probably, or definitely attributed to any protocol therapy in all patients (N=11).
| Adverse Event | Grades 1– 2 | Grade 3 | Grade 4 |
|---|---|---|---|
| Hematologic | |||
| Anemia | 0 | 3 | 0 |
| Leukopenia | 0 | 6 | 3 |
| Thrombocytopenia | 0 | 4 | 0 |
| Lymphopenia | 1 | 4 | 0 |
| Reduced ANC | 0 | 5 | 5 |
| General | |||
| Dehydration | 0 | 1 | 0 |
| Depression | 0 | 1 | 0 |
| Somnolence | 0 | 1 | 0 |
| Orthostasis | 1 | 0 | 0 |
| Rash | 1 | 0 | 0 |
| Hyperglycemia | 0 | 1 | 0 |
| Hypokalemia | 0 | 2 | 0 |
| Hyperkalemia | 0 | 1 | 0 |
| Hyponatremia | 0 | 1 | 0 |
| Sinusitis | 0 | 1 | 0 |
| Gastrointestinal | |||
| Nausea | 0 | 1 | 0 |
| Vomiting | 0 | 1 | 0 |
| ALT elevation | 0 | 2 | 1 |
| AST elevation | 0 | 3 | 0 |
| Pancreatitis | 0 | 1 | 0 |
| Genitourinary | |||
| Acute kidney injury | 1 | 0 | 0 |
| Urinary tract infection | 0 | 1 | 0 |
| Respiratory | |||
| Pneumonia | 0 | 0 | 1 |
| Acidosis | 0 | 1 | 1 |
| Sepsis | 0 | 0 | 1 |
| Pleural effusion | 0 | 0 | 1 |
| Acute respiratory distress syndrome | 0 | 0 | 1 |
| Acute pulmonary edema | 0 | 0 | 1 |
| Cardiac* | |||
| Myocarditis | 0 | 0 | 1 |
| Heart failure | 0 | 0 | 1 |
| Ventricular fibrillation | 0 | 0 | 1 |
| Myocardial infarction | 0 | 0 | 1 |
| Reduced ejection fraction | 0 | 1 | 0 |
*
One patient died of cardiac causes after the first cycle of chemotherapy; this patient had not received any other protocol therapy.