Table 2.
Treatment-related adverse events (the number of events is shown with number of affected patients in brackets). A total of 39 patients were evaluable for toxicity (3 of whom were not evaluable for efficacy).
| Treatment-related Adverse Events | All Grades (N = 39) | Grade ≥ 3 (N=39) |
|---|---|---|
| Any adverse event | 678 [38, 97.4%] | 127 [27, 69.2%] |
| General Disorders | ||
| Fatigue | 22 [17, 43.6%] | 3 [3, 7.7%] |
| Metabolism and Nutrition Disorders | ||
| Hypokalemia | 5 [4, 10.3%] | 0 [0, 0%] |
| Hyperkalemia | 2 [2, 5.1%] | 1 [1, 2.6%] |
| Hyponatremia | 4 [3, 7.7%] | 0 [0, 0%] |
| Gastrointestinal Disorder | ||
| Nausea | 38 [21, 53.8%] | 2 [1, 2.6%] |
| Abdominal pain | 7 [5, 12.8%] | 0 [0, 0%] |
| Vomiting | 12 [6, 15.4%] | 0 [0, 0%] |
| Diarrhea | 8 [8, 20.5%] | 0 [0, 0%] |
| Constipation | 2 [1, 2.6%] | 0 [0, 0%] |
| GERD | 2 [2, 5.1%] | 0 [0, 0%] |
| GI bleeding | 1 [1, 2.6%] | 1 [1, 2.6%] |
| ALT increased | 2 [1, 2.6%] | 0 [0, 0%] |
| Nervous system Disorder | ||
| Dizziness | 3 [3, 7.7%] | 0 [0, 0%] |
| Headache | 4 [4, 10.3%] | 0 [0, 0%] |
| Tinnitus | 2 [2, 5.1%] | 0 [0, 0%] |
| Respiratory System Disorder | ||
| Dyspnea | 4 [4, 10.3%] | 1 [1, 2.6%] |
| Pleural effusion | 2 [2, 5.1%] | 0 [0, 0%] |
| Pleural hemorrhage | 2 [1, 2.6%] | 0 [0, 0%] |
| Pneumonitis | 1 [1, 2.6%] | 0 [0, 0%] |
| Cardiovascular Disorders | ||
| Hypotension | 1 [1, 2.6%] | 0 [0, 0%] |
| Hypertension | 8 [6, 15.4%] | 4 [3, 7.7%] |
| Flushing | 3 [3, 7.7%] | 0 [0, 0%] |
| Cardiac troponin I increase | 1 [1, 2.6%] | 1 [1, 2.6%] |
| LV ejection fraction decrease | 1 [1, 2.6%] | 1 [1, 2.6%] |
| Chest pain | 1 [1, 2.6%] | 0 [0, 0%] |
| Palpitations | 2 [2, 5.1%] | 0 [0, 0%] |
| Sinus tachycardia | 1 [1, 2.6%] | 0 [0, 0%] |
| Atrial fibrillation | 2 [2, 5.1%] | 1 [1, 2.6%] |
| Atrial flutter | 1 [1, 2.6%] | 0 [0, 0%] |
| Ventricular arrhythmia | 1 [1, 2.6%] | 1 [1, 2.6%] |
| Hematologic Disorders | ||
| Lymphopenia | 185 [35, 89.7%] | 86 [24, 61.5%] |
| Leukopenia | 103 [23, 59.0%] | 5 [3, 7.7%] |
| Neutropenia | 24 [7, 17.9%] | 1 [1, 2.6%] |
| Thrombocytopenia | 52 [14, 35.9%] | 0 [0, 0%] |
| Anemia | 100 [29, 74.4%] | 11 [6, 15.4%] |
| Renal Disorder | ||
| Creatinine increase | 18 [8, 20.5%] | 0 [0, 0%] |
| Skin Disorders | ||
| Alopecia | 6 [5, 12.8%] | 0 [0, 0%] |
| Rash | 2 [2, 5.1%] | 0 [0, 0%] |
| Endocrine Disorders | ||
| Adrenal insufficiency | 8 [6, 15.4%] | 0 [0, 0%] |
| Hypothyroidism | 3 [3, 7.7%] | 0 [0, 0%] |
| Hypopituitarism | 1 [1, 2.6%] | 0 [0, 0%] |