Table 3.
Toxicity summary
| Toxicity type | Treatment arm A (n = 22), n | ||
|---|---|---|---|
| Grade | |||
| 3 | 4 | 5 | |
| Allergic reaction | — | 1 | — |
| Hemoglobin | 4 | — | — |
| Leukocytes | 2 | — | — |
| Lymphopenia | 3 | 2 | — |
| Neutrophils | 1 | — | — |
| Platelets | — | 2 | — |
| Heart block asystole | — | 1 | — |
| Atrial fibrillation | — | 1 | — |
| Cardiac troponin I | 1 | — | — |
| Hypotension | 1 | 1 | — |
| Fatigue | 4 | 1 | — |
| Weight loss | 1 | — | — |
| PTT | 1 | — | — |
| Thrombotic microangiopathy | — | 1 | — |
| Coagulation—other | 1 | 1 | — |
| Alopecia | 1 | — | — |
| Rash/desquamation | 1 | — | — |
| Rash: acne/acneiform | 1 | — | — |
| Radiation dermatitis | 1 | — | — |
| Death—multiorgan failure | — | — | 1 |
| Anorexia | 5 | — | — |
| Constipation | 1 | — | — |
| Dehydration | 8 | — | — |
| Diarrhea without prior colostomy | 4 | — | — |
| Distention/bloating, abdominal | 1 | — | — |
| Dysphagia | 3 | — | — |
| Esophagitis | 5 | — | — |
| Malabsorption | 1 | — | — |
| Mucositis/stomatitis (symptom) esophagus | 3 | — | — |
| Nausea | 5 | — | — |
| Necrosis, small bowel NOS | — | 1 | — |
| Perforation, colon | 1 | — | — |
| Stenosis (including anastomotic) esophagus | 1 | — | — |
| Vomiting | 2 | — | — |
| Surgical hemorrhage | — | 1 | — |
| Infection grade 0–2 neutropenia, brain | — | 1 | — |
| Infection grade 0–2 neutropenia, colon | 1 | — | — |
| Infection grade 0–2 neutropenia, lung | — | 1 | — |
| Infection grade 0–2 neutropenia, small bowel | — | 1 | — |
| Infection with unknown ANC wound | 2 | — | — |
| Infection grade 0–2 neutropenia, blood | — | 1 | 1 |
| Hypoalbuminemia | 3 | — | — |
| Alkaline phosphatase | 1 | — | — |
| Hypocalcemia | 4 | — | — |
| Hyperglycemia | 1 | — | — |
| Hypomagnesemia | — | 1 | — |
| Hypophosphatemia | 1 | — | — |
| Hypokalemia | 2 | — | — |
| Hyponatremia | 2 | — | — |
| Nonneuropathic generalized weakness | 1 | — | — |
| Laryngeal nerve dysfunction | 1 | — | — |
| Neuropathy‐motor | — | 1 | — |
| Depressed level of consciousness | — | 1 | — |
| Syncope | 1 | — | — |
| Abdomen, pain | 1 | — | — |
| Esophagus, pain | 1 | — | — |
| ARDS | — | 1 | 4 |
| Dyspnea | 2 | — | — |
| Hiccoughs | 1 | — | — |
| Hypoxia | — | 4 | — |
| Pleural effusion (nonmalignant) | 1 | 1 | — |
| Pneumonitis/pulmonary infiltrates | 1 | 1 | — |
| Pulmonary/upper respiratory—other | 1 | — | — |
| Vascular access, thrombosis/embolism | — | 1 | — |
| Thrombosis/thrombus/embolism | — | 2 | 1 |
| Worst degree | 7 | 6 | 6 |
Grade 3 or higher adverse events.
Abbreviations: ANC, absolute neutrophil count; ARDS, acute respiratory distress syndrome; NOS, not otherwise specified; PTT, partial thromboplastin time.