Table 3.
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.