Table 2.
Grade 3 and 4 treatment‐related adverse events by treatment arm
| Adverse event | Arm A (n = 173), % | Arm B (n = 174), % | ||
|---|---|---|---|---|
| 3 | 4 | 3 | 4 | |
| Allergic reaction | 1 | — | 2 | 1 |
| Hemoglobin | 1 | — | 1 | — |
| Leukocytes | 27 | 1 | 21 | 1 |
| Lymphopenia | 9 | — | 5 | 1 |
| Neutrophils | 28 | 8 | 25 | 5 |
| Platelets | 6 | 1 | 1 | — |
| Cardiac‐ischemia | — | 1 | 1 | 1 |
| Hypertension | — | — | 6 | 1 |
| Cardiomyopathy, restrictive | — | — | 1 | — |
| Fatigue | 7 | — | 11 | — |
| Fever without neutropenia | 1 | 1 | — | — |
| Weight gain | 1 | — | — | — |
| Weight loss | 1 | — | — | — |
| INR | — | — | 1 | — |
| Hand–foot reaction | — | — | 3 | — |
| Wound—noninfectious | — | — | 1 | — |
| Anorexia | 2 | — | 3 | — |
| Dehydration | 4 | — | 5 | — |
| Diarrhea without prior colostomy | 9 | — | 11 | — |
| Dysphagia | — | — | 1 | — |
| Enteritis | 1 | — | — | — |
| Fistula, colon/cecum/appendix | — | — | 1 | — |
| Fistula, rectum | — | — | 1 | 1 |
| Dyspepsia | — | — | 1 | — |
| Ileus | 1 | — | 1 | — |
| Leak, including anastomotic, rectum | — | — | 1 | 1 |
| Muco/stomatitis oral cavity | 1 | — | 2 | — |
| Nausea | 3 | 1 | 3 | — |
| Obstruction, small bowel | 1 | — | 1 | — |
| Proctitis | 1 | — | — | — |
| Vomiting | 3 | 1 | — | 1 |
| GI—other | — | — | 1 | — |
| Lower GI, hemorrhage | 2 | — | 1 | — |
| Febrile neutropenia | 1 | — | 2 | — |
| Infection with grade 3–4 neutropenia | 1 | — | 2 | 1 |
| Infection with grade 0–2 neutropenia | 1 | — | 5 | — |
| Infection with unknown ANC | 1 | — | 2 | 1 |
| LFTs (AST, ALT) | — | — | 2 | — |
| Hypocalcemia | — | 1 | 1 | — |
| Creatinine | — | — | 1 | — |
| Hyperglycemia | 2 | — | 2 | — |
| Hypophosphatemia | 1 | — | — | — |
| Hypokalemia | 2 | — | 2 | — |
| Proteinuria | — | — | 1 | — |
| Hyponatremia | 1 | — | 2 | 1 |
| Fracture | 1 | — | — | — |
| Avascular necrosis | — | — | 1 | — |
| Ataxia/dizziness | — | — | 2 | — |
| Laryngeal nerve dysfunction | 1 | — | — | — |
| Leukoencephalopathy | — | — | 1 | — |
| Depression | — | — | — | 1 |
| Neuropathy—sensory/motor | 16 | — | 19 | — |
| Syncope | 1 | — | 1 | — |
| Neurologic—other | — | — | — | 1 |
| Tearing | — | — | 1 | — |
| Ocular—other | — | — | 1 | — |
| Abdomen, pain | 1 | — | 2 | — |
| Pain, musculoskeletal | — | 1 | 3 | — |
| Gallbladder, pain | 1 | — | — | — |
| Head/headache | 1 | — | 1 | — |
| Pain, musculoskeletal | 3 | 1 | 7 | — |
| Dyspnea | 1 | — | 3 | 1 |
| Hypoxia | — | — | 1 | — |
| Prolonged intubation post pulmonary resection | — | — | — | 1 |
| Voice changes/dysarthria | — | — | 1 | — |
| Pulmonary/upper respiratory | — | — | — | 1 |
| Incontinence urinary | — | — | 1 | — |
| Obstruction—ureteral | — | — | 1 | — |
| Renal failure | — | — | 1 | — |
| Urinary frequency/urgency | — | — | 1 | — |
| Urinary retention | — | — | 1 | — |
| Secondary malignancy | — | 1 | — | — |
| Thrombosis/embolism | 3 | 1 | 2 | 4 |
| WORST DEGREE | 55 | 13 | 57 | 13 |
Abbreviations: ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; GI, gastrointestinal; INR, international normalized ratio; LFTs, liver function tests.