Table 1.
Treatment-related toxicities by treatment arm
| Toxicity | Treatment arm |
|||||
|---|---|---|---|---|---|---|
| A (n = 83) |
B (n = 82) |
|||||
| Grade |
Grade |
|||||
| 3 | 4 | 5 | 3 | 4 | 5 | |
| (%) | (%) | (%) | (%) | (%) | (%) | |
| Anemia | 7 | – | – | 12 | – | – |
| Febrile neutropenia | – | – | – | 9 | – | – |
| Fatigue | 6 | – | – | 20 | 1 | – |
| Fever | 1 | – | – | – | 2 | – |
| Infusion-related reaction | 1 | 1 | – | 1 | – | – |
| Pruritus | – | – | – | 1 | – | – |
| Anal fistula | – | – | – | 1 | – | – |
| Colitis | – | – | – | – | 1 | – |
| Colonic perforation | 1 | – | – | – | – | – |
| Dental caries | 1 | – | – | – | – | – |
| Diarrhea | 2 | – | – | 2 | – | – |
| Dysphagia | 1 | – | – | – | – | – |
| Mucositis oral | 1 | – | – | 1 | – | – |
| Nausea | 5 | – | – | 11 | – | – |
| Oral pain | – | – | – | 1 | – | – |
| Pancreatitis | – | – | – | 1 | – | – |
| Rectal pain | – | – | – | 1 | – | – |
| Rectal ulcer | – | – | – | 1 | – | – |
| Vomiting | 1 | – | – | 6 | 1 | – |
| Catheter-related infection | – | – | – | 1 | – | – |
| Enterocolitis infectious | 1 | – | – | – | – | – |
| Gum infection | – | – | – | 1 | – | – |
| Joint infection | – | – | – | 1 | – | – |
| Lung infection | – | – | – | 4 | – | – |
| Mucosal infection | – | – | – | 1 | – | – |
| Sepsis | – | – | – | – | 1 | – |
| Tooth infection | – | – | – | 1 | – | – |
| Urinary tract infection | 1 | – | – | 1 | – | – |
| Wound infection | – | – | – | 1 | – | – |
| Wound complication | – | – | – | 1 | – | – |
| Alanine aminotransferase increased | 1 | – | – | 2 | – | – |
| Aspartate aminotransferase increased | 1 | – | – | 1 | – | – |
| Lipase increased | – | – | – | 2 | – | – |
| Lymphocyte count decreased | 10 | 1 | – | 11 | – | – |
| Neutrophil count decreased | 16 | 17 | – | 17 | 38 | – |
| Platelet count decreased | 5 | 5 | – | 17 | 9 | – |
| Serum amylase increased | – | – | – | 1 | – | – |
| Weight gain | 1 | – | – | – | – | – |
| Weight loss | – | – | – | 1 | – | – |
| White blood cell decreased | 5 | – | – | 16 | 4 | – |
| Anorexia | 2 | – | – | 6 | 1 | – |
| Dehydration | 4 | 1 | – | 10 | – | – |
| Hyperglycemia | – | – | – | 10 | 1 | – |
| Hyperkalemia | – | – | – | 1 | – | – |
| Hypoalbuminemia | 1 | – | – | – | – | – |
| Hypocalcemia | – | 1 | – | – | – | – |
| Hypokalemia | – | 1 | – | 1 | – | – |
| Hypomagnesemia | 2 | 1 | – | – | – | – |
| Hyponatremia | 5 | 1 | – | 6 | 1 | – |
| Arthralgia | 1 | – | – | – | – | – |
| Back pain | 1 | – | – | 2 | – | – |
| Bone pain | 1 | – | – | 1 | – | – |
| Generalized muscle weakness | 1 | – | – | 2 | 1 | – |
| Muscle weakness lower limb | 1 | – | – | – | – | – |
| Myalgia | – | – | – | 2 | – | – |
| Musculoskeletal and connective—Other | – | – | – | 1 | – | – |
| Ataxia | 1 | – | – | – | – | – |
| Encephalopathy | – | – | – | – | 1 | – |
| Headache | – | – | – | 1 | – | – |
| Intracranial hemorrhage | – | – | 1 | – | – | – |
| Peripheral motor neuropathy | 1 | – | – | 1 | – | – |
| Peripheral sensory neuropathy | 5 | – | – | 5 | – | – |
| Reversible posterior leukoencephalopathy | – | – | – | 1 | – | – |
| Spasticity | – | – | – | 1 | – | – |
| Nervous system disorders—Other | 1 | – | – | – | – | – |
| Blurred vision | – | – | – | 1 | – | – |
| Confusion | – | – | – | 1 | – | – |
| Depression | – | – | – | – | 1 | – |
| Bronchopulmonary hemorrhage | – | – | – | 1 | – | 1 |
| Dyspnea | 1 | – | – | 2 | – | – |
| Pleuritic pain | 1 | – | – | – | – | – |
| Respiratory thoracic mediastinal—Other | 1 | – | – | – | – | – |
| Chronic kidney disease | – | – | – | 1 | – | – |
| Cystitis non-infective | – | – | – | 1 | – | – |
| Proteinuria | 2 | – | – | 5 | – | – |
| Irregular menstruation | 1 | – | – | – | – | – |
| Hypertension | 14 | – | – | 21 | – | – |
| Hypotension | 2 | – | – | 1 | – | – |
| Thromboembolic event | 7 | 1 | – | 6 | – | – |
| WORST DEGREE | 42 | 25 | 1 | 45 | 44 | 1 |