Table 2.
Summary of Worst Toxicities by Patient Grade1, n=18 Participants
| Toxicity | Grades 1–22 | Grade 3 | Grade 4 | |||
|---|---|---|---|---|---|---|
| Anemia | 14 | 78% | 4 | 22% | 0 | 0% |
| Hyperglycemia | 8 | 44% | 9 | 50% | 1 | 6% |
| Alkaline phosphatase increased | 17 | 94% | 0 | 0% | 0 | 0% |
| Fatigue | 14 | 78% | 3 | 17% | 0 | 0% |
| Peripheral sensory neuropathy | 12 | 67% | 5 | 28% | 0 | 0% |
| Platelet count decreased | 14 | 78% | 3 | 17% | 0 | 0% |
| Diarrhea | 11 | 61% | 5 | 28% | 0 | 0% |
| Hypoalbuminemia | 15 | 83% | 0 | 0% | 1 | 6% |
| Hyponatremia | 11 | 61% | 3 | 17% | 0 | 0% |
| Nausea | 12 | 67% | 2 | 11% | 0 | 0% |
| Hypomagnesemia | 13 | 72% | 0 | 0% | 0 | 0% |
| Lymphocyte count decreased | 8 | 44% | 5 | 28% | 0 | 0% |
| Pain | 13 | 72% | 0 | 0% | 0 | 0% |
| Alanine aminotransferase increased | 12 | 67% | 0 | 0% | 0 | 0% |
| Anorexia | 11 | 61% | 1 | 6% | 0 | 0% |
| Hypokalemia | 6 | 33% | 5 | 28% | 1 | 6% |
| Abdominal pain | 7 | 39% | 4 | 22% | 0 | 0% |
| Anxiety | 11 | 61% | 0 | 0% | 0 | 0% |
| Aspartate aminotransferase increased | 11 | 61% | 0 | 0% | 0 | 0% |
| Dysgeusia | 11 | 61% | 0 | 0% | 0 | 0% |
| Hypertension | 10 | 56% | 1 | 6% | 0 | 0% |
| Hypocalcemia | 10 | 56% | 0 | 0% | 0 | 0% |
| Weight loss | 9 | 50% | 1 | 6% | 0 | 0% |
| White blood cell decreased | 9 | 50% | 0 | 0% | 0 | 0% |
| Neutrophil count decreased | 3 | 17% | 4 | 22% | 1 | 6% |
| Constipation | 7 | 39% | 0 | 0% | 0 | 0% |
| Cough | 7 | 39% | 0 | 0% | 0 | 0% |
| Insomnia | 7 | 39% | 0 | 0% | 0 | 0% |
| Vomiting | 4 | 22% | 3 | 17% | 0 | 0% |
| Back pain | 4 | 22% | 1 | 6% | 0 | 0% |
| Chronic kidney disease | 5 | 28% | 0 | 0% | 0 | 0% |
| Dehydration | 3 | 17% | 2 | 11% | 0 | 0% |
| Dizziness | 5 | 28% | 0 | 0% | 0 | 0% |
| Dyspnea | 4 | 22% | 1 | 6% | 0 | 0% |
| Edema limbs | 5 | 28% | 0 | 0% | 0 | 0% |
| Fever | 4 | 22% | 1 | 6% | 0 | 0% |
| Cardiac disorders - Other | 2 | 11% | 2 | 11% | 0 | 0% |
| Chills | 4 | 22% | 0 | 0% | 0 | 0% |
| Gastroesophageal reflux disease | 4 | 22% | 0 | 0% | 0 | 0% |
| General disorders and administration site conditions - Other | 3 | 17% | 1 | 6% | 0 | 0% |
| Hypophosphatemia | 2 | 11% | 2 | 11% | 0 | 0% |
| Sinus tachycardia | 4 | 22% | 0 | 0% | 0 | 0% |
| Urinary frequency | 4 | 22% | 0 | 0% | 0 | 0% |
| Activated partial thromboplastin time prolonged | 3 | 17% | 0 | 0% | 0 | 0% |
| Atelectasis | 3 | 17% | 0 | 0% | 0 | 0% |
| Blood bilirubin increased | 3 | 17% | 0 | 0% | 0 | 0% |
| Depression | 2 | 11% | 1 | 6% | 0 | 0% |
| Flatulence | 3 | 17% | 0 | 0% | 0 | 0% |
| Gastrointestinal disorders - Other | 3 | 17% | 0 | 0% | 0 | 0% |
| Leukocytosis | 0 | 0% | 3 | 17% | 0 | 0% |
| Pleural effusion | 3 | 17% | 0 | 0% | 0 | 0% |
| Thromboembolic event | 0 | 0% | 3 | 17% | 0 | 0% |
| Urinary tract infection | 3 | 17% | 0 | 0% | 0 | 0% |
| Ventricular arrhythmia | 2 | 11% | 1 | 6% | 0 | 0% |
| Ascites | 2 | 11% | 0 | 0% | 0 | 0% |
| Blurred vision | 2 | 11% | 0 | 0% | 0 | 0% |
| Dysphagia | 1 | 6% | 1 | 6% | 0 | 0% |
| Edema face | 2 | 11% | 0 | 0% | 0 | 0% |
| Fall | 2 | 11% | 0 | 0% | 0 | 0% |
| Generalized muscle weakness | 2 | 11% | 0 | 0% | 0 | 0% |
| Headache | 2 | 11% | 0 | 0% | 0 | 0% |
| Hypernatremia | 2 | 11% | 0 | 0% | 0 | 0% |
| Hypoxia | 1 | 6% | 1 | 6% | 0 | 0% |
| Nasal congestion | 2 | 11% | 0 | 0% | 0 | 0% |
| Palpitations | 2 | 11% | 0 | 0% | 0 | 0% |
| Pericardial effusion | 2 | 11% | 0 | 0% | 0 | 0% |
| Productive cough | 2 | 11% | 0 | 0% | 0 | 0% |
| Proteinuria | 2 | 11% | 0 | 0% | 0 | 0% |
| Rash maculo-papular | 2 | 11% | 0 | 0% | 0 | 0% |
| Respiratory, thoracic and mediastinal disorders - Other | 2 | 11% | 0 | 0% | 0 | 0% |
| Skin and subcutaneous tissue disorders - Other | 2 | 11% | 0 | 0% | 0 | 0% |
| Weight gain | 2 | 11% | 0 | 0% | 0 | 0% |
| Enterocolitis infectious | 0 | 0% | 1 | 6% | 0 | 0% |
| Esophageal infection | 0 | 0% | 1 | 6% | 0 | 0% |
| GGT increased | 0 | 0% | 1 | 6% | 0 | 0% |
| Glucose intolerance | 0 | 0% | 1 | 6% | 0 | 0% |
| Infections and infestations - Other | 0 | 0% | 1 | 6% | 0 | 0% |
| Lung infection | 0 | 0% | 1 | 6% | 0 | 0% |
| Pancreatitis | 0 | 0% | 1 | 6% | 0 | 0% |
| Sepsis | 0 | 0% | 0 | 0% | 1 | 6% |
1
There were no grade 5 toxicities
2
For incidence greater than 10%