Table 3.
Adverse events.
| Adverse event | N = 18 (%) |
||
|---|---|---|---|
| Grades 1-2 | Grade 3 | Grade 4 | |
| Any treatment-related adverse event | |||
| Neutropenia | 10 (55.6) | 2 (11.1) | 0 |
| Albuminuria | 10 (55.6) | 1 (5.6) | 0 |
| Leukopenia | 11 (61.1) | 0 | 0 |
| Anemia | 11 (61.1) | 0 | 0 |
| Reactive capillary hyperplasia | 10 (55.6) | 0 | 0 |
| Hand-foot syndrome | 7 (38.9) | 2 (11.1) | 0 |
| Hypertension | 7 (38.9) | 1 (5.6) | 0 |
| Blood triglyceride elevation | 7 (38.9) | 1 (5.6) | 0 |
| Fatigue | 7 (38.9) | 1 (5.6) | 0 |
| Thrombocytopenia | 3 (16.7) | 4 (22.2) | 0 |
| Hypothyroidism | 7 (38.9) | 0 | 0 |
| Diarrhea | 7 (38.9) | 0 | 0 |
| Lymphopenia | 5 (27.8) | 1 (5.6) | 0 |
| Pharyngolaryngeal pain | 6 (33.3) | 0 | 0 |
| Headache | 6 (33.3) | 0 | 0 |
| Blood cholesterol elevation | 6 (33.3) | 0 | 0 |
| Mucositis oral | 6 (33.3) | 0 | 0 |
| Hematuria | 6 (33.3) | 0 | 0 |
| AST elevation | 4 (22.2) | 1 (5.6) | 0 |
| ALT elevation | 5 (27.8) | 0 | 0 |
| Rash | 3 (16.7) | 1 (5.6) | 0 |
| Nasopharyngeal necrosis | 0 | 2 (11.1) | 2 (11.1) |
| Epistaxis | 1 (5.6) | 1 (5.6) | 1 (5.6) |
| Nausea | 3 (16.7) | 0 | 0 |
| Hyperuricemia | 3 (16.7) | 0 | 0 |
| Serum creatinine elevation | 3 (16.7) | 0 | 0 |
| Total bilirubin elevation | 3 (16.7) | 0 | 0 |
| Electrocardiogram QTc interval prolonged | 3 (16.7) | 0 | 0 |
| Upper respiratory infection | 1 (5.6) | 1 (5.6) | 0 |
| Cough | 2 (11.1) | 0 | 0 |
| Periodontal disease | 2 (11.1) | 0 | 0 |
| Anorexia | 2 (11.1) | 0 | 0 |
| Vomiting | 2 (11.1) | 0 | 0 |
| Chest pain | 2 (11.1) | 0 | 0 |
| Left-sided ventricular systolic dysfunction | 0 | 1 (5.6) | 0 |
| Fever | 0 | 1 (5.6) | 0 |
| Creatine phosphokinase elevation | 1 (5.6) | 0 | 0 |
| Creatine phosphokinase MB soenzyme | 1 (5.6) | 0 | 0 |
| Hyponatraemia | 1 (5.6) | 0 | 0 |
| Expectoration | 1 (5.6) | 0 | 0 |
| Constipation | 1 (5.6) | 0 | 0 |
| Tuberculosis | 1 (5.6) | 0 | 0 |
| Abdominal pain | 1 (5.6) | 0 | 0 |
| Hemoptysis | 1 (5.6) | 0 | 0 |
| Cardiac troponin I increased | 1 (5.6) | 0 | 0 |
| Atrioventricular block first degree | 1 (5.6) | 0 | 0 |
| Atrial tachyarrhythmias | 1 (5.6) | 0 | 0 |
| Oral hemorrhage | 1 (5.6) | 0 | 0 |
| Dizziness | 1 (5.6) | 0 | 0 |
| Facial pain | 1 (5.6) | 0 | 0 |
| Atrioventricular block first degree | 1 (5.6) | 0 | 0 |
| Premature ventricular contraction | 1 (5.6) | 0 | 0 |
| Pneumonia | 1 (5.6) | 0 | 0 |
| Potential immune-related adverse events | |||
| Reactive capillary proliferation | 10 (55.6) | 0 | 0 |
| Hypothyroidism | 7 (38.9) | 0 | 0 |
| Diarrhoea | 7 (38.9) | 0 | 0 |
| Fatigue | 5 (27.8) | 0 | 0 |
| Rash | 1 (5.6) | 1 (5.6) | 0 |
| Anemia | 2 (11.1) | 0 | 0 |
| Anorexia | 2 (11.1) | 0 | 0 |
| Cough | 2 (11.1) | 0 | 0 |
| Fever | 0 | 1 (5.6) | 0 |
| Upper respiratory infection | 0 | 1 (5.6) | 0 |
| Albuminuria | 1 (5.6) | 0 | 0 |
| Troponin I increased | 1 (5.6) | 0 | 0 |
| Blood creatine phosphokinase increased | 1 (5.6) | 0 | 0 |
| Tuberculosis | 1 (5.6) | 0 | 0 |
| Pneumonia | 1 (5.6) | 0 | 0 |
| Nausea | 1 (5.6) | 0 | 0 |
| Vomiting | 1 (5.6) | 0 | 0 |
| Dysgeusia | 1 (5.6) | 0 | 0 |
| Hair color changes | 1 (5.6) | 0 | 0 |
| Atrioventricular block first degree | 1 (5.6) | 0 | 0 |
| Premature ventricular contraction | 1 (5.6) | 0 | 0 |
| Adverse events of special interest | none | ||
AST, Aspartate aminotransferase; ALT, Alanine aminotransferase; QTc, QT corrected; MB, Myocardial band.