Table 5.
Treatment-emergent adverse events.
| Adverse events | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total |
|---|---|---|---|---|---|---|
| Any adverse event | 3 | 10 | 9 | 3 | 1 | 26 |
| Fatigue | 8 | 8 | 0 | 0 | 0 | 16 |
| Aspartate aminotransferase increased | 7 | 5 | 1 | 0 | 0 | 13 |
| Blood bilirubin increased | 4 | 5 | 2 | 1 | 0 | 12 |
| Abdominal pain | 8 | 3 | 0 | 0 | 0 | 11 |
| Alanine aminotransferase increased | 10 | 0 | 1 | 0 | 0 | 11 |
| Lymphocyte count decreased | 1 | 5 | 4 | 1 | 0 | 11 |
| Nausea | 7 | 2 | 0 | 0 | 0 | 9 |
| White blood cell decreased | 5 | 4 | 0 | 0 | 0 | 9 |
| Alkaline phosphatase increased | 6 | 2 | 0 | 0 | 0 | 8 |
| Anorexia | 4 | 4 | 0 | 0 | 0 | 8 |
| Anemia | 6 | 0 | 0 | 0 | 0 | 6 |
| Hypertension | 0 | 3 | 3 | 0 | 0 | 6 |
| Platelet count decreased | 4 | 0 | 1 | 0 | 0 | 5 |
| Pruritus | 5 | 0 | 0 | 0 | 0 | 5 |
| Vomiting | 5 | 0 | 0 | 0 | 0 | 5 |
| Ascites | 1 | 1 | 2 | 0 | 0 | 4 |
| Hypoalbuminemia | 2 | 2 | 0 | 0 | 0 | 4 |
| Neutrophil count decreased | 3 | 1 | 0 | 0 | 0 | 4 |
| Bloating | 3 | 0 | 0 | 0 | 0 | 3 |
| Chills | 3 | 0 | 0 | 0 | 0 | 3 |
| Dry skin | 3 | 0 | 0 | 0 | 0 | 3 |
| Fever | 3 | 0 | 0 | 0 | 0 | 3 |
| Hyperthyroidism | 3 | 0 | 0 | 0 | 0 | 3 |
| Hypomagnesemia | 3 | 0 | 0 | 0 | 0 | 3 |
| Hypothyroidism | 1 | 2 | 0 | 0 | 0 | 3 |
| Rash maculo-papular | 1 | 2 | 0 | 0 | 0 | 3 |
| Arthritis | 1 | 1 | 0 | 0 | 0 | 2 |
| Blood and lymphatic system disorders—other, specify | 1 | 1 | 0 | 0 | 0 | 2 |
| Creatinine increased | 1 | 1 | 0 | 0 | 0 | 2 |
| Dyspnea | 2 | 0 | 0 | 0 | 0 | 2 |
| Gastrointestinal disorders—other, specify | 2 | 0 | 0 | 0 | 0 | 2 |
| Hypocalcemia | 1 | 1 | 0 | 0 | 0 | 2 |
| Hypophosphatemia | 0 | 0 | 2 | 0 | 0 | 2 |
| Pneumonitis | 0 | 1 | 1 | 0 | 0 | 2 |
| Portal vein thrombosis | 0 | 2 | 0 | 0 | 0 | 2 |
| Thrombotic thrombocytopenic purpura | 0 | 2 | 0 | 0 | 0 | 2 |
| Cardiac disorders—other, specify | 1 | 0 | 0 | 0 | 0 | 1 |
| Colitis | 0 | 1 | 0 | 0 | 0 | 1 |
| Constipation | 1 | 0 | 0 | 0 | 0 | 1 |
| Cough | 1 | 0 | 0 | 0 | 0 | 1 |
| Diarrhea | 1 | 0 | 0 | 0 | 0 | 1 |
| Dizziness | 1 | 0 | 0 | 0 | 0 | 1 |
| Dry eye | 1 | 0 | 0 | 0 | 0 | 1 |
| Dyspepsia | 1 | 0 | 0 | 0 | 0 | 1 |
| Edema limbs | 1 | 0 | 0 | 0 | 0 | 1 |
| Encephalopathy | 0 | 1 | 0 | 0 | 0 | 1 |
| Endocrine disorders—other, specify | 0 | 1 | 0 | 0 | 0 | 1 |
| Erythema multiforme | 1 | 0 | 0 | 0 | 0 | 1 |
| Facial nerve disorder | 0 | 1 | 0 | 0 | 0 | 1 |
| Facial pain | 1 | 0 | 0 | 0 | 0 | 1 |
| GGT increased | 1 | 0 | 0 | 0 | 0 | 1 |
| Hepatic failure | 0 | 0 | 0 | 0 | 1 | 1 |
| Hepatobiliary disorders—other, specify | 1 | 0 | 0 | 0 | 0 | 1 |
| Hyperglycemia | 0 | 0 | 0 | 1 | 0 | 1 |
| Hyperkalemia | 1 | 0 | 0 | 0 | 0 | 1 |
| Hypernatremia | 1 | 0 | 0 | 0 | 0 | 1 |
| Hyperuricemia | 0 | 0 | 1 | 0 | 0 | 1 |
| Hypoglycemia | 1 | 0 | 0 | 0 | 0 | 1 |
| Hypokalemia | 1 | 0 | 0 | 0 | 0 | 1 |
| Hyponatremia | 1 | 0 | 0 | 0 | 0 | 1 |
| Insomnia | 1 | 0 | 0 | 0 | 0 | 1 |
| Musculoskeletal and connective tissue disorder—other, specify | 1 | 0 | 0 | 0 | 0 | 1 |
| Myalgia | 1 | 0 | 0 | 0 | 0 | 1 |
| Neck edema | 1 | 0 | 0 | 0 | 0 | 1 |
| Pain in extremity | 1 | 0 | 0 | 0 | 0 | 1 |
| Rash acneiform | 0 | 1 | 0 | 0 | 0 | 1 |
| Skin and subcutaneous tissue disorders—other, specify | 1 | 0 | 0 | 0 | 0 | 1 |
| Thromboembolic event | 0 | 1 | 0 | 0 | 0 | 1 |
| Urticaria | 0 | 1 | 0 | 0 | 0 | 1 |
| Weight loss | 0 | 1 | 0 | 0 | 0 | 1 |