Table 4. Adverse events (n) reported during the observation, classified by CTCAE grade.
Adverse event (>1)* | Grade1 | Grade2 | Grade3 | Grade4 | Grade5 |
ALT Elevation | 21 | 18 | 9 | 1§ | – |
AST Elevation | 31 | 2 | 6 | 1§ | – |
Triglyceride elevation | 64 | 64 | 28 | – | – |
Total Cholesterol elevation | 157 | 32 | 1 | – | – |
CK Elevation | 2 | – | 1 | – | – |
Non-Hodgkin’s Lymphoma | – | – | – | 1 | 5 |
Liver Cirrhosis | 26 | 22 | 18 | 15 | 3 |
Acute Myocardial Infarction | – | – | 2 | – | 1 |
Pulmonary Tuberculosis | – | – | – | – | 1 |
Hepatocarcinoma | – | – | – | 2 | – |
Acute psychosis | – | 1 | – | 1 | – |
Fatigue/Malaise | – | – | 2 | – | – |
Gastrointestinal Intolerance | 2 | 1 | 1 | – | – |
Anxiety | – | 1 | 1 | – | – |
Headache | – | 2 | – | – | – |
Weight Loss | – | 2 | – | – | – |
Flu-like Symptoms | 2 | 1 | – | – | – |
Myalgia | 2 | 1 | – | – | – |
Acute hepatitis HBV,
Plus one case of: renal cancer, grade 3 rhabdomyolysis, non-Hodgkin’s lymphoma, coronary heart disease, diabetes, Basedow’s disease, portal hypertension, arterial hypertension, urinary tract infection, fever, acute psychosis, dizziness, flushing, macular rash of skin and glans, gout, cataract, dry skin, asymptomatic hyperuricemia and LDH increase.