Table 8.
Consolidated report of adverse events.
| Classification | Grade 1 | Grade 4 | Grade 1 | Grade 4 | ||||
|---|---|---|---|---|---|---|---|---|
| Case | Subject (%) | Case | Subject (%) | Case | Subject (%) | Case | Subject (%) | |
| ALT elevation | 24 | 26.37 | 0 | 0 | 21 | 23.59 | 0 | 0 |
| GT range lifting | 6 | 6.59 | 0 | 0 | 7 | 7.86 | 0 | 0 |
| AST elevation | 4 | 4.39 | 0 | 0 | 6 | 6.74 | 0 | 0 |
| Headache | 2 | 2.19 | 0 | 0 | 6 | 6.74 | 0 | 0 |
| Phlebitis MS | 1 | 1.09 | 0 | 0 | 3 | 3.37 | 0 | 0 |
| GT gamma reduction | 1 | 1.09 | 0 | 0 | 2 | 2.24 | 0 | 0 |
| High fever | 2 | 2.19 | 0 | 0 | 1 | 1.12 | 0 | 0 |
| Dizziness | 0 | 0 | 0 | 0 | 2 | 2.24 | 0 | 0 |
| Sodium reduction | 0 | 0 | 0 | 2 | 2.24 | 0 | 0 | |
| Potassium reduction | 1 | 1.09 | 0 | 0 | 2 | 2.24 | 0 | 0 |
| Hemoglobin reduction | 1 | 1.09 | 0 | 0 | 1 | 1.12 | 0 | 0 |
| Hyperglycemia | 1 | 1.09 | 0 | 0 | 1 | 1.12 | 0 | 0 |
| Hypoglycemia | 1 | 1.09 | 0 | 0 | 0 | 0 | 0 | 0 |
| Calcium reduction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Creatinine increase | 1 | 1.09 | 0 | 0 | 0 | 0 | 0 | 0 |
| CPK increase | 0 | 0 | 0 | 0 | 1 | 1.12 | 0 | 0 |
| Troponin I increase | 1 | 1.09 | 0 | 0 | 0 | 0 | 0 | 0 |
| Backache | 0 | 0 | 0 | 0 | 1 | 1.12 | 0 | 0 |
| Diarrhea | 1 | 1.09 | 0 | 0 | 0 | 0 | 0 | 0 |
| Tachycardia | 1 | 1.09 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nauseas | 1 | 1.09 | 0 | 0 | 0 | 0 | 0 | 0 |
| Respiratory insufficiency | 0 | 0 | 3 | 3.29 | 0 | 0 | 4 | 4.49 |
| Severe mitral insufficiency | 0 | 0 | 1 | 1.09 | 0 | 0 | 0 | 0 |
| Leukopenia | 1 | 1.09 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total | 50 | 54.81 | 4 | 4.38 | 56 | 62.86 | 4 | 4.49 |