Table 4.
Most Frequent Adverse Events (AEs) and Serious Adverse Events (SAEs) (N = 25)
| AEs (over 10%) | n | % of Patients |
|---|---|---|
| Pyrexia | 5 | 20 |
| Anemia | 4 | 16 |
| Blood urea increased | 4 | 16 |
| Diarrhea | 4 | 16 |
| Hypotension | 4 | 16 |
| Edema peripheral | 4 | 16 |
| Convulsion | 3 | 12 |
| Decubitus ulcer | 3 | 12 |
| Deep vein thrombosis | 3 | 12 |
| Hematuria | 3 | 12 |
| Hypertension | 3 | 12 |
| Metabolic acidosis | 3 | 12 |
| Pneumonia | 3 | 12 |
| Respiratory failure | 3 | 12 |
| Sepsis | 3 | 12 |
| Sinus tachycardia | 3 | 12 |
| Urinary tract infection | 3 | 12 |
| SAEs a (over 8%) | n | % of Patients |
| Respiratory failure | 3 | 12 |
| Convulsion | 2 | 8 |
| Pulmonary embolism | 2 | 8 |
| Renal failure acute | 2 | 8 |
| Sepsis | 2 | 8 |
a
None assessed as drug related.