Table 2. Reported Adverse Events.
Frequencies of the maximum grade of acute adverse events within a system organ class or specific term, regardless of attribution, over all patients who initiated study treatment and have been evaluated for toxicity (CTCAE v4.0).
| System Organ Class/Term | Treatment/Adverse Event Grade | |||||
|---|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | 4 | 5 | |
| Blood/Lymphatics | 13 | 5 | 8 | 1 | 1 | 0 |
| Anemia | 13 | 5 | 8 | 1 | 1 | 0 |
| Gastrointestinal | 3 | 13 | 7 | 4 | 0 | 1 |
| Abdominal distension | 24 | 2 | 2 | 0 | 0 | 0 |
| Abdominal pain | 20 | 6 | 2 | 0 | 0 | 0 |
| Ascites | 24 | 0 | 2 | 2 | 0 | 0 |
| Constipation | 11 | 12 | 5 | 0 | 0 | 0 |
| Diarrhea | 22 | 5 | 1 | 0 | 0 | 0 |
| Gastric hemorrhage | 27 | 0 | 0 | 0 | 0 | 1 |
| Nausea | 16 | 11 | 1 | 0 | 0 | 0 |
| Rectal fistula | 27 | 0 | 0 | 1 | 0 | 0 |
| Rectal hemorrhage | 26 | 2 | 0 | 0 | 0 | 0 |
| Vomiting | 19 | 8 | 0 | 1 | 0 | 0 |
| General and administration site | 2 | 18 | 7 | 1 | 0 | 0 |
| Edema face | 26 | 1 | 1 | 0 | 0 | 0 |
| Edema limbs | 11 | 15 | 2 | 0 | 0 | 0 |
| Fatigue | 4 | 17 | 6 | 1 | 0 | 0 |
| Infections/infestations | 23 | 1 | 4 | 0 | 0 | 0 |
| Investigations | 15 | 6 | 6 | 1 | 0 | 0 |
| Activated partial thromboplastin time prolonged | 27 | 0 | 0 | 1 | 0 | 0 |
| Alkaline phosphatase increased | 22 | 4 | 2 | 0 | 0 | 0 |
| Creatinine increased | 19 | 5 | 4 | 0 | 0 | 0 |
| Lymphocyte count decreased | 25 | 1 | 1 | 1 | 0 | 0 |
| Weight loss | 24 | 2 | 2 | 0 | 0 | 0 |
| Metabolism/nutrition | 14 | 5 | 7 | 2 | 0 | 0 |
| Anorexia | 24 | 2 | 2 | 0 | 0 | 0 |
| Dehydration | 26 | 0 | 2 | 0 | 0 | 0 |
| Hyperglycemia | 22 | 5 | 1 | 0 | 0 | 0 |
| Hypoalbuminemia | 19 | 4 | 4 | 1 | 0 | 0 |
|
| ||||||
| Hypoglycemia | 27 | 0 | 1 | 0 | 0 | 0 |
| Hypokalemia | 24 | 1 | 2 | 1 | 0 | 0 |
| Musculoskeletal/connective tissue | 11 | 10 | 5 | 2 | 0 | 0 |
| Arthralgia | 24 | 4 | 0 | 0 | 0 | 0 |
| Back pain | 19 | 4 | 4 | 1 | 0 | 0 |
| Myalgia | 25 | 3 | 0 | 0 | 0 | 0 |
| Nervous system | 11 | 16 | 1 | 0 | 0 | 0 |
| Dizziness | 26 | 2 | 0 | 0 | 0 | 0 |
| Headache | 15 | 13 | 0 | 0 | 0 | 0 |
| Neuralgia | 27 | 0 | 1 | 0 | 0 | 0 |
| Renal/urinary | 24 | 3 | 0 | 1 | 0 | 0 |
| Urinary tract obstruction | 27 | 0 | 0 | 1 | 0 | 0 |
| Reproductive/breast | 25 | 3 | 0 | 0 | 0 | 0 |
| Respiratory/thoracic/mediastinal | 11 | 13 | 2 | 2 | 0 | 0 |
| Dyspnea | 18 | 8 | 1 | 1 | 0 | 0 |
| Epistaxis | 24 | 4 | 0 | 0 | 0 | 0 |
| Pleural effusion | 24 | 1 | 2 | 1 | 0 | 0 |
| Vascular disorders | 23 | 1 | 2 | 2 | 0 | 0 |
| Hypertension | 25 | 1 | 1 | 1 | 0 | 0 |
| Thromboembolic event | 26 | 0 | 1 | 1 | 0 | 0 |