Table 4.
Selected Grade 3 and 4 Toxicities
| Toxicity | No. of Episodes | ||
|---|---|---|---|
| Sorafenib | Sorafenib+IFN | Total | |
| Fatigue* | 10 | 18 | 28 |
| Diarrhea | 13 | 8 | 21 |
| Hand-foot syndrome | 10 | 7 | 17 |
| Hyperuricemia* | 12 | 3 | 15 |
| Hyperamylasemia or lipasemia | 5 | 4 | 9 |
| Dyspnea | 4 | 4 | 8 |
| Hypophosphatemia | 3 | 5 | 8 |
| Neutropenia* | 0 | 6 | 6 |
| Hypertension | 2 | 3 | 5 |
| Nausea and vomiting | 1 | 3 | 4 |
| Rash/desquamation | 2 | 2 | 4 |
| Proteinuria | 1 | 2 | 3 |
| Syncope (fainting) | 0 | 3 | 3 |
| Weight loss | 0 | 3 | 3 |
| Transaminitis | 0 | 3 | 3 |
| Hyponatremia | 2 | 1 | 3 |
| Non-neutropenic infection | 2 | 0 | 2 |
| Sensory neuropathy | 1 | 1 | 2 |
| Cardiac ischemia/infarction | 1 | 0 | 1 |
| Appendicitis | 1 | 0 | 1 |
| Pancreatitis | 1 | 0 | 1 |
| Adrenal insufficiency | 0 | 1 | 1 |
| Reversible posterior leukonencephalopathy | 0 | 1 | 0 |
| Small bowel obstruction | 1 | 0 | 1 |
| Pneumonitis | 1 | 0 | 1 |
IFN indicates interferon alfa.
*
Indicates statistically a significant difference between arms.