Table 3.
Maximum Adverse Event1, by Study Component
| Body System | Toxicity | Arm | Grade 3 | Grade 4 | Grade 5 | |||
|---|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | |||
| PHASE I COHORT | ||||||||
| Constitutional Symptoms | Fatigue | Sorafenib + Bevacizumab | 4 | 23.5 | 0 | 0.0 | 0 | 0.0 |
| Weight loss | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Dermatology/Skin | Hand-and-foot syndrome/reaction | Sorafenib + Bevacizumab | 3 | 17.6 | 0 | 0.0 | 0 | 0.0 |
| Hematology | Platelet count decreased | Sorafenib + Bevacizumab | 2 | 11.8 | 0 | 0.0 | 0 | 0.0 |
| Lymphocyte count decreased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Leukocyte count decreased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Hepatic | Alanine aminotransferase increased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 |
| Aspartate aminotransferase increased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Bilirubin increased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Metabolic/Laboratory | Acidosis | Sorafenib + Bevacizumab | 0 | 0.0 | 1 | 5.9 | 0 | 0.0 |
| Serum glucose decreased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Serum phosphate decreased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Serum potassium increased | Sorafenib + Bevacizumab | 0 | 0.0 | 1 | 5.9 | 0 | 0.0 | |
| Serum sodium decreased | Sorafenib + Bevacizumab | 0 | 0.0 | 1 | 5.9 | 0 | 0.0 | |
| Neurology | Syncope | Sorafenib + Bevacizumab | 0 | 0.0 | 1 | 5.9 | 0 | 0.0 |
| Renal /Genitourinary | Creatinine increased | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 |
| Death | Sudden death | Sorafenib + Bevacizumab | 0 | 0.0 | 0 | 0.0 | 1 | 5.9 |
| Cardiovascular | Arrhythmia | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 |
| Hypertension | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Electrocardiogram QTc interval prolonged | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Gastrointestinal | Anorexia | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 |
| Dehydration | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Esophageal ulcer | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Nausea | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| Vomiting | Sorafenib + Bevacizumab | 1 | 5.9 | 0 | 0.0 | 0 | 0.0 | |
| PHASE II COHORT | ||||||||
| Dermatology/Skin | Hand-and-foot syndrome/reaction | Sorafenib + Bevacizumab | 1 | 25.0 | 0 | 0.0 | 0 | 0.0 |
| Rash desquamating | Sorafenib | 1 | 33.3 | 0 | 0.0 | 0 | 0.0 | |
| Hematology | Lymphocyte count decreased | Sorafenib | 1 | 33.3 | 0 | 0.0 | 0 | 0.0 |
| Hepatic | Alanine aminotransferase increased | Sorafenib + Bevacizumab | 1 | 25.0 | 0 | 0.0 | 0 | 0.0 |
| Aspartate aminotransferase increased | Sorafenib + Bevacizumab | 0 | 0.0 | 1 | 25.0 | 0 | 0.0 | |
| Bilirubin increased | Sorafenib | 1 | 33.3 | 0 | 0.0 | 0 | 0.0 | |
| Serum albumin decreased | Sorafenib | 1 | 33.3 | 0 | 0.0 | 0 | 0.0 | |
| Metabolic/Laboratory | Serum phosphate decreased | Sorafenib + Bevacizumab | 1 | 25.0 | 0 | 0.0 | 0 | 0.0 |
| Serum potassium decreased | Sorafenib + Bevacizumab | 1 | 25.0 | 0 | 0.0 | 0 | 0.0 | |
| Gastrointestinal | Dehydration | Sorafenib + Bevacizumab | 1 | 25.0 | 0 | 0.0 | 0 | 0.0 |
| Infection/Febrile Neutropenia | Urinary tract infection(gr 0/1/2 ANC) | Sorafenib + Bevacizumab | 1 | 25.0 | 0 | 0.0 | 0 | 0.0 |
| Lymphatics | Localized edema | Sorafenib | 1 | 33.3 | 0 | 0.0 | 0 | 0.0 |
| Musculoskeletal | Muscle weakness | Sorafenib + Bevacizumab | 1 | 25.0 | 0 | 0.0 | 0 | 0.0 |
1
AEs at least possibly related to study treatment. Events are by patient across all cycles of treatment.