Table 4.
CTCAE v4.0 treatment-related Grade 1–2 and all Grade 3–4 adverse events, Expansion Cohort
| Adverse Event | Grade 1–2 (#Patients) | Grade 3–4 (#Events / #Patients [#Treatment-Related]) |
|---|---|---|
| Fatigue | 3 | 0 |
| Hypertriglyceridemia | 2 | 0 |
| Nausea | 2 | 0 |
| Activated partial thromboplastin time prolonged | 1 | 0 |
| Alanine aminotransferase increased | 1 | 4/1 (4) |
| Alkaline phosphatase increased | 1 | 0 |
| Anemia | 1 | 0 |
| Aspartate aminotransferase increased | 1 | 4/1 (4) |
| Bloating | 1 | 0 |
| Blood bilirubin increased | 1 | 0 |
| Cholesterol high | 1 | 0 |
| Concentration impairment | 1 | 0 |
| Constipation | 1 | 0 |
| Dyspnea | 1 | 0 |
| Dry Skin | 1 | 0 |
| Edema limbs | 1 | 0 |
| Hiccups | 1 | 0 |
| Hypoalbuminemia | 1 | 0 |
| Hyperglycemia | 1 | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 1 | 0 |
| 1 | 0 | |
| Platelet count decreased | 1 | 0 |
| Peripheral motor neuropathy | ||
| Resp, thoracic & mediastinal disorder Other; | 1 | 0 |
| Rhinorrhea | 1 | 0 |
| Vomiting | 1 | 0 |
| Weight loss | 1 | 2/1 (0) |
| Lymphocyte count decreased | 0 | 1/1 (0) |
| Rash maculo-papular |