Table 4.
Adverse events possibly, probably, or definitely related to romidepsin use, in the phase II component (n = 40)
| Adverse event | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|
| Hematologic | ||||
| Anemia | 8 | 0 | 0 | 0 |
| Leucopenia | 1 | 6 | 1 | 0 |
| Neutropenia | 1 | 0 | 6 | 0 |
| Lymphopenia | 1 | 4 | 4 | 0 |
| Thrombocytopenia | 13 | 2 | 0 | 0 |
| Nonhematologic | ||||
| Ventricular arrhythmia | 1 | 0 | 0 | 0 |
| Cardiac general | 0 | 0 | 1 | 0 |
| Hypotension | 0 | 0 | 1 | 0 |
| PT prolongation | 1 | 0 | 0 | 0 |
| Fatigue | 7 | 6 | 3 | 1 |
| Fever without neutropenia | 1 | 0 | 0 | 0 |
| Weight loss | 1 | 0 | 0 | 0 |
| Alopecia | 1 | 0 | 0 | 0 |
| Dry skin | 1 | 0 | 0 | 0 |
| Injection site reaction | 0 | 0 | 1 | 0 |
| Pruritis | 0 | 1 | 0 | 0 |
| Skin rash | 2 | 0 | 1 | 0 |
| Anorexia | 4 | 0 | 0 | 0 |
| Constipation | 6 | 0 | 1 | 0 |
| Diarrhea | 3 | 1 | 0 | 0 |
| Dry mouth | 1 | 0 | 0 | 0 |
| Flatulence | 0 | 1 | 0 | 0 |
| Heartburn | 1 | 1 | 0 | 0 |
| Mucositis | 0 | 1 | 0 | 0 |
| Nausea | 11 | 2 | 0 | 0 |
| Taste alteration | 1 | 0 | 0 | 0 |
| Vomiting | 1 | 1 | 1 | 0 |
| Petechiae | 1 | 0 | 0 | 0 |
| Edema–limb | 1 | 1 | 0 | 0 |
| ALT elevation | 7 | 0 | 1 | 0 |
| AST elevation | 0 | 1 | 0 | 0 |
| Alkaline phosphatase elevation | 1 | 0 | 0 | 0 |
| Bilirubin elevation | 0 | 1 | 0 | 0 |
| Cholesterol elevation | 0 | 1 | 0 | 0 |
| Creatinine elevation | 1 | 0 | 0 | 0 |
| Hyperglycemia | 1 | 3 | 0 | 0 |
| Hypermagnesemia | 1 | 0 | 0 | 0 |
| Hypoalbuminemia | 1 | 0 | 0 | 0 |
| Hypocalcemia | 2 | 0 | 0 | 0 |
| Hypokalemia | 3 | 0 | 0 | 0 |
| Hypomagnesemia | 1 | 0 | 0 | 0 |
| Hyponatremia | 1 | 0 | 0 | 0 |
| Hypophosphatemia | 2 | 2 | 1 | 0 |
| Muscle weakness (lower extremity) | 0 | 2 | 0 | 0 |
| Muscle weakness (whole body) | 0 | 1 | 0 | 0 |
| Extremity-upper (function) | 0 | 1 | 0 | 0 |
| Joint–function | 1 | 0 | 0 | 0 |
| Confusion | 1 | 0 | 0 | 0 |
| Dizziness | 1 | 2 | 0 | 0 |
| Blurred vision | 1 | 0 | 0 | 0 |
| Abdominal pain | 3 | 0 | 0 | 0 |
| Chest/thorax pain | 1 | 0 | 0 | 0 |
| Limb pain | 1 | 0 | 0 | 0 |
| Headache | 0 | 1 | 0 | 0 |
| Joint pain | 2 | 1 | 0 | 0 |
| Thrombosis or embolism of vascular access | 0 | 0 | 0 | 1 |
ALT, alanine aminotransferse; AST, aspartate aminotransferase; and PT, prothrombin time.