TABLE 3.
Summary of Adverse Events, Regardless of Attribution
| Adverse Event | No. of Adverse Events (%) |
||
|---|---|---|---|
| Any Grade | Grade 3 | Grade 4 | |
| Hyperglycemia | 15 (100) | 5 (33) | 1 (7) |
| Low hemoglobin | 14 (93) | 1 (7) | 0 (0) |
| Thrombocytopenia | 13 (87) | 1 (7) | 1 (7) |
| Fatigue | 13 (87) | 2 (13) | 0 (0) |
| ALT elevation | 12 (80) | 0 (0) | 0 (0) |
| Hypercholesterolemia | 12 (80) | 0 (0) | 0 (0) |
| Hypertriglyceridemia | 12 (80) | 0 (0) | 0 (0) |
| AST elevation | 11 (73) | 0 (0) | 0 (0) |
| Leukopenia | 10 (67) | 6 (40) | 1 (7) |
| Lymphopenia | 10 (67) | 6 (40) | 4 (27) |
| Hypomagnesemia | 10 (67) | 0 (0) | 0 (0) |
| Hypoalbuminemia | 9 (60) | 0 (0) | 0v |
| Diarrhea | 9 (60) | 0 (0) | 0 (0) |
| Nausea | 9 (60) | 0 (0) | 0 (0) |
| Hyponatremia | 9 (60) | 1 (7) | 0 (0) |
| Constipation | 8 (53) | 0 (0) | 0 (0) |
| Creatinine elevation | 8 (53) | 0 (0) | 0 (0) |
| Rash, acneiform | 8 (53) | 0 (0) | 0 (0) |
| Alkaline phosphatase elevation | 7 (47) | 0 (0) | 0v |
| Neutropenia | 7 (47) | 3 (20) | 3 (20) |
| Hypokalemia | 7 (47) | 3 (20) | 0 (0) |
| Dysgeusia | 6 (40) | 0 (0) | 0 (0) |
| Febrile neutropenia | 3 (20) | 2 (13) | 1 (7) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.