Table 5.
Adverse events reported by two or more subjects through study day 56 (safety population)
| Adverse Event | FG-3019 3 mg/kg (n = 14) | FG-3019 10 mg/kg (n = 10) | All (n = 24) |
|---|---|---|---|
| Overall | 14 (100%) | 7 (70%) | 21 (88%) |
| Headache | 3 (21%) | 0 | 3 (13%) |
| AST increased | 2 (14%) | 0 | 2 (8%) |
| LDH increased | 2 (14%) | 0 | 2 (8%) |
| Herpes simplex | 0 | 2 (20%) | 2 (8%) |
| Fatigue | 1 (7%) | 1 (10%) | 2 (8%) |
| Edema | 1 (7%) | 1 (10%) | 2 (8%) |
| Excoriation | 1 (7%) | 1 (10%) | 2 (8%) |
| Laceration | 2 (14%) | 0 | 2 (8%) |
| Pain in extremity | 1 (7%) | 1 (10%) | 2 (8%) |
| Hyperglycemia | 2 (14%) | 0 | 2 (8%) |
| Anemia | 1 (7%) | 1 (10%) | 2 (8%) |
| Anxiety | 1 (7%) | 1 (10%) | 2 (8%) |
Data presented as n (%). LDH, lactate dehydrogenase.