TABLE 3.
Treatment-Emergent Adverse Events (>10%): All Grades
| No. of Patients (%) | ||||
|---|---|---|---|---|
| Dalantercept Dose | ||||
| Preferred AE Term | 80 mg, N = 2 | 0.6 mg/kg, N = 13 | 1.2 mg/kg, N = 31 | Overall, N = 46 |
| Fatigue | 1 (50) | 8 (61.5) | 12 (38.7) | 21 (45.7) |
| Anemia | 0 (0) | 2 (15.4) | 16 (51.6) | 18 (39.1) |
| Headache | 1 (50) | 4 (30.8) | 11 (35.5) | 16 (34.8) |
| Peripheral edema | 0 (0) | 2 (15.4) | 11 (35.5) | 13 (28.3) |
| Hyponatremia | 1 (50) | 1 (7.7) | 9 (29) | 11 (23.9) |
| Decreased appetite | 0 (0) | 3 (23.1) | 5 (16.1) | 8 (17.4) |
| Dyspnea | 0 (0) | 2 (15.4) | 5 (16.1) | 7 (15.2) |
| Arthralgia | 0 (0) | 0 (0) | 6 (19.4) | 6 (13) |
| Constipation | 1 (50) | 3 (23.1) | 2 (6.5) | 6 (13) |
| Cough | 0 (0) | 2 (15.4) | 4 (12.9) | 6 (13) |
| Hyperglycemia | 0 (0) | 0 (0) | 6 (19.4) | 6 (13) |
| Nausea | 1 (50) | 1 (7.7) | 4 (12.9) | 6 (13) |
| Pleural effusion | 0 (0) | 1 (7.7) | 5 (16.1) | 6 (13) |
| Vomiting | 1 (50) | 2 (15.4) | 3 (9.7) | 6(13) |
| Face edema | 0 (0) | 0 (0) | 5 (16.1) | 5 (10.9) |
| Hypoalbuminemia | 0 (0) | 2 (15.4) | 3 (9.7) | 5 (10.9) |
Abbreviation: AE: adverse event.