Table 4.
Adverse Event, n (%) | Cohort A (0.05 mg/kg SC Q4W n = 45) | Cohort B (0.075 mg/kg SC Q4W n = 15) | Cohort C (0.025 mg/kg SC Q4W n = 15) | Cohort D (0.05 mg/kg IV Q4W n = 15) | Cohort E (0.025 mg/kg SC Q2W n = 15) | Cohort F (0.0375 mg/kg SC Q2W n = 4) | Cohort G (4.0 mg SC Q4W n = 15) | Cohort H (3.0 mg SC Q4W n = 15) | Total (n = 139) |
---|---|---|---|---|---|---|---|---|---|
Nasopharyngitis | 3 (6.7) | 2 (13.3) | 1 (6.7) | 2 (13.3) | 5 (33.3) | 1 (25.0) | 3 (20.0) | 1 (6.7) | 18 (12.9) |
Hypertension | 3 (6.7) | 3 (20.0) | 1 (6.7) | 1 (6.7) | 3 (20.0) | 1 (25.0) | 0 (0) | 2 (13.3) | 14 (10.1) |
Diarrhea | 4 (8.9) | 0 | 1 (6.7) | 0 | 0 | 2 (50.0) | 0 | 3 (20.0) | 10 (7.2) |
Urinary tract infection | 6 (13.3) | 1 (6.7) | 0 | 0 | 0 | 1 (25.0) | 1 (6.7) | 1 (6.7) | 10 (7.2) |
Nausea | 1 (2.2) | 2 (13.3) | 1 (6.7) | 1 (6.7) | 1 (6.7) | 1 (25.0) | 0 | 2 (13.3) | 9 (6.5) |
Back pain | 3 (6.7) | 2 (13.3) | 0 | 0 | 0 | 1 (25.0) | 1 (6.7) | 1 (6.7) | 8 (5.8) |
Peripheral edema | 2 (4.4) | 0 | 0 | 0 | 4 (26.7) | 0 | 1 (6.7) | 1 (6.7) | 8 (5.8) |
Chronic renal failure | 1 (2.2) | 0 | 1 (6.7) | 1 (6.7) | 1 (6.7) | 0 | 1 (6.7) | 3 (20.0) | 8 (5.8) |
Increased blood pressure | 2 (4.4) | 0 | 1 (6.7) | 0 | 3 (20.0) | 1 (25.0) | 0 | 0 | 7 (5.0) |
SC, subcutaneous; Q4W, every 4 weeks; IV, intravenous; Q2W, every 2 weeks.