Table 4.
Summary of all adverse events by treatment.
| Number (%) of subjects | |||||
|---|---|---|---|---|---|
| Placebo (N = 5) |
3 mg/kg Drisapersen (N = 6) |
6 mg/kg Drisapersen (N = 6) |
9 mg/kg Drisapersen (N = 3) |
Total (N = 20) |
|
| Any AE by phase | |||||
| Treatment emergent | 2 (40) | 6 (100) | 6 (100) | 3 (100) | 17 (85) |
| Follow-up | 2 (40) | 3 (50) | 4 (67) | 0 | 9 (45) |
| Drug related AEs (per investigator judgment) | 1 (20) | 5 (83) | 5 (83) | 3 (100) | 14 (70) |
| AEs of special interest | |||||
| Injection site reaction | 1 (20) | 4 (67) | 5 (83) | 3 (100) | 13 (65) |
| Renal toxicity | 0 | 0 | 0 | 1 (33) | 1 (5) |
| Inflammation | 0 | 0 | 1 (17) | 3 (100) | 4 (20) |