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. Author manuscript; available in PMC: 2014 Aug 27.
Published in final edited form as: Neuromuscul Disord. 2013 Sep 11;24(1):16–24. doi: 10.1016/j.nmd.2013.09.004

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)