Table 5.

Summary of adverse events of special interest by treatment.

Special interest category preferred term	Placebo (N = 5)	3 mg/kg Drisapersen (N = 6)	6 mg/kg Drisapersen (N = 6)	9 mg/kg Drisapersen (N = 3)
Injection site reaction, any event, n (%)	1 (20)	4 (67)	5 (83)	3 (100)
Injection site discoloration	1 (20)	3 (50)	5 (83)	3 (100)
Injection site induration	1 (20)	3 (50)	4 (67)	2 (67)
Injection site erythema	0	3 (50)	1 (17)	2 (67)
Injection site hematoma	0	1 (17)	2 (33)	1 (33)
Injection site inflammation	0	0	1 (17)	3 (100)
Injection site edema	0	0	0	2 (67)
Injection site pruritus	0	2 (33)	0	0
Injection site pain	0	1 (17)	0	0
Injection site warmth	0	0	1 (17)	0
Renal Toxicity, any event, n (%)	0	0	0	1 (33)
Alpha 1 microglobulin increaseda	0	0	0	1 (33)
Inflammation, any event, n (%)	0	0	1 (17)	3 (100)
Pyrexia	0	0	1 (17)	3 (100)
C reactive protein increasedb	0	0	0	1 (33)
Immunology test abnormalc	0	0	0	1 (33)

^aLaboratory reference range: less than 12.0 mg/L.

^bLaboratory reference range: 0–3.0 mg/L.

^cIncrease in complement split products.