Twenty-two percent (22%) of subjects experienced an adverseevent related to the site of injection. Injection site pain was the most frequently experienced adverseevent classified asan injection site reaction, occurring in 11% of subjects. Ecchymosis at the site of injection and inflammation at the site of injection occurred with an incidence of 9% and 4%, respectively.
There was one serious adverseevent (in patient 105015) in which “myositis” occurred at the injection site. This patient was a 53-year-old female with poorly controlled diabetes mellitus at study entry (serum glucose was 727 mg/dL at screening and 348 mg/dL at baseline). She developed awarm tender areaat the injection site in the left thigh, approximately one month after starting study drug. This areabecame swollen andwas initially diagnosedas a cellulitis. The patient underwent incisional drainage andbiopsy of the left thigh. The biopsy report showed an acute necrotizing myositis suggestive of an infectious processandoccasional gram positive organisms were seenon the tissue section. The patient was treated with antibiotics and received physical therapy. Shewas hospitalized for approximately 10 days, andthen was transferred to an extended care facility for approximately 2 months. Sheremained in the extended care facility primarily dueto fluctuations in serum glucose levels that were initially noted upon entranceto the study. The event resolved without sequelaeat the time of the final follow-up approximately 5 months after the start of the event. The investigator statedthat the relationship between this event and study drug was “none”. In addition, the investigator statedthat the event was dueto the patient’s injection technique and poorly controlled diabetesmellitus. However, Biogen statedthat the relationship between this event and study drug was “likely related” since this was a more conservative interpretation of causality. Therefore, this serious adverseevent was reported as anIND safety report.