Serious adverse events data availability

The pharmacokinetics and safety of the 5% lidocaine patches have been studied in 20 healthy volunteers, who applied four patches to the skin either every 24 hours or every 12 hours for 3 days (67). Mean steady-state plasma concentrations were 186 and 225 ng/ml respectively, well below those required for an antidysrhythmic effect (1500 ng/ml) or a risk of toxicity (5000 ng/ml). The patches were well tolerated, with no major cutaneous adverse effects. This is in line with data from postmarketing surveillance studies, which have shown that since the availability of lidocaine patches in 1999, no adverse cardiac or other serious adverse events have been reported (68). 

In terms of efficacy, data such as the number of infusions needed and treatment outcome rAHF-PFM were effective in preventing and controlling bleedings in patients with severe hemophilia A. In safety and immunogenicity studies, no serious adverse events reported to date have been deemed related to rAHF-PFM. The incidence rates for the most common non-serious adverse events indicate that drag-related adverse events were similar or even lower in number and in nature to those observed in chnical trials with other rFVlll concentrates. To date, no inhibitors have been reported. The first rAHF, Recombinate, was developed by Baxter and became commercially available in 1992. Its long record of efficacy and safety has made Recombinate the standard for care in hemophiha A therapy [9-11]. rAHF-PFM, Advate , received market authorization in 2003 in the US and in 2004 in Europe. 

Certain adverse events, e.g those leading to discontinuation, death, and other serious adverse events, require narrative summaries to be written and submitted. These narratives should not simply repeat in sentence format the information that was presented in the body of the clinical study report in numerical format. Rather, the narratives should permit an adequate understanding of the nature of each adverse event by providing a complete synthesis of all available clinical data and an informed discussion of the case (FDA 2005, p. 26). Useful components in a narrative include ... 

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