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12:06 Apr 26, 2008
English to Russian translations [PRO] Medical - Medical: Pharmaceuticals
English term or phrase:was comparable
In the clinical trials of TYSABRI in MS and Crohn’s disease, although serious hepatic events consistent with liver injury were reported, the proportions of affected individuals was comparable in patients receiving active drug or placebo. The post-marketing data has prompted the Marketing Authorisation Holder to amend the Summary of Product Characteristics. The incidence of these serious events is not precisely known as the reports arise from post-marketing surveillance, however they are likely to be rare, since they were not observed in the clinical studies involving over 3000 patients studied for up to 2 years or longer.