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委托协议书(职业健康体类) Title委托协议书(职业健康体检类) Title.ppt

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Tysabri? (natalizumab)Biogen Idec Inc.BLA 125104/15 Peripheral and Central Nervous System Drugs Advisory Committee Gaithersburg, Maryland March 7-8, 2006 Alice Hughes, M.D. Division of Neurology Products Review of Non-PML Safety Issues Outline Infections other than PML Immunogenicity and hypersensitivity reactions Carcinogenicity Post-marketing reports of serious adverse events Summary of major safety concerns Infections other than PML:Placebo-controlled MS studies Natalizumab- and placebo-treated patients had similar incidences of: infections overall: 73.7% vs. 73.9% (natalizumab vs. placebo) serious infections: 2.4% vs. 2.3% Natalizumab- and placebo-treated patients had similar incidences of: upper respiratory tract infections: 59.6% vs. 59.8% UTIs: 21.5% vs. 21.4% serious UTIs: 0.6% vs. 0.5% gastroenteritis: 9.1% vs. 9.0% Infections other than PML:MS studies Incidences of specific infections in placebo-controlled studies: all lower respiratory tract infections: 13.3% vs. 12.2% (natalizumab vs. placebo) serious pneumonias: 0.4% vs. 0.2% vaginal infections: 7.5% vs. 6.2% all herpes infections: 7.0% vs. 6.1% gingival infections: 1.1% vs. 0.5% Atypical infections cryptosporidial gastroenteritis with prolonged course (in monotherapy Study 1801) acute CMV infection with transaminitis (in open-label Study 1808) Infections other than PML:Placebo-controlled CD studies Incidence of infections overall: 40.4% vs. 35.8% (natalizumab vs. placebo) Incidence of serious infections: 2.5% vs. 2.6% Incidences of selected infections: URIs: 27% vs. 21% UTIs: 2.9% vs. 2.0% vaginal infections: 2.1% vs. 1.6% all herpes infections: 1.6% vs. 1.0% perianal abcesses: 1.1% vs. 0.6% serious viral meningitides: 0.2% (2) vs. 0 serious UTIs: 0.2% (2) vs. 0 One serious CMV infection (CMV colitis) Patient also receiving azathioprine Infections other than PML:Long-term CD studies Atypical Infections Six serious atypical lower respiratory tract infections