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

下载文档

4
0
约8.47千字
约 19页
2017-01-12 发布于贵州
举报
版权申诉
保障服务

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

1、本文档共19页，可阅读全部内容。
2、有哪些信誉好的足球投注网站（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。

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