Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions

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Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions

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作者：Giancarlo Comi^a ; ^{g.comi@hsr.it" class="auth_mail" title="E-mail the corresponding author} ; Mark S Freedman^b ; ^{mfreedman@toh.on.ca" class="auth_mail" title="E-mail the corresponding author} ; Ludwig Kappos^c ; ^{Ludwig.Kappos@usb.ch" class="auth_mail" title="E-mail the corresponding author} ; Tomas P Olsson^d ; ^{Tomas.Olsson@ki.se" class="auth_mail" title="E-mail the corresponding author} ; Aaron E Miller^e ; ^{aaron.miller@mssm.edu" class="auth_mail" title="E-mail the corresponding author} ; Jerry S Wolinsky^f ; ^{Jerry.S.Wolinsky@uth.tmc.edu" class="auth_mail" title="E-mail the corresponding author} ; Paul W O'Connor^g ; ^{opaul362@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Myriam Benamor^h ; ^{Myriam.Benamor@sanofi.com" class="auth_mail" title="E-mail the corresponding author} ; Deborah Dukovicⁱ ; ^{Deborah.Dukovic@sanofi.com" class="auth_mail" title="E-mail the corresponding author} ; Philippe Truffinet^h ; ^{Philippe.Truffinet@sanofi.com" class="auth_mail" title="E-mail the corresponding author} ; Thomas P Leist^j ; ^{Thomas.Leist@jefferson.edu" class="auth_mail" title="E-mail the corresponding author}
关键词：Multiple sclerosis ; Relapsing-remitting multiple sclerosis ; Teriflunomide ; Safety analysis ; Clinical trials
刊名：Multiple Sclerosis and Related Disorders
出版年：2016
出版时间：January 2016
年：2016
卷：5
期：Complete
页码：97-104
全文大小：601 K

文摘

•: Pooled analysis with cumulative exposure to teriflunomide >6800 patient-years.
•: Safety and tolerability data consistent with results from individual studies.
•: No new or unexpected safety signals identified.
•: Most events mild-to-moderate and infrequently led to treatment discontinuation.
•: Both doses of teriflunomide had similar and manageable safety profiles.

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