Safety and tolerability profile of daclizumab in patients with relapsing-remitting multiple sclerosis: An integrated analysis of clinical studies
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- 作者：Gavin Giovannonia ; g.giovannoni@qmul.ac.uk" class="auth_mail" title="E-mail the corresponding author ; Ludwig Kapposb ; ludwig.kappos@usb.ch" class="auth_mail" title="E-mail the corresponding author ; Ralf Goldc ; Ralf.Gold@ruhr-uni-bochum.de" class="auth_mail" title="E-mail the corresponding author ; Bhupendra O Khatrid ; bokhatri@aol.com" class="auth_mail" title="E-mail the corresponding author ; Krzysztof Selmaje ; kselmaj@afazja.am.lodz.pl" class="auth_mail" title="E-mail the corresponding author ; Kimberly Umansf ; kim.umans@biogen.com" class="auth_mail" title="E-mail the corresponding author ; Steven J Greenbergg ; steven.greenberg@abbvie.com" class="auth_mail" title="E-mail the corresponding author ; Marianne Sweetserf ; 1 ; msweetser@alnylam.com" class="auth_mail" title="E-mail the corresponding author ; Jacob Elkinsf ; jake.elkins@biogen.com" class="auth_mail" title="E-mail the corresponding author ; Peter McCroskeryf ; peter.mccroskery@biogen.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：AE ; adverse event ; ALT ; alanine aminotransferase ; AST ; aspartate aminotransferase ; DRESS ; drug reaction with eosinophilia and systematic symptoms ; DSMB ; data safety monitoring board ; GGT ; gamma-glutamyl transferase ; GI ; gastrointestinal ; IL-2 ; interleukin 2 ; IM ; intramuscular ; MedDRA ; Medical Dictionary for Regulatory Activities ; MS ; multiple sclerosis ; RRMS ; relapsing-remitting multiple sclerosis ; SAE ; serious adverse event ; SMQ ; Standardised MedDRA Query ; SOC ; System Organ Class ; ULN ; upper li
- 刊名：Multiple Sclerosis and Related Disorders
- 出版年：2016
- 出版时间：September 2016
- 年：2016
- 卷：9
- 期：Complete
- 页码：36-46
- 全文大小：490 K
文摘
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Daclizumab safety was evaluated in an integrated analysis of six RRMS trials.
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Most AEs were mild or moderate in severity.
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A risk for potentially immune-mediated SAEs in liver, skin, and GI organ systems.
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AEs occurred throughout treatment with no evidence of accumulated toxicity.
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Most AEs resolved spontaneously or with standard medical therapies.