Introduction to Observational Post Marketing
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Methods
All patients with Type 1, 2, or 3 GD administered velaglucerase alfa 60 U/kg every 2 weeks via intravenous infusion after its launch date in Japan in 2014, were enrolled in a non-interventional, observational post-marketing surveillance (PMS).
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We conducted an observational post-marketing safety study utilising real-world data.
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This publication presents the interim results of a multicenter retrospective – prospective observational post-marketing study of the safety and efficacy of the drug Extimia ® BIOCAD (INN: empegfilgrastim) in patients with lymphoproliferative diseases receiving cytotoxic therapy (LEGERITY).
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Material and Methods Data from two observational post-marketing surveillance (PMS) databases compiled by 139 and 52 German centers in 2004–2011 and 2011–2013, respectively, were pooled, yielding data on a total of 148,489 patients examined over a 10-year period.
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