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ulteriori reazioni avverse emerse dall’esperienza post-marketing con talidomide e non osservate nello studio registrativo comprendono la neutropenia febbrile e la pancitopenia.
additional adverse reactions from post-marketing experience with thalidomide and not seen in the pivotal study include febrile neutropenia and pancytopenia.
lo studio clinico registrativo sulla mancata consolidazione tibiale ha paragonato osigraft all’innesto di osso autologo con un parametro primario di efficacia a 9 mesi post-trattamento.
the tibial nonunion pivotal trial compared osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment.
ulteriori reazioni avverse correlate all’ esperienza post-marketing con talidomide e non osservate nello studio registrativo comprendono: necrolisi epidermica tossica, occlusione intestinale, ipotiroidismo e disfunzione sessuale.
additional adverse reactions related to post-marketing experience with thalidomide and not seen in the pivotal study include: toxic epidermal necrolysis, intestinal obstruction, hypothyroidism and sexual dysfunction.
tabella 1: reazioni avverse osservate nei 302 pazienti inclusi negli studi clinici epn e seua e in fase post-registrativa
table 1: adverse reactions reported in 302 patients included in pnh and ahus clinical trials and in postmarketing reports