{"id":4492,"date":"2025-08-13T14:02:19","date_gmt":"2025-08-13T12:02:19","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub&#038;p=4492"},"modified":"2025-11-24T10:43:58","modified_gmt":"2025-11-24T09:43:58","slug":"unerwuenschte-ereignisse","status":"publish","type":"knowledge-hub","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/glossar\/unerwuenschte-ereignisse\/","title":{"rendered":"Unerw\u00fcnschte Ereignisse (UE)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4492\" class=\"elementor elementor-4492 elementor-543\" data-elementor-post-type=\"knowledge-hub\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d921505 e-flex e-con-boxed e-con e-parent\" data-id=\"d921505\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-00c6bd4 elementor-widget elementor-widget-text-editor\" data-id=\"00c6bd4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Ein<span style=\"color: #000000;\">\u00a0<\/span><strong><span style=\"color: #000000;\">unerw\u00fcnschtes Ereignis<\/span>\u00a0<\/strong>(UE) bezeichnet im Rahmen einer klinischen Studie:<\/p><p>&#8211; neues Anzeichen (z.B. ver\u00e4nderter Laborwert), Symptom oder neue Krankheit\/Verletzung bei einem Studienteilnehmer,ung\u00fcnstig\/ und unbeabsichtigt und zeitlich im Zusammenhang mit der Anwendung eines Studien-Arzneimittels (oder einer Studienprozedur), unabh\u00e4ngig davon, ob damit ein kausaler Zusammenhang besteht oder nicht.<\/p><p><em>Hinweis:<\/em>\u00a0Klinisch signifikante anormale Laborbefunde werden als UEs betrachtet, anormale Laborbefunde k\u00f6nnen jedoch nicht als UEs betrachtet werden, wenn keine Ver\u00e4nderung im Vergleich zu den Ausgangswerten (bei der Randomisierung f\u00fcr die klinische Studie) vorliegt.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Jede unerw\u00fcnschte Erfahrung im Zusammenhang mit der Verwendung eines medizinischen Produkts bei einem Patienten.<\/p>\n","protected":false},"featured_media":0,"template":"","knowledge-hub-categories":[],"class_list":["post-4492","knowledge-hub","type-knowledge-hub","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - 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