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Pirfenidone post-authorization safety registry (PASSPORT) update

D Koschel, V Cottin, T Maher, A Azuma, LJ Groves, P Hormel, M Sköld, S Tomassetti · Pneumologie · Ausgabe 02/2016

DOI 10.1055/s-0036-1572065

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Autor:innenD Koschel, V Cottin, T Maher, A Azuma, LJ Groves, P Hormel, M Sköld, S Tomassetti
ZeitschriftPneumologie
Ausgabe02/2016
Jahrgang / SeitenNicht angegeben

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Abstract-Vorschau

Background: PASSPORT is a post-authorization safety registry for pirfenidone to collect “real-world” data in EU patients with idiopathic pulmonary fibrosis (IPF). Objectives: 1) Assess the safety of pirfenidone as monotherapy and with N-acetylcysteine (NAC) and/or corticosteroids (CS); 2) examine country-specific differences. Methods: 109 EU sites dosed 1009 patients; largest enrolling countries were Germany (N = 45…

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D Koschel, V Cottin, T Maher, A Azuma, LJ Groves, P Hormel, M Sköld, S Tomassetti (2016) Pirfenidone post-authorization safety registry (PASSPORT) update. Pneumologie (02). https://doi.org/10.1055/s-0036-1572065

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