Ontology highlight
ABSTRACT:
SUBMITTER: Cottin V
PROVIDER: S-EPMC6194203 | biostudies-literature | 2018 Oct
REPOSITORIES: biostudies-literature
Cottin Vincent V Koschel Dirk D Günther Andreas A Albera Carlo C Azuma Arata A Sköld C Magnus CM Tomassetti Sara S Hormel Philip P Stauffer John L JL Strombom Indiana I Kirchgaessler Klaus-Uwe KU Maher Toby M TM
ERJ open research 20181019 4
Real-world studies include a broader patient population for a longer duration than randomised controlled trials (RCTs) and can provide relevant insights for clinical practice. PASSPORT was a multicentre, prospective, post-authorisation study of patients who were newly prescribed pirfenidone and followed for 2 years after initiating treatment. Physicians collected data on adverse drug reactions (ADRs), serious ADRs (SADRs) and ADRs of special interest (ADRSI) at baseline and then every 3 months. ...[more]