Sophie Micon

Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort

Hervé Ghesquières, Fanny Cherblanc, Aurélien Belot, Sophie Micon et autres

ABSTRACT: Real-world data (RWD) are essential to complement clinical trial (CT) data, but major challenges remain, such as data quality. REal world dAta in LYmphoma and Survival in Adults (REALYSA) is a prospective noninterventional multicentric cohort started in 2018 that included patients …

fr, ch (code pays fourni par la source)

Corrigendum to: Use of Nalmefene in Routine Practice: Results from a French Prospective Cohort Study and a National Database Analysis

Henri‐Jean Aubin, Caroline Dureau‐Pournin, Bruno Falissard, François Paillé et autres

When this paper first published, it was missing the below conflict of interest statements from the authors. These conflict of interest statements now appear in the paper online. Dr Patrick Blin wishes to record that he is an employee of the Bordeaux …

fr, de (code pays fourni par la source)

Use of Nalmefene in Routine Practice: Results from a French Prospective Cohort Study and a National Database Analysis

Henri‐Jean Aubin, Caroline Dureau‐Pournin, Bruno Falissard, François Paillé et autres

AIMS: Two complementary studies were used to assess the real-life use of nalmefene in alcohol-dependent patients and its impact on alcohol use health status. METHODS: USE-PACT was a prospective cohort study designed to evaluate the real-life effectiveness of nalmefene in the management …

fr, de (code pays fourni par la source)

Drug exposure and risk of Acute Liver Failure leading to registration for liver Transplantation (ALFT): Results of the SALT III study in adults in France

Dominique G. Larrey, Lucy Meunier, G.-P. Pageaux, S. Maleyran et autres

fr (code pays fourni par la source)

Liver transplant associated with paracetamol overdose: results from the seven‐country SALT study

Sinem Ezgi Gülmez, Dominique G. Larrey, Georges‐Philippe Pageaux, Jacques Bernuau et autres

AIMS: Acute drug overdose, especially with paracetamol, may cause acute liver failure leading to registration for transplantation (ALFT). Population statistics and between-country differences for ALFT related to overdose have been poorly described. The aim of the present study was to evaluate overdose …

fr, be, gb, ie, nl (code pays fourni par la source)

Causality of Drugs Involved in Acute Liver Failure Leading to Transplantation: Results from the Study of Acute Liver Transplant (SALT)

Sinem Ezgi Gülmez, Nicholas D Moore, Georges‐Philippe Pageaux, S. Lignot et autres

fr, be, nl, gb (code pays fourni par la source)

Transplantation for Acute Liver Failure in Patients Exposed to NSAIDs or Paracetamol (Acetaminophen)

Sinem Ezgi Gülmez, Dominique G. Larrey, Georges‐Philippe Pageaux, S. Lignot et autres

BACKGROUND: Most NSAIDs are thought to be able to cause hepatic injury and acute liver failure (ALF), but the event rates of those leading to transplantation (ALFT) remain uncertain. OBJECTIVES: The aim of the study was to estimate population event rates for …

fr, it, ie, nl, gb, gr, be (code pays fourni par la source)

Administrative complexities for a European observational study despite directives harmonising requirements

Sinem Ezgi Gülmez, S. Lignot-Maleyran, Corinne S de Vries, Miriam Sturkenboom et autres

PURPOSE: For pharmacoepidemiological studies in Europe, accessing data should require only authorisation by the relevant data protections committees, as expected from the 1995 Data Protection Directive (95/46/EC). Our experience from a multinational observational study across seven European countries shows that this is …

fr, gb, nl (code pays fourni par la source)

P73 Preliminary results of the Study of Acute Liver Transplant (SALT): NSAID exposure and risk of acute liver failure leading to transplantation in 7 European countries

Douglas Thorburn, E. Gülmez, S. Lignot, Dominique G. Larrey et autres

Introduction The risk of acute liver failure (ALF) related to NSAIDs is still discussed and the European Medicines Agency requested a study investigating this. University Bordeaux Segalen conducted the study independently. Aim To estimate the incidence rates of ALF leading to registration …

gb, fr, us, nl, it, be, pt, ie (code pays fourni par la source)

921 CONTRIBUTION OF DRUG-INDUCED LIVER INJURY (DILI) IN LIVER TRANSPLANTATION (OLT) INDICATION FOR ACUTE LIVER FAILURE (ALF) IN ADULTS IN FRANCE

P. Larrey, G.-P. Pageaux, E. Gülmez, S. Lignot et autres

NSAID Exposure and Risk of Acute Liver Failure Leading to Transplantation: Principal Results of the 7-Country Case-Population Study (SALT)

E. Gülmez, S. Lignot, Dominique G. Larrey, Corinne S de Vries et autres