A5082323092- Pharmacovigilance and Adverse Drug Reactions
- Cancer Immunotherapy and Biomarkers
- Chemotherapy-induced cardiotoxicity and mitigation
- Drug-Induced Adverse Reactions
- Chronic Lymphocytic Leukemia Research
- Melanoma and MAPK Pathways
- Heparin-Induced Thrombocytopenia and Thrombosis
- Cardiac Structural Anomalies and Repair
- Computational Drug Discovery Methods
- Cardiac Imaging and Diagnostics
- PARP inhibition in cancer therapy
- Cancer Treatment and Pharmacology
- Schizophrenia research and treatment
- Intensive Care Unit Cognitive Disorders
- Pharmaceutical Economics and Policy
- Peptidase Inhibition and Analysis
- Electroconvulsive Therapy Studies
- Atrial Fibrillation Management and Outcomes
- CAR-T cell therapy research
- Biosimilars and Bioanalytical Methods
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- HER2/EGFR in Cancer Research
- Academic integrity and plagiarism
- Takotsubo Cardiomyopathy and Associated Phenomena
- Cardiovascular Function and Risk Factors
Centre Hospitalier Universitaire de Caen Normandie
2017-2025
Université de Caen Normandie
2017-2025
Normandie Université
2018-2025
Inserm
2021-2025
Sorbonne Université
2023-2025
Assistance Publique – Hôpitaux de Paris
2023-2025
Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers
2020-2024
Pitié-Salpêtrière Hospital
2023-2024
Cancers et Préventions
2020-2024
Fondation pour l’innovation en Cadiométabolisme et Nutrition
2024
Limited information is available on the safety of a rechallenge with an immune checkpoint inhibitor (ICI) after immune-related adverse event (irAE).To identify recurrence rate same irAE that prompted discontinuation ICI therapy in patients cancer and to clinical features associated such recurrences.This observational, cross-sectional, pharmacovigilance cohort study examined individual case reports from World Health Organization database VigiBase, which contains more than 130 countries. Case...
The considerable progress made in the field of cancer treatment has led to a dramatic improvement prognosis patients with cancer. However, toxicities resulting from these treatments represent cost that can be harmful short‐ and long‐term outcomes. Adverse events affecting cardiovascular system are one greatest challenges overall management cancer, as they compromise success optimal against tumor. Such adverse associated not only older chemotherapy drugs such anthracyclines but also many...
While multiple pharmacological drugs have been associated with myocarditis, temporal trends and overall mortality not reported. Here we report the spectrum main features of 5108 reports drug-induced in a worldwide pharmacovigilance analysis, comprising more than 21 million individual-case-safety from 1967 to 2020. Significant association between myocarditis suspected drug is assessed using disproportionality analyses, which use Bayesian information component estimates. Overall, identify 62...
In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect signals. Unfortunately, publishing lacks specific guidelines, often leading incomplete and ambiguous reporting, carries the risk of incorrect conclusions when data not placed in correct context. The REporting A Disproportionality analysis for drUg Safety signal detection using PharmacoVigilance (READUS-PV) statement was developed address this issue by promoting transparent...
Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their and results generally poorly reported published articles existing guidelines do not capture specific features disproportionality analyses. We here describe development a guideline (REporting A analysis drUg Safety signal detection individual case PharmacoVigilance [READUS-PV]) reporting abstracts....
Background Immune checkpoint inhibitor (ICI)-associated early cardiac adverse events (CAEs), mostly acute and fulminant myocarditis, have been well characterized mainly occur during the first 90 days after ICI therapy initiation. ICI-associated late CAEs (occurring of treatment) not yet described. Methods First, we compared characteristics a cohort involving (defined as CAE time to onset (TTO) <90 initiation) TTO ≥90 consecutive cases who were referred three French cardio-oncology units....
Immune checkpoint inhibitors (ICIs) have transformed cancer treatment, but ICI myocarditis (ICI-M) remains a potentially fatal complication. The clinical implications and predictors of left ventricular ejection fraction (LVEF) <50% in ICI-M are not well understood. aim this study was to identify factors associated with LVEF vs ≥50% at the time hospitalization for ICI-M. A secondary objective evaluate relationship between 30-day all-cause mortality. International ICI-Myocarditis Registry,...
The explosion of novel anticancer therapies has meant emergence cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability drugs in inducing AF are scarce. Using World Health Organization individual case safety report database, VigiBase®, we aimed to determine association between and AF.A disproportionality analysis evaluating multivariable-adjusted reporting odds ratios for with their 99.97% confidence intervals was performed 176 U.S. Food Drug...
Atrial fibrillation (AF) is one of the most common side effects ibrutinib, a drug that has dramatically improved prognosis chronic B-cell malignancies such as lymphocytic leukaemia (CLL). The true incidence ibrutinib-related AF (IRAF) not well known and its therapeutic management poses unique challenges especially due to inherent risk bleeding. We aimed determine predictors IRAF, analyse outcome.
The incidence of atrial fibrillation (AF) associated with anticancer drugs in cancer patients remains incompletely defined.The primary outcome was the annualized rate AF reporting exposure to 1 19 used as monotherapy clinical trials. authors also report reported placebo arms these trials.The systematically searched ClinicalTrials.gov for phase 2 and 3 trials studying different interest monotherapy, up September 18, 2020. performed a random-effects meta-analysis compute summary its 95% CI...
Disproportionality analysis is traditionally used in spontaneous reporting systems to generate working hypotheses about potential adverse drug reactions: the so-called disproportionality signals. We aim map methods by researchers assess and increase validity of their published signals.From a systematic literature search analyses up until 1 January 2020, we randomly selected analyzed 100 studies. considered five domains: (1) rationale for study, (2) design analyses, (3) case-by-case...
Giant cell arteritis (GCA) causes severe inflammation of the aorta and its branches is characterized by intense effector T-cell infiltration. The roles that immune checkpoints play in pathogenesis GCA are still unclear. Our aim was to study checkpoint interplay GCA.First, we used VigiBase, World Health Organization international pharmacovigilance database, evaluate relationship between occurrence inhibitors treatments. We then further dissected role GCA, using immunohistochemistry,...
Abstract Background Clozapine is mainly used in patients with treatment-resistant schizophrenia and may lead to potentially severe haematologic adverse events, such as agranulocytosis. Whether clozapine might be associated malignancies unknown. We aimed assess the association between using Vigibase®, WHO pharmacovigilance database. Methods performed a disproportionality analysis compute reporting odds-ratio adjusted for age, sex concurrent of antineoplastic/immunomodulating agents (aROR)...
The safety profile of a rechallenge with BRAF inhibitors (BRAFi) or combination and MEK (MEKi) following an adverse drug reaction (ADR) remains largely unexplored. To identify the reported recurrence rate same ADR after BRAFi±MEKi targeted therapy (TT) in patients cancer to factors associated recurrence. In this observational, pharmacovigilance study, reports were sourced from VigiBase, World Health Organization database. inclusion criteria encompassed all BRAFi cases (with without MEKi)...
The objective is to investigate the association between antidepressant drugs intake and falls reporting, as well potential mediators in-between, in older adults. In VigiBase®, World Health Organization's pharmacovigilance database, we performed a disproportionality analysis probe putative associations each class (non-selective monoamine reuptake inhibitors [NSMRIs], selective serotonin [SSRIs], serotonin-norepinephrine [SNRIs], alpha-2-adrenergic receptor antagonists, "other...