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Safety of Empagliflozin: An Individual Participant-Level Data Meta-Analysis from Four Large Trials
IntroductionEmpagliflozin is a sodium-glucose co-transporter-2 inhibitor used to treat type 2 diabetes (T2D) to improve glycemic control, reduce risk...
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Use of Electronic Health Record Data for Drug Safety Signal Identification: A Sco** Review
IntroductionPharmacovigilance programs protect patient health and safety by identifying adverse event signals through postmarketing surveillance of...
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Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data
BackgroundBrexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years....
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Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials
BackgroundWe report long-term, end-of-study program safety outcomes from 25 randomized clinical trials (RCTs) in adult patients with psoriasis (PsO),...
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Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
Introduction and ObjectiveThe ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the...
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Validation of a neighborhood sentiment and safety index derived from existing data repositories
BackgroundThe communities we live in are central to our health. Neighborhood disadvantage is associated with worse physical and mental health and...
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Safety of herbal dietary supplements used for weight loss: sales data and phytovigilance awareness
PurposeOverweight/obesity is a metabolic risk factor contributing to chronic diseases. People use herbal dietary supplements (HDS) to promote weight...
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Target trial emulation of carfilzomib safety among patients with relapsed/refractory multiple myeloma using a nationwide observational data in Korea
PurposeCarfilzomib, commonly used for relapsed/refractory multiple myeloma (RRMM), has been associated with various adverse events in randomized...
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Clinical nurses’ work-life balance prediction due to patient safety incidents using classification and regression tree analysis: a secondary data analysis
BackgroundPatient safety incidents lead to performance difficulties for nurses when providing nursing practice. This affects work-life balance and...
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Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data
ObjectiveDissemination of patient safety data is key to understanding safety events and improving the quality of patient care. However, there is...
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Associations between patient safety culture and workplace safety culture in hospital settings
BackgroundStrong cultures of workplace safety and patient safety are both critical for advancing safety in healthcare and eliminating harm to both...
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Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
BackgroundBiosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference...
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Long-term Efficacy and Safety Following Switch Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: 5-Year Data from SELECT-COMPARE
IntroductionThis study aimed to describe the long-term efficacy and safety of upadacitinib and adalimumab through 228 weeks following immediate...
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Safety and safety protocols for living donor nephrectomy in Italy
Living donor kidney transplantation (LDKTx) is recommended by all scientific societies. Living donor nephrectomy (LDN) is probably one of the safest...
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A Narrative Review of Real-World Data on the Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis
Nintedanib is a tyrosine kinase inhibitor approved for the treatment of idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing...
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Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials
BackgroundConventional, non-specific preventive migraine treatments often demonstrate low rates of treatment persistence due to poor efficacy or...
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Clinical efficacy and safety of switching from eculizumab to ravulizumab in adult patients with aHUS– real-world data
BackgroundThe complement factor 5 (C5)-inhibitor eculizumab has been established as standard-of-care for the treatment of atypical hemolytic uremic...
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Effectiveness and safety of secukinumab updosing in patients with moderate to severe plaque psoriasis: data from the PURE registry
Secukinumab is a fully human IgG1 antibody that selectively binds to and neutralizes the proinflammatory cytokine interleukin-17A. Secukinumab is an...
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Controversies regarding lithium-associated weight gain: case–control study of real-world drug safety data
BackgroundThe impact of long-term lithium treatment on weight gain has been a controversial topic with conflicting evidence. We aim to assess...
