Drug Safety

Article	Citations
Authors’ Reply to Braillon and Martin’s Comment on “Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessme	93
Comment on: Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration A	85
Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”	66
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use	64
Supervised Machine Learning-Based Decision Support for Signal Validation Classification	59
Leveraging FDA Labeling Documents and Large Language Model to Enhance Annotation, Profiling, and Classification of Drug Adverse Events with AskFDALabel	58
Antiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa	58
Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception	57
Bridging the Evidence Gap: Sotrovimab Use in Pregnancy and the Need for Comprehensive Drug Safety Data	54
Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exp	48
The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey	45
Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Tria	45
Proceedings of the Canadian Medication Appropriateness and Deprescribing Network’s 2023 National Meeting	40
Comment on: “Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: A Swedish Population-Based Cohort Study”	40
Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury	38
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups	38
Safety of Eslicarbazepine Acetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience	35
Maternal Complications and Prescription Opioid Exposure During Pregnancy: Using Marginal Structural Models	35
An Update on the International Society of Pharmacovigilance China Chapter	32
The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan	28
Artificial Intelligence and Machine Learning for Safe Medicines	28
Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional Survey	28
Montelukast and Nightmares: Further Characterisation Using Data from VigiBase	27
A Review of Causal Inference for External Comparator Arm Studies	27
What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study	26

Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case–Control Study with a Focus on Medicines Used in Primary Care	26
Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project	24
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance	23
Role of Drug–Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity	22
Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin	22
Impact of Preventive Strategies on Gastrointestinal Complications in Elderly Patients on Concomitant Use of Oral Anticoagulants and Nonsteroidal Anti-Inflammatory Drugs: A Nationwide Cohort Study	21
Safety Profile of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Populations: An Overview of Six Trials	20
Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities	20
Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events: A Retrospective Case Series	19
Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review	19
The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology	19
Authors’ Reply to Mungmunpuntipantip et al.’s Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”	19
Analytical Approaches to Reduce Selection Bias in As-Treated Analyses with Missing In-Hospital Drug Information	19
Authors’ Reply to Noguchi’s comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting	18
Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study	18
Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion	17
Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)	17
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems	17
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System	17
Levothyroxine Treatment Among Pregnant Women and Risk of Seizure in Children: A Population-Based Cohort Study	17
Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”	16
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry	16
Correction to: The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)	16
Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making	16
Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach	15
Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling	15
Authors’ Reply to Cappello et al. Comment on: “Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting Syste	15
Impact of Policy Interventions on Oxycodone Prescribing in Queensland, Australia: An Uncontrolled Interrupted Time Series Study	15
Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients	15
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre	15
Comment on: “The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications”	14
Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective	14
Off-the-Shelf Large Language Models for Causality Assessment of Individual Case Safety Reports: A Proof-of-Concept with COVID-19 Vaccines	14
Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance	14
Future of ChatGPT in Pharmacovigilance	14
Drug-Induced Cognitive Impairment	14
The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System	14
Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis	14
Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study	13
Authors' response to Tran et al.'s comment on “The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore P	13
Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study	13
NSAIDs and COVID-19: A Systematic Review and Meta-analysis	12
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study	12
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy	12
Acknowledgement to Referees	12
Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season	12
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration	12
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative	12
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR	12
Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data	12

Machine Learning in Causal Inference: Application in Pharmacovigilance	12
Gastrointestinal Bleeding on Oral Anticoagulation: What is Currently Known	12
Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy	12
Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports	12
Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)	12
Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase®	12
Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data	11
Authors’ Response to Yoshihiro Noguchi’s Comment on: “A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)”	11
Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports	11
Using Iterative Pairwise External Validation to Contextualize Prediction Model Performance: A Use Case Predicting 1-Year Heart Failure Risk in Patients with Diabetes Across Five Data Sources	11
Erice Manifesto 2022: On the Surveillance of Potential Harms Caused by Food Supplements in Europe	11
Hybrid Method Incorporating a Rule-Based Approach and Deep Learning for Prescription Error Prediction	11
The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions	11
Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media	11
Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands	11
Cancer Chemotherapy-Induced Sinus Bradycardia: A Narrative Review of a Forgotten Adverse Effect of Cardiotoxicity	11
Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach	11
Comment on: "Should Antidepressants be Avoided in Pregnancy?"	11
Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard	10
Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis	10
High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases	10
A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review	10
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance	10
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data	10
Conundrum of Clinical QTc Monitoring	10
Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities	10
Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand	10
Desloratadine Exposure and Incidence of Seizure: A Nordic Post-authorization Safety Study Using a New-User Cohort Study Design, 2001–2015	10
Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis	10
Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases	10
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study	10
A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge	9
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study	9
Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease	9
Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends	9
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database	9
Fatal Intoxications with Zopiclone—A Cause for Concern?	9
Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation	9
Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination	9
Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics	8
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally	8
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure	8
Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database	8
Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media	8
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS	8
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations	8
Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers	8
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies	8
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers	8
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review	8
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study	8
Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”	8
Emerging Skin Toxicities in Patients with Breast Cancer Treated with New Cyclin-Dependent Kinase 4/6 Inhibitors: A Systematic Review	7
Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study	7
A 13-Year National Monitoring Study to Assess Narcotic Prescriptions and Indications (2007–2019)	7
Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study	7
Incidence, Pathogenesis, and Management of Proton Pump Inhibitor-Induced Nephrotoxicity	7
“Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?	7
Mechanisms, Management and Prevention of Pemetrexed-Related Toxicity	7
Artificial Intelligence in Pharmacovigilance: An Introduction to Terms, Concepts, Applications, and Limitations	7
Augmenting Product Defect Surveillance Through Web Crawling and Machine Learning in Singapore	7
Patient Safety Incidents Related to the Use of Parenteral Nutrition in All Patient Groups: A Systematic Scoping Review	7
The Effectiveness and Value of Written Medicine Information Across Asia and Africa: Systematic Review	7
Identifying and Mitigating Potential Biases in Predicting Drug Approvals	7
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions	7
Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity	7
Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data	7
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study	6
Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials	6
Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey	6
Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature	6
Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study	6
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review	6
22nd ISoP Annual Meeting “Putting Patients First in Pharmacovigilance: International Perspectives from Global South” 6–9 November 2023 Bali, Indonesia	6
Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data	6
Authors’ Reply to Michael Auerbach’s Comment on: “Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using	6
Signaling COVID-19 Vaccine Adverse Events	6
The Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients	6
Renin–Angiotensin–Aldosterone System Inhibitors and Risk of Acute Pancreatitis: A Population-Based Cohort Study	6
New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence	6

Acknowledgement to Referees	6
An Update of the North American Chapter of the International Society of Pharmacovigilance (NASoP)	6
Prevalence and Preventability of Adverse Medicine Events in a Sample of Australian Aged-Care Residents: A Secondary Analysis of Data from the ReMInDAR Trial	6
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update	6
Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database	6
Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles	5
Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy	5
Correction to: Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature	5
Risk Minimization of Antibody–Drug Conjugates in Oncology: A Review	5
The International Society of Pharmacovigilance (ISoP) Pharmacogenomic Special Interest Group: Pharmacogenomics in Pharmacovigilance	5
Safety and Efficacy of Ivermectin and Doxycycline Monotherapy and in Combination in the Treatment of COVID-19: A Scoping Review	5
Comment on: "Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholde	5
The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan	5
Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions	5
Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System	5
Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France	5
Pharmacovigilance in the Community: A Special-Interest Group of the International Society of Pharmacovigilance	5
A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes	5
Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis	5
In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life	4
Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations	4
Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines	4
Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy	4
Drug–Drug Interactions and the Risk of Emergency Hospitalizations: A Nationwide Population-Based Study	4
Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study	4
Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s Promoted by the Special Interest Group of the International Society of Pharmacovigilance	4
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea	4
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy	4
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22	4
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury	4
Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting	4
A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)	4
Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting	4
Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database	4
Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility	4
Comment on "Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"	4
Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values	4
Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies	4
Authors’ Reply to Braillon et al. ’s Comment on “Should Antidepressants be Avoided in Pregnancy?”	4
Network Analysis for Signal Detection in Spontaneous Adverse Event Reporting Database: Application of Network Weighting Normalization to Characterize Cardiovascular Drug Safety	4
Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose	4
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls	4
Cardiovascular Toxicities Associated with Anaplastic Lymphoma Kinase Inhibitors: A Disproportionality Analysis of the WHO Pharmacovigilance Database (VigiBase)	4
Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study	4
Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis	4
Impact of Lifestyle and Socioeconomic Position on the Association Between Non-steroidal Anti-inflammatory Drug Use and Major Adverse Cardiovascular Events: A Case-Crossover Study	4
Drug Induced Liver Injury: Highlights and Controversies in the 2023 Literature	3
Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis	3
Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review	3
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients	3
Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment	3
Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy	3
23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics” 1–5 October 2024 Montreal, Canada	3
Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK	3
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study	3
Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission	3
Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries	3
A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs	3
Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study	3
Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review	3
Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance	3
Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians	3
Risk of Fracture Associated with Pregabalin or Mirogabalin Use: A Case-Case-Time-Control Study Based on Japanese Health Insurance Claims Data	3
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement	3
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ	3
Drug-Related Problems in Hospitalised Patients with Chronic Kidney Disease: A Systematic Review	3
Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study	3
Should Antidepressants be Avoided in Pregnancy?	3
Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase	3
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database	3
Population-Based Observational Study of Adverse Drug Event-Related Mortality in the Super-Aged Society of Japan	3
Black Swan Events and Intelligent Automation for Routine Safety Surveillance	3
An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine	3
COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Mar	3
Assessment of the Frequency, Phenotypes, and Outcomes of Acute Liver Injury Associated with Amoxicillin/Clavulanate in 1.4 Million Patients in the Veterans Health Administration	3
Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders	3
Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel	3
Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data	3
Might We Come Together on a Paradigm Shift to Manage ICSRs with a Decentralized Data Model?	3
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update	3
Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making	3
Pharmacogenetic Testing in the Outpatient Setting in Switzerland: A Descriptive Study Using Swiss Claims Data	3
Adopting STOPP/START Criteria Version 3 in Clinical Practice: A Q&A Guide for Healthcare Professionals	3
Stakeholders’ Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey	3
Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries	3
Comparison of Longitudinal and Cross-Sectional Approaches in Studies About Knowledge, Attitude, and Practices Related to Antibiotic Misuse	3
Identifying Actionability as a Key Factor for the Adoption of ‘Intelligent’ Systems for Drug Safety: Lessons Learned from a User-Centred Design Approach	3
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance	3