Documents, Presentations, & Publications

Sentinel is committed to publishing findings in journals and sharing information at relevant conferences. The following table provides summary information about Sentinel activities that have appeared in peer-reviewed journals or in conference materials.

Search Documents, Presentations, & Publications

	Title	Date Posted
	Core Concepts in Pharmacoepidemiology: Multi-Database Distributed Data Networks Publication	07/06/2025
	Prenatal and Congenital Syphilis in the US: Characterizing Screening and Treatment Presentation	07/03/2025
	Safety Signal Identification in the Sentinel System: Consistent Findings for Medical Products Over Various Study Designs Presentation	06/11/2025
	Cannabis-Related Healthcare Encounters Among U.S. Commercially Insured Adults Publication	06/11/2025
	The Importance of Information Extraction from Unstructured Clinical Data in Pharmacoepidemiology Presentation	05/20/2025
	Assessing Treatment Effects in Observational Data with Missing Confounders: A Comparative Study of Practical Doubly-robust and Traditional Missing-data Methods Presentation	05/15/2025
	Characteristics and Medication Use Patterns of Pregnancies With COVID-19 Ending in Live-Birth in the Sentinel System Publication	03/26/2025
	A Cautionary Note for Plasmode Simulation Studies in the Setting of Causal Inference Presentation	03/25/2025
	A Practical Overview of Real-Life Challenges Leveraging EHR Data for the FDA Sentinel System Presentation	02/14/2025
	Interplay of Adverse Events, Spontaneous Reporting, and Longitudinal Electronic Health Records for Signal Management Presentation	01/27/2025
	High-Dimensional Multiple Imputation (HDMI) for Partially Observed Confounders Including Natural Language Processing-Derived Auxiliary Covariates Publication	01/22/2025
	Enhancing Causes of Death Prediction from Electronic Health Records through Multi-Modal Integration of Structured and Unstructured EHR Data Presentation	11/13/2024
	Data-Driven Automated Classification Algorithms for Acute Health Conditions: Applying PheNorm to Anaphylaxis Presentation	11/12/2024
	Letter to the Editor: Considerations Regarding Association of Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy Publication	10/31/2024
	Lyme Disease Prophylaxis by Single-Dose Doxycycline in the United States, 2010–2020 Publication	10/29/2024
	Applications of Real-World Data (RWD) in FDA’s Sentinel System Presentation	10/24/2024
	Assessing the Harmonization of Structured Electronic Health Record Data to Reference Terminologies and Data Completeness Through Data Provenance Publication	10/21/2024
	Analyzing Missingness Patterns in Real-World Data Using the SMDI Toolkit: Application to a Linked EHR-Claims Pharmacoepidemiology Study Publication	10/19/2024
	Dexamethasone Dose for COVID-19 in a Large U.S. Hospital Network From April 2020 to May 2023 Publication	10/17/2024
	Pediatric Utilization of New Molecular Entities (NMEs): A Summary of Early Post-marketing Uptake in the Sentinel Distributed Database Presentation	10/16/2024
	Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk Publication	10/13/2024
	The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE) Publication	10/10/2024
	Scalable Incident Detection Via Natural Language Processing and Probabilistic Language Models Publication	10/08/2024
	Safety Signal Identification for Risankizumab-rzaa in the Sentinel Distributed Database Using Self-Controlled and Active Comparator Study Designs Presentation	10/01/2024
	Exposure to Valsartan Products Containing Nitrosamine Impurities in the United States, Canada, and Denmark Publication	09/18/2024
	Tree-Based Mining of Real-World Data for Potential Safety Signals Associated with the Use of Dupilumab in the United States (2017-2023) Presentation	08/28/2024
	Characterization of COVID-19 Vaccine Data in the Sentinel System Presentation	08/28/2024
	Characterizing Pediatric Members in the Sentinel Distributed Database: An Update with Data from Medicaid Presentation	08/28/2024
	Comparative Bleeding Risks Among NOAC Users for Nonvalvular Atrial Fibrillation Aged Under 65 years in the Sentinel System Presentation	08/28/2024
	Assessing Exposure to Recently Approved Medications to Inform Feasibility for Signal Identification Analyses in the FDA’s Sentinel System Presentation	08/28/2024
	Characterizing Infants in the Sentinel Distributed Database Mother-Infant Linkage Table Presentation	08/28/2024
	Characterizing Inpatient Electronic Health Records (EHR) from a Large Hospital Network for Use in Neonatal Pharmacoepidemiology Studies in the United States Presentation	08/28/2024
	Beta-Blocker-Associated Hypoglycemia in Pediatric Patients: Findings from the FDA Adverse Event Reporting System, National Poison Data System, Medical Literature, and Sentinel Distributed Database Presentation	08/28/2024
	Prenatal Syphilis in the US: Characterizing Screening and Treatment During Pregnancy in Publicly and Commercially Insured Individuals Presentation	08/27/2024
	Assessment of Non-Cardiac Congenital Malformations and in Utero Exposure to Modafinil/Armodafinil in the Sentinel Distributed Database Presentation	08/27/2024
	Patterns of Prescribing and Dispensing Medicines Among Non-Hospitalized Pregnant Women with COVID-19: a Prospective Meta-Analysis Pooling Findings from Healthcare Databases in Europe and North America Presentation	08/27/2024
	Prevalence of Selected Health Conditions among Individuals with Childbearing Potential to Inform the Development of the Pregnancy Safety Study Framework Presentation	08/27/2024
	Predicting Causes of Death from Structured Electronic Health Records Using Machine Learning Presentation	08/27/2024
	High-Dimensional Multiple Imputation (hdMI) Strategies for Partially Observed Confounders with Structured and Natural Language Processing-Derived Auxiliary Covariates Presentation	08/27/2024
	Methodological Advances in Regulatory Real World Evidence Generation Systems: Perspectives from Sentinel and DARWIN-EU Presentation	08/27/2024
	Comparing the Risk of Adverse Infant Outcomes Among Pregnancies with and without COVID-19 in the Sentinel System Presentation	08/27/2024
	Pediatric Utilization of New Molecular Entities (NMEs): A Summary of Early Post-Marketing Uptake in the Sentinel Distributed Database Presentation	08/27/2024
	Analysis of Medicinal Product Utilization Data in the FDA Sentinel System to Inform the Development of a Pregnancy Safety Study Framework Presentation	08/27/2024
	Risk of Incident Inflammatory Bowel Disease in New Users of Dipeptidyl Peptidase 4 Inhibitors and Sodium-Dependent Glucose Co-Transporter 2 Inhibitors in the FDA Sentinel System Presentation	08/27/2024
	Natural Language Processing in Pharmacoepidemiology: Lessons from the Multi-Source Observational Safety study for Advanced Information Classification Using NLP (MOSAIC-NLP) Presentation	08/26/2024
	Advancing Drug Safety Signal Management through Multimodal Approaches in Networking Presentation	08/26/2024
	Comparative Postmarketing Safety Assessment of Baloxavir Marboxil vs Oseltamivir Using TreeScan Presentation	08/26/2024
	Untangling National Medicaid Data: 30 Data Quality Metrics to Support Maternal Health Studies in Two Common Data Models Presentation	08/26/2024
	Analysis of New Molecular Entity Utilization Patterns using the Sentinel Distributed Database Presentation	08/26/2024
	COVID-19 Related Changes in Healthcare Utilization Among Insured Persons in the U.S. and its Impact on Pharmacoepidemiologic Research Presentation	08/26/2024
	Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk Presentation	08/26/2024
	Identifying Pediatric Hypertension in Observational Data: Comparing Clinical and Claims Cohorts in Real World Data Publication	07/24/2024
	Research in Action Podcast: Transforming Public Health with Unstructured Data and NLP in FDA's Sentinel Initiative Presentation	07/23/2024
	A Future of Data-Rich Pharmacoepidemiology Studies - Transitioning to Large-Scale Linked EHR+Claims Data Publication	07/16/2024
	A Distributed Regression Analysis Application Package Using SAS Publication	07/09/2024
	A Simple Cox Approach to Estimating Risk Ratios Without Sharing Individual-Level Data in Multi-Site Studies Publication	07/05/2024
	Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy Publication	06/28/2024
	Triple Challenges – Small Sample Size in Both Exposure and Control Groups to Scan Rare Maternal Outcomes in a Signal Identification Approach: A Simulation Study Publication	06/24/2024
	Innovative Methods for Evaluating Medical Product Safety and Effectiveness Using Real World Data: The U.S. Food and Drug Administration’s Sentinel Innovation Center Presentation	06/14/2024
	The U.S. Food and Drug Administration’s Sentinel System: A Post-Market Active Drug Safety Surveillance System Presentation	06/14/2024
	A Description of the Active Risk Identification and Analysis System of the U.S. Food and Drug Administration Presentation	06/14/2024
	Transparency, Reproducibility, and Replicability of Pharmacoepidemiology Studies in a Distributed Network Environment Publication	05/23/2024
	A Principled Approach to Characterize and Analyze Partially Observed Confounder Data from Electronic Health Records Publication	05/21/2024
	Finding Uncoded Anaphylaxis in Electronic Health Records to Estimate the Sensitivity of ICD10 Codes Publication	05/16/2024
	A General Framework for Developing Computable Clinical Phenotype Algorithms Publication	05/15/2024
	Validity of Inpatient Electronic Health Record-Based Measures of Oxygen-Related Therapy in the United States: Lessons Applicable for Studying COVID-19 Endpoints Publication	04/02/2024
	Targeted Learning with an Undersmoothed Lasso Propensity Score Model for Large-Scale Covariate Adjustment in Healthcare Database Studies Publication	03/21/2024
	Process Guide for Inferential Studies Using Healthcare Data from Routine Clinical Practice to Evaluate Causal Effects of Drugs (PRINCIPLED): Considerations from the FDA Sentinel Innovation Center Publication	02/12/2024
	Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States Publication	02/10/2024
	smdi: An R Package to Perform Structural Missing Data Investigations on Partially Observed Confounders in Real-world Evidence Studies Publication	01/31/2024
	Data-Driven Automated Classification Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19 Disease Publication	12/18/2023
	Assessing the Risk of Intentional Self-Harm in Montelukast Users: An Updated Sentinel System Analysis Using ICD-10 Coding Publication	12/08/2023
	Drug Safety Surveillance with EHR Data: A Promise Not Yet Fulfilled Presentation	11/13/2023
	Assessing the Risk of Intentional Self-Harm in Montelukast Users: An Observational Study in the Sentinel System Using ICD-10 Coding Presentation	10/28/2023
	SMDI: An R Package to Perform Routine Structural Missing Data Investigations in Real-World Data Presentation	10/26/2023
	Unexpected Issues in Pharmacoepidemiology Studies Applying Natural Language Processing to Clinical Notes Presentation	10/17/2023
	The FDA Sentinel System Presentation	09/19/2023
	Preliminary Analysis of Drug Utilization Data to Inform the Development of the Pregnancy Safety Study Framework Presentation	09/18/2023
	Innovation Center (IC) Master Plan Document	09/01/2023
	Using Real-World Data to Evaluate Comparative Effectiveness Cohorts of Azithromycin Relative to Roflumilast in Individuals with Uncontrolled Chronic Obstructive Pulmonary Disease Presentation	08/27/2023
	Percutaneous Transluminal Septal Myocardial Ablation and Common Procedural Complications Before and After the Approval of Ablysinol Presentation	08/27/2023
	Exploring the Use of Electronic Health Records (EHR) Data for Active Safety Surveillance of Epidiolex in PCORnet, July 1, 2018 - July 1, 2022 Presentation	08/27/2023
	Expanding Capabilities for Unapproved Cannabis-Derived Product Surveillance in the United States, TriNetX, July 1, 2018 – June 30, 2022 Presentation	08/27/2023
	Triple Challenges – Small Sample Sizes in Both Exposure and Control Groups When Scanning Rare Maternal Outcomes in Signal Identification: A Simulation Study Presentation	08/27/2023
	Principled Approaches to Handle Partially Observed Confounder Data from Electronic Health Records: A Plasmode Simulation Study Presentation	08/27/2023
	Investigating Potential Differences in the Safety Profiles of Biosimilars Relative to Originator Products Using a Tree-Based Scan Statistic Presentation	08/27/2023
	Hospitalized Arterial and Venous Thrombotic Events in Patients Diagnosed in the Ambulatory Setting with COVID-19 Compared to Influenza Presentation	08/27/2023
	NLP Detection of Mortality Information from Publicly Available Data Using Deep Learning Modeling Presentation	08/26/2023
	Diversifying the FDA’s Sentinel System with Rigorous Quality Inclusion Rules for the U.S. Medicaid Population Presentation	08/26/2023
	Variation in Mother-Infant Linkage Rates by Jurisdiction in U.S. Medicaid Data Presentation	08/26/2023
	Racial and Ethnic Differences in Treatment of Hospitalized and Critical COVID-19, January 2021 - April 2022 Presentation	08/25/2023
	High Dose Dexamethasone for COVID-19 Not Common in a Large US Hospital Network Presentation	08/25/2023
	Association Between Race and COVID-19 Outcomes in the United States (2020-2021) Presentation	08/25/2023
	Utilization of Beta-blockers Among the Pediatric Population in the United States: A Study in the FDA’s Sentinel System from 2008 to 2022 Presentation	08/25/2023
	Characterizing Medication Use Patterns Among Pregnant and Non-Pregnant Patients with COVID-19 in the Sentinel System Presentation	08/25/2023
	Introducing CoLab: The Evolution of US-Canada International Collaboration on Drug Safety and Effectiveness Presentation	08/25/2023
	Improving Data Capture of Race and Ethnicity for the Food and Drug Administration Sentinel Database: A Narrative Review Publication	07/20/2023
	External Validity in Distributed Data Networks Publication	07/18/2023
	Treatment and Care Received by Children Hospitalized with COVID-19 in a Large Hospital Network in the United States, February 2020 to September 2021 Publication	07/11/2023
	Six Years of FDA's Postmarket Active Risk Identification and Analysis System (ARIA) in the Sentinel Initiative: Implications for Real World Evidence Generation Publication	06/30/2023
	Signal Detection and Refinement Activities within FDA’s Sentinel System Presentation	06/28/2023
	Switching Patterns of Immediate-Release Forms of Generic Mixed Amphetamine Salts Products Among Privately and Publicly Insured Individuals Aged 15-64 Years in the United States, 2013-2019 Publication	06/22/2023
	Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review Publication	06/20/2023
	Pragmatic Guidance for Embedding Pragmatic Clinical Trials in Health Plans: Large Simple Trials Aren’t So Simple Publication	06/15/2023
	An R Package to Perform Routine Structural Missing Data Investigations in Real-World Data Presentation	06/06/2023
	Risk of Admission to Hospital with Arterial or Venous Thromboembolism Among Patients Diagnosed in the Ambulatory Setting with COVID-19 Compared with Influenza: Retrospective Cohort Study Publication	06/06/2023
	An Assessment of the Sentinel System: Focus on the Active Risk Identification and Analysis (ARIA) System Document	05/25/2023
	Characterizing Missing Data Processes in EHR Data Presentation	05/10/2023
	Valsartan, Losartan and Irbesartan Use in the USA, UK, Canada and Denmark After the Nitrosamine Recalls: A Descriptive Cohort Study Publication	04/17/2023
	Identifying Pediatric Hypertension in Real World Data: Comparing Two Computable Phenotypes Presentation	03/27/2023
	Active Surveillance of Medical Product Use in the FDA’s Sentinel System: A Focus on Pediatric Populations Presentation	03/24/2023
	Improving Data Capture of Race and Ethnicity Presentation	02/23/2023
	Comparative Risk of Angioedema with Sacubitril-Valsartan Versus Renin-Angiotensin-Aldosterone Inhibitors Publication	01/31/2023
	Transforming Medicaid Data into the Sentinel Common Data Model Presentation	01/17/2023
	Using the Food and Drug Administration's Sentinel System for Surveillance of TB Infection Publication	12/01/2022
	Scalable Phenotyping for Safety Outcomes Using Electronic Health Record Data Presentation	11/17/2022
	Assessing Medical Product Safety During Pregnancy using Parameterizable Tools in the Sentinel Distributed Database Publication	11/09/2022
	Data-Driven Automated Classification Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19 Disease Presentation	11/07/2022
	Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning Publication	11/04/2022
	A New Analytic Tool for Assessing the Impact of the US Food and Drug Administration Regulatory Actions Publication	11/04/2022
	Spironolactone Utilization among Patients with Reduced and Preserved Ejection Fraction Heart Failure Publication	10/20/2022
	Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients Presentation	10/20/2022
	Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs Publication	10/18/2022
	COVID-19 Real-World Evidence Primer Publication	09/23/2022
	How Big Data Support Post Marketing Surveillance in USA: The Sentinel Initiative Presentation	09/22/2022
	Should Insulin Billing Procedure Codes be Considered for Exposure Ascertainment in Pharmacoepidemiology Studies? Publication	09/21/2022
	Describing Prenatal Exposures and Evaluating Maternal and Infant Outcomes in Sentinel Presentation	09/13/2022
	The US Food and Drug Administration Sentinel System: A National Resource for a Learning Health System Publication	09/12/2022
	Characterizing Pediatric Members in the Sentinel Distributed Database Presentation	08/28/2022
	Characterizing Infants in the Sentinel Distributed Database Mother-Infant Linkage Table Presentation	08/28/2022
	Identification of Obesity and Tobacco Use in Claims Compared to Electronic Health Record (EHR) Data Presentation	08/28/2022
	Data-Driven Approaches to Improve Phenotype Sensitivity Using EHR Data Presentation	08/28/2022
	Use of Valganciclovir/Ganciclovir [(v)GCV] for Treatment of Congenital Cytomegalovirus (cCMV) Infection in the United States: Evidence from the Sentinel Distributed Database, 2008-2020 Presentation	08/28/2022
	Racial Differences in U.S. COVID-19 Positivity, Hospitalization, and Mortality Presentation	08/28/2022
	Systemic Corticosteroids for COVID-19 in U.S. Outpatient Settings Presentation	08/28/2022
	What Do Real World Data Validation Best Practices Look Like? Operationalizing Guidance for Real-World Studies Intended for Decision-Making Presentation	08/28/2022
	Switching Patterns of Mixed Amphetamine Salt Products in the FDA’s Sentinel Distributed Database Presentation	08/27/2022
	Comparative Evaluation of Automated Approaches for Confounder Selection in High-Dimensional Data with Rare Outcomes Presentation	08/27/2022
	Arterial and Venous Thrombotic Events in Patients with COVID-19 Compared to Influenza Presentation	08/27/2022
	Design Considerations for Using the Tree-based Scan Statistic in Surveillance of Maternal Outcomes Following Medication Use during Gestation Presentation	08/26/2022
	Impact of Nitrosamine Contamination Recalls on Angiotensin-Receptor-Blocker (ARB) Utilization in the U.S., U.K., Canada, and Denmark Presentation	08/26/2022
	Leuprolide and Fracture Risk in Patients with Central Precocious Puberty Presentation	08/26/2022
	Inverse Probability Treatment Weighting Versus Propensity Score Matching in the Sentinel System: A Test Case Presentation	08/26/2022
	Characterizing Medication Use Among Pregnancies with COVID-19 in the Sentinel System Presentation	08/26/2022
	Data Harmonization, Standardization, and Quality Assessment in Distributed Health Data Networks: Lessons from Around the World Presentation	08/26/2022
	Methods and Considerations for Hypothesis-Free Signal Detection Studies Accommodating Various Types of Medications, Populations and Regions Presentation	08/26/2022
	Validation of Acute Pancreatitis Among Adults in an Integrated Healthcare System Publication	08/22/2022
	Association of COVID-19 vs Influenza with Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients Publication	08/16/2022
	Using TreeScan as a Signal Identification Approach to Screen for Adverse Maternal Outcomes of Medication Use in Pregnancy Presentation	08/09/2022
	A Cohort Study to Assess Risk of Cutaneous Small Vessel Vasculitis Among Users of Different Oral Anticoagulants Publication	07/31/2022
	Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System Publication	07/24/2022
	New-Onset Cancer Cases in FDA’s Sentinel System: A Large Distributed System of US Electronic Healthcare Data Publication	07/15/2022
	Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics Presentation	06/28/2022
	Scalable Algorithm Development: An Alternative to Algorithm Reuse? Presentation	05/17/2022
	Use of Real-World Data for Surveillance of Medications in Pregnancy Presentation	05/09/2022
	Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021 Publication	04/08/2022
	A Landscape Analysis of Valganciclovir Treatment for Congenital Cytomegalovirus Infection in the United States (US), 2008-2021 Presentation	03/28/2022
	Utility of Fertility Procedures and Prenatal Tests to Estimate Gestational Age for Live-births and Stillbirths in Electronic Health Plan Databases Publication	02/05/2022
	Evaluating Confounding Control in Estimations of Influenza Antiviral Effectiveness in Electronic Health Plan Data Publication	02/02/2022
	Real-World Data: Data Networks, Standardization, and Federated Analysis Presentation	01/18/2022
	Broadening the Reach of the FDA Sentinel System: A Roadmap for Integrating Electronic Health Record Data in a Causal Analysis Framework Publication	12/20/2021
	Validation of Diagnosis Codes to Identify Hospitalized COVID-19 Patients in Health Care Claims Data Publication	12/16/2021
	Self‑Controlled Assessment of Thromboembolic Event (TEE) Risk Following Intravenous Immune Globulin (IGIV) in the U.S. (2006–2012) Publication	11/24/2021
	Emerging Technologies and Their Impact on Regulatory Science Publication	11/16/2021
	Reliable Insights Regarding Medication Outcomes From Real World Data – Key Principles of an Evidence Generation Framework Presentation	11/01/2021
	Using Inpatient Electronic Medical Records to Study Influenza for Pandemic Preparedness Publication	10/25/2021
	Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network Publication	10/14/2021
	Natural History of Coagulopathy in COVID-19 Presentation	10/06/2021
	Risk of Hospitalized Depression and Intentional Self-Harm with Brand and Authorized Generic Sertraline Publication	10/05/2021
	Utilization of Post-Exposure Prophylaxis to Prevent Lyme Disease in a Large US Healthcare Database Presentation	09/29/2021
	Monitoring Medication Use During the COVID-19 Pandemic in the Sentinel System: The Case of Anticoagulation for Thrombosis Presentation	09/15/2021
	Incidence of Severe Uterine Bleeding Outcomes among Oral Anticoagulant Users and Nonusers Publication	09/01/2021
	Characteristics and Outcomes of Pregnancies in Women with Heart Failure: A Retrospective Cohort Study in the Sentinel Distributed Database Presentation	08/25/2021
	Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning Presentation	08/25/2021
	Strategies for the Use of Real-World Data to Conduct COVID-19-Related Pharmacoepidemiology Presentation	08/25/2021
	A New Analytic Tool for Interrupted Times Series Analysis to Assess the Impact of FDA Regulatory Actions Presentation	08/24/2021
	No Differential Risk of Cutaneous Small Vessel Vasculitis with Oral Anticoagulant Use Among Patients with Atrial Fibrillation Presentation	08/24/2021
	New Frontiers in Computable Phenotyping for Medical Product Safety Evaluation Presentation	08/24/2021
	Early Uptake of New Molecular Entities Approved in 2017 in a Multisite National US Healthcare Data Network Presentation	08/23/2021
	Outpatient-Identified COVID-19 and Subsequent Hospitalized Thrombotic Events Presentation	08/23/2021
	Comparing Outcomes in Trial-Eligible vs Real-World COVID-19 Patients: The Case of Invasive Mechanical Ventilation Presentation	08/23/2021
	Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network: The Sentinel Distributed Database Mother-Infant Linkage Table Presentation	08/23/2021
	Pregnancy in Women with Heart Failure: A Cross-Sectional Study in the Sentinel Distributed Database Presentation	08/23/2021
	How Under-Coded is Pediatric Hypertension?: Comparison of Claims and Electronic Health Record (EHR) Data Presentation	08/23/2021
	Post-Keratoplasty Fungal Keratitis in the Sentinel Distributed Database: Prevalence and Time Trends Presentation	08/23/2021
	Statistical Power for Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use Presentation	08/23/2021
	Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: A Propensity Score Matched Case Study Presentation	08/23/2021
	Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research Presentation	08/23/2021
	Who Gets Treated for Influenza: A Surveillance Study From the US Food and Drug Administration’s Sentinel System Publication	08/05/2021
	The Sentinel Experience Presentation	07/10/2021
	Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research Publication	07/03/2021
	Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data Presentation	06/29/2021
	Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System Publication	06/04/2021
	Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin Publication	05/20/2021
	Utilization of Hydroxyprogesterone Caproate among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database Publication	04/29/2021
	Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM Publication	04/26/2021
	Validity of ICD‐10‐CM Diagnoses to Identify Hospitalizations for Serious Infections Among Patients Treated With Biologic Therapies Publication	04/22/2021
	A COVID‐19‐Ready Public Health Surveillance System: The Food and Drug Administration's Sentinel System Publication	04/18/2021
	Electronic Phenotyping of Health Outcomes of Interest Using a Linked Claims-Electronic Health Record Database: Findings from a Machine Learning Pilot Project Publication	03/12/2021
	A General Propensity Score for Signal Identification using Tree-Based Scan Statistics Publication	02/22/2021
	Risk of Non-Melanoma Skin Cancer in Association with Use of Hydrochlorothiazide-Containing Products in the United States Publication	02/04/2021
	Identification and Validation of Anaphylaxis Using Electronic Health Data in a Population-Based Setting Publication	02/02/2021
	Medical Chart Validation of Inpatient Diagnosis Codes for Transfusion‐Related Acute Lung Injury 2013‐2015 Publication	01/27/2021
	Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM Presentation	12/15/2020
	Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data Presentation	12/15/2020
	The FDA MyStudies App: A Reusable Platform for Distributed Clinical Trials and Real-World Evidence Studies Publication	12/11/2020
	Validation of Claims-based Algorithms to Identify Hospitalized COVID-19 Events within the FDA Sentinel System Presentation	12/02/2020
	Incidence of Uterine Bleeding following Oral Anticoagulant Use in Food and Drug Administration’s Sentinel System Publication	11/26/2020
	Antipsychotic Medication Use Among Hospitalized Infants Using Inpatient Data in FDA’s Sentinel System Presentation	11/17/2020
	Functional Clustering Methods for Longitudinal Data with Application to Electronic Health Records Publication	11/11/2020
	Natural History of Coagulopathy in Patients with COVID-19 in a Real-World Electronic Health Data Network Presentation	11/05/2020
	Natural History of Coagulopathy in COVID-19 Presentation	10/26/2020
	Leveraging the Capabilities of the FDA’s Sentinel System To Improve Kidney Care Publication	10/19/2020
	Studying the Natural History of COVID-19: Risk of Arterial and Venous Thrombotic Events in the Sentinel System Presentation	10/14/2020
	Leveraging the Sentinel System for COVID-19 Presentation	10/14/2020
	Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis Publication	10/08/2020
	Phosphodiesterase Type 5 Inhibitor Use Among Pregnant and Reproductive‐Age Women in the United States Publication	10/05/2020
	Risk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin Publication	09/28/2020
	Utilization of Spironolactone in Patients with Reduced or Preserved Ejection Fraction Heart Failure Presentation	09/23/2020
	Utilization of Sacubitril/Valsartan in Real-World Settings Presentation	09/23/2020
	Risk of Neuropsychiatric Adverse Events among Montelukast Users Presentation	09/23/2020
	Comparative Risk Assessment of Severe Abnormal Uterine Bleeding associated with Non-Vitamin K Oral Anticoagulants Presentation	09/22/2020
	Replicating the Findings of a Medicare Study on Stroke, and Bleeding Risk in Patients Using NOACs for Atrial Fibrillation in the Sentinel System Presentation	09/22/2020
	Use of Hydroxyprogesterone Caproate and Progesterone During the 2nd and/or 3rd Trimester Among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database Presentation	09/22/2020
	Utilization Characteristics for Inhaled Corticosteroid‐based Asthma Medications in the Sentinel System, 2008‐2019 Presentation	09/22/2020
	Factors Related to Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) and Dipeptidyl Peptidase 4 Inhibitor (DPP4i) Dispensing among Naive, Incident, and Prevalent New Users Presentation	09/21/2020
	Assessing the Feasibility of Evaluating Tacrolimus Use after Solid Organ Transplantation in the Sentinel Distributed Database Presentation	09/21/2020
	Risk of Non-Melanoma Skin Cancer Associated with Hydrochlorothiazide-Containing Products in the United States Presentation	09/21/2020
	Incidence of Severe Abnormal Uterine Bleeding Following Oral Anticoagulant Use Presentation	09/21/2020
	Utilization of IV Iron among Pregnant Women with Live Births or Stillbirths; A Study in the Sentinel Distributed Database Presentation	09/20/2020
	Antipsychotic Medication Use among Hospitalized Infants Using Inpatient Data in FDA’s Sentinel System Presentation	09/20/2020
	Risk of Stroke and Bleeding in Nonvalvular Atrial Fibrillation Treated with Apixaban Compared to Warfarin in the Sentinel System Presentation	09/20/2020
	Incidence of Cutaneous Small Vessel Vasculitis associated with Oral Anticoagulant Use Presentation	09/20/2020
	Utilization of Sacubitril/Valsartan in Real-World Settings Publication	08/24/2020
	Risk of Psychiatric Adverse Events among Montelukast Users Publication	08/11/2020
	Consequences of Depletion of Susceptibles for Hazard Ratio Estimators Based on Propensity Scores Publication	08/06/2020
	Underuse of Oral anticoagulants in privately insured patients with atrial fibrillation: A population targeted by IMplementation of a randomized controlled trial to ImProve treatment with Oral AntiCoagulanTs in atrial fibrillation patients (IMPACT-AFib) Publication	07/24/2020
	Practical Challenges in the Conduct of Pragmatic Trials Embedded in Health Plans: Lessons of IMPACT-AFib, an FDA-Catalyst Trial Publication	06/26/2020
	Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer Presentation	06/11/2020
	Concomitant Filled Prescriptions of Oxymorphone or Oxycodone with CYP3A Inhibitors and Inducers Publication	05/26/2020
	Conducting Prospective Sequential Surveillance in Real‐World Dynamic Distributed Databases Publication	05/25/2020
	Assessing Natural History, Drug Use and Treatment Impact for COVID-19 in the Sentinel System Presentation	05/13/2020
	Using and Improving Distributed Data Networks to Generate Actionable Evidence: the Case of Real-World Outcomes in the Food and Drug Administration’s Sentinel System Publication	04/11/2020
	Distributed Regression Analysis Application in Large Distributed Data Networks: Analysis of Precision and Operational Performance Publication	04/06/2020
	Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer Presentation	03/05/2020
	Sentinel Mother-Infant Linkage and Pregnancy Analyses Presentation	02/19/2020
	Translating Claims‐Based CHA2DS2‐VaSc and HAS‐BLED to ICD‐10‐CM: Impacts of Mapping Strategies Publication	02/17/2020
	The Risk of Febrile Seizures following Influenza and 13-Valent Pneumococcal Conjugate Vaccines Publication	01/31/2020
	Understanding Utilization Patterns of Biologics and Biosimilars in the United States to Support Postmarketing Studies of Safety and Effectiveness Publication	12/11/2019
	Medical Product Safety Surveillance: Data Quality in the Sentinel Initiative Presentation	12/02/2019
	Use of Antidiabetic Drugs During Pregnancy among U.S. Women with Livebirth Deliveries in the Mini-Sentinel System Publication	11/27/2019
	Redesigning PopMedNet for Distributed Regression Analysis with Vertically Partitioned Data Presentation	11/19/2019
	Quantifying How Small Variations in Design Elements Affect Risk in an Incident Cohort Study in Claims Publication	11/17/2019
	Myopathy and Rhabdomyolysis with Concomitant Use of Ticagrelor and High-Intensity Statins in the Elderly Presentation	11/14/2019
	Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy Publication	10/22/2019
	Reproducing Protocol‐based Studies Using Parameterizable Tools – Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks Publication	10/19/2019
	Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis Publication	10/10/2019
	Use of Time-Dependent Propensity Scores to Adjust Hazard Ratio Estimates in Cohort Studies with Differential Depletion of Susceptibles Publication	09/26/2019
	Identification of Potential Drug Name Confusion Errors in the Sentinel System Publication	09/04/2019
	Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis Presentation	08/27/2019
	Biosimilar Use in the United States: A Sentinel Analysis of Filgrastim and Infliximab Presentation	08/27/2019
	Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy Presentation	08/27/2019
	Characteristics and Treatment Status of Those with Influenza-Like Illness: Implications for Effectiveness Studies and Surveillance Presentation	08/27/2019
	Utilization of Prescription Anti-Obesity Drugs in the U.S. Food and Drug Administration's (FDA) Sentinel System, 2008-2017 Presentation	08/27/2019
	Identification of Ordinal Endpoints Indicating Influenza Complications: A Feasibility Analysis Relevant to the Study of Medical Countermeasures Presentation	08/27/2019
	Utility of Prenatal Tests and Fertility Coding to Estimate Pregnancy Start in the Sentinel Distributed Database Presentation	08/26/2019
	Duration of Follow-up of Chronic Condition Cohorts in the Sentinel System Presentation	08/26/2019
	13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Kawasaki Disease Presentation	08/26/2019
	Confounding Variable Capture in Large Healthcare Administrative Claims Database: A Trend Analysis in the Sentinel System Presentation	08/26/2019
	Exposure to N-nitrosodimethylamine (NDMA)/N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States Presentation	08/25/2019
	Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings Presentation	08/25/2019
	A General Propensity Score for Signal Detection using Tree-Based Scan Statistics Presentation	08/25/2019
	Thinking Globally While Acting Locally: Developing Time-on-Treatment Data In International Settings Presentation	08/25/2019
	Experience from US FDA Sentinel Initiative Studies Presentation	08/25/2019
	Phosphodiesterase Type 5 (PDE-5) Inhibitor Use Among Pregnant Women and Women of Reproductive Age in the United States Presentation	08/25/2019
	Epidemiology of Pediatric Respiratory Syncytial Virus-Associated Illnesses in Young Children Presentation	08/25/2019
	Characteristics of NOAC Users Aged Less Than 65 Years in the Sentinel System Presentation	08/25/2019
	Evidence of Residual Confounding in Healthcare Database Studies of Oseltamivir and Influenza Complications Presentation	08/25/2019
	Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis Presentation	08/25/2019
	First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies Publication	08/20/2019
	Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations Publication	08/20/2019
	Development of an Algorithm to Detect Methotrexate Wrong Frequency Error Using Computerized Health Care Data Publication	08/13/2019
	Kawasaki Disease and 13-Valent Pneumococcal Conjugate Vaccination Among Young Children: A Self-Controlled Risk Interval and Cohort Study with Null Results Publication	07/02/2019
	Signal Identification Methods in the Sentinel System Presentation	06/12/2019
	Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program Publication	06/08/2019
	Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population Publication	06/04/2019
	Medical Product Safety: Ten Years of the U.S. Sentinel System Presentation	05/23/2019
	Evaluation of Use of Technologies to Facilitate Medical Chart Review Publication	05/20/2019
	Leveraging the Entire Cohort in Drug Safety Monitoring: Part 1 Methods for Sequential Surveillance that Use Regression Adjustment or Weighting to Control Confounding in a Multi-Site, Rare Event, Distributed Data Setting Publication	05/17/2019
	Applying Sequential Surveillance Methods That Use Regression Adjustment or Weighting to Control Confounding in a Multi-Site, Rare Event, Distributed Setting: Part 2 In-Depth Example of a Re-Analysis of the MMRV Combination Vaccine and Seizure Risk Publication	05/02/2019
	Evaluating the Use of Bootstrapping in Cohort Studies Conducted with 1:1 Propensity Score Matching — A Plasmode Simulation Study Publication	04/24/2019
	The Devil's in the Details: Reports on Reproducibility in Pharmacoepidemiologic Studies Publication	03/06/2019
	Evidence from Real-World Data Sentinel Initiative of U.S. FDA Presentation	02/20/2019
	Cross‐Network Directory Service: Infrastructure to Enable Collaborations Across Distributed Research Networks Publication	02/14/2019
	A New Analytic Tool Developed in the Sentinel System to Assess Safe Use Recommendations Publication	02/12/2019
	Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure Publication	02/08/2019
	Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users Publication	01/19/2019
	How Pharmacoepidemiology Networks Can Manage Distributed Analyses to Improve Replicability and Transparency and Minimize Bias Publication	01/15/2019
	Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel Presentation	11/30/2018
	Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10 Presentation	11/30/2018
	Drug Safety in Pregnancy in a Large, Multisite Database: Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System Presentation	11/30/2018
	Hydroxyurea Utilization Patterns Among Sickle Cell Disease Patients in the United States, US FDA Sentinel Database Presentation	11/29/2018
	The FDA Sentinel Initiative — An Evolving National Resource Publication	11/29/2018
	Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App Presentation	11/29/2018
	Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review Publication	11/23/2018
	FDA-Catalyst - Using FDA's Sentinel Initiative for Large-Scale Pragmatic Randomized Trials: Approach and Lessons Learned During the Planning Phase of the First Trial Publication	11/19/2018
	Use of Tumor Necrosis Factor-alpha Inhibitors During Pregnancy Among Women Who Delivered Liveborn Infants Publication	11/14/2018
	Overall and Cause-Specific Mortality in the Sentinel System: A Power Analysis Publication	11/13/2018
	A Generalizable Smartphone-Based Clinical Research Platform Presentation	11/05/2018
	Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance Presentation	11/04/2018
	Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System Publication	10/31/2018
	Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative Presentation	10/19/2018
	Misclassification in Assessment of First Trimester In-Utero Exposure to Drugs used Proximally to Conception - The Example of Letrozole Utilization for Infertility Treatment Publication	10/15/2018
	Association of Risk for Venous Thromboembolism With Use of Low-Dose Extended- and Continuous-Cycle Combined Oral Contraceptives: A Safety Study Using the Sentinel Distributed Database Publication	10/01/2018
	International Comparison of Approaches to Common Data Models for Comparative Effectiveness Research Presentation	09/12/2018
	Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System Publication	08/28/2018
	Validation of Transfusion Administrations Among Potential Transfusion-Related Acute Lung Injury (TRALI) Patients Included in the Sentinel Distributed Database Presentation	08/25/2018
	Assessment of Transfusion-Related Acute Lung Injury (TRALI) after Blood Transfusion Presentation	08/24/2018
	Misclassification of Time-at-Risk Due to Free Drug Sample Use: A Simulation Study Presentation	08/22/2018
	Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic Presentation	08/22/2018
	First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies Presentation	08/22/2018
	Using Time-Dependent Propensity Scores to Correct for Differential Depletion of Susceptibles when Estimating Hazard Ratios in Time-to-Event Data Presentation	08/22/2018
	Assessing the Impact of the New U.S. ICD-10-CM Coding System on Pharmacoepidemiologic Studies: An Application Between Angiotensin-Converting Enzyme Inhibitors and Angioedema Presentation	08/21/2018
	Early Lessons on ICD-10-CM/PCS Transition in Claims-Based Drug Safety Assessments Presentation	08/21/2018
	Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs Presentation	08/21/2018
	A Comparison of Drug Utilization Metrics for Two Drug Classes with Nationally Projected Sales and Patient-level Data from the Sentinel Database Presentation	08/21/2018
	Minor Differences, Major Consequences? Lessons Learned from Replication of a Claims-Based Drug Safety Assessment Presentation	08/21/2018
	Use of Multiple Sclerosis Drugs Among Live Birth Pregnancies in the United States Presentation	08/21/2018
	Signal Detection using TreeScan with Drug Classes: Pilot Projects in Sentinel Presentation	08/21/2018
	Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes Of Interest – An Empirical Evaluation Presentation	08/20/2018
	Long Live the "Medical Data Janitors": International Data Quality Assurance Practices in Distributed Data Network Presentation	08/20/2018
	Advances in the Study of Medication Errors in Computerized Healthcare Databases and Spontaneous Reporting Systems in Europe and North America Presentation	08/20/2018
	Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA's Sentinel System Presentation	08/20/2018
	Developing the Infrastructure to Assess Pregnancy Outcomes Following Vaccination: Influenza Vaccines and Spontaneous Abortion as a Use Case Presentation	08/20/2018
	Diagnostic Algorithms for Identification of Cardiovascular Death in Administrative Claims Databases: A Systematic Review Presentation	08/20/2018
	Computational Algorithms for Distributed Regression Analysis Based on SAS Software Presentation	08/20/2018
	A New Analytic Tool Developed in the Sentinel System to Assess Adherence To FDA’s Safe Use Recommendations Presentation	08/20/2018
	Estimating “Optimal” Durations for Initial Opioid Analgesic Prescription Following Common Surgical Procedures Presentation	08/20/2018
	Data-Mining for Adverse Events Using the Self-Controlled Tree-Temporal Scan Statistic Presentation	08/20/2018
	Validation of the Combined Comorbidity Score in the ICD-10 Era: Application to High-Risk Populations Presentation	08/20/2018
	Performance of a Distributed Regression Analysis Software and Workflow Presentation	08/20/2018
	Sequential and SequentialDesign: Tools For Prospective Sequential Medical Product Safety Surveillance Presentation	08/20/2018
	Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs Publication	08/17/2018
	Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study Publication	08/10/2018
	Data Enclaves for Sharing Information Derived From Clinical and Administrative Data Publication	08/06/2018
	Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic Publication	08/01/2018
	Outpatient Influenza Antivirals in a Distributed Data Network for Influenza Surveillance Publication	07/27/2018
	Assessing the Impact of the New ICD‐10‐CM Coding System on Pharmacoepidemiologic Studies — An Application to the Known Association Between Angiotensin‐Converting Enzyme Inhibitors and Angioedema Publication	06/26/2018
	Early Impact of the ICD‐10‐CM Transition on Selected Health Outcomes in 13 Electronic Health Care Databases in the United States Publication	06/26/2018
	Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes of Interest- An Empirical Evaluation Publication	06/26/2018
	Diagnosis‐Based Cohort Augmentation using Laboratory Results Data: The Case of Chronic Kidney Disease Publication	06/22/2018
	A Query Workflow Design to Perform Automatable Distributed Regression Analysis in Large Distributed Data Networks Publication	05/25/2018
	Small Changes, Big Differences? Cohort Variation by Parameter Specifications in Claims-Based Drug Use Evaluations Presentation	05/21/2018
	Relative Performance of Propensity Score Matching Strategies for Subgroup Analyses Publication	03/15/2018
	Evaluation of the US Food and Drug Administration Sentinel Analysis Tools in Confirming Previously Observed Drug-Outcome Associations: The Case of Clindamycin and Clostridium difficile Infection Publication	03/13/2018
	Utilization of Drugs with Pregnancy Exposure Registries During Pregnancy Publication	03/08/2018
	Sequential Surveillance for Drug Safety in a Regulatory Environment Publication	03/05/2018
	Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System Publication	02/23/2018
	Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Venous Thromboembolism among Intravenous Immune Globulin Users in the Sentinel Distributed Database Publication	02/23/2018
	Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Acute Myocardial Infarction (AMI) Among Intravenous Immune Globulin (IGIV) Users in the Sentinel Distributed Database Publication	02/15/2018
	Butterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal Inference Presentation	01/12/2018
	Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System Publication	01/10/2018
	Methods for Examining Data Quality in Healthcare Integrated Data Repositories Presentation	01/03/2018
	Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database Publication	12/01/2017
	Opioid Tolerance and Urine Drug Testing among Initiates of Extended-Release or Long-Acting Opioids in Food and Drug Administration's Sentinel System Publication	11/20/2017
	Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study Publication	11/14/2017
	Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System Publication	11/06/2017
	Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study Publication	11/01/2017
	Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network Publication	10/06/2017
	A Review of the Performance of Different Methods for Propensity Score Matched Subgroup Analyses and a Summary of their Application in Peer-Reviewed Research Studies Publication	10/06/2017
	Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia (Video Abstract) Presentation	10/06/2017
	The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011 Publication	09/14/2017
	Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies Publication	08/29/2017
	Promises and Challenges of Screening for Adverse Events in Sentinel Presentation	08/27/2017
	Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System Presentation	08/25/2017
	Dispensings of Influenza Antiviral Medications in the Sentinel System as a Source of Data for Influenza Surveillance Presentation	08/25/2017
	Curating Inpatient Medication Use Data from a Hospital Network Electronic Medication Administration Record (eMAR) System: Lessons from the Sentinel System About Expanding Drug Safety Surveillance Potential Presentation	08/25/2017
	Distributed Regression Analysis in a Distributed Health Data Network Presentation	08/25/2017
	Listening to Patient Voices in Pharmacoepidemiological Research - Opportunities for Innovation and Inclusion Presentation	08/25/2017
	Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System Presentation	08/25/2017
	Developing a Mother-Infant Cohort in Sentinel's PRISM Program as a Resource to Monitor the Safety of Vaccine Use During Pregnancy Presentation	08/25/2017
	Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year Presentation	08/25/2017
	Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database Presentation	08/25/2017
	Protocol-Based Assessment of Thromboembolic Events (TEEs) after Intravenous Immune Globulin (IVIg) in the Sentinel Distributed Database (2006-2012) Presentation	08/25/2017
	Expansion of the US FDA's Sentinel System to Inpatient Blood Transfusion Data from Hospital Corporation of America: New Surveillance Options Presentation	08/25/2017
	Evaluation of Case-Finding Algorithm for Venous Thromboembolism Outcome Presentation	08/25/2017
	Opportunities for Rapid Monitoring of New Cancer Treatments: Tyrosine Kinase Inhibitors in the Sentinel Distributed Database Presentation	08/25/2017
	Using the Self-Controlled Risk Interval (SCRI) Method to Study Vaccine Safety Presentation	08/25/2017
	Assessment of Transfusion-Related Acute Lung Injury After Red Blood Cell, Plasma and Platelet Administration: Initial Results in the Sentinel System Presentation	08/25/2017
	Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth Presentation	08/25/2017
	Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System Presentation	08/25/2017
	Impact of ICD-10-CM Transition on Selected Cardiovascular-Related Events in the Sentinel System Presentation	08/25/2017
	TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance Presentation	08/25/2017
	A Review of Methods for Propensity Score Matched Subgroup Analysis and Their Application in Peer Reviewed Research Studies Presentation	08/25/2017
	Identification of Name Confusion Medication Errors in the US FDA's Sentinel System Presentation	08/25/2017
	Early Post-Approval Surveillance of New Molecular Entity Uptake in the Sentinel Distributed Database Presentation	08/25/2017
	Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database Presentation	08/25/2017
	Evaluation of Test Data in Distributed Research Networks: A Sentinel System Example Presentation	08/25/2017
	Randomized Clinical Trial Using FDA's Sentinel Infrastructure: An Analysis Assessing Feasibility Presentation	08/24/2017
	Medical Product and Performance Evaluation Programs Using Distributed Data Sources Presentation	08/24/2017
	Developing a Mobile App for Studies of Medication Safety Presentation	08/24/2017
	Type 1 and Type 2 Diabetes Mellitus Identification Using ICD-9-CM Codes Within a Cohort of New Users of Drugs Labeled for Type 2 Diabetes Mellitus Presentation	08/23/2017
	Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners Publication	08/10/2017
	Sentinel Modular Program for Propensity-Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia Publication	07/04/2017
	Statistical Power for Postlicensure Medical Product Safety Data-Mining Publication	06/12/2017
	Antiemetic Use Among Pregnant Women in the United States: The Escalating Use of Ondansetron Publication	02/20/2017
	Missing Laboratory Results Data in Electronic Health Databases: Implications for Monitoring Diabetes Risk Publication	01/06/2017
	Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making Publication	12/01/2016
	Distributed Data Networks: A Blueprint for Big Data Sharing and Healthcare Analytics Publication	11/18/2016
	The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies Publication	11/14/2016
	A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data Publication	09/06/2016
	Pilot Test of the Sentinel Modular Program for Propensity Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Severe Hypoglycemia Presentation	08/24/2016
	Do Hemoglobin Lab Test Results Increase Detection of Upper Gastrointestinal Bleeding (UGIB)? Presentation	08/23/2016
	Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA's Sentinel Program Presentation	08/23/2016
	A Framework for Rapid Medical Product Safety Assessment: FDA's Sentinel Toolkit Presentation	08/23/2016
	ICD-10-CM: Is Sentinel Ready? Presentation	08/23/2016
	Assessment of the US Food and Drug Administration’s Sentinel Analysis Tools: Angiotensin-Converting Enzyme Inhibitors and Angioedema Presentation	08/23/2016
	Ondasetron Use Among Pregnancies Identified in the Sentinel Distributed Database Presentation	08/23/2016
	Utilization Patterns for Products with Pregnancy Exposure Registries in Pregnant Versus Non-Pregnant Women in the Sentinel Database Presentation	08/23/2016
	Diagnosis-Based Cohort Augmentation Using Laboratory (Lab) Data in the FDA Sentinel Initiative: The Case of Chronic Kidney Disease (CKD) Presentation	08/23/2016
	Monitoring All Drugs for a Specific Outcome in the Sentinel System Presentation	08/23/2016
	Assessing Quadrivalent HPV Vaccine Safety using the Self-Controlled Tree-Temporal Scan Statistic Presentation	08/23/2016
	A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems Presentation	08/23/2016
	Utilization of Laboratory Results Data to Enhance Pregnancy Cohort Identification in a Distributed Data Network Presentation	08/23/2016
	Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association Publication	08/22/2016
	Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association Publication	07/14/2016
	Quantitative Bias Analysis in Regulatory Settings Publication	06/10/2016
	Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study Publication	06/07/2016
	Evidence Generation from Healthcare Databases: Recommendations for Managing Change Publication	05/17/2016
	Use of Selective Serotonin Reuptake Inhibitors (SSRIs) in Women Delivering Liveborn Infants and other Women of Child-Bearing Age within the U.S. Food and Drug Administration's Mini-Sentinel Program Publication	05/13/2016
	Uptake of New Drugs in the Early Post-Approval Period in the Mini-Sentinel Distributed Database Publication	05/04/2016
	Methods for using Clinical Laboratory Test Results as Baseline Confounders in Multi-Site Observational Database Studies when Missing Data are Expected Publication	05/04/2016
	Prospective Influenza Vaccine Safety Surveillance Using Fresh Data in the Sentinel System Publication	04/30/2016
	Intravenous Immune Globulin and Thromboembolic Adverse Events: A Systematic Review and Meta-Analysis of RCTs Publication	04/24/2016
	Changing Patterns of Asthma Medication use Related to U.S. Food and Drug Administration Long-Acting Beta2-agonist Regulation from 2005-2011 Publication	03/01/2016
	Evaluation of Propensity Scores, Disease Risk Scores, and Regression in Confounder Adjustment for the Safety of Emerging Treatment with Group Sequential Monitoring Publication	02/15/2016
	Data Extraction and Management in Networks of Observational Health Care Databases for Scientific Research: A Comparison of EU-ADR, OMOP, Mini-Sentinel and MATRICE Strategies Publication	02/08/2016
	The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance Publication	01/12/2016
	Evaluation of the Risk of Venous Thromboembolism after Quadrivalent Human Papillomavirus Vaccination among U.S. Females Publication	01/02/2016
	Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011 Publication	01/02/2016
	Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance Publication	01/01/2016
	Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program Publication	12/08/2015
	Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine Publication	09/14/2015
	Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin Publication	07/14/2015
	Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Publication	05/22/2015
	A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program Publication	03/13/2015
	Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study Publication	12/22/2014
	Adherence to Guidelines for Glucose Assessment in Starting Second-Generation Antipsychotics Publication	10/06/2014
	Characteristics of Study Design and Elements that may Contribute to the Success of Electronic Safety Monitoring Systems Publication	09/28/2014
	Four Health Data Networks Illustrate The Potential For A Shared National Multipurpose Big-Data Network Publication	07/01/2014
	Electronic Clinical Laboratory Test Results Data Tables: Lessons from Mini-Sentinel Publication	02/18/2014
	Intussusception Risk after Rotavirus Vaccination in U.S. Infants Publication	02/06/2014
	Framework for Assessment of Positive Results from Signal Refinement Publication	01/01/2014
	Postlicensure Rapid Immunization Safety Monitoring Program (PRISM) Data Characterization Publication	12/30/2013
	PRISM Supplement to Vaccine - Active Surveillance of Vaccine Safety in the US Food and Drug Administration’s Mini-Sentinel Program: Identification of Exposures and Outcomes Publication	12/30/2013
	Methods for Systematic Reviews of Administrative Database Studies Capturing Health Outcomes of Interest Publication	12/30/2013
	A Systematic Review of Validated Methods for Identifying Bell's Palsy using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods to Capture Acute Bronchospasm using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods to Capture Several Rare Conditions using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods for Identifying Kawasaki Disease using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods to Capture Myopericarditis using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods for Identifying Patients with Rheumatoid Arthritis using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods for Identifying Systemic Lupus Erythematosus (SLE) using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods to Capture Stillbirth and Spontaneous Abortion using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods for Identifying Transverse Myelitis using Administrative or Claims Data Publication	12/30/2013
	A Systematic Review of Validated Methods for Identifying Uveitis using Administrative or Claims Data Publication	12/30/2013
	Validation of Anaphylaxis in the Food and Drug Administration's Mini-Sentinel Publication	09/05/2013
	Self-Control Tree Scan Data Mining for Vaccine Adverse Events Presentation	08/27/2013
	Re-Using Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals via Modular Analytic Programs Publication	08/07/2013
	Multivariable Confounding Adjustment in Distributed Data Networks without Sharing of Patient-Level Data Publication	07/22/2013
	A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions Publication	07/12/2013
	Validity of Diagnostic Codes to Identify Cases of Severe Acute Liver Injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database Publication	06/25/2013
	Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program Publication	05/13/2013
	Investments in Infrastructure for Diverse Research Resources and the Health of the Public Publication	05/08/2013
	Is Size the Next Big Thing in Epidemiology? Publication	05/01/2013
	Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding Publication	04/04/2013
	Comparative Risk for Angioedema Associated with the Use of Drugs that Target the Renin-Angiotensin-Aldosterone System Publication	11/12/2012
	Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance Publication	11/01/2012
	Validation of Acute Myocardial Infarction in the Food and Drug Administration's Mini-Sentinel Program Publication	06/29/2012
	Health Outcomes of Interest for Evaluation in the Postlicensure Rapid Immunization Safety Monitoring Program Publication	04/16/2012
	Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative Data: Summary of Findings and Suggestions for Future Research Publication	02/05/2012
	PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program Publication	01/31/2012
	A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack using Administrative Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Pulmonary Fibrosis and Interstitial Lung Disease using Administrative and Claims Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Heart Failure using Administrative Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Acute Respiratory Failure using Administrative and Claims Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Atrial Fibrillation using Administrative Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Orthopedic Implant Removal and Revision using Administrative Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Ventricular Arrhythmias using Administrative and Claims Data Publication	01/19/2012
	Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel Publication	01/19/2012
	The U.S. Food and Drug Administration's Mini-Sentinel Program: Status and Direction Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Venous Thromboembolism using Administrative and Claims Data Publication	01/19/2012
	A Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical Agent Publication	01/19/2012
	The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product Safety Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Depression using Administrative Data Publication	01/19/2012
	The Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise Publication	01/19/2012
	The Organizational Structure and Governing Principles of the Food and Drug Administration's Mini-Sentinel Pilot Program Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Suicide or Suicidal Ideation using Administrative or Claims Data Publication	01/19/2012
	A Policy Framework for Public Health uses of Electronic Health Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Seizures, Convulsions, or Epilepsy using Administrative and Claims Data Publication	01/19/2012
	Design Considerations, Architecture, and Use of the Mini-Sentinel Distributed Data System Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Pancreatitis using Administrative Data Publication	01/19/2012
	Design Considerations in an Active Medical Product Safety Monitoring System Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Lymphoma using Administrative Data Publication	01/19/2012
	Using High-Dimensional Propensity Scores to Automate Confounding Control in a Distributed Medical Product Safety Surveillance System Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims Data Publication	01/19/2012
	When Should Case-Only Designs be used for Safety Monitoring of Medical Products? Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Infection Related to Blood Products, Tissue Grafts, or Organ Transplants using Administrative Data Publication	01/19/2012
	Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Transfusion-Related ABO Incompatibility Reactions using Administrative and Claims Data Publication	01/19/2012
	Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Erythema Multiforme Major/Minor/Not otherwise specified, Stevens–Johnson Syndrome, or Toxic Epidermal Necrolysis using Administrative and Claims Data Publication	01/19/2012
	Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons Learned Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Anaphylaxis, Including Anaphylactic Shock and Angioneurotic Edema, using Administrative and Claims Data Publication	01/19/2012
	A Systematic Review of Validated Methods for Identifying Hypersensitivity Reactions other than Anaphylaxis (Fever, Rash, and Lymphadenopathy), using Administrative and Claims Data Publication	01/19/2012
	Effects of Adjusting for Instrumental Variables on Bias and Precision of Effect Estimates Publication	06/08/2011
	Developing the Sentinel System — A National Resource for Evidence Development Publication	02/10/2011