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