Publications and Presentations

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 conference materials.

Title Authors Date Postedsort ascending
Identification of Potential Drug Name Confusion Errors in the Sentinel System

Noelle M. Cocoros, Kevin Haynes, Qoua Her, Austin Cosgrove, Elizabeth Dee, Nancy D. Lin, Chi‐Ming Tu, Yulan Ding, Michael Nguyen, Sengwee Toh

2019 ICPE Poster: Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy

James Phillip Trinidad, Talia Menzin, Elizabeth Dee, Monique Falconer, Mayura Shinde

2019 ICPE Poster: Characteristics and Treatment Status of Those with Influenza-Like Illness: Implications for Effectiveness Studies and Surveillance

Crystal J. Garcia, Nicole R. Haug, Catherine A. Panozzo, Austin C. Cosgrove, Henry Francis, Alfred F. Sorbello, Orbert P. Orr, Gregory T. Measer, Sarah K. Dutcher, Noelle M. Cocoros

2019 ICPE Poster: Utilization of Prescription Anti-Obesity Drugs in the U.S. Food and Drug Administration's (FDA) Sentinel System, 2008-2017

Sara Azimi-Bolourian, Emily C. Welch, Candace C. Fuller, Rajani Rajbhandari, Christian Hampp, Michael D. Nguyen

2019 ICPE Poster: Identification of Ordinal Endpoints Indicating Influenza Complications: A Feasibility Analysis Relevant to the Study of Medical Countermeasures

Austin Cosgrove, Nicole Haug, Catherine Panozzo, Gregory Measer, Robert Orr, Alfred Sorbello, Henry Francis, Crystal Garcia, Sarah Dutcher, Noelle Cocoros

2019 ICPE Poster: Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis

Mohamed Mohamoud, Casie Horgan, Veronica Sansing-Foster, Elizabeth Dee, Justin Bohn, Oren Shapira, Efe Eworuke, Monica Munoz, Danijela Stojanovic, Lois La Grenade

2019 ICPE Poster: Biosimilar Use in the United States: A Sentinel Analysis of Filgrastim and Infliximab

Sarah K. Dutcher, Efe Eworuke, Elnara Fazio-Eynullayeva, Elizabeth Dee, Michael D. Nguyen, Catherine A. Panozzo

2019 ICPE Presentation: Utility of Prenatal Tests and Fertility Coding to Estimate Pregnancy Start in the Sentinel Distributed Database

Lockwood G. Taylor, Steven T. Bird, Danijela Stojanovic, Darren Toh, Elnara Fazio-Eynullayeva, Andrew Petrone, Rajani Rajbhandari, Jennifer G. Lyons

2019 ICPE Poster: Confounding Variable Capture in Large Healthcare Administrative Claims Database: A Trend Analysis in the Sentinel System

Wei Liu, Austin Cosgrove, Sarah Dutcher, Justin Bohn

2019 ICPE Presentation: 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Kawasaki Disease

Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, Katherine Yih

2019 ICPE Poster: Duration of Follow-up of Chronic Condition Cohorts in the Sentinel System

Emily C. Welch, Ting-Ying Huang, Mayura Shinde, Michael D. Nugyen, Sarah K. Dutcher

2019 ICPE Poster: Exposure to N-nitrosodimethylamine (NDMA)/N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States

Efe Eworuke, Emily C. Welch, Veronica Sansing-Foster, Marie Bradley, Judith C. Maro

2019 ICPE Presentation: Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings

Marie Bradley

2019 ICPE Presentation: Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis

Christian Hampp

2019 ICPE Presentation: A General Propensity Score for Signal Detection using Tree-Based Scan Statistics

Shirley V. Wang, Joshua J. Gagne, Judith C. Maro, Sushama Kattinakere, Danijela Stojanovic, Efe Eworuke, Elande Baro, Rita Ouellet-Hellstrom, Michael Nguyen, Elisabetta Patorno, Sandra DeLuccia, Ella Pestine, Yong Ma, Martin Kulldorff

2019 ICPE Symposium: Thinking Globally While Acting Locally: Developing Time-on-Treatment Data In International Settings

Judith C. Maro, Kristian B. Fillion, Achim Wolf, Kevin Haynes, Michael D. Nguyen

2019 ICPE Poster: Phosphodiesterase Type 5 (PDE-5) Inhibitor Use Among Pregnant Women and Women of Reproductive Age in the United States

Wei Liu, Talia Menzin, Corinne M. Woods, Nicole Haug, Jie Li, Justin A. Mathew, Christine P. Nguyen, Grace P. Chai, David Moeny, Mayura Shinde

2019 ICPE Symposium: Experience from US FDA Sentinel Initiative Studies

Darren Toh

2019 ICPE Poster: Epidemiology of Pediatric Respiratory Syncytial Virus-Associated Illnesses in Young Children

Amol Purandare, Prabha Viswanathan, Nicole Haug, Noelle Cocoros, Rongmei Zhang, Marscha Reichman, Michael Nguyen, Ann McMahon

2019 ICPE Poster: Characteristics of NOAC Users Aged Less Than 65 Years in the Sentinel System

Marie C. Bradley, Emily C. Welch, Efe Eworuke, Rongmei Zhang, Elande Baro, David J. Graham, Mayura Shinde

2019 ICPE Poster: Evidence of Residual Confounding in Healthcare Database Studies of Oseltamivir and Influenza Complications

Phyo T. Htoo, Gregory Measer, Robert Orr, Justin Bohn, Alfred Sorbello, Henry Francis, Sarah Dutcher, Sengwee Darren Toh, Noelle M. Cocoros

First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies

Steven T. Bird, Kate Gelperin, Leyla Sahin, Karen B. Bleich, Elnara Fazio-Eynullayeva, Corinne Woods, Erica Radden, Patty Greene, Carolyn McCloskey, Tamara Johnson, Mayura Shinde, Ira Krefting

Development of an Algorithm to Detect Methotrexate Wrong Frequency Error Using Computerized Health Care Data

Lisa J. Herrinton, Tiffany S. Woodworth, Efe Eworuke, Laura B. Amsden, Liyan Liu, Jo Wyeth, Andrew Petrone, Talia J. Menzin, James Williams, Robert Goldfien, Michael Nguyen

Kawasaki Disease and 13-Valent Pneumococcal Conjugate Vaccination Among Young Children: A Self-Controlled Risk Interval and Cohort Study with Null Results

Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, W. Katherine Yih

Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program

Alison Tse Kawai, David Martin, Sarah E. Henrickson, Ashleigh Goff, Megan Reidy, Diana Santiago, Nandini Selvam, Mano Selvan, Cheryl McMahill-Walraven, Grace M. Lee

Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population

Lockwood G. Taylor, Genna Panucci, Andrew D. Mosholder, Sengwee Toh, Ting-Ying Huang

Medical Product Safety: Ten Years of the U.S. Sentinel System

Sarah Dutcher, Judith C. Maro, David Martin

Evaluation of Use of Technologies to Facilitate Medical Chart Review

Loreen Straub, Joshua J. Gagne, Judith C. Maro, Michael D. Nguyen, Nicolas Beaulieu, Jeffrey S. Brown, Adee Kennedy, Margaret Johnson, Adam Wright, Li Zhou, Shirley V. Wang

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

Jennifer C. Nelson, Ernesto Ulloa-Pe’rez, Jennifer F. Bobb, Judith C. Maro

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

Andrea J. Cook, Robert D. Wellman, Tracey Marsh, Azadeh Shoaibi, Ram C. Tiwari, Michael Nguyen, Denise Boudreau, Eric S. Weintraub, Lisa Jackson, Jennifer C. Nelson

Evaluating the Use of Bootstrapping in Cohort Studies Conducted with 1:1 Propensity Score Matching — A Plasmode Simulation Study

Rishi J. Desai, Richard Wyss, Younathan Abdia, Sengwee Toh, Margaret Johnson, Hana Lee, Sara Karami, Jacqueline M. Major, Michael Nguyen, Shirley V. Wang, Jessica M. Franklin, Joshua J. Gagne

The Devil's in the Details: Reports on Reproducibility in Pharmacoepidemiologic Studies

Andrew B. Petrone, April DuCott, Joshua J. Gagne, Sengwee Toh, Judith C. Maro

Evidence from Real-World Data Sentinel Initiative of U.S. FDA

Darren Toh

Cross‐Network Directory Service: Infrastructure to Enable Collaborations Across Distributed Research Networks

Jessica M. Malenfant, Jenny Hochstadt, Bridget Nolan, Kimberly Barrett, Dean Corriveau, Daniel Dee, Marcelline Harris, Chayim Herzig‐Marx, Vinit P. Nair, Zachary Wyner, Jeffrey S. Brown

A New Analytic Tool Developed in the Sentinel System to Assess Safe Use Recommendations

Noelle M. Cocoros, Anita Wagner, Kevin Haynes, Andrew B. Petrone, Elnara Fazio‐Eynullayeva, Yulan Ding, Rima Izem, Joo‐Yeon Lee, Jacqueline M. Major, Michael Nguyen, Jing Ju

Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure

Efe Eworuke, Emily C. Welch, Anne Tobenkin, Judith C. Maro

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

Ryan M. Carnahan, Joshua J. Gagne, Christian Hampp, Charles E. Leonard, Sengwee Toh, Candace C. Fuller, Sean Hennessy, Laura Hou, Noelle M. Cocoros, Genna Panucci, Tiffany Woodworth, Austin Cosgrove, Aarthi Iyer, Elizabeth A. Chrischilles

How Pharmacoepidemiology Networks Can Manage Distributed Analyses to Improve Replicability and Transparency and Minimize Bias

Robert W. Platt, Richard Platt, Jeffrey S. Brown, David A. Henry, Olaf H. Klungel, Samy Suissa

FDA Voices: The Future of FDA's Electronic Safety Surveillance

Scott Gottlieb and Gerald Dal Pan

Sentinel System Five-Year Strategy: 2019-2023

U.S. Food and Drug Administration

Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel

Danijela Stojanovic

Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10

Elizabeth Suarez

Drug Safety in Pregnancy in a Large, Multisite Database: Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System

Susan Andrade

Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App

David Martin

The FDA Sentinel Initiative — An Evolving National Resource

Richard Platt, Jeffrey S. Brown, Melissa Robb, Mark McClellan, Robert Ball, Michael D. Nguyen, Rachel E. Sherman

Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review

Hassan Fouayzi, Kathryn Anzuoni, Leah Goldman, Jea Young Min, Marie Griffin, Carlos G. Grijalva, James A. Morrow, Christine C. Whitmore, Charles E. Leonard, Mano Selvan, Vinit Nair, Yunping Zhou, Sengwee Toh, Andrew Petrone, James Williams, Elnara Fazio-Eynullayeva, Richard Swain, D. Tyler Coyle, Susan Andrade

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

Sean D. Pokorney, Kevin Haynes, Crystal Garcia, Hussein R. Al-Khalidi, Sana M. Al-Khatib, Patrick Archdeacon, Jennifer C. Goldsack, Thomas Harkins, Nancy D. Lin, David Martin, Debbe McCall, Vinit Nair, Lauren Parlett, Robert Temple, Cheryl McMahill-Walraven, Christopher B. Granger, Richard Platt

Use of Tumor Necrosis Factor-alpha Inhibitors During Pregnancy Among Women Who Delivered Liveborn Infants

Efe Eworuke, Genna Panucci, Margie Goulding, Rosemarie Neuner, Sengwee Toh

Overall and Cause-Specific Mortality in the Sentinel System: A Power Analysis

Richard S. Swain, Lockwood G. Taylor, Tiffany S. Woodworth, Candace C. Fuller, Andrew B. Petrone, Talia J. Menzin, Nicole R. Haug, Sengwee Toh, Andrew D. Mosholder

Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance

Zachary Wyner, Juliane Reynolds, Chayim Herzig-Marx, Shyam Deval, Adam Rauch, Jeffrey Brown, David Martin

A Generalizable Smartphone-Based Clinical Research Platform

Zachary Wyner

Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System

Noelle M. Cocoros, Marc R. Larochelle, Jennifer Popovic, Andrew B. Petrone, Cynthia Kornegay, Jing Ju, Judith A. Racoosin

Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative

Judith C. Maro

Misclassification in Assessment of First Trimester In-Utero Exposure to Drugs used Proximally to Conception - The Example of Letrozole Utilization for Infertility Treatment

Steven T. Bird, Sengwee Toh, Leyla Sahin, Susan E. Andrade, Kate Gelperin, Lockwood Taylor, Jaejoon Song, Christian Hampp

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

Jie Li, Genna Panucci, David Moeny, Wei Liu, Judith C. Maro, Sengwee Toh, Ting-Ying Huang

International Comparison of Approaches to Common Data Models for Comparative Effectiveness Research

Jeffrey Brown

Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System

Robert Ball, Sengwee Toh, Jamie Nolan, Kevin Haynes, Richard Forshee, Taxiarchis Botsis

2018 ICPE Poster: First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies

Steven Bird, Kate Gelperin, Leyla Sahin, Karen B. Bleich, Elnara Fazio-Eynullayeva, Corinne Woods, Erica Radden, Tamara Johnson, Mayura Shinde, Ira Krefting

2018 ICPE Poster: Misclassification of Time-at-Risk Due to Free Drug Sample Use: A Simulation Study

Zilu Zhang, Efe Eworuke, Margie R. Goulding, Michael D. Nguyen, Bruce Fireman, Judith C. Maro

2018 ICPE Presentation: Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic

Shirley V. Wang, Judith C. Maro, Elande Baro, Rima Izem, Inna Dashevsky, James R. Rogers, Michael Nguyen, Joshua J. Gagne, Elisabetta Patorno, Krista F. Huybrechts, Jacqueline M Major, Esther Zhou, Megan Reidy, Austin Cosgrove, Sebastian Schneeweiss, Martin Kulldorff

2018 ICPE Presentation: Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs

Sarah K. Dutcher, Jennifer R. Popovic, Michael Nguyen, Sukhminder K. Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B. Petrone, Anita K. Wagner, Joshua J. Gagne

2018 ICPE Poster: A Comparison of Drug Utilization Metrics for Two Drug Classes with Nationally Projected Sales and Patient-level Data from the Sentinel Database

Mohamed Mohamoud, Yanmin Zhu, Steven Bird, Rima Izem, Nicole R. Haug, Anita Wagner, Judith C. Maro, Efe Eworuke

2018 ICPE Presentation: Minor Differences, Major Consequences? Lessons Learned from Replication of a Claims-Based Drug Safety Assessment

Ting-Ying Jane Huang, Laura Hou, Laura Shockro, Ella Pestine, Michael Nguyen, Judith C. Maro, Rima Izem

2018 ICPE Presentation: Use of Multiple Sclerosis Drugs Among Live Birth Pregnancies in the United States

Danijela Stojanovic, Mayura Shinde, Nicole Haug, Mohamed Mohamoud, Leyla Sahin, Genna Panucci, Rajani Rajbhandari, Lockwood Taylor

2018 ICPE Presentation: Signal Detection using TreeScan with Drug Classes: Pilot Projects in Sentinel

Judith C. Maro, Michael D. Nguyen, Rima Izem, Ya‐Hui Hsueh, Inna Dashevsky, Austin Cosgrove, S. Christopher Jones, Jacqueline M. Major, Esther H. Zhou, Elande Baro, Joshua J. Gagne, Shirley V. Wang, Martin Kulldorff

2018 ICPE Poster: 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

Catherine A. Panozzo, Emily C. Welch, Tiffany S. Woodworth, Ting-Ying Huang, Qoua L. Her, Joshua J. Gagne, Jenny W. Sun, Catherine Rogers, Talia J. Menzin, Max Ehrmann, Katherine E. Freitas, Nicole R. Haug, Sengwee Toh

2018 ICPE Presentation: Early Lessons on ICD-10-CM/PCS Transition in Claims-Based Drug Safety Assessments

Ting‐Ying Huang, Emily C. Welch, Margie Goulding, David J. Graham, Rongmei Zhang, Marie Bradley

2018 ICPE Poster: Developing the Infrastructure to Assess Pregnancy Outcomes Following Vaccination: Influenza Vaccines and Spontaneous Abortion as a Use Case

Alison Tse Kawai, Megan Reidy, Lauren Zichittella, Colleen Stockdale, Erin Longley, Cheryl Walraven, Chunfu Liu, Azadeh Shoaibi, Sandra Feibelmann, Grace Lee

2018 ICPE Poster: Diagnostic Algorithms for Identification of Cardiovascular Death in Administrative Claims Databases: A Systematic Review

Sonal Singh, Hassan Fouyazi, Kathryn Anzuoni, Leah Goldman, Jea Young Min, Marie Griffin, Carlos G. Grijalva, James A. Morrow, Christine Whitmore, Charles E. Leonard, Mano Selvan, Vinit Nair, Yunping Zhou, Sengwee Toh, Andrew Petrone, James Williams, Elnara Fazio-Eynullayeva, Richard S. Swain, D. Tyler Coyle, Susan Andrade

2018 ICPE Poster: A New Analytic Tool Developed in the Sentinel System to Assess Adherence To FDA’s Safe Use Recommendations

Noelle Cocoros, Anita Wagner, Andrew Petrone, Elnara Fazio-Eynullayeva, Yulan Ding, Rima Izem, Joo-Yeon Lee, Jacqueline Major, Michael Nguyen, Jing Ju

2018 ICPE Presentation: Estimating “Optimal” Durations for Initial Opioid Analgesic Prescription Following Common Surgical Procedures

Mallika L. Mundkur, Tamra Meyer, Talia Menzin, Judy Staffa, Corinne Woods, Judith C. Maro, Justin Bohn

2018 ICPE Presentation: Validation of the Combined Comorbidity Score in the ICD-10 Era: Application to High-Risk Populations

Justin Bohn, Emily C. Welch, Jenny W. Sun, Joshua J. Gagne, Sengwee Darren Toh

2018 ICPE Presentation: Performance of a Distributed Regression Analysis Software and Workflow

Qoua L. Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Darren Toh

2018 ICPE Presentation: Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes Of Interest – An Empirical Evaluation

Rishi J. Desai, Richard Wyss, Yinzhu Jin, Justin Bohn, Sengwee Toh, Austin Cosgrove, Adee Kennedy, Jessica Kim, Clara Kim, Rita Ouellet-Hellstrom, Sara Karami, Jacqueline M. Major, Aaron Niman, Shirley V. Wang, Joshua J. Gagne

2018 ICPE Symposium: Advances in the Study of Medication Errors in Computerized Healthcare Databases and Spontaneous Reporting Systems in Europe and North America

Michael D. Nguyen, Jo Wyeth, Kevin Haynes, Lisa Herrinton, Rodrigo Postigo, Adrian Levy, Chi-Ming (Alice) Tu