Publications & Presentations | Sentinel Initiative

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

Search Publications & Presentations

Title	Type	Author(s)	Date Posted
Real-World Data: Data Networks, Standardization, and Federated Analysis Presentation	Presentation	Darren Toh View More Presenters	01/18/2022
Broadening the Reach of the FDA Sentinel System: A Roadmap for Integrating Electronic Health Record Data in a Causal Analysis Framework Publication	Publication	Rishi J. Desai, Michael E. Matheny, Kevin Johnson, Keith Marsolo, Lesley H. Curtis, Jennifer C. Nelson, Patrick J. Heagerty, Judith Maro, Jeffrey Brown, Sengwee Toh, Michael Nguyen, Robert Ball, Gerald Dal Pan, Shirley V. Wang, Joshua J. Gagne, Sebastian Schneeweiss View More Authors	12/20/2021
Validation of Diagnosis Codes to Identify Hospitalized COVID-19 Patients in Health Care Claims Data Publication	Publication	Sheryl A. Kluberg, Laura Hou, Sarah K. Dutcher, Monisha Billings, Brian Kit, Sengwee Toh, Sascha Dublin, Kevin Haynes, Anne Marie Kline, Mahesh Maiyani, Pamala A. Pawloski, Eric S. Watson, Noelle M. Cocoros View More Authors	12/16/2021
Self‑Controlled Assessment of Thromboembolic Event (TEE) Risk Following Intravenous Immune Globulin (IGIV) in the U.S. (2006–2012) Publication	Publication	Eric M Ammann, Elizabeth A Chrischilles, Ryan M Carnahan, Bruce Fireman, Candace C Fuller, Marin L Schweizer, Crystal Garcia, Madelyn Pimentel, Charles E Leonard, Meghan A Baker, Adam Cuker, Enrique C Leira, Jennifer G Robinson, Scott K Winiecki View More Authors	11/24/2021
Emerging Technologies and Their Impact on Regulatory Science Publication	Publication	Elke Anklam, Martin Iain Bahl, Robert Ball, Richard D. Beger, Jonathan Cohen, Suzanne Fitzpatrick, Philippe Girard, Blanka Halamoda-Kenzaoui, Denise Hinton, Akihiko Hirose, Arnd Hoeveler, Masamitsu Honma, Marta Hugas, Seichi Ishida, George E.N. Kass, Hajime Kojima, Ira Krefting, Serguei Liachenko, Yan Liu, Shane Masters, Uwe Marx, Timothy McCarthy, Tim Mercer, Anil Patri, Carmen Pelaez, Munir Pirmohamed, Stefan Platz, Alexandre J.S. Ribeiro, Joseph V. Rodricks, Ivan Rusyn, Reza M. Salek, Reinhilde Schoonjans, Primal Silva, Clive N. Svendsen, Susan Sumner, Kyung Sung, Danilo Tagle, Li Tong, Weida Tong, Janny van den Eijnden-van-Raaij, Neil Vary, Tao Wang, John Waterton, May Wang, Hairuo Wen, David Wishart, Yinyin Yuan, William Slikker Jr. View More Authors	11/16/2021
Using Inpatient Electronic Medical Records to Study Influenza for Pandemic Preparedness Publication	Publication	Candace C. Fuller, Austin Cosgrove, Kenneth Sands, Karla M. Miller, Russell E. Poland, Edward Rosen, Alfred Sorbello, Henry Francis, Robert Orr, Sarah K. Dutcher, Gregory T. Measer, Noelle M. Cocoros View More Authors	10/25/2021
Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network Publication	Publication	Elizabeth A. Suarez, Nicole Haug, Aaron Hansbury, Danijela Stojanovic, Catherine Corey View More Authors	10/14/2021
Risk of Hospitalized Depression and Intentional Self-Harm with Brand and Authorized Generic Sertraline Publication	Publication	Dinci D. Pennap, Richard S. Swain, Emily C. Welch, Justin Bohn, Jennifer G. Lyons, Sarah Dutcher, Andrew D. Mosholder View More Authors	10/04/2021
Monitoring Medication Use During the COVID-19 Pandemic in the Sentinel System: The Case of Anticoagulation for Thrombosis Presentation	Presentation	Ashley I. Martinez View More Presenters	09/15/2021
Incidence of Severe Uterine Bleeding Outcomes among Oral Anticoagulant Users and Nonusers Publication	Publication	Ting-Ying Huang, Laura Hou, Abby Andersen, Audrey Gassman, David Moeny, Efe Eworuke View More Authors	09/01/2021
Characteristics and Outcomes of Pregnancies in Women with Heart Failure: A Retrospective Cohort Study in the Sentinel Distributed Database Presentation	Presentation	Yan Li, Austin Cosgrove, Efe Eworuke, Catherine Corey, Joy Kolonoski, Mayura Shinde View More Presenters	08/25/2021
Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning Presentation	Presentation	David Carrell View More Presenters	08/25/2021
Strategies for the Use of Real-World Data to Conduct COVID-19-Related Pharmacoepidemiology Presentation	Presentation	Noelle M. Cocoros View More Presenters	08/25/2021
A New Analytic Tool for Interrupted Times Series Analysis to Assess the Impact of FDA Regulatory Actions Presentation	Presentation	Christine Y. Lu, Laura Hou, Joy Kolonoski, Andrew Petrone, Fang Zhang, Catherine Corey, Ting-Ying Huang, Marie C. Bradley View More Presenters	08/24/2021
No Differential Risk of Cutaneous Small Vessel Vasculitis with Oral Anticoagulant Use Among Patients with Atrial Fibrillation Presentation	Presentation	Adebola Ajao, Austin Cosgrove, Efe Eworuke, Mohamed Mohamoud, Rongmei Zhang, Oren Shapira, Joy Kolonoski, John Connolly View More Presenters	08/24/2021
New Frontiers in Computable Phenotyping for Medical Product Safety Evaluation Presentation	Presentation	David S. Carrell View More Presenters	08/24/2021
Early Uptake of New Molecular Entities Approved in 2017 in a Multisite National US Healthcare Data Network Presentation	Presentation	Andrew L. Simon, Sruthi Adimadhyam, Catherine Corey, Michael D. Nguyen View More Presenters	08/23/2021
Outpatient-Identified COVID-19 and Subsequent Hospitalized Thrombotic Events Presentation	Presentation	Silvia Perez-Vilar View More Presenters	08/23/2021
Comparing Outcomes in Trial-Eligible vs Real-World COVID-19 Patients: The Case of Invasive Mechanical Ventilation Presentation	Presentation	Ashley I. Martinez, Silvia Perez-Vilar, Mayura Shinde, Maria E. Kempner, Joy Kolonoski, Sarah K. Dutcher, Brian Kit View More Presenters	08/23/2021
Prescription Medication Use and Baseline Health Status of Women with Live Birth Deliveries in a National Data Network: The Sentinel Distributed Database Mother-Infant Linkage Table Presentation	Presentation	Elizabeth A Suarez, Nicole Haug, Aaron Hansbury, Danijela Stojanovic, Catherine Corey View More Presenters	08/23/2021
How Under-Coded is Pediatric Hypertension?: Comparison of Claims and Electronic Health Record (EHR) Data Presentation	Presentation	Casie Horgan, Jillian Burk, Judith C. Maro, Efe Eworuke, Danijela Sojanovic, Jennifer Lyons, Brian Kit View More Presenters	08/23/2021
Pregnancy in Women with Heart Failure: A Cross-Sectional Study in the Sentinel Distributed Database Presentation	Presentation	Yan Li, Austin Cosgrove, Efe Eworuke, Catherine Corey, Joy Kolonoski, Mayura Shinde View More Presenters	08/23/2021
Post-Keratoplasty Fungal Keratitis in the Sentinel Distributed Database: Prevalence and Time Trends Presentation	Presentation	Tancy C. Zhang, Sheryl A. Kluberg, Mayura Shinde, Dave Martin, Katherine Dea, Scott A. Brubaker, Brychan Clark, Christopher Jason, Cindy Ke Zhou, Joyce Obidi, Kinnera Chada, Azadeh Shoaibi, Hui-Lee Wong View More Presenters	08/23/2021
Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: A Propensity Score Matched Case Study Presentation	Presentation	Elizabeth A Suarez, Michael Nguyen, Di Zhang, Yueqin Zhao, Danijela Stojanovic, Monica Munoz, Jane Liedtka, Abby Anderson, Wei Liu, Inna Dashevsky, David Cole, Sandra DeLuccia, Talia Menzin, Jennifer Noble, Judith C Maro View More Presenters	08/23/2021
Statistical Power for Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use Presentation	Presentation	Elizabeth A Suarez, Michael Nguyen, Di Zhang, Yueqin Zhao, Danijela Stojanovic, Monica Munoz, Jane Liedtka, Abby Anderson, Wei Liu, Inna Dashevsky, Sandra DeLuccia, Talia Menzin, Jennifer Noble, Judith C Maro View More Presenters	08/23/2021
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research Presentation	Presentation	Claire W. Rothschild, Sascha Dublin, Jeffrey S. Brown, Predrag Klasnja, Chayim Herzig-Marx, Juliane S. Reynolds, Zachary Wyner, Christina Chambers, David Martin View More Presenters	08/23/2021
Who Gets Treated for Influenza: A Surveillance Study From the US Food and Drug Administration’s Sentinel System Publication	Publication	Noelle M. Cocoros, Nicole Haug, Austin Cosgrove, Catherine A. Panozzo, Alfred Sorbello, Henry Francis, Crystal Garcia, Robert Orr, Sengwee Toh, Sarah K. Dutcher, Gregory T. Measer View More Authors	08/05/2021
The Sentinel Experience Presentation	Presentation	Darren Toh View More Presenters	07/10/2021
Use of a Mobile App to Capture Supplemental Health Information During Pregnancy: Implications for Clinical Research Publication	Publication	Claire W. Rothschild, Sascha Dublin, Jeffrey S. Brown, Predrag Klasnja, Chayim Herzig-Marx, Juliane S. Reynolds, Zachary Wyner, Christina Chambers, David Martin View More Authors	07/03/2021
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data Presentation	Presentation	Jennifer Lyons, Steven Bird, Danijela Stojanovic, Judith Maro, Darren Toh, Elnara Eynullayeva, Andrew Petrone, Rajani Rajbhandari View More Presenters	06/29/2021
Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System Publication	Publication	Susan E. Andrade, Mayura Shinde, Tiffany A. Moore Simas, Steven T. Bird, Justin Bohn, Kevin Haynes, Lockwood G. Taylor, Julianne R. Lauring, Erin Longley, Cheryl N. McMahill-Walraven, Connie M. Trinacty, Cassandra Saphirak, Christopher Delude, Sandra DeLuccia, Tancy Zhang, David V. Cole, Nina DiNunzio, Autumn Gertz, Elnara Fazio-Eynullayeva, Danijela Stojanovic View More Authors	06/04/2021
Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin Publication	Publication	Efe Eworuke, Laura Hou, Rongmei Zhang, Hui-Lee Wong, Peter Waldron, Abby Anderson, Audrey Gassman, David Moeny, Ting-Ying Huang View More Authors	05/20/2021
Utilization of Hydroxyprogesterone Caproate among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database Publication	Publication	Mayura Shinde, Austin Cosgrove, Corinne M. Woods, Christina Chang, Christine P. Nguyen, David Moeny, Adebola Ajao, Joy Kolonoski, Huei-Ting Tsai View More Authors	04/29/2021
Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM Publication	Publication	Mara M. Epstein, Sarah K. Dutcher, Judith C. Maro, Cassandra Saphirak, Sandra DeLuccia, Muthalagu Ramanathan, Tejaswini Dhawale, Sonali Harchandani, Christopher Delude, Laura Hou, Autumn Gertz, Nina DiNunzio, Cheryl N. McMahill-Walraven, Mano S. Selvan, Justin Vigeant, David V. Cole, Kira Leishear, Jerry H. Gurwitz, Susan Andrade, Noelle M. Cocoros View More Authors	04/26/2021
Validity of ICD‐10‐CM Diagnoses to Identify Hospitalizations for Serious Infections Among Patients Treated With Biologic Therapies Publication	Publication	Vincent Lo Re III, Dena M. Carbonari, Jerry Jacob, William R. Short, Charles E. Leonard, Jennifer G. Lyons, Adee Kennedy, Jolene Damon, Nicole Haug, Esther H. Zhou, David J. Graham, Cheryl N. McMahill‐Walraven, Lauren E. Parlett, Vinit Nair, Mano Selvan, Yunping Zhou, Gaia Pocobelli, Judith C. Maro, Michael D. Nguyen View More Authors	04/22/2021
A COVID‐19‐Ready Public Health Surveillance System: The FDA's Sentinel System Publication	Publication	Noelle M. Cocoros, Candace C. Fuller, Sruthi Adimadhyam, Robert Ball, Jeffrey S. Brown, Gerald Dal Pan, Sheryl A. Kluberg, Vincent Lo Re 3rd, Judith Maro, Michael Nguyen, Robert Orr, Dianne Paraoan, Jonathan Perlin, Russell E. Poland, Meighan Rogers Driscoll, Kenneth Sands, Sengwee Toh, W. Katherine Yih, Richard Platt, and the FDA‐Sentinel COVID‐19 Working Group View More Authors	04/02/2021
Electronic Phenotyping of Health Outcomes of Interest Using a Linked Claims-Electronic Health Record Database: Findings from a Machine Learning Pilot Project Publication	Publication	Teresa B. Gibson, Michael D. Nguyen, Timothy Burrell, Frank Yoon, Jenna Wong, Sai Dharmarajan, Rita Ouellet-Hellstrom, Wei Hua, Yong Ma, Elande Baro, Sarah Bloemers, Cory Pack, Adee Kennedy, Sengwee Toh, Robert Ball View More Authors	03/12/2021
A General Propensity Score for Signal Identification using Tree-Based Scan Statistics Publication	Publication	Shirley V. Wang, Judith C. Maro, Joshua J. Gagne, Elisabetta Patorno, Sushama Kattinakere, Danijela Stojanovic, Efe Eworuke, Elande Baro, Rita Ouellet-Hellstrom, Michael Nguyen, Yong Ma, Inna Dashevsky, David Cole, Sandra DeLuccia, Aaron Hansbury, Ella Pestine, Martin Kulldorff View More Authors	02/22/2021
Community Building and Outreach Center (CBOC) Master Plan Publication	Publication		02/10/2021
Innovation Center (IC) Master Plan Publication	Publication		02/10/2021
Risk of Non-Melanoma Skin Cancer in Association with Use of Hydrochlorothiazide-Containing Products in the United States Publication	Publication	Efe Eworuke, Nicole Haug, Marie Bradley, Austin Cosgrove, Tancy Zhang, Elizabeth C. Dee, Sruthi Adimadhyam, Andrew Petrone, Hana Lee, Tiffany Woodworth, Sengwee Toh View More Authors	02/04/2021
Identification and Validation of Anaphylaxis Using Electronic Health Data in a Population-Based Setting Publication	Publication	Maralyssa A. Bann, David S. Carrell, Susan Gruber, Mayura Shinde, Robert Ball, Jennifer C. Nelson, James S. Floyd View More Authors	02/02/2021
Medical Chart Validation of Inpatient Diagnosis Codes for Transfusion‐Related Acute Lung Injury 2013‐2015 Publication	Publication	Candace C. Fuller, Vinod E. Nambudiri, Caren Spencer‐Smith, Lesley H. Curtis, Mayura Shinde, Austin Cosgrove, Margaret Johnson, Jason Hickok, Stacey Honda, Heba Ismail, Richard Max Kaufman, Adee Kennedy, Karla M. Miller, David J. Mohlman, Russell E. Poland, Robert Rosofsky, Kimberly Smith, Salim R. Surani, Meghan A. Baker View More Authors	01/27/2021
Validation of an Electronic Algorithm for Hodgkin and Non-Hodgkin Lymphoma in ICD-10-CM Presentation	Presentation	Mara M. Epstein, Sarah K. Dutcher, Judith C. Maro, Cassandra Saphirak, Sandra DeLuccia, Muthalagu Ramanathan, Tejaswini Dhawale, Sonali Harchandani, Christopher Delude, Laura Hou, Autumn Gertz, Nina DiNunzio, Cheryl N. McMahill-Walraven, Mano S. Selvan, Justin Vigeant, David V. Cole, Kira Leishear, Jerry H. Gurwitz, Susan Andrade, Noelle M. Cocoros View More Presenters	12/15/2020
Using Prenatal Tests to Estimate Pregnancy Start in Health Insurance Claims Data Presentation	Presentation	Jennifer G. Lyons, Steven T. Bird, Judith C. Maro, Darren Toh, Elnara Fazio-Eynullayeva, Andrew Petrone, Rajani Rajbhandari, Lockwood Taylor View More Presenters	12/15/2020
The FDA MyStudies App: A Reusable Platform for Distributed Clinical Trials and Real-World Evidence Studies Publication	Publication	Zachary Wyner, Sascha Dublin, Christina Chambers, Shyam Deval, Chayim Herzig-Marx, Shanthala Rao, Adam Rauch, Juliane Reynolds, Jeffrey S. Brown, David Martin View More Presenters	12/11/2020
Validation of Claims-based Algorithms to Identify Hospitalized COVID-19 Events within the FDA Sentinel System Presentation	Presentation	Sheryl Kluberg, Sarah Dutcher, Laura Hou, Tancy Zhang, Adee Kennedy, Monica Ter-Minassian, Eric X. Watson, Sundeep S. Basra, Brian Kit, Monisha Billings, Robert Ball, Darren Toh, Noelle Cocoros View More Presenters	12/02/2020
Incidence of Uterine Bleeding following Oral Anticoagulant Use in Food and Drug Administration’s Sentinel System Publication	Publication	Abby Anderson, Audrey Gassman, Laura Hou, Ting-Ying Huang, Efe Eworuke, David Moeny, Hui-Lee Wong View More Authors	11/26/2020
Functional Clustering Methods for Longitudinal Data with Application to Electronic Health Records Publication	Publication	Bret Zeldow, James Flory, Alisa Stephens-Shields, Marsha Raebel, Jason A. Roy View More Authors	11/11/2020
Natural History of Coagulopathy in Patients with COVID-19 in a Real-World Electronic Health Data Network Presentation	Presentation	Maria Kempner, Mayura Shinde, Joshua Hartman, Jennifer Lyons, Joy Kolonoski, Danijela Stojanovic, Brian Kit View More Presenters	11/05/2020
Descriptive Assessment of Coagulopathy Among COVID-19 Patients: Feasibility Data Review Presentation	Presentation	Noelle Cocoros View More Presenters	10/27/2020
Natural History of Coagulopathy in COVID-19 Presentation	Presentation	Vincent Lo Re View More Presenters	10/26/2020
Leveraging the Capabilities of the FDA’s Sentinel System To Improve Kidney Care Publication	Publication	Sruthi Adimadhyam, Erin F. Barreto, Noelle M. Cocoros, Sengwee Toh, Jeffrey S. Brown, Judith C. Maro, Jacqueline Corrigan-Curay, Gerald J. Dal Pan, Robert Ball, David Martin, Michael Nguyen, Richard Platt, Xiaojuan Li View More Authors	10/19/2020
Studying the Natural History of COVID-19: Risk of Arterial and Venous Thrombotic Events in the Sentinel System Presentation	Presentation	Vincent Lo Re View More Presenters	10/14/2020
Leveraging the Sentinel System for COVID-19 Presentation	Presentation	Jeffrey Brown View More Presenters	10/14/2020
When Decisions Can't Wait: Delivering Rapid Real World Studies Presentation	Presentation	Judith C. Maro, Simone Pinheiro View More Presenters	10/13/2020
Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis Publication	Publication	Mohamed Mohamoud, Casie Horgan, Efe Eworuke, Elizabeth Dee, Justin Bohn, Oren Shapira, Monica A. Munoz, Danijela Stojanovic, Veronica Sansing‐Foster, Adebola Ajao, Lois La Grenade View More Authors	10/08/2020
Phosphodiesterase Type 5 Inhibitor Use Among Pregnant and Reproductive‐Age Women in the United States Publication	Publication	Wei Liu, Talia J. Menzin, Corinne M. Woods, Nicole R. Haug, Jie Li, Justin A. Mathew, Christine P. Nguyen, Grace P. Chai, David G. Moeny, Mayura Shinde View More Authors	10/05/2020
Risk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin Publication	Publication	Marie Bradley, Emily C. Welch, Efe Eworuke, David J. Graham, Rongmei Zhang, Ting-Ying Huang View More Authors	09/28/2020
Utilization of Spironolactone in Patients with Reduced or Preserved Ejection Fraction Heart Failure Presentation	Presentation	Sruthi Adimadhyam, Austin Cosgrove, Qoua Her, Jennifer G. Lyons, Dave Martin, Efe Eworuke View More Presenters	09/23/2020
Utilization of Sacubitril/Valsartan in Real-World Settings Presentation	Presentation	Efe Eworuke, Talia J. Menzin, Joy Kolonoski, Ting-Ying Huang View More Presenters	09/23/2020
Risk of Neuropsychiatric Adverse Events among Montelukast Users Presentation	Presentation	Efe Eworuke, Nicole Haug, Andrew Mosholder, Noelle M. Cocoros, Marie Bradley, Yong Ma, Dinci Pennap, Elizabeth C. Dee, Sengwee Toh, Ella Pestine, Andrew B. Petrone, Ivone Kim, Jennifer G. Lyons, Veronica V. Sansing-Foster View More Presenters	09/23/2020
Comparative Risk Assessment of Severe Abnormal Uterine Bleeding associated with Non-Vitamin K Oral Anticoagulants Presentation	Presentation	Efe Eworuke, Laura Hou, Rongmei Zhang, Hui-Lee Wong, Peter Waldron, Abby Anderson, Audrey Gassman, David Moeny, Ting-Ying Huang View More Presenters	09/22/2020
Replicating the Findings of a Medicare Study on Stroke, and Bleeding Risk in Patients Using NOACs for Atrial Fibrillation in the Sentinel System Presentation	Presentation	Marie Bradley, Emily C. Welch, Mayura Shinde, Efe Eworuke, Rongmei Zhang, Elande Baro, David J. Graham View More Presenters	09/22/2020
Use of Hydroxyprogesterone Caproate and Progesterone During the 2nd and/or 3rd Trimester Among Pregnancies with Live Birth Deliveries in the Sentinel Distributed Database Presentation	Presentation	Huei-Ting Tsai View More Presenters	09/22/2020
Utilization Characteristics for Inhaled Corticosteroid‐based Asthma Medications in the Sentinel System, 2008‐2019 Presentation	Presentation	Tancy C. Zhang, Inna Dashevsky, Yan Li, Marie Bradley, Jianmeng Chen, Stacy Chin, Sandra DeLuccia, Efe Eworuke, Judith C. Maro, Yunzhao Ren, Rongmei Zhang, Chandrahas Sahajwalla, David Martin, Sally Seymour, Kenneth Quinto, Robert Busch, Catherine A. Panozzo View More Presenters	09/22/2020
Risk of Non-Melanoma Skin Cancer Associated with Hydrochlorothiazide-Containing Products in the United States Presentation	Presentation	Efe Eworuke, Nicole Haug, Marie Bradley, Austin Cosgrove, Tancy Zhang, Elizabeth C. Dee, Sruthi Adimadhyam, Andrew Petrone, Hana Lee, Tiffany Siu Woodworth, Sengwee Toh View More Presenters	09/21/2020
Incidence of Severe Abnormal Uterine Bleeding Following Oral Anticoagulant Use Presentation	Presentation	Ting-Ying Huang, Laura Hou, Abby Anderson, Hui-Lee Wong, Rongmei Zhang, Peter Waldron, David Moeny, Audrey Gassman, Efe Eworuke View More Presenters	09/21/2020
Factors Related to Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) and Dipeptidyl Peptidase 4 Inhibitor (DPP4i) Dispensing among Naive, Incident, and Prevalent New Users Presentation	Presentation	Yandong Qiang, Casie E. Horgan, Andrew B Petrone, Joy Kolonoski, Aaron Hansbury, Christian Hampp, Sarah Dutcher, Sruthi Adimadhyam, Sengwee Toh View More Presenters	09/21/2020
Assessing the Feasibility of Evaluating Tacrolimus Use after Solid Organ Transplantation in the Sentinel Distributed Database Presentation	Presentation	Mingfeng Zhang, Sarah Dutcher, Monique Falconer, Nicole Haug, Lockwood Taylor, Andrew Petrone, Sheryl Kluberg, Justin Bohn View More Presenters	09/21/2020
Antipsychotic Medication Use among Hospitalized Infants Using Inpatient Data in FDA’s Sentinel System Presentation	Presentation	Mayura Shinde, Candace C. Fuller, Rong Tilney, Austin Cosgrove, Jason Hickok, Russell Poland, Karla M. Miller, Crystal Garcia, Corinne Woods, Andrew Mosholder View More Presenters	09/20/2020
Risk of Stroke and Bleeding in Nonvalvular Atrial Fibrillation Treated with Apixaban Compared to Warfarin in the Sentinel System Presentation	Presentation	Marie C. Bradley, Emily C. Welch, Efe Eworuke, David J. Graham, Rongmei Zhang, Ting-Ying Huang View More Presenters	09/20/2020
Incidence of Cutaneous Small Vessel Vasculitis associated with Oral Anticoagulant Use Presentation	Presentation	Adebola Ajao, Oren Shapira, Efe Eworuke, Mohamed Mohamoud, Rongmei Zhang, Joy Kolonoski, John Connolly View More Presenters	09/20/2020
Utilization of IV Iron among Pregnant Women with Live Births or Stillbirths; A Study in the Sentinel Distributed Database Presentation	Presentation	Steven T. Bird, Nicole Haug, Richard S. Swain, Leyla Sahin, Kate Gelperin, Joy Kolonoski, Justin Bohn, Mayura Shinde View More Presenters	09/20/2020
Comparing Three Signal Identification Methods with Self-Controlled Designs Presentation	Presentation	Judith C. Maro, Shirley Wang, Inna Dashevsky, Joshua Gagne, Sandra DeLuccia, Jesper Hallas, G.Niklas Norén, Martin Kulldorff, Sai Dharmarajan, Esther Zhou, Elande Baro, Monica Munoz, Danijela Stojanovic, Michael Nguyen View More Presenters	09/17/2020
Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System Presentation	Presentation	Susan E. Andrade View More Presenters	09/17/2020
Asthma Maintenance Medication Users in the Sentinel System Presentation	Presentation	Marie Bradley, Elnara Fazio-Eynullayeva, Sandra DeLuccia, Katherine Freitas, Judith C. Maro, Catherine A. Panozzo, Efe Eworuke, Rongmei Zhang, David Martin, Sally Seymour, Kenneth Quinto, Robert Busch, Yan Li, Jianmeng Chen, Stacy Chin, Yunzhao Ren, Chandrahas Sahajwalla View More Presenters	09/17/2020
Percutaneous Transluminal Septal Myocardial Ablation and Common Procedural Complications: A Descriptive Study Presentation	Presentation	John G. Connolly, Laura Hou, Justin Bohn, Talia Menzin, Jane Huang, Fortunato Senatore, Efe Eworuke, Marie Bradley View More Presenters	09/17/2020
Replication of Protocol-Based Analyses of Saxagliptin and Sitagliptin using Sentinel Modular Programs Presentation	Presentation	Christian Hampp, Sheryl Kluberg, Laura Hou, Sengwee Toh, David Graham, Rongmei Zhang, Yandong Qiang, Justin Bohn View More Presenters	09/17/2020
Incidence of Ocular Adverse Events Associated with Mometasone Implants among Patients with Nasal Polyposis Presentation	Presentation	Efe Eworuke, Emmanuel Ojo, Miya Paterniti, Emily Welch, Mayura Shinde View More Presenters	09/17/2020
Improving Identification of Anaphylaxis Presentation	Presentation	James S. Floyd, David S. Carrell, Maralyssa A. Bann, Susan Gruber, Ron L. Johnson, Vina F. Graham, Cosmin A. Bejan, Mayura Shinde, Jennifer C. Nelson, Yong Ma, Robert Ball View More Presenters	09/17/2020
Assessing Data Source Characteristics in Multi-site Analyses Presentation	Presentation	Jeffrey Brown View More Presenters	09/08/2020
Utilization of Sacubitril/Valsartan in Real-World Settings Publication	Publication	Efe Eworuke, Talia J. Menzin, Emily C. Welch, Joy Kolonoski, Ting-Ying Huang View More Authors	08/24/2020
Defining COVID-19 Cohorts in Real-World Data Presentation	Presentation	Noelle Cocoros, Judith C. Maro, Jeff Brown View More Presenters	08/18/2020
Risk of Psychiatric Adverse Events among Montelukast Users Publication	Publication	Veronica V. Sansing-Foster, Nicole Haug, Andrew Mosholder, Noelle M. Cocoros, Marie Bradley, Yong Ma, Dinci Pennap, Elizabeth C. Dee, Sengwee Toh, Ella Pestine, Andrew B. Petrone, Ivone Kim, Jennifer G. Lyons, Efe Eworuke View More Authors	08/11/2020
Consequences of Depletion of Susceptibles for Hazard Ratio Estimators Based on Propensity Scores Publication	Publication	Bruce Fireman, Susan Gruber, Zilu Zhang, Robert Wellman, Jennifer Clark Nelson, Jessica Franklin, Judith C. Maro, Catherine Rogers Murray, Sengwee Toh, Joshua Gagne, Sebastian Schneeweiss, Laura Amsden, Richard Wyss View More Authors	08/06/2020
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Focus on Endpoints Presentation	Presentation	Vincent Lo Re View More Presenters	08/04/2020
Underuse of Oral anticoagulants in privately insured patients with atrial fibrillation: A population targeted by IMplementation of a randomized controlled trial to ImProve treatment with Oral AntiCoagulanTs in atrial fibrillation patients (IMPACT-AFib) Publication	Publication	Sana M. Al-Khatib, Sean D. Pokorney, Hussein R. Al-Khalidi, Kevin Haynes, Crystal Garcia, David Martin, Jennifer C. Goldsack, Thomas Harkins, Noelle M. Cocoros, Nancy D. Lin, Hana Lipowicz, Debbe McCall, Vinit Nair, Lauren Parlett, Cheryl N. McMahill-Walraven, Richard Platt, Christopher B. Granger View More Authors	07/24/2020
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Update on Methods Presentation	Presentation	Vincent Lo Re View More Presenters	07/14/2020
Practical Challenges in the Conduct of Pragmatic Trials Embedded in Health Plans: Lessons of IMPACT-AFib, an FDA-Catalyst Trial Publication	Publication	Crystal J. Garcia, Kevin Haynes, Sean D. Pokorney, Nancy D. Lin, Cheryl McMahill-Walraven, Vinit Nair, Lauren Parlett, David Martin, Hussein R. Al-Khalidi, Debbe McCall, Christopher B. Granger, Richard Platt, Noelle M. Cocoros View More Authors	06/26/2020
Coagulopathy Assessment in Patients with COVID-19: A TriNetX Analysis Presentation	Presentation	Mayura Shinde View More Presenters	06/23/2020
Risk of Thromboembolic Events With COVID-19: A Sentinel System Investigation – Potential Aims/Methods Presentation	Presentation	Vincent Lo Re View More Presenters	06/23/2020
Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer Presentation	Presentation	Darren Toh View More Presenters	06/11/2020
Concomitant Filled Prescriptions of Oxymorphone or Oxycodone with CYP3A Inhibitors and Inducers Publication	Publication	D. Tyler Coyle, Tiffany S. Woodworth, David Moeny, Judy Staffa, Tamra Meyer, Corinne Woods, Emily C. Welch, Kevin Haynes, Sengwee Toh, Judith C. Maro View More Authors	05/26/2020
Conducting Prospective Sequential Surveillance in Real‐World Dynamic Distributed Databases Publication	Publication	Judith C. Maro, Efe Eworuke, Laura Hou, Emily C. Welch, Margie R. Goulding, Rima Izem, Joo‐Yeon Lee, Sengwee Toh, Bruce Fireman, Michael D. Nguyen View More Authors	05/25/2020
Assessing Natural History, Drug Use and Treatment Impact for COVID-19 in the Sentinel System Presentation	Presentation	Robert Ball, Jennifer Stacey, Jeffrey S. Brown View More Presenters	05/13/2020
Using and Improving Distributed Data Networks to Generate Actionable Evidence: the Case of Real-World Outcomes in the Food and Drug Administration’s Sentinel System Publication	Publication	Jeffrey S. Brown, Judith C. Maro, Michael Nguyen, Robert Ball View More Authors	04/11/2020
Distributed Regression Analysis Application in Large Distributed Data Networks: Analysis of Precision and Operational Performance Publication	Publication	Qoua Her, Jessica Malenfant, Zilu Zhang, Yury Vilk, Jessica Young, David Tabano, Jack Hamilton, Ron Johnson, Marsha Raebel, Denise Boudreau, Sengwee Toh View More Authors	04/06/2020
Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer Presentation	Presentation	Darren Toh View More Presenters	03/05/2020
Sentinel Mother-Infant Linkage and Pregnancy Analyses Presentation	Presentation	Elizabeth Suarez View More Presenters	02/19/2020
Translating Claims‐Based CHA2DS2‐VaSc and HAS‐BLED to ICD‐10‐CM: Impacts of Mapping Strategies Publication	Publication	Michael Webster‐Clark, Ting‐Ying Huang, Laura Hou, Sengwee Toh View More Authors	02/17/2020
The Risk of Febrile Seizures following Influenza and 13-Valent Pneumococcal Conjugate Vaccines Publication	Publication	Meghan A. Baker, Christopher Jankosky, Katherine Yih, Susan Gruber, Lingling Li, Noelle M. Cocoros, Hana Lipowicz, Claudia Coronel-Moreno, Sandra DeLuccia, Nancy D. Lin, Cheryl N. McMahill-Walraven, David Menschik, Mano S. Selvan, Nandini Selvam, Rong Chen Tilney, Lauren Zichittella, Grace M. Lee, Alison Tse Kawai View More Authors	01/31/2020
Understanding Utilization Patterns of Biologics and Biosimilars in the United States to Support Postmarketing Studies of Safety and Effectiveness Publication	Publication	Sarah K. Dutcher, Elnara Fazio‐Eynullayeva, Efe Eworuke, Amanda Carruth, Elizabeth C. Dee, Michael D. Blum, Michael D. Nguyen, Sengwee Toh, Catherine A. Panozzo, Jennifer G. Lyons View More Authors	12/11/2019
Medical Product Safety Surveillance: Data Quality in the Sentinel Initiative Presentation	Presentation	Judith C. Maro View More Presenters	12/02/2019
Use of Antidiabetic Drugs During Pregnancy among U.S. Women with Livebirth Deliveries in the Mini-Sentinel System Publication	Publication	Katrina Mott, Marsha E. Reichman, Sengwee Toh, Caren Kieswetter, Katherine Haffenreffer, Susan E. Andrade View More Authors	11/27/2019
Redesigning PopMedNet for Distributed Regression Analysis with Vertically Partitioned Data Presentation	Presentation	Qoua L. Her View More Presenters	11/19/2019
Quantifying How Small Variations in Design Elements Affect Risk in an Incident Cohort Study in Claims Publication	Publication	Rima Izem, Ting-Ying Huang, Laura Hou, Ella Pestine, Michael D. Nguyen, Judith C. Maro View More Authors	11/17/2019
Myopathy and Rhabdomyolysis with Concomitant Use of Ticagrelor and High-Intensity Statins in the Elderly Presentation	Presentation	Mohamed Mohamoud, Daniel Woronow, Nicole Haug, Daniel Bak, Eileen Wu, Corinne Woods, Monica Munoz, Grace Chai, Danijela Stojanovic, Ting-Ying Huang View More Presenters	11/14/2019
Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy Publication	Publication	Janet Sultana, Francesco Trotta, Antonio Addis, Jeffrey S. Brown, Miguel Gil, Francesca Menniti-Ippolito, Federica Milozzi, Samy Suissa, Gianluca Trifirò View More Authors	10/22/2019
Reproducing Protocol‐based Studies Using Parameterizable Tools – Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks Publication	Publication	Ting‐Ying Huang, Emily C. Welch, Mayura U. Shinde, Robert W. Platt, Kristian B. Filion, Laurent Azoulay, Judith C. Maro, Richard Platt, Sengwee Toh View More Authors	10/19/2019
Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis Publication	Publication	Christian Hampp, Richard S. Swain, Casie Horgan, Elizabeth Dee, Yandong Qiang, Sarah K. Dutcher, Andrew Petrone, Rong Chen Tilney, Judith C. Maro, Catherine A. Panozzo View More Authors	10/10/2019
Use of Time-Dependent Propensity Scores to Adjust Hazard Ratio Estimates in Cohort Studies with Differential Depletion of Susceptibles Publication	Publication	Richard Wyss, Joshua Gagne, Yueqin Zhao, Esther Zhou, Jacqueline Major, Shirley Wang, Rishi Desai, Jessica Franklin, Sebastian Schneeweiss, Sengwee Toh, Margaret Johnson, Bruce Fireman View More Authors	09/26/2019
Identification of Potential Drug Name Confusion Errors in the Sentinel System Publication	Publication	Noelle M. Cocoros, Kevin Haynes, Qoua Her, Austin Cosgrove, Elizabeth Dee, Nancy D. Lin, Chi‐Ming Tu, Yulan Ding, Michael Nguyen, Sengwee Toh View More Authors	09/04/2019
Identification of Ordinal Endpoints Indicating Influenza Complications: A Feasibility Analysis Relevant to the Study of Medical Countermeasures Presentation	Presentation	Austin Cosgrove, Nicole Haug, Catherine Panozzo, Gregory Measer, Robert Orr, Alfred Sorbello, Henry Francis, Crystal Garcia, Sarah Dutcher, Noelle Cocoros View More Presenters	08/27/2019
Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis Presentation	Presentation	Mohamed Mohamoud, Casie Horgan, Veronica Sansing-Foster, Elizabeth Dee, Justin Bohn, Oren Shapira, Efe Eworuke, Monica Munoz, Danijela Stojanovic, Lois La Grenade View More Presenters	08/27/2019
Biosimilar Use in the United States: A Sentinel Analysis of Filgrastim and Infliximab Presentation	Presentation	Sarah K. Dutcher, Efe Eworuke, Elnara Fazio-Eynullayeva, Elizabeth Dee, Michael D. Nguyen, Catherine A. Panozzo View More Presenters	08/27/2019
Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy Presentation	Presentation	James Phillip Trinidad, Talia Menzin, Elizabeth Dee, Monique Falconer, Mayura Shinde View More Presenters	08/27/2019
Characteristics and Treatment Status of Those with Influenza-Like Illness: Implications for Effectiveness Studies and Surveillance Presentation	Presentation	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 View More Presenters	08/27/2019
Utilization of Prescription Anti-Obesity Drugs in the U.S. Food and Drug Administration's (FDA) Sentinel System, 2008-2017 Presentation	Presentation	Sara Azimi-Bolourian, Emily C. Welch, Candace C. Fuller, Rajani Rajbhandari, Christian Hampp, Michael D. Nguyen View More Presenters	08/27/2019
Utility of Prenatal Tests and Fertility Coding to Estimate Pregnancy Start in the Sentinel Distributed Database Presentation	Presentation	Lockwood G. Taylor, Steven T. Bird, Danijela Stojanovic, Darren Toh, Elnara Fazio-Eynullayeva, Andrew Petrone, Rajani Rajbhandari, Jennifer G. Lyons View More Presenters	08/26/2019
Duration of Follow-up of Chronic Condition Cohorts in the Sentinel System Presentation	Presentation	Emily C. Welch, Ting-Ying Huang, Mayura Shinde, Michael D. Nugyen, Sarah K. Dutcher View More Presenters	08/26/2019
13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Kawasaki Disease Presentation	Presentation	Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, Katherine Yih View More Presenters	08/26/2019
Confounding Variable Capture in Large Healthcare Administrative Claims Database: A Trend Analysis in the Sentinel System Presentation	Presentation	Wei Liu, Austin Cosgrove, Sarah Dutcher, Justin Bohn View More Presenters	08/26/2019
Exposure to N-nitrosodimethylamine (NDMA)/N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States Presentation	Presentation	Efe Eworuke, Emily C. Welch, Veronica Sansing-Foster, Marie Bradley, Judith C. Maro View More Presenters	08/25/2019
Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings Presentation	Presentation	Marie Bradley View More Presenters	08/25/2019
A General Propensity Score for Signal Detection using Tree-Based Scan Statistics Presentation	Presentation	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 View More Presenters	08/25/2019
Thinking Globally While Acting Locally: Developing Time-on-Treatment Data In International Settings Presentation	Presentation	Judith C. Maro, Kristian B. Fillion, Achim Wolf, Kevin Haynes, Michael D. Nguyen View More Presenters	08/25/2019
Experience from US FDA Sentinel Initiative Studies Presentation	Presentation	Darren Toh View More Presenters	08/25/2019
Phosphodiesterase Type 5 (PDE-5) Inhibitor Use Among Pregnant Women and Women of Reproductive Age in the United States Presentation	Presentation	Wei Liu, Talia Menzin, Corinne M. Woods, Nicole Haug, Jie Li, Justin A. Mathew, Christine P. Nguyen, Grace P. Chai, David Moeny, Mayura Shinde View More Presenters	08/25/2019
Epidemiology of Pediatric Respiratory Syncytial Virus-Associated Illnesses in Young Children Presentation	Presentation	Amol Purandare, Prabha Viswanathan, Nicole Haug, Noelle Cocoros, Rongmei Zhang, Marscha Reichman, Michael Nguyen, Ann McMahon View More Presenters	08/25/2019
Characteristics of NOAC Users Aged Less Than 65 Years in the Sentinel System Presentation	Presentation	Marie C. Bradley, Emily C. Welch, Efe Eworuke, Rongmei Zhang, Elande Baro, David J. Graham, Mayura Shinde View More Presenters	08/25/2019
Evidence of Residual Confounding in Healthcare Database Studies of Oseltamivir and Influenza Complications Presentation	Presentation	Phyo T. Htoo, Gregory Measer, Robert Orr, Justin Bohn, Alfred Sorbello, Henry Francis, Sarah Dutcher, Sengwee Darren Toh, Noelle M. Cocoros View More Presenters	08/25/2019
Analysis of SGLT2 Inhibitor Use in Patients with Type-1 Diabetes Mellitus and Rates of Diabetic Ketoacidosis Presentation	Presentation	Christian Hampp View More Presenters	08/25/2019
First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies Publication	Publication	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 View More Authors	08/20/2019
Bystander Ethics and Good Samaritanism: A Paradox for Learning Health Organizations Publication	Publication	James E. Sabin, Noelle M. Cocoros, Crystal J. Garcia, Jennifer C. Goldsack, Kevin Haynes, Nancy D. Lin, Debbe McCall, Vinit Nair, Sean D. Pokorney, Cheryl N. McMahill‐Walraven, Christopher B. Granger, Richard Platt View More Authors	08/20/2019
Development of an Algorithm to Detect Methotrexate Wrong Frequency Error Using Computerized Health Care Data Publication	Publication	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 View More Authors	08/13/2019
Kawasaki Disease and 13-Valent Pneumococcal Conjugate Vaccination Among Young Children: A Self-Controlled Risk Interval and Cohort Study with Null Results Publication	Publication	Meghan A. Baker, Bethany Baer, Martin Kulldorff, Lauren Zichittella, Rebecca Reindel, Sandra DeLuccia, Hana Lipowicz, Katherine Freitas, Robert Jin, W. Katherine Yih View More Authors	07/02/2019
Signal Identification Methods in the Sentinel System Presentation	Presentation	Judith C. Maro View More Presenters	06/12/2019
Validation of Febrile Seizures Identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program Publication	Publication	Alison Tse Kawai, David Martin, Sarah E. Henrickson, Ashleigh Goff, Megan Reidy, Diana Santiago, Nandini Selvam, Mano Selvan, Cheryl McMahill-Walraven, Grace M. Lee View More Authors	06/08/2019
Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population Publication	Publication	Lockwood G. Taylor, Genna Panucci, Andrew D. Mosholder, Sengwee Toh, Ting-Ying Huang View More Authors	06/04/2019
Medical Product Safety: Ten Years of the U.S. Sentinel System Presentation	Presentation	Sarah Dutcher, Judith C. Maro, David Martin View More Presenters	05/23/2019
Evaluation of Use of Technologies to Facilitate Medical Chart Review Publication	Publication	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 View More Authors	05/20/2019
Leveraging the Entire Cohort in Drug Safety Monitoring: Part 1 Methods for Sequential Surveillance that Use Regression Adjustment or Weighting to Control Confounding in a Multi-Site, Rare Event, Distributed Data Setting Publication	Publication	Jennifer C. Nelson, Ernesto Ulloa-Pe’rez, Jennifer F. Bobb, Judith C. Maro View More Authors	05/17/2019
Applying Sequential Surveillance Methods That Use Regression Adjustment or Weighting to Control Confounding in a Multi-Site, Rare Event, Distributed Setting: Part 2 In-Depth Example of a Re-Analysis of the MMRV Combination Vaccine and Seizure Risk Publication	Publication	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 View More Authors	05/02/2019
Evaluating the Use of Bootstrapping in Cohort Studies Conducted with 1:1 Propensity Score Matching — A Plasmode Simulation Study Publication	Publication	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 View More Authors	04/24/2019
The Devil's in the Details: Reports on Reproducibility in Pharmacoepidemiologic Studies Publication	Publication	Andrew B. Petrone, April DuCott, Joshua J. Gagne, Sengwee Toh, Judith C. Maro View More Authors	03/06/2019
Evidence from Real-World Data Sentinel Initiative of U.S. FDA Presentation	Presentation	Darren Toh View More Presenters	02/20/2019
Cross‐Network Directory Service: Infrastructure to Enable Collaborations Across Distributed Research Networks Publication	Publication	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 View More Authors	02/14/2019
A New Analytic Tool Developed in the Sentinel System to Assess Safe Use Recommendations Publication	Publication	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 View More Authors	02/12/2019
Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure Publication	Publication	Efe Eworuke, Emily C. Welch, Anne Tobenkin, Judith C. Maro View More Authors	02/08/2019
Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users Publication	Publication	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 View More Authors	01/19/2019
How Pharmacoepidemiology Networks Can Manage Distributed Analyses to Improve Replicability and Transparency and Minimize Bias Publication	Publication	Robert W. Platt, Richard Platt, Jeffrey S. Brown, David A. Henry, Olaf H. Klungel, Samy Suissa View More Authors	01/15/2019
Drug Safety in Pregnancy in a Large, Multisite Database: Mother-Infant Linkage in Sentinel Presentation	Presentation	Danijela Stojanovic View More Presenters	11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: Sentinel Pregnancy Tool and Transition to ICD-10 Presentation	Presentation	Elizabeth Suarez View More Presenters	11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: Validation of an ICD-10-based Algorithm to Identify Stillbirth in the Sentinel System Presentation	Presentation	Susan Andrade View More Presenters	11/30/2018
Drug Safety in Pregnancy in a Large, Multisite Database: FDA MyStudies App Presentation	Presentation	David Martin View More Presenters	11/29/2018
The FDA Sentinel Initiative — An Evolving National Resource Publication	Publication	Richard Platt, Jeffrey S. Brown, Melissa Robb, Mark McClellan, Robert Ball, Michael D. Nguyen, Rachel E. Sherman View More Authors	11/29/2018
Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review Publication	Publication	Sonal Singh, 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 View More Authors	11/23/2018
FDA-Catalyst - Using FDA's Sentinel Initiative for Large-Scale Pragmatic Randomized Trials: Approach and Lessons Learned During the Planning Phase of the First Trial Publication	Publication	Noelle M. Cocoros, 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 View More Authors	11/19/2018
Use of Tumor Necrosis Factor-alpha Inhibitors During Pregnancy Among Women Who Delivered Liveborn Infants Publication	Publication	Efe Eworuke, Genna Panucci, Margie Goulding, Rosemarie Neuner, Sengwee Toh View More Authors	11/14/2018
Overall and Cause-Specific Mortality in the Sentinel System: A Power Analysis Publication	Publication	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 View More Authors	11/13/2018
A Generalizable Smartphone-Based Clinical Research Platform Presentation	Presentation	Zachary Wyner View More Presenters	11/05/2018
Collection of Patient‐Provided Information through a Mobile Device Application for Use in Medical Product Safety Surveillance Presentation	Presentation	Zachary Wyner, Juliane Reynolds, Chayim Herzig-Marx, Shyam Deval, Adam Rauch, Jeffrey Brown, David Martin View More Presenters	11/04/2018
Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA’s Sentinel System Publication	Publication	Noelle M. Cocoros, Marc R. Larochelle, Jennifer Popovic, Andrew B. Petrone, Cynthia Kornegay, Jing Ju, Judith A. Racoosin View More Authors	10/31/2018
Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative Presentation	Presentation	Judith C. Maro View More Presenters	10/19/2018
Misclassification in Assessment of First Trimester In-Utero Exposure to Drugs used Proximally to Conception - The Example of Letrozole Utilization for Infertility Treatment Publication	Publication	Steven T. Bird, Sengwee Toh, Leyla Sahin, Susan E. Andrade, Kate Gelperin, Lockwood Taylor, Jaejoon Song, Christian Hampp View More Authors	10/15/2018
Association of Risk for Venous Thromboembolism With Use of Low-Dose Extended- and Continuous-Cycle Combined Oral Contraceptives: A Safety Study Using the Sentinel Distributed Database Publication	Publication	Jie Li, Genna Panucci, David Moeny, Wei Liu, Judith C. Maro, Sengwee Toh, Ting-Ying Huang View More Authors	10/01/2018
International Comparison of Approaches to Common Data Models for Comparative Effectiveness Research Presentation	Presentation	Jeffrey Brown View More Presenters	09/12/2018
Evaluating Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data from the FDA Sentinel System Publication	Publication	Robert Ball, Sengwee Toh, Jamie Nolan, Kevin Haynes, Richard Forshee, Taxiarchis Botsis View More Authors	08/28/2018
Validation of Transfusion Administrations Among Potential Transfusion-Related Acute Lung Injury (TRALI) Patients Included in the Sentinel Distributed Database Presentation	Presentation	Mayura U. Shinde, Meghan A. Baker, Caren Spencer‐Smith, Lesley H. Curtis, Steven A. Anderson, Austin Cosgrove, Richard Forshee, Jason Hickok, Adee Kennedy, David J. Mohlman, Mikhail Menis, Karla M. Miller, Manette Niu, Joyce Obidi, Wendy Paul, Russell Poland, Robert Rosofsky, Kimberly Smith, Salim Surani, Vinod Easwaran Nambudiri, Craig Zinderman, Azadeh Shoaibi, Candace C. Fuller View More Presenters	08/25/2018
Assessment of Transfusion-Related Acute Lung Injury (TRALI) after Blood Transfusion Presentation	Presentation	Candace C. Fuller, Craig Zinderman, Caren Spencer-Smith, Kimberly Smith, Steven A. Anderson, Lesley H. Curtis, Richard Forshee, Jason Hickok, Stacey Honda, Richard Max Kaufman, Adee Kennedy, Mikhail Menis, Karla M. Miller, Manette Niu, Joyce Obidi, Wendy Paul, Russell Poland, Robert Rosofsky, Robert Jin, Rong Tilney, Mayura U. Shinde, Azadeh Shoaibi, Fang Zhang, Lauren Zichittella, Meghan A. Baker View More Presenters	08/24/2018
Misclassification of Time-at-Risk Due to Free Drug Sample Use: A Simulation Study Presentation	Presentation	Zilu Zhang, Efe Eworuke, Margie R. Goulding, Michael D. Nguyen, Bruce Fireman, Judith C. Maro View More Presenters	08/22/2018
Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic Presentation	Presentation	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 View More Presenters	08/22/2018
First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies Presentation	Presentation	Steven Bird, Kate Gelperin, Leyla Sahin, Karen B. Bleich, Elnara Fazio-Eynullayeva, Corinne Woods, Erica Radden, Tamara Johnson, Mayura Shinde, Ira Krefting View More Presenters	08/22/2018
Using Time-Dependent Propensity Scores to Correct for Differential Depletion of Susceptibles when Estimating Hazard Ratios in Time-to-Event Data Presentation	Presentation	Richard Wyss View More Presenters	08/22/2018
Assessing the Impact of the New U.S. ICD-10-CM Coding System on Pharmacoepidemiologic Studies: An Application Between Angiotensin-Converting Enzyme Inhibitors and Angioedema Presentation	Presentation	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 View More Presenters	08/21/2018
Early Lessons on ICD-10-CM/PCS Transition in Claims-Based Drug Safety Assessments Presentation	Presentation	Ting‐Ying Huang, Emily C. Welch, Margie Goulding, David J. Graham, Rongmei Zhang, Marie Bradley View More Presenters	08/21/2018
Evaluation of Switching Patterns in FDA’s Sentinel System – A New Tool to Assess the Substitutability of Generic Drugs Presentation	Presentation	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 View More Presenters	08/21/2018
A Comparison of Drug Utilization Metrics for Two Drug Classes with Nationally Projected Sales and Patient-level Data from the Sentinel Database Presentation	Presentation	Mohamed Mohamoud, Yanmin Zhu, Steven Bird, Rima Izem, Nicole R. Haug, Anita Wagner, Judith C. Maro, Efe Eworuke View More Presenters	08/21/2018
Minor Differences, Major Consequences? Lessons Learned from Replication of a Claims-Based Drug Safety Assessment Presentation	Presentation	Ting-Ying Jane Huang, Laura Hou, Laura Shockro, Ella Pestine, Michael Nguyen, Judith C. Maro, Rima Izem View More Presenters	08/21/2018
Use of Multiple Sclerosis Drugs Among Live Birth Pregnancies in the United States Presentation	Presentation	Danijela Stojanovic, Mayura Shinde, Nicole Haug, Mohamed Mohamoud, Leyla Sahin, Genna Panucci, Rajani Rajbhandari, Lockwood Taylor View More Presenters	08/21/2018
Signal Detection using TreeScan with Drug Classes: Pilot Projects in Sentinel Presentation	Presentation	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 View More Presenters	08/21/2018
Performance of a Distributed Regression Analysis Software and Workflow Presentation	Presentation	Qoua L. Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Darren Toh View More Presenters	08/20/2018
Sequential and SequentialDesign: Tools For Prospective Sequential Medical Product Safety Surveillance Presentation	Presentation	Judith C. Maro, Efe Eworuke, Andreia Leite, Martin Kulldorff View More Presenters	08/20/2018
Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes Of Interest – An Empirical Evaluation Presentation	Presentation	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 View More Presenters	08/20/2018
Long Live the "Medical Data Janitors": International Data Quality Assurance Practices in Distributed Data Network Presentation	Presentation	Judith C. Maro, Christian G. Reich, Keith Marsolo, Yoshiaki Uyama, Kristian B. Filion, Miriam C.J.M. Sturkenboom View More Presenters	08/20/2018
Advances in the Study of Medication Errors in Computerized Healthcare Databases and Spontaneous Reporting Systems in Europe and North America Presentation	Presentation	Michael D. Nguyen, Jo Wyeth, Kevin Haynes, Lisa Herrinton, Rodrigo Postigo, Adrian Levy, Chi-Ming (Alice) Tu View More Presenters	08/20/2018
Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA's Sentinel System Presentation	Presentation	Marie C. Bradley, Mayura Shinde, Yodit Belew, D. Tyler Coyle, Jason Hickok, Russell Poland, Karla M. Miller, Austin Cosgrove, Crystal Garcia, Rong Tilney, Caren Spencer-Smith, Kimberly Smith, Ronald Holt, Candace Fuller View More Presenters	08/20/2018
Developing the Infrastructure to Assess Pregnancy Outcomes Following Vaccination: Influenza Vaccines and Spontaneous Abortion as a Use Case Presentation	Presentation	Alison Tse Kawai, Megan Reidy, Lauren Zichittella, Colleen Stockdale, Erin Longley, Cheryl Walraven, Chunfu Liu, Azadeh Shoaibi, Sandra Feibelmann, Grace Lee View More Presenters	08/20/2018
Diagnostic Algorithms for Identification of Cardiovascular Death in Administrative Claims Databases: A Systematic Review Presentation	Presentation	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 View More Presenters	08/20/2018
Computational Algorithms for Distributed Regression Analysis Based on SAS Software Presentation	Presentation	Qoua Her, Yury Vilk, Jessica Young, Zilu Zhang, Jessica Malenfant, Sarah Malek, Sengwee Toh View More Presenters	08/20/2018
A New Analytic Tool Developed in the Sentinel System to Assess Adherence To FDA’s Safe Use Recommendations Presentation	Presentation	Noelle Cocoros, Anita Wagner, Andrew Petrone, Elnara Fazio-Eynullayeva, Yulan Ding, Rima Izem, Joo-Yeon Lee, Jacqueline Major, Michael Nguyen, Jing Ju View More Presenters	08/20/2018
Estimating “Optimal” Durations for Initial Opioid Analgesic Prescription Following Common Surgical Procedures Presentation	Presentation	Mallika L. Mundkur, Tamra Meyer, Talia Menzin, Judy Staffa, Corinne Woods, Judith C. Maro, Justin Bohn View More Presenters	08/20/2018
Data-Mining for Adverse Events Using the Self-Controlled Tree-Temporal Scan Statistic Presentation	Presentation	Katherine Yih View More Presenters	08/20/2018
Validation of the Combined Comorbidity Score in the ICD-10 Era: Application to High-Risk Populations Presentation	Presentation	Justin Bohn, Emily C. Welch, Jenny W. Sun, Joshua J. Gagne, Sengwee Darren Toh View More Presenters	08/20/2018
Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs Publication	Publication	Joshua J. Gagne, Jennifer R. Popovic, Michael Nguyen, Sukhminder K. Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B. Petrone, Anita K. Wagner, Sarah K. Dutcher View More Authors	08/17/2018
Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study Publication	Publication	Andrew D. Mosholder, Lockwood Taylor, Glenn Mannheim, Lisa Ortendahl, Tiffany S. Woodworth, Sengwee Toh View More Authors	08/10/2018
Data Enclaves for Sharing Information Derived From Clinical and Administrative Data Publication	Publication	Richard Platt and Tracy Lieu View More Authors	08/06/2018
Data Mining for Adverse Drug Events with a Propensity Score Matched Tree-Based Scan Statistic Publication	Publication	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 View More Authors	08/01/2018
Outpatient Influenza Antivirals in a Distributed Data Network for Influenza Surveillance Publication	Publication	Noelle M. Cocoros, Genna Panucci, Nicole Haug, Carmen Maher, Marsha Reichman, Sengwee Toh View More Authors	07/27/2018
Assessing the Impact of the New ICD‐10‐CM Coding System on Pharmacoepidemiologic Studies — An Application to the Known Association Between Angiotensin‐Converting Enzyme Inhibitors and Angioedema Publication	Publication	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 View More Authors	06/26/2018
Early Impact of the ICD‐10‐CM Transition on Selected Health Outcomes in 13 Electronic Health Care Databases in the United States Publication	Publication	Catherine A. Panozzo, Tiffany S. Woodworth, Emily C. Welch, Ting‐Ying Huang, Qoua L. Her, Kevin Haynes, Catherine Rogers, Talia J. Menzin, Max Ehrmann, Katherine E. Freitas, Nicole R. Haug, Sengwee Toh View More Authors	06/26/2018
Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes of Interest- An Empirical Evaluation Publication	Publication	Rishi Desai, Richard Wyss, Yinzhu Jin, Justin Bohn, Sengwee Toh, Austin Cosgrove, Adee Kennedy, Jessica Kim, Clara Kim, Rita Ouellet-Hellstrom, Sara Karami, Jacqueline Major, Aaron Niman, Shirley Wang, Joshua Gagne View More Authors	06/26/2018
Diagnosis‐Based Cohort Augmentation using Laboratory Results Data: The Case of Chronic Kidney Disease Publication	Publication	David Smith, Susan Shetterly, James Flory, Kevin Haynes, Christine Lu, Joshua Gagne, Lisa Herrinton, Carsie Nyirenda, Elisabetta Patorno, Azadeh Shoaibi, Marsha Raebel View More Authors	06/22/2018
A Query Workflow Design to Perform Automatable Distributed Regression Analysis in Large Distributed Data Networks Publication	Publication	Qoua L. Her, Jessica M. Malenfant, Sarah Malek, Yury Vilk, Jessica Young, Lingling Li, Jeffery Brown, Sengwee Toh View More Authors	05/25/2018
Small Changes, Big Differences? Cohort Variation by Parameter Specifications in Claims-Based Drug Use Evaluations Presentation	Presentation	Ting-Ying Huang, Laura Shockro, Ella Pestine, Michael Nguyen, Judith Maro, Rima Izem View More Presenters	05/21/2018
Relative Performance of Propensity Score Matching Strategies for Subgroup Analyses Publication	Publication	Shirley V. Wang PhD, ScM; Yinzhu Jin MS, MPH; Bruce Fireman MA; Susan Gruber PhD, MPH; Mengdong He MS; Richard Wyss PhD; HoJin Shin MS; Yong Ma PhD, MS; Stephine Keeton PhD; Sara Karami PhD, MPH; Jacqueline M. Major PhD; Sebastian Schneeweiss MD, ScD; Joshua J. Gagne PharmD, ScD View More Authors	03/15/2018
Evaluation of the US Food and Drug Administration Sentinel Analysis Tools in Confirming Previously Observed Drug-Outcome Associations: The Case of Clindamycin and Clostridium difficile Infection Publication	Publication	Ryan M. Carnahan, Jennifer L. Kuntz, Shirley V. Wang, Candace Fuller, Joshua J. Gagne, Charles E. Leonard, Sean Hennessy, Tamra Meyer, Patrick Archdeacon, Chih‐Ying Chen, Catherine A. Panozzo, Sengwee Toh, Hannah Katcoff, Tiffany Woodworth, Aarthi Iyer, Sophia Axtman, Elizabeth A. Chrischilles View More Authors	03/13/2018
Utilization of Drugs with Pregnancy Exposure Registries During Pregnancy Publication	Publication	Onyekachukwu A. Illoh, Sengwee Toh, Susan E. Andrade, Christian Hampp, Leyla Sahin, Kate Gelperin, Lockwood Taylor, Steven T. Bird View More Authors	03/08/2018
Sequential Surveillance for Drug Safety in a Regulatory Environment Publication	Publication	David Martin MD, MPH; Joshua J. Gagne PharmD, ScD; Susan Gruber PhD, MPH; Rima Izem PhD; Jennifer C. Nelson PhD; Michael D. Nguyen MD; Rita Ouellet-Hellstrom PhD, MPH; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD; Alexander M. Walker MD, PhD View More Authors	03/05/2018
Assessment of Quadrivalent Human Papillomavirus Vaccine Safety Using the Self-Controlled Tree-Temporal Scan Statistic Signal-Detection Method in the Sentinel System Publication	Publication	W. Katherine Yih, PhD, MPH; Judith C. Maro, PhD; Michael Nguyen, MD; Meghan A. Baker, MD, ScD; Carolyn Balsbaugh, MPH; David V. Cole, BM; Inna Dashevsky, MS; Adamma Mba-Jonas, MD; Martin Kulldorff, PhD View More Authors	02/23/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Venous Thromboembolism among Intravenous Immune Globulin Users in the Sentinel Distributed Database Publication	Publication	Eric M. Ammann, Adam Cuker, Ryan M. Carnahan, Usha S. Perepu, Scott K. Winiecki, Marin L. Schweizer, Charles E. Leonard, Candace C. Fuller, Crystal Garcia, Cole Haskins, Elizabeth A. Chrischilles View More Authors	02/23/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Acute Myocardial Infarction (AMI) Among Intravenous Immune Globulin (IGIV) Users in the Sentinel Distributed Database Publication	Publication	Eric M. Ammann PhD, MS; Marin L. Schweizer PhD; Jennifer G. Robinson MD, MPH; Jayasheel O. Eschol MD; Rami Kafa MD; Saket Girotra MD, MS; Scott K. Winiecki MD; Candace C. Fuller PhD; Ryan M. Carnahan PharmD, MS, BCPP; Charles E. Leonard PharmD, MSCE; Cole Haskins BS; Crystal Garcia MPH; Elizabeth A. Chrischilles PhD, MS View More Authors	02/15/2018
Butterfly Effect in Studies Using Claims Data? Some Small Perturbations in Study Design Lead to Differences in Causal Inference Presentation	Presentation	Rima Izem PhD View More Presenters	01/12/2018
Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System Publication	Publication	Elizabeth A. Chrischilles PhD, MS; Joshua J. Gagne PharmD, ScD; Bruce Fireman MA; Jennifer Nelson PhD; Sengwee Toh ScD; Azadeh Shoaibi PhD, MHS; Marsha E. Reichman PhD; Shirley Wang PhD, ScM; Michael Nguyen MD; Rongmei Zhang PhD; Rima Izem PhD; Margie R. Goulding PhD; Mary Ross Southworth PharmD; David J. Graham MD, MPH; Candace Fuller PhD; Hannah Katcoff MPH; Tiffany Woodworth MPH; Catherine Rogers MPH; Ryan Saliga BBA; Nancy D. Lin ScD; Cheryl N. McMahill-Walraven PhD, MSW; Vinit P. Nair BPharm, MS, RPh; Kevin Haynes PharmD, MSCE; Ryan M. Carnahan PharmD, MS, BCPP View More Authors	01/10/2018
Methods for Examining Data Quality in Healthcare Integrated Data Repositories Presentation	Presentation	Vojtech Huser, Michael Kahn, and Jeffrey Brown View More Presenters	01/03/2018
Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database Publication	Publication	Eric M. Ammann MS; Enrique C. Leira MD, MS; Scott K. Winiecki MD; Nandakumar Nagaraja MD, MS; Sudeepta Dandapat MD; Ryan M. Carnahan PharmD, MS, BCPP; Marin L. Schweizer PhD; James C. Torner PhD; Candace C. Fuller PhD; Charles E. Leonard PharmD, MSCE; Crystal Garcia MPH; Madelyn Pimentel; Elizabeth A. Chrischilles PhD, MS View More Authors	12/01/2017
Opioid Tolerance and Urine Drug Testing among Initiates of Extended-Release or Long-Acting Opioids in Food and Drug Administration's Sentinel System Publication	Publication	Marc R. Larochelle MD, MPH; Noelle M. Cocoros DSc, MPH; Jennifer Popovic DVM, MA; Elizabeth C. Dee MPH; Cynthia Kornegay PhD; Jing Ju PharmD, PhD; Judith A. Racoosin MD, MPH View More Authors	11/20/2017
Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study Publication	Publication	Alan S. Go MD; Daniel E. Singer MD; Sengwee Toh ScD; T. Craig Cheetham PharmD, MS; Marsha E. Reichman PhD; David J. Graham MD, MPH; Mary Ross Southworth PharmD; Rongmei Zhang PhD; Rima Izem PhD; Margie R. Goulding PhD; Monika Houstoun PharmD; Katrina Mott MS; Sue Hee Sung MPH; Joshua J. Gagne PharmD, ScD View More Authors	11/14/2017
Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System Publication	Publication	Joshua J. Gagne PharmD, ScD; Monika Houstoun PharmD; Marsha E. Reichman PhD; Christian Hampp PhD; James H. Marshall MPH; Sengwee Toh ScD View More Authors	11/06/2017
Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study Publication	Publication	Sengwee Toh ScD; Marsha E. Reichman PhD; David J. Graham MD, MPH; Christian Hampp PhD; Rongmei Zhang PhD; Melissa G. Butler PharmD PhD; Aarthi Iyer MPH; Malcolm Rucker MS; Madelyn Pimentel BA; Jack Hamilton; Samuel Lendle; Bruce H. Fireman MA; the Mini-Sentinel Saxagliptin-AMI Surveillance Writing Group View More Authors	11/01/2017
Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network Publication	Publication	John G. Connolly SM; Shirley V. Wang PhD, ScM; Candace C. Fuller PhD; Sengwee Toh ScD; Catherine A. Panozzo PhD; Noelle Cocoros DSc; Meijia Zhou MHS; Joshua J. Gagne PharmD, ScD; Judith C. Maro PhD, MS View More Authors	10/06/2017
A Review of the Performance of Different Methods for Propensity Score Matched Subgroup Analyses and a Summary of their Application in Peer-Reviewed Research Studies Publication	Publication	Shirley V. Wang PhD, ScM; Mengdong He MS; Yinzhu Jin MS, MPH; Richard Wyss PhD; HoJin Shin MS; Yong Ma PhD, MS; Stephine Keeton PhD; Bruce Fireman MA; Sara Karami PhD, MPH; Jacqueline M. Major PhD; Sebastian Schneeweiss MD, ScD; Joshua Gagne PharmD, ScD View More Authors	10/06/2017
Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia (Video Abstract) Presentation	Presentation	Meijia Zhou, Sean Hennessy View More Presenters	10/06/2017
The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011 Publication	Publication	Meghan A. Baker MD, ScD; Melissa G. Butler PharmD, PhD, MPH; Sally Seymour MD; Fang Zhang PhD; Yute Wu PhD; Ann Chen Wu MD, MPH; Mark S. Levenson PhD; Pingsheng Wu PhD; Aarthi Iyer MPH; Sengwee Toh ScD; Solomon Iyasu MD, MPH; Esther H. Zhou MD, PhD View More Authors	09/14/2017
Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies Publication	Publication	Steven T. Bird PharmD, PhD, MS; Kate Gelperin MD; Lockwood Taylor PhD, MPH; Leyla Sahin MD; Hoda Hammad MS, MPH; Susan E. Andrade ScD; Mohamed A. Mohamoud PharmD, MPH; Sengwee Toh, ScD; Christian Hampp PhD View More Authors	08/29/2017
Promises and Challenges of Screening for Adverse Events in Sentinel Presentation	Presentation	Michael Nguyen View More Presenters	08/27/2017
Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database Presentation	Presentation	Richard Scott Swain View More Presenters	08/25/2017
Evaluation of Test Data in Distributed Research Networks: A Sentinel System Example Presentation	Presentation	Emily C. Welch View More Presenters	08/25/2017
Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System Presentation	Presentation	Noelle Cocoros View More Presenters	08/25/2017
Dispensings of Influenza Antiviral Medications in the Sentinel System as a Source of Data for Influenza Surveillance Presentation	Presentation	Noelle Cocoros View More Presenters	08/25/2017
Curating Inpatient Medication Use Data from a Hospital Network Electronic Medication Administration Record (eMAR) System: Lessons from the Sentinel System About Expanding Drug Safety Surveillance Potential Presentation	Presentation	Jennifer R. Popovic View More Presenters	08/25/2017
Distributed Regression Analysis in a Distributed Health Data Network Presentation	Presentation	Jessica M. Malenfant, MPH, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA View More Presenters	08/25/2017
Listening to Patient Voices in Pharmacoepidemiological Research - Opportunities for Innovation and Inclusion Presentation	Presentation	Wendy Camello Castillo View More Presenters	08/25/2017
Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System Presentation	Presentation	Elizabeth Chrischilles View More Presenters	08/25/2017
Developing a Mother-Infant Cohort in Sentinel's PRISM Program as a Resource to Monitor the Safety of Vaccine Use During Pregnancy Presentation	Presentation	Alison Kawai View More Presenters	08/25/2017
Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year Presentation	Presentation	Michael D. Nguyen, Judith C. Maro, Lockwood G. Taylor, David Moeny, Efe Eworuke, Steven Bird View More Presenters	08/25/2017
Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database Presentation	Presentation	Crystal Garcia View More Presenters	08/25/2017
Protocol-Based Assessment of Thromboembolic Events (TEEs) after Intravenous Immune Globulin (IVIg) in the Sentinel Distributed Database (2006-2012) Presentation	Presentation	Eric Ammann PhD, University of Iowa, College of Public Health, Iowa City, IA View More Presenters	08/25/2017
Expansion of the US FDA's Sentinel System to Inpatient Blood Transfusion Data from Hospital Corporation of America: New Surveillance Options Presentation	Presentation	Candace Fuller View More Presenters	08/25/2017
Evaluation of Case-Finding Algorithm for Venous Thromboembolism Outcome Presentation	Presentation	Megan Reidy, Jill L.O. de Jong, Lauren Zichittella, W. Katherine Yih View More Presenters	08/25/2017
Opportunities for Rapid Monitoring of New Cancer Treatments: Tyrosine Kinase Inhibitors in the Sentinel Distributed Database Presentation	Presentation	Anita K. Wagner, PharmD, MPH, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA View More Presenters	08/25/2017
Using the Self-Controlled Risk Interval (SCRI) Method to Study Vaccine Safety Presentation	Presentation	Katherine Yih View More Presenters	08/25/2017
Assessment of Transfusion-Related Acute Lung Injury After Red Blood Cell, Plasma and Platelet Administration: Initial Results in the Sentinel System Presentation	Presentation	Candace C. Fuller View More Presenters	08/25/2017
Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth Presentation	Presentation	Efe Eworuke View More Presenters	08/25/2017
Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System Presentation	Presentation	Genna Panucci View More Presenters	08/25/2017
Impact of ICD-10-CM Transition on Selected Cardiovascular-Related Events in the Sentinel System Presentation	Presentation	Tiffany Siu Woodworth View More Presenters	08/25/2017
TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance Presentation	Presentation	Judith Maro, Rima Izem, Martin Kulldorff, Azadeh Shoaibi View More Presenters	08/25/2017
A Review of Methods for Propensity Score Matched Subgroup Analysis and Their Application in Peer Reviewed Research Studies Presentation	Presentation	Shirley Wang, PhD, ScM, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA View More Presenters	08/25/2017
Identification of Name Confusion Medication Errors in the US FDA's Sentinel System Presentation	Presentation	Noelle Cocoros View More Presenters	08/25/2017
Early Post-Approval Surveillance of New Molecular Entity Uptake in the Sentinel Distributed Database Presentation	Presentation	Nicole R. Haug, MPH, Dept. of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, MA View More Presenters	08/25/2017
Randomized Clinical Trial Using FDA's Sentinel Infrastructure: An Analysis Assessing Feasibility Presentation	Presentation	Noelle Cocoros on behalf of Crystal Garcia View More Presenters	08/24/2017
Medical Product and Performance Evaluation Programs Using Distributed Data Sources Presentation	Presentation	Richard Platt MD, Robert Ball View More Presenters	08/24/2017
Developing a Mobile App for Studies of Medication Safety Presentation	Presentation	Sascha Dublin View More Presenters	08/24/2017
Type 1 and Type 2 Diabetes Mellitus Identification Using ICD-9-CM Codes Within a Cohort of New Users of Drugs Labeled for Type 2 Diabetes Mellitus Presentation	Presentation	Laura Hou View More Presenters	08/23/2017
Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners Publication	Publication	Crystal Garcia MPH; Candace Fuller PhD; Madelyn Pimentel BA; Eric Ammann MS; Elizabeth Chrischilles PhD, MS; Scott Winiecki MD View More Authors	08/10/2017
Sentinel Modular Program for Propensity-Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia Publication	Publication	Meijia Zhou MHS; Shirley V. Wang PhD, ScM; Charles E. Leonard PharmD, MSCE; Joshua J. Gagne PharmD, ScD; Candace Fuller PhD; Christian Hampp PhD; Patrick Archdeacon MD; Sengwee Toh ScD; Aarthi Iyer MPH; Tiffany S. Woodworth MPH; Elizabeth Cavagnaro MPH; Catherine A. Panozzo PhD; Sophia Axtman; Ryan M. Carnahan PharmD, MS, BCPP; Elizabeth Chrischilles PhD, MS, Sean Hennessy PharmD, PhD View More Authors	07/04/2017
Statistical Power for Postlicensure Medical Product Safety Data-Mining Publication	Publication	Judith C. Maro PhD; Michael D. Nguyen MD; Inna Dashevsky MS; Meghan A. Baker MD, ScD; Martin Kulldorff PhD View More Authors	06/12/2017
Antiemetic Use Among Pregnant Women in the United States: The Escalating Use of Ondansetron Publication	Publication	Lockwood G. Taylor PhD, MPH; Steven T. Bird PharmD, PhD, MS; Leyla Sahin MD; Melissa S. Tassinari PhD; Patty Greene PharmD; Marsha E. Reichman PhD; Susan E. Andrade ScD; Katherine Haffenreffer BS; Sengwee Toh ScD View More Authors	02/20/2017
Missing Laboratory Results Data in Electronic Health Databases: Implications for Monitoring Diabetes Risk Publication	Publication	James H. Flory MD, MS; Jason Roy PhD; Joshua Gagne PharmD, ScD; Kevin Haynes PharmD, ScD; Lisa Herrinton PhD; Christine Lu PhD, MSc; Elisabetta Patorno MD, DrPH; Azadeh Shoaibi PhD, MHS; Marsha Raebel PharmD View More Authors	01/06/2017
Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making Publication	Publication	Sebastian Schneeweiss MD, ScD; Hans Georg Eichler MD, MSc; Anna Garcia-Altes; Chris Chinn; Anne-Virginie Eggimann; Sarah E. Garner; W. Goettsch; Robyn R. Lim; W. Löbker; David Martin MD, MPH; T. Müller; B.J. Park; Richard Platt MD, MSc; Sarah A. Priddy; Michael Ruhl; Almoth Spooner; B Vannieuwenhuyse; Richard J Willke View More Authors	12/01/2016
Distributed Data Networks: A Blueprint for Big Data Sharing and Healthcare Analytics Publication	Publication	Jennifer R. Popovic DVM, MA View More Authors	11/18/2016
The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies Publication	Publication	Elisabetta Patorno MD, DrPH; Joshua Gagne PharmD, ScD; Christine Lu PhD, MSc; Kevin Haynes PharmD, MSCE; Andrew Sterret PhD; Jason Roy PhD; Marsha Raebel PharmD; Xingmei Wang MS View More Authors	11/14/2016
A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data Publication	Publication	Jennifer C. Nelson PhD; Robert Wellman MS; Onchee Yu MS; Andrea J. Cook PhD; Judith C. Maro PhD; Rita Ouellet-Hellstrom PhD, MPH; Denise Boudreau RPh, PhD; James S. Floyd MD, MS; Susan R. Heckbert MD, PhD; Simone Pinheiro ScD, MSc; Marsha Reichman PhD; Azadeh Shoaibi PhD, MHS, MS View More Authors	09/06/2016
Pilot Test of the Sentinel Modular Program for Propensity Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Severe Hypoglycemia Presentation	Presentation	Meijia Zhou, Shirley V. Wang, Charles E. Leonard, Joshua J. Gagne, Candace Fuller, Christian Hampp, Patrick Archdeacon, Sengwee Toh, Aarthi Iyer, Tiffany Siu Woodworth, Elizabeth Cavagnaro, Catherine A. Panozzo, Sophia Axtman, Ryan M. Carnahan, Elizabeth A. Chrischilles, Sean Hennessey View More Presenters	08/24/2016
Utilization of Laboratory Results Data to Enhance Pregnancy Cohort Identification in a Distributed Data Network Presentation	Presentation	Kevin Haynes, Andrew Sterrett, Susan M. Shetterly, Mano S. Selvan, Joshua J. Gagne, Christine Y. Lu, Azadeh Shoaibi, Marsha A. Raebel View More Presenters	08/23/2016
Do Hemoglobin Lab Test Results Increase Detection of Upper Gastrointestinal Bleeding (UGIB)? Presentation	Presentation	Elisabetta Patorno, Joshua J. Gagne, Christine Y. Lu, Kevin Haynes, Andrew T. Sterrett, Jason Roy, Xingmei Wang, Marsha A. Raebel View More Presenters	08/23/2016
Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA's Sentinel Program Presentation	Presentation	John G. Connolly, Joshua J. Gagne View More Presenters	08/23/2016
A Framework for Rapid Medical Product Safety Assessment: FDA's Sentinel Toolkit Presentation	Presentation	Elizabeth Cavagnaro, Hannah Katcoff, Candace Fuller, Jennifer R. Popovic, Tiffany S. Woodworth, Nicolas Beaulieu, April Duddy, Eric Gravel, Erick Moyneur, Sengwee Toh, Jeffrey Brown View More Presenters	08/23/2016
ICD-10-CM: Is Sentinel Ready? Presentation	Presentation	Darren Toh View More Presenters	08/23/2016
Assessment of the US Food and Drug Administration’s Sentinel Analysis Tools: Angiotensin-Converting Enzyme Inhibitors and Angioedema Presentation	Presentation	Joshua Gagne View More Presenters	08/23/2016
Ondasetron Use Among Pregnancies Identified in the Sentinel Distributed Database Presentation	Presentation	Lockwood G. Taylor View More Presenters	08/23/2016
Utilization Patterns for Products with Pregnancy Exposure Registries in Pregnant Versus Non-Pregnant Women in the Sentinel Database Presentation	Presentation	Steven T. Bird, Lockwood Taylor, Christian Hampp, Kate Gelperin, Darren Toh, Susan Andrade, Katie Haffenreffer, Marsha Reichman, Leyla Sahin View More Presenters	08/23/2016
Diagnosis-Based Cohort Augmentation Using Laboratory (Lab) Data in the FDA Sentinel Initiative: The Case of Chronic Kidney Disease (CKD) Presentation	Presentation	David H. Smith View More Presenters	08/23/2016
Monitoring All Drugs for a Specific Outcome in the Sentinel System Presentation	Presentation	Judith C. Maro, Gerald Dal Pan, Jeffrey S. Brown, Inna Dashevsky, Martin Kulldorff View More Presenters	08/23/2016
Assessing Quadrivalent HPV Vaccine Safety using the Self-Controlled Tree-Temporal Scan Statistic Presentation	Presentation	Martin Kulldorff, Katherine Yih View More Presenters	08/23/2016
A Systematic Review of Enrollment and Retention in US Pregnancy Exposure Registries and Corresponding Pharmacovigilance Systems Presentation	Presentation	Steven T. Bird, Kate Gelperin, Lockwood Taylor, Leyla Sahin, Mohamed Mohamoud, Christian Hampp View More Presenters	08/23/2016
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association Publication	Publication	Joshua Gagne PharmD, ScD; X. Han PharmD, PhD, MS; Sean Hennessy PharmD, PhD; Charles E. Leonard PharmD, MSCE; Elizabeth Chrischilles PhD, MS; Ryan M. Carnahan PharmD, MS, BCPP; Shirley V. Wang PhD; Candace Fuller PhD; Aarthi Iyer MPH; Hannah Katcoff MPH; Tiffany S. Woodworth MPH; Patrick Archdeacon MD; Tamra E. Meyer PhD; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD View More Authors	08/22/2016
Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association Publication	Publication	Susan Gruber PhD, MPH; Aloka Chakravarty PhD; Susan R. Heckbert MD, PhD; Mark S. Levenson PhD; David Martin MD, MPH; Jennifer C. Nelson PhD; Bruce M. Psaty MD, PhD; Simone Pinheiro ScD, MSc; Christian G. Reich MD, PhD; Sengwee Toh ScD; Alexander M. Walker MD, PhD View More Authors	07/14/2016
Quantitative Bias Analysis in Regulatory Settings Publication	Publication	Timothy L. Lash DSc, MPH; Matthew P. Fox DSc, MPH; Darryl Cooney MStat; Yun Lu PhD, MS; Richard A. Forshee PhD View More Authors	06/10/2016
Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study Publication	Publication	Darren Toh ScD; Christian Hampp PhD; Marsha E. Reichman PhD; David J. Graham MD, MPH; Suchitra Balakrishnan; Frank Pucino; Jack Hamilton; Samuel Lendle; Aarthi Iyer MPH; Malcolm Rucker MS; Madelyn Pimentel BA; Neesha Nathwani; Marie R. Griffin MD, MPH; Nancy J. Brown; Bruce H. Fireman MA View More Authors	06/07/2016
Evidence Generation from Healthcare Databases: Recommendations for Managing Change Publication	Publication	Alison Bourke, Andrew Bate PhD; Brian C. Sauer PhD, MS; Jeffrey S. Brown PhD; Gillian C. Hall PhD View More Authors	05/17/2016
Use of Selective Serotonin Reuptake Inhibitors (SSRIs) in Women Delivering Liveborn Infants and other Women of Child-Bearing Age within the U.S. Food and Drug Administration's Mini-Sentinel Program Publication	Publication	Susan E. Andrade ScD; Marsha E. Reichman PhD; Katrina Mott MS; Marilyn Pitts PharmD; Caren Kieswetter MD, MPH; Miriam Dinatale DO; Marc B. Stone MD; Jennifer Popovic DVM, MA; Katherine Haffenreffer BS; Sengwee Toh ScD View More Authors	05/13/2016
Uptake of New Drugs in the Early Post-Approval Period in the Mini-Sentinel Distributed Database Publication	Publication	Katrina Mott MS; David J. Graham MD, MPH; Sengwee Toh ScD; Joshua J. Gagne PharmD, ScD; Mark Levenson PhD; Yong Ma PhD, MS; Marsha E. Reichman PhD View More Authors	05/04/2016
Methods for using Clinical Laboratory Test Results as Baseline Confounders in Multi-Site Observational Database Studies when Missing Data are Expected Publication	Publication	Marsha A. Raebel PharmD; Susan Shetterly MS; Christine Y. Lu PhD, MSc; James S. Flory MD, MS; Joshua J. Gagne PharmD, ScD; Frank E. Harrell PhD; Kevin Haynes PharmD, MSCE; Lisa J. Herrinton PhD; Elisabetta Patorno MD, DrPH; Jennifer Popovic DVM, MA; Mano Selvan PhD; Azadeh Shoaibi PhD, MHS; Xingmei Wang MS; Jason Roy PhD View More Authors	05/04/2016
Prospective Influenza Vaccine Safety Surveillance Using Fresh Data in the Sentinel System Publication	Publication	W. Katherine Yih, PhD, MPH; Martin Kulldorff, PhD; Sukhminder K. Sandhu, PhD, MPH, MS; Lauren Zichittella, MS; Judith C. Maro, PhD, MS; David V. Cole, BM; Robert Jin, MS; Alison Tse Kawai, ScD; Meghan A. Baker, MD, ScD; Chunfu Liu, ScD; Cheryl N McMahill-Walraven, PhD, MSW; Mano S. Selvan, PhD; Richard Platt, MD, MSc; Michael Nguyen, MD; Grace M. Lee, MD, MPH View More Authors	04/30/2016
Intravenous Immune Globulin and Thromboembolic Adverse Events: A Systematic Review and Meta-Analysis of RCTs Publication	Publication	Eric M. Ammann PhD, MS; Cole B. Haskins BS; Kelsey M. Fillman; Rebecca L. Ritter; Xiaomei Gu; Scott K. Winiecki MD; Ryan M. Carnahan PharmD, MS; James C. Torner PhD; Bruce H. Fireman MA; Michael P. Jones; Elizabeth A. Chrischilles PhD, MS View More Authors	04/24/2016
Changing Patterns of Asthma Medication use Related to U.S. Food and Drug Administration Long-Acting Beta2-agonist Regulation from 2005-2011 Publication	Publication	Melissa G. Butler PharmD, PhD, MPH; Esther H. Zhou MD, PhD; Fang Zhang PhD; Yu-te Wu PhD; Ann Chen Wu MD, MPH; Mark S. Levenson PhD; Pingsheng Wu PhD; Sally Seymour MD; Sengwee Toh ScD; Aarthi Iyer MPH; Solomon Iyasu MD, MPH; Meghan A. Baker MD, ScD View More Authors	03/01/2016
Evaluation of Propensity Scores, Disease Risk Scores, and Regression in Confounder Adjustment for the Safety of Emerging Treatment with Group Sequential Monitoring Publication	Publication	Stanley Xu PhD; Susan Shetterly MS; Andrea J. Cook PhD; Marsha A. Raebel PharmD; Sunali Goonesekera MS; Azadeh Shoaibi PhD, MS, MHS; Jason Roy PhD; Bruce Fireman MA View More Authors	02/15/2016
Data Extraction and Management in Networks of Observational Health Care Databases for Scientific Research: A Comparison of EU-ADR, OMOP, Mini-Sentinel and MATRICE Strategies Publication	Publication	Rosa Gini PhD; Martijn Schuemie PhD; Jeffrey Brown PhD; Patrick Ryan PhD; Edoardo Vacchi PhD; Massimo Coppola; Walter Cazzola PhD; Preciosa Coloma MD, PhD; Roberto Berni; Gayo Diallo PhD; José Luis Oliveira PhD; Paul Avillach MD, PhD; Gianluca Trifirò MD, PhD; Peter Rijnbeek PhD, MSc; Mariadonata Bellentani; Johan van Der Lei MD, PhD; Niek Klazinga MD, PhD; Miriam Sturkenboom PhD, MS View More Authors	02/08/2016
The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance Publication	Publication	Robert Ball MD, MPH, ScM; Melissa A. Robb RN; Stephen A. Anderson PhD, MPP; Gerald Dal Pan MD, MHS View More Authors	01/12/2016
Evaluation of the Risk of Venous Thromboembolism after Quadrivalent Human Papillomavirus Vaccination among U.S. Females Publication	Publication	W. Katherine Yih PhD, MPH; Sharon K. Greene PhD, MPH; Lauren Zichittella MS; Martin Kulldorff PhD; Meghan A. Baker MD, ScD; Jill L.O. de Jong MD, PhD; Ruth Gil Prieto PhD, MPH, MSc; Marie R. Griffin MD, MPH; Robert Jin MS; Nancy D. Lin ScD; Cheryl McMahill-Walraven PhD, MSW; Megan Reidy MPH; Nandini Selvam; PhD, MPH; Mano Selvan PhD; Michael D. Nguyen MD View More Authors	01/02/2016
Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011 Publication	Publication	Allison L. Naleway PhD; Brad Crane; Ning Smith; Matthew F. Daley MD; James Donahue; Julianne Gee Sharon K. Greene PhD, MPH; Theresa Harrington; Lisa A. Jackson MD, MPH; Nicola P. Klein MD, PhD; Hung Fu Tseng; Claudia Vellozzi MD; Eric S. Weintraub View More Authors	01/02/2016
Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance Publication	Publication	Matthew F. Daley MD; Kristen Goddard MPH; Melissa McClung MSPH; Arthur Davidson MD, MPH; Gretchen Weiss MPH; Ted Palen PhD, MD, MSPH; Carsie Nyirenda MPH; Richard Platt MD, MSc; Brooke Courtney JD, MPH; Marsha E. Reichman PhD View More Authors	01/01/2016
Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program Publication	Publication	Susan Andrade ScD; Darren Toh ScD; Monika Houstoun PharmD, MPH; Katrina Mott MHS; Marilyn Pitts PharmD; Caren Kieswetter MD, MPH; Carrie Ceresa PharmD, MPH; Katie Haffenreffer BS; Marsha Reichman PhD View More Authors	12/08/2015
Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine Publication	Publication	Alison Tse Kawai ScD; David Martin MD, MPH; Martin Kulldorff PhD; Lingling Li PhD; David V. Cole BM; Cheryl N. McMahill-Walraven PhD, MSW; Nandini Selvam PhD, MPH; Mano S. Selvan PhD; Grace M. Lee MD, MPH View More Authors	09/14/2015
Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin Publication	Publication	Scott K. Winiecki MD; Bethany Baer MD; Wambui Chege MD; Christopher Jankosky MD; Paul D. Mintz MD; Meghan A. Baker MD, ScD; Tiffany S. Woodworth MPH; Michael D. Nguyen MD View More Authors	07/14/2015
Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Publication	Publication	Ivair R. Silva PhD; Martin Kulldorff PhD View More Authors	05/22/2015
A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program Publication	Publication	Meghan A. Baker MD, ScD; Tracy A. Lieu MD, MPH; Lingling Li PhD; Wei Hua MD; Yandong Qiang MD, PhD, MPH; Alison Tse Kawai ScD; Bruce Fireman MA; David B. Martin MD, MPH; Michael Nguyen MD View More Authors	03/13/2015
Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study Publication	Publication	Judith C. Maro PhD; Dennis G. Fryback PhD; Tracy A. Lieu MD, MPH; Grace M. Lee MD, MPH; David B. Martin MD, MPH View More Authors	12/22/2014
Adherence to Guidelines for Glucose Assessment in Starting Second-Generation Antipsychotics Publication	Publication	Marsha Raebel PharmD; Robert Penfold PhD; Ann McMahon MD, MSc; Marsha Reichman PhD; Susan Shetterly MS; Glenn Goodrich MS; Susan Andrade ScD; Christoph Correll MD; Tobias Gerhard PhD View More Authors	10/06/2014
Characteristics of Study Design and Elements that may Contribute to the Success of Electronic Safety Monitoring Systems Publication	Publication	Carlos Bell MPH; Aloka Chakravarty PhD; Susan Gruber PhD, MPH, MS; Susan R. Heckbert; Mark Levenson; David Martin MD; Jennifer C. Nelson PhD; Simone Pinheiro ScD; Bruce M. Psaty MD, PhD; Christian G. Reich MD, PhD; Sebastian Schneeweiss MD, ScD; Azadeh Shoaibi PhD, MS, MHS; Sengwee Toh ScD; Alexander M. Walker MD, PhD View More Authors	09/28/2014
Four Health Data Networks Illustrate The Potential For A Shared National Multipurpose Big-Data Network Publication	Publication	Lesley H. Curtis PhD; Jeffrey S. Brown PhD; Richard Platt MD, MSc View More Authors	07/01/2014
Electronic Clinical Laboratory Test Results Data Tables: Lessons from Mini-Sentinel Publication	Publication	Marsha A. Raebel PharmD; Kevin Haynes PharmD, MSCE; Tiffany S. Woodworth MPH; Gwyn Saylor; Elizabeth Cavagnaro MPH; Kara O. Coughlin; Lesley H. Curtis PhD; Mark G. Weiner MD; Patrick Archdeacon MD; Jeffrey S. Brown PhD View More Authors	02/18/2014
Intussusception Risk after Rotavirus Vaccination in U.S. Infants Publication	Publication	W. Katherine Yih PhD, MPH; Tracy A. Lieu MD, MPH; Martin Kulldorff PhD; David Martin MD, MPH; Cheryl McMahill-Walraven PhD, MSW; Richard Platt MD, MSc; Nandini Selvam PhD, MPH; Mano Selvan PhD; Grace M. Lee MD, MPH; Michael Nguyen MD View More Authors	02/06/2014
Framework for Assessment of Positive Results from Signal Refinement Publication	Publication	David L. McClure PhD; Marsha A. Raebel PharmD; W. Katherine Yih PhD, MPH; Azadeh Shoaibi PhD, MHS, MS; Jerald E. Mullersman MD, PhD, MPH; Colin Anderson-Smits MPH; Jason M. Glanz PhD View More Authors	01/01/2014
A Systematic Review of Validated Methods for Identifying Uveitis using Administrative or Claims Data Publication	Publication	S. Elizabeth Williams MD; Ryan Carnahan PharmD, MS, BCPP; Melissa L. McPheeters PhD, MPH View More Authors	12/30/2013
Postlicensure Rapid Immunization Safety Monitoring Program (PRISM) Data Characterization Publication	Publication	Meghan A. Baker MD, ScD; Michael Nguyen MD; David Cole BM; Grace M. Lee MD, MPH; Tracy A. Lieu MD, MPH View More Authors	12/30/2013
PRISM Supplement to Vaccine - Active Surveillance of Vaccine Safety in the US Food and Drug Administration’s Mini-Sentinel Program: Identification of Exposures and Outcomes Publication	Publication	Melissa L. McPheeters PhD, MPH; Ryan Carnahan PharmD, MS, BCPP View More Authors	12/30/2013
Methods for Systematic Reviews of Administrative Database Studies Capturing Health Outcomes of Interest Publication	Publication	Melissa L. McPheeters PhD, MPH; Nila Sathe MA, MLIS; Rebecca N. Jerome MLIS, MPH; Ryan Carnahan PharmD, MS, BCPP View More Authors	12/30/2013
A Systematic Review of Validated Methods for Identifying Bell's Palsy using Administrative or Claims Data Publication	Publication	Christopher D. Lee MD, MPH; Ryan Carnahan PharmD, MS, BCPP; Melissa L. McPheeters PhD, MPH View More Authors	12/30/2013
A Systematic Review of Validated Methods to Capture Acute Bronchospasm using Administrative or Claims Data Publication	Publication	Mona Sharifi MD, MPH; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH View More Authors	12/30/2013
A Systematic Review of Validated Methods to Capture Several Rare Conditions using Administrative or Claims Data Publication	Publication	Christopher D. Lee MD, MPH; S. Elizabeth Williams MD; Nila A. Sathe MA, MLIS; Melissa L. McPheeters PhD, MPH View More Authors	12/30/2013
A Systematic Review of Validated Methods for Identifying Kawasaki Disease using Administrative or Claims Data Publication	Publication	Candice L. Williams MD, MPH; Nila A. Sathe MA, MLIS; Shanthi Krishnaswami MMS; Melissa McPheeters PhD, MPH View More Authors	12/30/2013
A Systematic Review of Validated Methods to Capture Myopericarditis using Administrative or Claims Data Publication	Publication	Rachel T. Idowu MD; Ryan Carnahan PharmD, MS, BCPP; Nila Sathe MA, MLIS; Melissa L. McPheeters PhD, MPH View More Authors	12/30/2013
A Systematic Review of Validated Methods for Identifying Patients with Rheumatoid Arthritis using Administrative or Claims Data Publication	Publication	Cecilia P. Chung MD, MPH; Patricia Rohan MD; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH View More Authors	12/30/2013
A Systematic Review of Validated Methods for Identifying Systemic Lupus Erythematosus (SLE) using Administrative or Claims Data Publication	Publication	Kevin G. Moores PharmD; Nila Sathe MA, MLIS View More Authors	12/30/2013
A Systematic Review of Validated Methods to Capture Stillbirth and Spontaneous Abortion using Administrative or Claims Data Publication	Publication	Frances E. Likis DrPH, NP, CNM; Nila Sathe MA, MLIS; Ryan Carnahan PharmD, MS, BCPP; Melissa McPheeters PhD, MPH View More Authors	12/30/2013
A Systematic Review of Validated Methods for Identifying Transverse Myelitis using Administrative or Claims Data Publication	Publication	S. Elizabeth Williams MD; Ryan Carnahan PharmD, MS, BCPP; Shanthi Krishnaswami MMS; Melissa L. McPheeters PhD, MPH View More Authors	12/30/2013
Validation of Anaphylaxis in the Food and Drug Administration's Mini-Sentinel Publication	Publication	Kathleen Walsh MD, MSc; Sarah Cutrona MD, MPH; Sarah Foy BA; Meghan Baker MD, ScD; Susan Forrow BA; Azadeh Shoaibi PhD, MHS, MS; Pamala Pawloski PharmD; Michelle Conroy MD; Andrew Fine MD, MPH; Lise Nigrovic MD, MPH; Nandini Selvam PhD, MPH; Mano Selvan PhD; William Cooper MD, MPH; Susan Andrade ScD View More Authors	09/05/2013
Self-Control Tree Scan Data Mining for Vaccine Adverse Events Presentation	Presentation	Martin Kulldorf, Carolyn Balsbaugh, Inna Dashevsky, Ruth Gil-Prieto, Grace Lee, Michael Nguyen, David Martin, Estelle Russek-Cohen, Robert Ball, Robert Davis View More Presenters	08/27/2013
Re-Using Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals via Modular Analytic Programs Publication	Publication	Sengwee Toh ScD; Jerry Avorn MD; Ralph B. D'Agostino Sr. PhD; Jerry H. Gurwitz MD; Bruce M. Psaty MD, PhD; Kenneth J. Rothman DrPH; Kenneth G. Saag MD, MSc; Miriam C.J.M. Sturkenboom PhD; Jan P. Vandenbroucke MD, PhD; Almut G. Winterstein RPh, PhD; Brian L. Strom MD, MPH View More Authors	08/07/2013
Multivariable Confounding Adjustment in Distributed Data Networks without Sharing of Patient-Level Data Publication	Publication	Sengwee Toh ScD; Marsha E. Reichman PhD; Monika Houstoun PharmD; Xiao Ding PhD; Bruce H. Fireman MA; Eric Gravel; Mark Levenson PhD; Lingling Li PhD; Erick Moyneur; Azadeh Shoaibi PhD, MHS; Gwen Zornberg MD, MS, ScD; Sean Hennessy PharmD, PhD View More Authors	07/22/2013
A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions Publication	Publication	Becky A. Briesacher PhD; Stephen B. Soumerai ScD; Fang Zhang PhD; Sengwee Toh ScD; Susan Andrade ScD; Joann L. Wagner MSW; Azadeh Shaoibi PhD, MS, MHS; Jerry H. Gurwitz MD View More Authors	07/12/2013
Validity of Diagnostic Codes to Identify Cases of Severe Acute Liver Injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database Publication	Publication	Vincent Lo Re MD, MSCE; Kevin Haynes PharmD, MSCE; David Goldberg MD, MSCE; Kimberly L. Forde MD, MHS; Dena M. Carbonari MS; Kimberly B. F. Leidi MPH; Sean Hennessy PharmD, PhD; K. Rajender Reddy MD; Pamela A. Pawloski PharmD; Gregory W. Daniel PhD, MPH, RPh; Craig Cheetham PharmD, MS; Aarthi Iyer MPH; Kara O. Coughlin; Sengwee Toh ScD, Denise M. Boudreau RPh, PhD; Nandani Selvam PhD, MPH; William O. Cooper MD, MPH; Mano S. Selvan PhD; Jeffery J. VanWormer PhD; Mark I. Avigan MD, CM; Monika Houstoun PharmD; Gwen L. Zornberg MD, ScD, MS; Judith A. Racoosin MD, MPH; Azadeh Shoaibi PhD, MHS, MS View More Authors	06/25/2013
Rapid Assessment of Cardiovascular Risk Among Users of Smoking Cessation Drugs Within the US Food and Drug Administration's Mini-Sentinel Program Publication	Publication	Sengwee Toh ScD; Meghan A. Baker MD, ScD; Jeffrey S. Brown PhD; Cynthia Kornegay PhD; Richard Platt MD, MS View More Authors	05/13/2013
Investments in Infrastructure for Diverse Research Resources and the Health of the Public Publication	Publication	Bruce M. Psaty MD, PhD; Eric B. Larson MD, MPH View More Authors	05/08/2013
Is Size the Next Big Thing in Epidemiology? Publication	Publication	Sengwee Toh ScD; Richard Platt MD, MSc View More Authors	05/01/2013
Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding Publication	Publication	Mary Ross Southworth PharmD; Marsha E. Reichman PhD; Ellis F. Unger MD View More Authors	04/04/2013
Comparative Risk for Angioedema Associated with the Use of Drugs that Target the Renin-Angiotensin-Aldosterone System Publication	Publication	Sengwee Toh ScD; Marsha E. Reichman PhD; Monika Houstoun PharmD; Mary Ross Southworth PharmD; Xiao Ding PhD; Adrian F. Hernandez MD; Mark Levenson PhD; Lingling Li PhD; Carolyn McCloskey MD, MPH; Azadeh Shoaibi MS, MHS; Eileen Wu PharmD; Gwen Zornberg MD, MS, ScD; Sean Hennessy PharmD, PhD View More Authors	11/12/2012
Success Of Program Linking Data Sources To Monitor H1N1 Vaccine Safety Points To Potential For Even Broader Safety Surveillance Publication	Publication	Daniel A. Salmon PhD, MPH; W. Katherine Yih PhD, MPH; Grace Lee MD, MPH; Robert Rosofsky MA; Jeffrey Brown PhD; Kirsten Vannice PhD, MHS; Jerome Tokars MD, MPH; James Roddy; Robert Ball MD, MPH, ScM; Bruce Gellin MD, MPH; Nicole Lurie MD, MSPH; Howard Koh MD; Richard Platt MD, MSc; Tracy Lieu MD, MPH View More Authors	11/01/2012
Validation of Acute Myocardial Infarction in the Food and Drug Administration's Mini-Sentinel Program Publication	Publication	Sarah L. Cutrona MD, MPH; Sengwee Toh ScD; Aarthi Iyer MPH; Sarah Foy BA; Gregory W. Daniel PhD, MPH; Vinit P. Nair BPharm, MS, RPh; Daniel Ng MD; Melissa G. Butler PharmD, MPH, PhD; Denise Boudreau RPh, PhD; Susan Forrow BA; Robert Goldberg PhD; Joel Gore MD; David McManus MD; Judith A. Racoosin MD, MPH; Jerry H. Gurwitz MD View More Authors	06/29/2012
Health Outcomes of Interest for Evaluation in the Postlicensure Rapid Immunization Safety Monitoring Program Publication	Publication	Tracy A. Lieu MD, MPH; Michael D. Nguyen MD; Robert Ball MD, MPH, ScM; David B. Martin MD, MPH View More Authors	04/16/2012
Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative Data: Summary of Findings and Suggestions for Future Research Publication	Publication	Ryan M. Carnahan PharmD, MS, BCPP View More Authors	02/05/2012
PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program Publication	Publication	Richard Platt MD, MSc; Ryan M. Carnahan PharmD, MS, BCPP View More Authors	01/31/2012
A Systematic Review of Validated Methods for Identifying Hypersensitivity Reactions other than Anaphylaxis (Fever, Rash, and Lymphadenopathy), using Administrative and Claims Data Publication	Publication	Gary Schneider ScD, MSPH; Sumesh Kachroo PhD, MS, BPharm; Natalie Jones BS; Sheila Crean MPH; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD; United BioSource Corporation, Epidemiology and Database Analytics, Lexington, MA View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Cerebrovascular Accident or Transient Ischemic Attack using Administrative Data Publication	Publication	Susan Andrade ScD; Leslie Harrold MD, MPH; Jennifer Tjia MD, MSCE; Sarah Cutrona MD; Jane Saczynski PhD; Katherine S. Dodd; Robert Goldberg PhD; Jerry Gurwitz MD; Meyers Primary Care Institute and University of Massachusetts Medical School, Worcester, MA View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Pulmonary Fibrosis and Interstitial Lung Disease using Administrative and Claims Data Publication	Publication	Natalie Jones BS; Gary Schneider ScD, MSPH; Sumesh Kachroo PhD; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD; United BioSource Corporation, Epidemiology and Database Analytics, Lexington, MA View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Heart Failure using Administrative Data Publication	Publication	Jane Saczynski PhD; Susan Andrade ScD; Leslie Harrold MD, MPH; Jennifer Tjia MD, MSCE; Sarah Cutrona MD; Katherine S. Dodd; Robert Goldberg PhD; Jerry Gurwitz MD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Acute Respiratory Failure using Administrative and Claims Data Publication	Publication	Natalie Jones BS; Gary Schneider ScD, MSPH; Sumesh Kachroo PhD, MS, BPharm; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Atrial Fibrillation using Administrative Data Publication	Publication	Paul N. Jensen BA; Karin Johnson PhD; James Floyd MD; Susan R. Heckbert MD, PhD; Ryan Carnahan PharmD, MS, BCPP; Sascha Dublin MD, PhD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Orthopedic Implant Removal and Revision using Administrative Data Publication	Publication	Jasvinder A. Singh MD, MPH; Joseph A. Kundukulam BS; Mohit Bhandari MD, MSc View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Ventricular Arrhythmias using Administrative and Claims Data Publication	Publication	Leo Tamariz MD; Thomas Harkins MA, MPH; Vinit Nair BPharm, MS, RPh View More Authors	01/19/2012
Design for Validation of Acute Myocardial Infarction Cases in Mini-Sentinel Publication	Publication	Sarah L. Cutrona MD, MPH; Sengwee Toh ScD; Aarthi Iyer MPH; Sarah Foy BA; Elizabeth Cavagnaro MPH; Susan Forrow BA; Judith A. Racoosin MD, MPH; Robert Goldberg PhD; Jerry H. Gurwitz MD View More Authors	01/19/2012
The U.S. Food and Drug Administration's Mini-Sentinel Program: Status and Direction Publication	Publication	Richard Platt MD, MSc; Ryan M. Carnahan PharmD, MS, BCPP; Jeffrey S. Brown PhD; Elizabeth Chrischilles PhD, MS; Lesley H. Curtis PhD; Sean Hennessy PharmD, PhD; Jennifer C. Nelson PhD; Judith A. Racoosin MD, MPH; Melissa Robb RN; Sebastian Schneeweiss MD, ScD; Sengwee Toh ScD; Mark G. Weiner MD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Venous Thromboembolism using Administrative and Claims Data Publication	Publication	Leo Tamariz MD, MPH; Thomas Harkins MA, MPH; Vinit Nair BPharm, MS, RPh View More Authors	01/19/2012
A Protocol for Active Surveillance of Acute Myocardial Infarction in Association with the use of a New Antidiabetic Pharmaceutical Agent Publication	Publication	Bruce Fireman MA; Sengwee Toh ScD; Melissa G. Butler PharmD, PhD, MPH; Alan S. Go MD; Hylton V. Joffe MD, MMSc; David J. Graham MD, MPH; Jennifer C. Nelson PhD; Gregory W. Daniel PhD, MPH, RPH; Joe V. Selby MD, MPH View More Authors	01/19/2012
The U.S. Food and Drug Administration's Sentinel Initiative: Expanding the Horizons of Medical Product Safety Publication	Publication	Melissa A. Robb RN; Judith A. Racoosin MD, MPH; Rachel E. Sherman MD, MPH, FACP; Thomas P. Gross MD; Robert Ball MD, MPH, ScM; Marsha E. Reichman PhD; Karen Midthun MD; Janet Woodcock MD, MPH View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Depression using Administrative Data Publication	Publication	Lisa Townsend PhD; James T. Walkup PhD; Stephen Crystal PhD; Mark Olfson MD View More Authors	01/19/2012
The Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise Publication	Publication	Michael Nguyen MD; Robert Ball MD, MPH, ScM; Karen Midthun MD; Tracy A. Lieu MD, MPH View More Authors	01/19/2012
The Organizational Structure and Governing Principles of the Food and Drug Administration's Mini-Sentinel Pilot Program Publication	Publication	Susan Forrow BA; Daniel M. Campion MBA; Lisa J. Herrinton PhD; Vinit P. Nair BPharm, MS, RPh; Melissa A. Robb RN; Marcus Wilson PharmD; Richard Platt MD, MSc View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Suicide or Suicidal Ideation using Administrative or Claims Data Publication	Publication	James T. Walkup PhD; Lisa Townsend PhD; Stephen Crystal PhD; Mark Olfson MD, MPH View More Authors	01/19/2012
A Policy Framework for Public Health uses of Electronic Health Data Publication	Publication	Deven McGraw JD, LLM; Kristen B. Rosati JD; Barbara Evans PhD, JD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Seizures, Convulsions, or Epilepsy using Administrative and Claims Data Publication	Publication	Vicki Kee PharmD; Bradley Gilchrist BS; Mark A. Granner MD; Nicola R. Sarrazin PharmD; Ryan M. Carnahan PharmD, MS View More Authors	01/19/2012
Design Considerations, Architecture, and Use of the Mini-Sentinel Distributed Data System Publication	Publication	Lesley H. Curtis PhD; Mark G. Weiner MD; Denise M. Boudreau RPh, PhD; William O. Cooper MD, MPH; Gregory W. Daniel PhD, MPH; Vinit P. Nair BPharm, MS, RPh; Marsha A. Raebel PharmD; Nicolas U. Beaulieu MA; Robert Rosofsky MA; Tiffany S. Woodworth MPH; Jeffrey S. Brown PhD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Pancreatitis using Administrative Data Publication	Publication	Kevin Moores PharmD; Bradley Gilchrist BS; Ryan Carnahan PharmD, MS; Thad Abrams MD, MSc View More Authors	01/19/2012
Design Considerations in an Active Medical Product Safety Monitoring System Publication	Publication	Joshua J. Gagne PharmD, ScD; Bruce Fireman, MA; Patrick B. Ryan PhD; Malcolm Maclure SM, SD; Tobias Gerhard PhD; Sengwee Toh ScD; Jeremy A. Rassen ScD; Jennifer C. Nelson PhD; Sebastian Schneeweiss MD, ScD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Lymphoma using Administrative Data Publication	Publication	Ronald Herman PhD; Bradley Gilchrist BS; Brian Link MD; Ryan Carnahan PharmD, MS View More Authors	01/19/2012
Using High-Dimensional Propensity Scores to Automate Confounding Control in a Distributed Medical Product Safety Surveillance System Publication	Publication	Jeremy A. Rassen ScD; Sebastian Schneeweiss MD, ScD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Transfusion-Related Sepsis using Administrative and Claims Data Publication	Publication	Ryan Carnahan, PharmD, MS, BCPP, Ronald Herman, PhD, Kevin G. Moores, PharmD View More Authors	01/19/2012
When Should Case-Only Designs be used for Safety Monitoring of Medical Products? Publication	Publication	Malcolm Maclure SM, SD; Bruce Fireman MA; Jennifer C. Nelson PhD; Wei Hua MD, PhD; Azadeh Shoaibi PhD, MHS, MS; Antonio Paredes PhD; David Madigan PhD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Infection Related to Blood Products, Tissue Grafts, or Organ Transplants using Administrative Data Publication	Publication	Ryan Carnahan PharmD, MS, BCPP; Kevin Moores PharmD; Eli Perencevich MD, MS; The University of Iowa, Iowa City, IA View More Authors	01/19/2012
Challenges in the Design and Analysis of Sequentially Monitored Postmarket Safety Surveillance Evaluations using Electronic Observational Health Care Data Publication	Publication	Jennifer C. Nelson PhD; Andrea J. Cook PhD; Onchee Yu MS; Clara Dominguez; Shanshan Zhao; Sharon K. Greene PhD, MPH; Bruce H. Fireman MA; Steven J. Jacobsen; Eric S. Weintraub; Lisa A. Jackson MD, MPH View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Transfusion-Related ABO Incompatibility Reactions using Administrative and Claims Data Publication	Publication	Ryan Carnahan PharmD, MS, BCPP; Vicki Kee PharmD View More Authors	01/19/2012
Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot Publication	Publication	Andrea J. Cook PhD; Ram C. Tiwari PhD; Robert D. Wellman MS; Susan R. Heckbert MD, PhD; Lingling Li, PhD; Patrick Heagerty PhD; Tracey Marsh MS; Jennifer C. Nelson PhD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Erythema Multiforme Major/Minor/Not otherwise specified, Stevens–Johnson Syndrome, or Toxic Epidermal Necrolysis using Administrative and Claims Data Publication	Publication	Gary Schneider ScD, MSPH; Sumesh Kachroo PhD, MS, BPharm; Natalie Jones BS; Sheila Crean MPH; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD View More Authors	01/19/2012
Mini-Sentinel's Systematic Reviews of Validated Methods for Identifying Health Outcomes using Administrative and Claims Data: Methods and Lessons Learned Publication	Publication	Ryan M. Carnahan PharmD, MS, BCPP; Kevin G. Moores PharmD View More Authors	01/19/2012
A Systematic Review of Validated Methods for Identifying Anaphylaxis, Including Anaphylactic Shock and Angioneurotic Edema, using Administrative and Claims Data Publication	Publication	Gary Schneider ScD, MSPH; Sumesh Kachroo PhD, MS, BPharm; Natalie Jones BS; Sheila Crean MPH; Philip Rotella MS; Ruzan Avetisyan MD, MPH; Matthew W. Reynolds PhD View More Authors	01/19/2012
Effects of Adjusting for Instrumental Variables on Bias and Precision of Effect Estimates Publication	Publication	Jessica A. Myers PhD, ScD; Jeremy A. Rassen ScD; Joshua J. Gagne PharmD, MS; Krista F. Huybrechts PhD, MS; Sebastian Schneeweiss MD, ScD; Kenneth J. Rothman MPH, DrPH; Marshall M. Joffe MD, PhD, MPH; Robert J. Glynn PhD, ScD View More Authors	06/08/2011
Developing the Sentinel System — A National Resource for Evidence Development Publication	Publication	Rachel E. Behrman MD, MPH; Joshua S. Benner PharmD, ScD; Jeffrey S. Brown PhD; Mark McClellan MD, PhD; Janet Woodcock MD; Richard Platt MD, MSc View More Authors	02/10/2011