Publications and Presentations

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

Title Authors Date Postedsort ascending
Sentinel Initiative Principles and Policies: HIPAA and Common Rule Compliance

Kristen Rosati, Naomi Jorgensen, and Melissa Soliz, Coppersmith Brockelman PLC

Barbara J. Evans, University of Houston

Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System

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

Methods for Examining Data Quality in Healthcare Integrated Data Repositories

Vojtech Huser, Michael Kahn, and Jeffrey Brown

Chart Validation of Inpatient ICD-9-CM Administrative Diagnosis Codes for Ischemic Stroke Among IGIV Users in the Sentinel Distributed Database

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, 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  


CDER Conversation: The FDA’s Sentinel Initiative 11/27/2017
Opioid Tolerance and Urine Drug Testing among Initiates of Extended-Release or Long-Acting Opioids in Food and Drug Administration's Sentinel System

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

Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study

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

Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System

Joshua J. Gagne, PharmD, ScD, Monika Houstoun, PharmD, Marsha E. Reichman, PhD, Christian Hampp, PhD, James H. Marshall, MPH, Sengwee Toh, ScD

Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study

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

Pharmacoepidemiology in the Era of Real-World Evidence 10/18/2017
Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network

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

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

Shirley V. Wang, PhD, ScM,  Mengdong He, MS, Yinzhu Jin, MS, MPH, Richard Wyss, PhD, HoJin Shin, MS, Yong Ma, MS, PhD, Stephine Keeton, PhD, Bruce Fireman, MA, Sara Karami, PhD, MPH, Jacqueline M. Major, PhD, Sebastian Schneeweiss, MD, ScD, Joshua Gagne, PharmD, ScD

Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia (Video Abstract)

Meijia Zhou, Sean Hennessy

PDUFA V Commitment: Sentinel Program Interim and Final Assessments 09/27/2017
The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011

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

Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies

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

2017 ICPE Presentation: Promises and Challenges of Screening for Adverse Events in Sentinel

Michael Nguyen

2017 ICPE Presentation: Practical Lessons Learned for Identification of Thromboembolic Events and Intravenous Immunoglobulin Exposure in the Sentinel Distributed Database

Crystal Garcia

2017 ICPE Poster: Evaluation of Case-Finding Algorithm for Venous Thromboembolism Outcome

Megan Reidy, Jill L.O. de Jong, Lauren Zichittella, W. Katherine Yih

2017 ICPE Presentation: Protocol-Based Assessment of Thromboembolic Events (TEEs) after Intravenous Immune Globulin (IVIg) in the Sentinel Distributed Database (2006-2012)

Eric Ammann, PhD, University of Iowa, College of Public Health, Iowa City, IA

2017 ICPE Poster: Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination During Pregnancy in the Sentinel System

Genna Panucci

2017 ICPE Pre-Conference Course: Using the Self-Controlled Risk Interval (SCRI) Method to Study Vaccine Safety

Katherine Yih

2017 ICPE Presentation: Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth

Efe Eworuke

2017 ICPE Poster: A Review of Methods for Propensity Score Matched Subgroup Analysis and Their Application in Peer Reviewed Research Studies

Shirley Wang, PhD, ScM, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

2017 ICPE Presentation: Impact of ICD-10-CM Transition on Selected Cardiovascular-Related Events in the Sentinel System

Tiffany Siu Woodworth

2017 ICPE Poster: Early Post-Approval Surveillance of New Molecular Entity Uptake in the Sentinel Distributed Database

Nicole R. Haug, MPH, Dept. of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, Boston, MA

2017 ICPE Workshop: TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance

Judith Maro, Rima Izem, Martin Kulldorff, Azadeh Shoaibi

2017 ICPE Poster: Evaluation of Test Data in Distributed Research Networks: A Sentinel System Example

Emily C. Welch

2017 ICPE Presentation: Identification of Name Confusion Medication Errors in the US FDA's Sentinel System

Noelle Cocoros

2017 ICPE Poster: Dispensings of Influenza Antiviral Medications in the Sentinel System as a Source of Data for Influenza Surveillance

Noelle Cocoros, DSc, MPH, Harvard Pilgrim Health Care Institute, Boston MA

2017 ICPE Presentation: Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database

Richard Scott Swain

2017 ICPE Poster: Distributed Regression Analysis in a Distributed Health Data Network

Jessica M. Malenfant, MPH, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

2017 ICPE Presentation: Assessment of Prior Opioid Tolerance Among New Users of Fentanyl Transdermal System in FDA's Sentinel System

Noelle Cocoros

2017 ICPE Presentation: Curating Inpatient Medication Use Data from a Hospital Network Electronic Medication Administration Record (eMAR) System: Lessons from the Sentinel System About Expanding Drug Safety Surveillance Potential

Jennifer R. Popovic

2017 ICPE Symposium: Listening to Patient Voices in Pharmacoepidemiological Research - Opportunities for Innovation and Inclusion

Wendy Camello Castillo

2017 ICPE Presentation: Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System

Elizabeth Chrischilles

2017 ICPE Presentation: Developing a Mother-Infant Cohort in Sentinel's PRISM Program as a Resource to Monitor the Safety of Vaccine Use During Pregnancy

Alison Kawai

2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year

Michael D. Nguyen, Judith C. Maro, Lockwood G. Taylor, David Moeny, Efe Eworuke, Steven Bird

2017 ICPE Plenary: Medical Product and Performance Evaluation Programs Using Distributed Data Sources

Richard Platt MD, MS, Harvard Pilgrim Health Care Institute and Harvard Medical School 

Robert Ball, MD, MPH, Office of Surveillance and Epidemiology, CDER

2017 ICPE Presentation: Developing a Mobile App for Studies of Medication Safety

Sascha Dublin

2017 ICPE Presentation: Randomized Clinical Trial Using FDA's Sentinel Infrastructure: An Analysis Assessing Feasibility

Noelle Cocoros on behalf of Crystal Garcia

2017 ICPE Poster: 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

Laura Hou

Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners

Crystal Garcia, MPH, Candace Fuller, PhD, Madelyn Pimentel, BA, Eric Ammann, MS, Elizabeth Chrischilles, PhD, MS, Scott Winiecki, MD

Sentinel Modular Program for Propensity-Score Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia

Sean Hennessy, PharmD, PhD, 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

Statistical Power for Postlicensure Medical Product Safety Data-Mining

Judith C. Maro, PhD, Michael D. Nguyen, MD, Inna Dashevsky, MS, Meghan A. Baker, MD, ScD, Martin Kulldorff, PhD

Antiemetic use among Pregnant Women in the United States: the Escalating use of Ondansetron

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

Missing Laboratory Results Data in Electronic Health Databases: Implications for Monitoring Diabetes Risk

James Flory, MD, MS, Jason Roy, PhD, Josh Gagne, PharmD, ScD, Kevin Haynes, PharmD, ScD, Lisa Herrinton, PhD, Elisabetta Patorno, MD, DrPH, Azadeh Shoaibi, PhD, MHS, Marsha Raebel, PharmD, Christine Lu, PhD, MSc 

Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making

Sebastian Schneeweiss, Hans Georg Eichler, Anna Garcia-Altes, Chris Chinn, A-V Eggimann, Sarah E. Garner, W Goettsch, Robyn R. Lim, W Löbker, D Martin, T Müller, BJ Park, Richard Platt, Sarah A. Priddy, Michael Ruhl, Almoth Spooner, B Vannieuwenhuyse, Richard J Willke

Distributed Data Networks: a Blueprint for Big Data Sharing and Healthcare Analytics

Jennifer R. Popovic, DVM, MA

The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies

Elisabetta Patorno, MD, DrPH, Josh Gagne, PharmD, ScD, Christine Lu, PhD, MSc, Kevin Haynes, PharmD, MSCE, Andrew Sterret, PhD, Jason Roy, PhD, Marsha Raebel, PharmD, Xingmei Wang, MS

A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data

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

Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

Josh 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

Use of Electronic Health Data to Estimate Heart Failure Events in a Population-Based Cohort with CKD

James S. Floyd, MD, MS, Robert Wellman, MS, Sharon Fuller, MA, Nisha Bansal, MD, MAS, Bruce M. Psaty, MD, PhD, Ian H. de Boer, MD, MS, Delia Scholes, PhD, MPH

Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug–Outcome Association

Susan Gruber, PhD, MPH, Aloka Chakravarty, PhD, Susan R. Heckbert, MD, PhD, Mark S. Levenson, PhD, David Martin, MD, 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

Quantitative Bias Analysis in Regulatory Settings

Timothy L. Lash, DSc, MPH, Matthew P. Fox, DSc, MPH, Darryl Cooney, MStat, Yun Lu, PhD, MS, and Richard A. Forshee, PhD

Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study

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 

Evidence Generation from Healthcare Databases: Recommendations for Managing Change

Alison Bourke, Andrew Bate, Brian C. Sauer, Jeffrey S. Brown, Gillian C. Hall 

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

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

Methods for using Clinical Laboratory Test Results as Baseline Confounders in Multi-Site Observational Database Studies when Missing Data are Expected

Marsha A. Raebel, PharmD, Susan Shetterly, MS, Christine Y. Lu, PhD, MSc, James S. Flory, MD, MS, Josh 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

Uptake of New Drugs in the Early Post-Approval Period in the Mini-Sentinel Distributed Database

Katrina Mott, MS, David J. Graham, MD, MPH, Sengwee Toh, ScD, Josh J. Gagne, PharmD, ScD, Mark Levenson, PhD, Yong Ma, MS, PhD, Marsha E. Reichman, PhD

Prospective Influenza Vaccine Safety Surveillance using Fresh Data in the Sentinel System

Katherine Yih, PhD, MPH; Martin Kulldorff, PhD; Sukhminder K. Sandhu, PhD, MPH, MS; Lauren Zichittella, MS; Judith C. Maro, PhD, MS; David V. Cole; 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

Intravenous Immune Globulin and Thromboembolic Adverse Events: A Systematic Review and Meta-Analysis of RCTs

Eric M. Ammann, PhD, 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

Changing Patterns of Asthma Medication use Related to U.S. Food and Drug Administration Long-Acting Beta2-agonist Regulation from 2005-2011

Melissa G. Butler, PharmD, MPH, PhD, 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

Evaluation of Propensity Scores, Disease Risk Scores, and Regression in Confounder Adjustment for the Safety of Emerging Treatment with Group Sequential Monitoring

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

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

Rosa Gini, Martijn Schuemie, Jeffrey Brown, Patrick Ryan, Edoardo Vacchi, Massimo Coppola, Walter Cazzola, Preciosa Coloma, Roberto Berni, Gayo Diallo, José Luis Oliveira, Paul Avillach, Gianluca Trifirò, Peter Rijnbeek, Mariadonata Bellentani, Johan van Der Lei, Niek Klazinga, Miriam Sturkenboom

Improving Therapeutic Effectiveness and Safety through Big Healthcare Data

Sebastian Schneeweiss, MD, ScD

The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance

Robert Ball, MD, MPH, ScM, Melissa A. Robb, RN, Stephen A. Anderson, PhD, MPP, Gerald Dal Pan, MD, MHS

Evaluation of the Risk of Venous Thromboembolism after Quadrivalent Human Papillomavirus Vaccination among U.S. Females

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

Absence of Venous Thromboembolism Risk Following Quadrivalent Human Papillomavirus Vaccination, Vaccine Safety Datalink, 2008–2011

Allison L. Naleway, Phd, Brad Cranea, 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


Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance

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

Surveillance of Medication Use During Pregnancy in the Mini-Sentinel Program

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

Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine

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

Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin

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

Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance

Ivair R Silva, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA and Department of Statistics, Universidade Federal de Ouro Preto, Ouro Preto, Minas Gerais, Brazil

Martin Kulldorff, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program

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