Report Finder

All Sentinel reports, surveillance tools, FDA assessments, and communication materials may be searched using the options below. Search results can be further sorted by title, project status, and date posted by clicking on the relevant column header. If you wish to search for FDA Center assessments more specifically by medical product and health outcome, please go to the CDER Assessments and CBER Assessments pages.

E.g., 2/17/2019
E.g., 2/17/2019
Title Status FDA Centersort descending Date Posted
Mini-Sentinel: Routine Prospective Safety Surveillance for New Drugs, Vaccines, and Other Biologic Products Complete 04/24/2016
Seizure Algorithm Defined in "Ranexa (Ranolazine) and Seizures" Complete 04/24/2018
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 1 Complete 11/11/2010
FDA-Catalyst COPD, Asthma, And Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies In progress 11/06/2018
TreeScan with Propensity Scores Complete 06/26/2017
Validating Type 1 and Type 2 Diabetes Mellitus in the Mini-Sentinel Distributed Database using the Surveillance PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) DataLink Complete 04/07/2016
Stroke Algorithm Defined in "Antipsychotics and Stroke" Complete 04/23/2018
Mini-Sentinel: Case-Based Methods Complete 10/04/2011
HOI Literature Review - Congestive Heart Failure Complete 02/08/2011
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete 08/15/2018
Developments, Applications, and Methodological Challenges to the use of Propensity Score Matching Approaches in FDA’s Sentinel Program Complete 10/04/2016
Stroke Algorithm Defined in "Antipsychotics/Selective Serotonin Reuptake Inhibitors (SSRIs) and Stroke" Complete 04/23/2018
Mini-Sentinel: Sequential Testing Methods Complete 08/11/2011
HOI Literature Review - Depression Complete 02/08/2011
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case In progress 09/15/2017
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel Complete 08/17/2018
Validation of Stillbirth in ICD-10-CM In progress 07/17/2018
Mini-Sentinel: Signal Evaluation Methods (Automated) Complete 08/17/2011
HOI Literature Review - Suicide Complete 02/08/2011
Evaluation of New Technologies Associated with Chart Review Complete 08/16/2017
Mini-Sentinel: Analytic Methods for Using Laboratory Test Results in Active Database Surveillance Complete 04/12/2017
Hypoglycemia Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide" Complete 04/26/2018
Vaccine Safety Monitoring - Adverse Events Complete 08/28/2013
HOI Literature Review - Cardiac Arrhythmias Complete 03/02/2011
Death Data Exploration Complete 08/17/2017
Sentinel Medical Chart Review Gap Analysis Complete 04/18/2018
Complex Regional Pain Syndrome (CRPS), Uveitis, Acute Disseminated Encephalomyelitis (ADEM), and Acute Pericarditis Algorithms Defined in "Sequential Analysis of Gardasil 9 Safety" Complete 04/30/2018
Mini-Sentinel: Statistical Methods for Estimating Causal Risk Differences (PRISM) Complete 03/07/2012
HOI Literature Review - Pancreatitis Complete 05/20/2011
Methotrexate Medication Errors Complete 12/31/2017
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case Complete 02/12/2018
Clostridium difficile Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins" Complete 04/30/2018
Mini-Sentinel: Methods to Evaluate Impact of FDA Regulatory Actions Complete 01/24/2013
HOI Literature Review- Transfusion/Graft Infections Complete 05/27/2011
Evaluating Variability with 1:1 Propensity Score-Matched Analyses In progress 08/18/2017
Disease Risk Score Exploratory Methods Complete 06/26/2018
Intussusception Algorithm Defined in "Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)" Complete 05/07/2018
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 2 Complete 04/09/2012
HOI Literature Review - Lymphomas Complete 05/27/2011
The Use of Propensity Score Matching for Estimating Hazard Ratios in Post-Market Surveillance with Heavy Censoring In progress 08/18/2017
Developing Disease Risk Score Estimation Functional Specification In progress 06/15/2017
Intracranial Hemorrhage Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Intracranial Hemorrhage" Complete 05/07/2018
Mini-Sentinel: Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs Complete 12/04/2012
HOI Literature Review - ABO Incompatibility Complete 05/27/2011
Inverse Probability of Treatment Weighting Functional Specifications and Prototype Development In progress 08/24/2017
Gastrointestinal Bleed Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Gastrointestinal Bleed" Complete 05/10/2018
Mini-Sentinel: Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings Complete 01/11/2013
HOI Literature Review - CVA/TIA Complete 06/02/2011
Development of Metrics to Assess Appropriate Prescribing of Opioids in the Mini-Sentinel Distributed Database (MSDD) Complete 11/20/2017
Coding Trend Analyses: Myositis Complete 06/15/2018
Mini-Sentinel: Framework for Assessment of Signal Refinement Positive Results Complete 01/27/2013
HOI Literature Review - Seizures Complete 06/06/2011
Data Infrastructure Expansion: Developing a Mother-Infant Linkage Table in the Sentinel Common Data Model (SCDM) Complete 10/30/2018
Coding Trend Analyses: Myocarditis Complete 06/15/2018
Mini-Sentinel: Developing, Implementing, and Testing a Program for High-Dimensional Propensity Score Adjustment in the Mini-Sentinel Distributed Data Environment Complete 10/11/2013
HOI Literature Review - Anaphylaxis Complete 06/10/2011
Conversion of Medicare Claims Synthetic Public Use Files (SynPUFs) to Sentinel Common Data Model (SCDM) Format Complete 01/25/2018
Coding Trend Analyses: Rhabdomyolysis Complete 06/15/2018
Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 3 Complete 11/20/2013
HOI Literature Review - Respiratory Failure Complete 06/13/2011
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins Complete 03/27/2018
Gastrointestinal Bleeding Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins" Complete 06/25/2018
Mini-Sentinel: Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities Complete 01/14/2014
HOI Literature Review - Transfusion Sepsis Complete 06/15/2011
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide Complete 07/18/2017
Coding Trend Analyses: Acute Myocardial Infarction Complete 09/18/2018
Demonstrate Feasibility of New Mini-Sentinel Group Sequential Monitoring Methods in a Distributed Setting by Implementing Them in Practice Complete 01/29/2014
HOI Literature Review - Erythema Multiforme Complete 06/16/2011
Mini-Sentinel: Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data Complete 03/07/2018
Coding Trend Analyses: Angioedema Complete 09/18/2018
Mini-Sentinel: Continuous versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance Complete 03/13/2014
HOI Literature Review - Atrial Fibrillation Complete 06/30/2011
Distributed Regression Analysis: Utilizing Data from Various Data Partners in a Distributed Manner Complete 12/14/2018
Coding Trend Analyses: Ischemic Stroke Complete 09/18/2018
Developing Approaches to Conducting Randomized Trials using the Mini-Sentinel Distributed Database Complete 04/23/2014