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., 6/25/2019
E.g., 6/25/2019
Title Status FDA Center Date Postedsort ascending
Distributed Regression Analysis: Utilizing Data from Various Data Partners in a Distributed Manner Complete 12/14/2018
Sequential TreeScan Signal Identification Methods Development In progress 12/11/2018
ARIA Tool Enhancement: Integrating TreeScan Signal Identification Capabilities In progress 12/10/2018
Use of Multiple Sclerosis Drugs Among Pregnant Women Complete CDER 12/06/2018
ARIA Tool Enhancement: Enabling Interrupted Time Series Analyses In progress 12/05/2018
Pulmonary Arterial Hypertension and Interstitial Lung Disease Events Among Interleukin Inhibitor Users Complete CDER 12/03/2018
Duration of Use for Teriparatide Complete CDER 11/29/2018
Sequential Analysis of Gardasil 9 Safety Discontinued CBER 11/28/2018
Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA’s Sentinel System Complete CDER 11/27/2018
Machine Learning Pilot for Electronic Phenotyping of Health Outcomes of Interest In progress 11/14/2018
COPD, Asthma, And Respiratory Disease Effectiveness (CARE) For 21st Century Cures: Feasibility Assessments for Comparative Effectiveness Studies In progress CDER 11/06/2018
Counts and Proportions of New Users of Fentanyl Transdermal System with Evidence of Prior Opioid Tolerance Complete CDER 11/06/2018
Data Infrastructure Expansion: Developing a Mother-Infant Linkage Table in the Sentinel Common Data Model (SCDM) Complete 10/30/2018
13-Valent Pneumococcal Conjugate Vaccination (PCV13) and Kawasaki Disease Complete CBER 10/24/2018
FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries In progress 10/16/2018
Phosphodiesterase Type 5 (PDE5) Inhibitor Utilization Among Women Complete CDER 10/12/2018
Validation of Anaphylaxis Using Machine Learning In progress 10/11/2018
Coding Trend Analyses: Acute Myocardial Infarction Complete 09/18/2018
Coding Trend Analyses: Angioedema Complete 09/18/2018
Coding Trend Analyses: Ischemic Stroke Complete 09/18/2018
Cross-Network Directory Service Complete 09/17/2018
Standardization and Querying of Data Quality Metrics and Characteristics for Electronic Health Data In progress 09/14/2018
Sofosbuvir and Amiodarone Use and Bradycardia or Pacemaker Insertion Complete CDER 08/29/2018
Algorithms Evaluating Dabigatran Use and Acute Myocardial Infarction Compared with Warfarin Complete CDER 08/23/2018
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel Complete 08/17/2018
Use of Dabigatran and Intracranial Hemorrhage, Gastrointestinal Hemorrhage, Ischemic Stroke, and Acute Myocardial Infarction Complete CDER 08/17/2018
New Pediatric Users of Leuprolide Acetate Depot Complete CDER 08/17/2018
Comparison of Safety Signaling Methods for Survival Outcomes to Control for Confounding in the Mini-Sentinel Distributed Database – Phase 2 Complete 08/15/2018
Descriptive Analyses in the Sentinel System for the FDA Office of Counterterrorism and Emerging Threats (OCET) In progress 07/18/2018
Validation of Stillbirth in ICD-10-CM In progress 07/17/2018
Functional Specifications for Propensity Score Table 1 Complete 07/11/2018
Disease Risk Score Exploratory Methods Complete 06/26/2018
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
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative Complete 06/21/2018
Coding Trend Analyses: Myositis Complete 06/15/2018
Coding Trend Analyses: Myocarditis Complete 06/15/2018
Coding Trend Analyses: Rhabdomyolysis Complete 06/15/2018
Prevalence and Incidence of Progressive Multifocal Leukoencephalopathy (PML), Clostridium Difficile, and Cytomegalovirus (CMV) Diagnoses Complete CDER 06/04/2018
Incident Use of Selective Serotonin Reuptake Inhibitor Antidepressants Complete CDER 05/21/2018
Gastrointestinal Bleed Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Gastrointestinal Bleed" Complete 05/10/2018
Intussusception Algorithm Defined in "Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)" Complete 05/07/2018
Intracranial Hemorrhage Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Intracranial Hemorrhage" Complete 05/07/2018
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
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
Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program Complete 04/27/2018
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
Identifying Suicide Codes in the Sentinel Distributed Database (SDD) Complete CDER 04/24/2018
Seizure Algorithm Defined in "Seizure following Ranolazine Use: A Self-Controlled Risk Interval Analysis" Complete 04/24/2018
Venous Thromboembolism Algorithm Defined in "Venous Thromboembolism following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis" Complete 04/23/2018
Stroke Algorithm Defined in "Stroke following Typical or Atypical Antipsychotic Use in Non-Elderly Patients: A Propensity Score Matched Analysis" Complete 04/23/2018
Stroke Algorithm Defined in "Stroke following Atypical Antipsychotic or Z-Hypnotic Use in Patients with Prior Use of Selective Serotonin Reuptake Inhibitors (SSRIs): A Propensity Score Matched Analysis" Complete 04/23/2018
Sentinel Medical Chart Review Gap Analysis Complete 04/18/2018
Clostridium difficile Infection Following Use of Vancomycin, Fidaxomicin, or Metronidzaole Complete CDER 04/03/2018
Availability of International Normalized Ratio (INR) Laboratory Test Values and Test Procedures among Warfarin Users Complete CDER 04/03/2018
Warfarin Use Followed by International Normalized Ratio (INR) Lab Codes Complete CDER 04/02/2018
Top Ten Causes of Death Complete CDER 03/29/2018
Prevalent and Incident Use of Fingolimod Complete CDER 03/28/2018
Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins Complete 03/27/2018
Risk of Acute Myocardial Infarction and Stroke among Carbidopa/Levodopa, Entacapone, and Carbidopa/Levodopa/Entacapone Users Complete CDER 03/27/2018
Prevalence and Incident Use of Promethazine Complete CDER 03/26/2018
Use of Clonazepam Complete CDER 03/26/2018
Diagnosis of Agranulocytosis Following New Use of Anti-epileptic Drugs, Clozapine, and Olanzapine Complete CDER 03/21/2018
Counts and Prevalence of Alendronate, Risedronate, Ibandronate, and Zolendronate Complete CDER 03/19/2018
Counts and Prevalence of Linezolid and Vancomycin Complete CDER 03/19/2018
Use of Atrial Fibrillation Drugs Complete CDER 03/16/2018
Optimal Propensity Score Matching Strategies for Subgroup Analyses Complete 03/15/2018
Incident Use of Hepatitis C Virus (HCV) Drugs In progress CDER 03/13/2018
Concomitancy and Indications for Idelalisib Use Complete CDER 03/13/2018
Prevalent and Incident Use of Generic Name Kinase Inhibitors In progress CDER 03/08/2018
Mini-Sentinel: Automated Approaches to Anaphylaxis Case Classification Using Unstructured Data Complete 03/07/2018
Incident Use of Rivaroxaban Complete CDER 03/07/2018
Selected Medications and Death, with Linkage of Mini-Sentinel Distributed Database with NDI+ Discontinued CDER 03/06/2018
Sensitivity of Safety Analyses to Minor Changes in Specifications Applied to Test Case Complete 03/06/2018
Drug Utilization Over Time for Three Drug Classes Complete CDER 03/05/2018
Sequential Surveillance for Drug Safety in a Regulatory Environment Complete 03/05/2018