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., 8/16/2017
E.g., 8/16/2017
Title Status FDA Center Date Postedsort ascending
Quantitative Bias Analysis Methodology Development Complete 8/4/2017
Rapid Surveillance Capability: 2017-18 Seasonal Influenza Vaccines Surveillance In progress CBER 8/4/2017
Tdap Vaccination During Pregnancy Complete CBER 7/27/2017
Pertussis Cases in Infants Complete CBER 7/27/2017
Routine Querying System Complete 7/19/2017
Hypoglycemia Events After Use of Glyburide vs. Glipizide Complete CDER 7/18/2017
Actemra (Tocilizumab) Utilization Among Pregnant Women Complete CDER 7/18/2017
AEDs and Angioedema Complete CDER 7/17/2017
Thromboembolic Events After Immunoglobulin Administration Complete CBER 7/13/2017
Comparison of safety signaling methods for survival outcomes to control for confounding in the MSDD – Phase 2 In progress 6/29/2017
TreeScan for Drugs In progress 6/26/2017
TreeScan with Propensity Scores In progress 6/26/2017
Evaluation of Propensity Score Based Methods in Sentinel Study Settings Using Simulation Experiments In progress 6/15/2017
Building Internal Processes and Planning Validation Activities Related to Use of ICD-10-CM Codes in the Sentinel Initiative In progress 6/15/2017
Sequential Surveillance for Drug Safety in a Regulatory Environment In progress 6/15/2017
Enhancing TreeScan for Long-Term Follow-up In progress 6/15/2017
Chart Review Gap Analysis In progress 6/15/2017
Developing Capacity for “Surveillance of Prescribing Behaviors” Analyses in Sentinel, with Dronedarone and ECGs as a Use Case In progress 6/15/2017
Disease Risk Score Exploratory Methods In progress 6/15/2017
Developing Disease Risk Score Estimation Functional Specification In progress 6/15/2017
Identification of Pregnant Women in the Sentinel Distributed Database and Determination of Drug Use Among Pregnant and Non-Pregnant Women – ICD-10-CM Pregnancy Tool Algorithm Update In progress 6/15/2017
Optimal Propensity Score Matching Strategies for Subgroup Analyses In progress 6/15/2017
Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema In progress 6/15/2017
New Molecular Entities Approved in 2015 Complete CDER 5/11/2017
Multiple Births and Preterm Deliveries Complete CDER 5/10/2017
Pharmacogenetic Testing Complete CDER 5/10/2017
Influenza antiviral drug use 2010-2015 Complete CDER 5/4/2017
Sentinel Common Data Model Complete 4/25/2017
Prevalent dispensings of ticagrelor (Brilinta) and vortioxetine hydrobromide (Brintellix) Complete CDER 4/24/2017
New Molecular Entities Approved in 2011 and 2012 Complete CDER 4/24/2017
Analytic Methods for Using Laboratory Test Results In Active Database Surveillance Complete 4/13/2017
Sentinel Data Quality Assurance Practices 3/23/2017
New Molecular Entities Approved in 2013 and 2014 Complete CDER 3/21/2017
Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib) In progress 3/1/2017
Data Quality Review and Characterization Programs v3.3.4 Complete 2/22/2017
Outcome-Based TreeScan Analyses (DrugSCAN) Complete 2/14/2017
Influenza Vaccines and Birth Outcomes Protocol (PRISM) In progress CBER 1/20/2017
Collection of Patient‐Provided Information through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research In progress 1/5/2017
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel In progress 12/12/2016
Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance Complete 12/1/2016
Blood transfusions Complete CBER 10/26/2016
ADHD medications and heart failure Complete CDER 10/25/2016
Developments, Applications, And Methodological Challenges to The Use Of Propensity Score Matching Approaches In FDA’s Sentinel Program Complete 10/4/2016
Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine Complete 9/29/2016
PROMPT: Mirabegron Surveillance Complete CDER 9/22/2016
Transfusion-Related Acute Lung Injury after Red Blood Cell, Plasma and Platelet Administration 2013-2015 In progress CBER 9/16/2016
Dronedarone and electrocardiograms Complete CDER 8/17/2016
Kawasaki Disease and PCV13 Vaccine In progress CBER 8/15/2016
Influenza Vaccines and Febrile Seizures in the 2013-2014 and 2014-2015 Influenza Seasons In progress CBER 8/1/2016
Parenteral Iron and Anaphylactoid Reactions Complete CDER 7/22/2016
Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel Complete 7/22/2016
Dabigatran and warfarin use among members with atrial fibrillation and other pre-existing conditions Complete CDER 7/21/2016
MRI and GBCA procedures Complete CDER 7/21/2016
Hysterectomy procedures among females Complete CDER 7/21/2016
Most frequent generic dispensings among members aged 65+ Complete CDER 7/21/2016
Incident testosterone indication diagnoses and testosterone use Complete CDER 7/6/2016
Hypogonadism and testosterone use Complete CDER 7/6/2016
Incident testosterone use Complete CDER 7/6/2016
Length of enrollment among adolescents after HPV vaccination Complete CDER 7/6/2016
Immunoglobulin products and hemolysis Complete CDER 7/6/2016
Isotretinoin and long-term antibiotic use and multiple sclerosis Complete CDER 6/30/2016
Length of enrollment among adolescents Complete CDER 6/30/2016
Evaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance Protocol In progress CBER 6/30/2016
New use of statins and rhabdomyolysis Complete CDER 6/30/2016
Epidural steroid use Complete CDER 6/30/2016
Serum creatinine procedures and labs Complete CDER 6/30/2016
Sentinel Distributed Query Tool Complete 6/29/2016
Distributed Query Tool Summary Table Descriptions Complete 6/24/2016
Summary Table V2 Programming Specifications Complete 6/24/2016
Technical Discussion of Summary Table V2 Package Complete 6/24/2016
Summary Tables SAS Package Complete 6/24/2016
Summary Tables Programming Package V2 Investigator Release Notes Complete 6/24/2016
Laparoscopic hysterectomy with and without robotic assistance and adverse outcomes Complete CDER 6/21/2016
New use of dabigatran or warfarin and gastrointestinal hemorrhage or intracerebral hemorrhage events Complete CDER 6/21/2016
New use of anti-epileptic drugs and agranulocytosis Complete CDER 6/21/2016