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., 2/19/2017
E.g., 2/19/2017
Title Status FDA Center Date Postedsort ascending
Outcome-Based TreeScan Analyses (DrugSCAN) Complete 2/15/2017
Influenza Vaccines and Birth Outcomes Protocol (PRISM) In progress CBER 1/20/2017
Implementation of a Randomized Controlled Trial to Improve Treatment with Oral Anticoagulants in Patients with Atrial Fibrillation (IMPACT-AFib) In progress 1/6/2017
Collection of Patient‐Provided Information through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research In progress 1/6/2017
Routine Querying System Complete 12/27/2016
Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel In progress 12/12/2016
Influenza antiviral drug use 2010-2015 Complete CDER 10/30/2016
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
Sentinel Common Data Model v6.0 Complete 9/23/2016
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
Data Quality Review and Characterization Programs v3.3.3 Complete 9/2/2016
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
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
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
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
Omalizumab or montelukast use among individuals with asthma and acute myocardial infarction, stroke, intracranial hemorrhage, or pulmonary embolism Complete CDER 6/21/2016
IVIg product use and hemolysis events Complete CDER 6/3/2016
Incident use of testosterone products among all members and members with pre-existing testosterone use Complete CDER 6/3/2016
Concomitant use of niacin and statins and concomitant use of fenofibrates and statins Complete CDER 6/3/2016
Anticoagulant use among members with atrial fibrillation and various pre-existing exlusions Complete CDER 5/27/2016
Anticoagulant use among members with pre-existing atrial fibrillation and various pre-existing exclusions Complete CDER 5/25/2016
Health Outcome Algorithm Inventory Complete 5/23/2016
Anticoagulants and bleeding events Complete CDER 5/20/2016
Anti-depressant use and bleeding events Complete CDER 5/20/2016
Dabigatran uptake and persistence Complete CDER 5/20/2016
Incident antipsychotic use Complete CDER 5/20/2016
Indications of intravenous immunoglobulin use Complete CDER 5/20/2016
Sequential Analysis of Gardasil 9 Safety Surveillance Plan In progress CBER 5/18/2016
Two-Dimensional Scan Statistics for Assessing Vaccine Safety in Pregnancy (PRISM) Complete 4/27/2016
Routine prospective safety surveillance for new drugs, vaccines, and other biologic products Complete 4/25/2016
Birth Certificate Data Matching for the Postlicensure Rapid Immunization Safety Monitoring (PRISM) Program Complete 4/24/2016
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 4/7/2016
SAS Macro Toolkit: Log Checker Complete 3/27/2016
SAS Macro Toolkit: Age Stratification Complete 3/24/2016
SAS Macro Toolkit: Data Subset Creation Complete 3/24/2016
SAS Macro Toolkit: De-Identification Complete 3/24/2016
Quantitative Bias Analysis Methodology Development In progress 3/10/2016
Testing routine querying tools with known positive exposure-outcome associations In progress 1/31/2016
Drug use among pregnant women with live births In progress 1/31/2016
Anticoagulant use among patients with atrial fibrillation Complete CDER 1/31/2016
Anti-diabetes Drugs & Acute Myocardial Infarction Protocol In progress CDER 1/26/2016
Metabolic Effects of Second Generation Antipsychotics in Youth, Subprojects 1, 2, and 3 In progress CDER 1/12/2016
Influenza Vaccines and Pregnancy Outcomes Protocol (PRISM) In progress CBER 12/29/2015
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 In progress 12/4/2015
Distributed Database Summary Report - Year 5 Complete 11/25/2015
Mini-Sentinel Coordinating Center Data Group: Year Five Report of Activities Complete 11/24/2015