This activity will investigate the feasibility of conducting outcome-based TreeScan analyses within the Mini-Sentinel Distributed Database (MSDD) using angioedema and Achilles tendon rupture (ATR) as test examples. This activity will assess whether TreeScan is able detect known associations at the specific drug and class level.
This protocol describes the PRISM program’s efforts to develop a large database to be used for retrospective studies of potential adverse events following vaccination in pregnant women by linking mothers with infants and by incorporating an additional data source, specifically birth certificate data.
Sentinel modular programs (MPs) allow rapid implementation of standard queries across the Sentinel Distributed Database (SDD). MPs are designed to run against the Sentinel Common Data Model (SCDM). They are written in SAS and can be customized using various parameter settings that define exposures, outcomes, covariates, inclusion/exclusion criteria, date ranges, age ranges, and other implementation details.
The Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER) is interested in exploring the potential for the Sentinel System to support investigations of manufacturer-level product switching. The aims of this project are:
The FDA has announced a public workshop titled “Ninth Annual Sentinel Initiative Public Workshop.” Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance.
Modular program-based one-time assessment of incident use of two influenza antiviral drugs during the five previous influenza seasons. The query was run against the Sentinel Distributed Database (SDD) for the time period of January 1, 2010 through December 31, 2015.
Modular program-based one-time assessment of the frequency distributions of females of child-bearing age, frequency of women with live births, and live births among patients with blood transfusions, as well as the frequency distributions of the immunocompromised population and blood transfusions among the immunocompromised population. The query was run against the Sentinel Distributed Database (SDD) for the time period of January 1, 2008 through November 30, 2015.
Modular program-based one-time assessment of heart failure diagnoses following new attention deficit hyperactivity disorder (ADHD) medication use. The query was run against the Sentinel Distributed Database (SDD) for the time period of January 1, 2000 through March 3, 2016.