• Print
  • E-mail

Health Outcomes Among Individuals Exposed to Medical Products

These assessments examine the occurrence of pre-specified health outcomes, or health events, among individuals exposed to particular medical products. Health outcomes can include the subsequent occurrence of new diagnoses, additional medical procedures, or use of other additional medical products (or combinations of these). The specifications of an assessment can vary widely based on the definition of exposures, comparators, outcomes, cohort inclusion and exclusion criteria, time periods, and analytic approaches. There are three subcategories of assessments:

  • Modular program based one-time assessments. These assessments provide rapid response by making use of adaptable standardized programs ("modular programs"). These assessments can provide stratified results by age group, sex, and calendar year.
  • Prospective Routine Observational Monitoring Program Tools (PROMPT) assessments. These assessments involve repeated evaluation of electronic, administrative and claims-based healthcare data as they accrue within the Mini-Sentinel Distributed Database. PROMPT assessments perform active surveillance of newly approved medical products in a prospective and semi-automated manner as experience with these products accumulates in near real time. A small number of study designs and analytical methods ("PROMPT tools") have been implemented that can be modified quickly to accommodate specific products, outcomes, populations, and time periods for evaluation. The emphasis is on detecting potential excess risk of adverse events associated medical products rather than formal assessment of causal relationships. This approach requires that signals be carefully followed up to understand the explanation for the finding.
  • Protocol based assessments.These assessments use customized study designs and protocols that allow 1) detailed specification of exposure groups and health events, 2) adjustment for a range of potential confounding factors, and 3) comparison of event rates between different medical products. These may be one-time assessments or may involve repeated evaluation of information as it accrues within the Mini-Sentinel Distributed Dataset. They may use a variety of study designs and statistical methods, including sequential methods.


The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.


Search by keywords:  

Results from Assessments of Diagnoses and Medical Procedures Search. Click on the title in each column header to sort based on that column; click twice to reverse the sort. By default, the list is sorted by date with newest postings first.
 TitleAssessment TypeStatusDate Posted
DetailsPROMPT: Mirabegron SurveillancePROMPTComplete 9-23-2016
DetailsPosted for Public Comment until September 30, 2016: Transfusion Related Acute Lung Injury after Red Blood Cell, Plasma and Platelet Administration 2013-2015ProtocolPosted for public comment 9-16-2016
DetailsKawasaki Disease and PCV13 VaccineProtocolIn progress 8-16-2016
DetailsInfluenza Vaccines and Febrile Seizures in the 2013-2014 and 2014-2015 Influenza Seasons ProtocolIn progress 8-01-2016
DetailsParenteral Iron and Anaphylactoid Reactions Protocol v2.0ProtocolComplete 7-22-2016
DetailsDabigatran and warfarin use among members with atrial fibrillation and other pre-existing conditionsModular programComplete 7-21-2016
DetailsMRI and GBCA proceduresModular programComplete 7-21-2016
DetailsDronedarone and electrocardiogramsModular programComplete 7-21-2016
DetailsHysterectomy procedures among femalesModular programComplete 7-21-2016
DetailsMost frequent generic dispensings among members aged 65+Modular programComplete 7-21-2016
DetailsEvaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance ProtocolProtocolIn progress 7-15-2016
DetailsIncident testosterone indication diagnoses and testosterone useModular programComplete 7-06-2016
DetailsHypogonadism and testosterone useModular programComplete 7-06-2016
DetailsIncident testosterone useModular programComplete 7-06-2016
DetailsLength of enrollment among adolescents after HPV vaccinationModular programComplete 7-06-2016
DetailsImmunoglobulin products and hemolysisModular programComplete 7-06-2016
DetailsEpidural steroid useModular programComplete 6-30-2016
DetailsNew use of statins and rhabdomyolysis Modular programComplete 6-30-2016
DetailsSerum creatinine procedures and labsModular programComplete 6-30-2016
DetailsLength of enrollment among adolescentsModular programComplete 6-30-2016
DetailsIsotretinoin and long-term antibiotic use and multiple sclerosisModular programComplete 6-30-2016
DetailsLaparoscopic hysterectomy with and without robotic assistance and adverse outcomesModular programComplete 6-21-2016
DetailsOmalizumab or montelukast use among individuals with asthma and acute myocardial infarction, stroke, intracranial hemorrhage, or pulmonary embolismModular programComplete 6-21-2016
DetailsNew use of dabigatran or warfarin and gastrointestinal hemorrhage or intracerebral hemorrhage events Modular programComplete 6-21-2016
DetailsNew use of anti-epileptic drugs and agranulocytosisModular programComplete 6-21-2016
DetailsIVIg product use and hemolysis eventsModular programComplete 6-03-2016
DetailsAnti-depressant use and bleeding eventsModular programComplete 5-20-2016
DetailsDabigatran uptake and persistenceModular programComplete 5-20-2016
DetailsIncident antipsychotic useModular programComplete 5-20-2016
DetailsIndications of intravenous immunoglobulin useModular programComplete 5-20-2016
DetailsAnticoagulants and bleeding eventsModular programComplete 5-20-2016
DetailsSequential Analysis of Gardasil 9 Safety Surveillance PlanProtocolIn progress 5-18-2016
DetailsAnti-diabetes Drugs & Acute Myocardial Infarction Protocol v6.0ProtocolIn progress 1-27-2016
DetailsMetabolic Effects of Second Generation Antipsychotics in Youth, Subprojects 1, 2, and 3ProtocolIn progress 1-14-2016
DetailsInfluenza Vaccines and Pregnancy Outcomes Protocol (PRISM) v3.0ProtocolIn progress 12-30-2015
DetailsPROMPT: Rivaroxaban Surveillance Plan v3.0PROMPTIn progress 10-29-2015
DetailsThromboembolic Events After Immunoglobulin Administration Protocol v3.0ProtocolIn progress 9-28-2015
DetailsInfluenza Vaccines and Febrile Seizures (PRISM)Protocol Complete 9-21-2015
DetailsGardasil Vaccination and Venous Thromboembolism (PRISM)Protocol Complete 4-23-2015
DetailsAccessing the Freshest Feasible Data for Conducting Active Influenza Vaccine Safety Surveillance (PRISM)ProtocolComplete 4-08-2015
DetailsA Protocol for Assessment of Dabigatran and Selected Safety Outcomes v3.0ProtocolIn progress 3-27-2015
DetailsSelect Bisphosphonates and Select Outcomes of InterestModular ProgramComplete 3-16-2015
DetailsIVIg exposure and renal failureModular ProgramComplete 3-09-2015
DetailsAnaphylaxis events following incident vaccine exposure among members with a pre-existing condition of milk allergyModular ProgramComplete 3-05-2015
DetailsInfluenza vaccinations and diagnosis of seizuresModular ProgramComplete 3-05-2015
DetailsHypoglycemic events following use of anti-diabetic agents (ADAs)Modular ProgramComplete 2-27-2015
DetailsInfluenza Vaccines and Birth Outcomes Protocol v2.0 (PRISM)ProtocolIn progress 12-05-2014
DetailsAntiepileptic drugs (AEDs) & kidney stones 2Modular ProgramComplete 9-25-2014
DetailsImmunoglobulin & hemolysis 1Modular ProgramComplete 6-10-2014
DetailsImmunoglobulin & hemolysis 3Modular ProgramComplete 6-10-2014


Page Updated: 9/18/2014