https://www.sentinelinitiative.org/methods-data-tools/methods/making-medicaid-data-more-accessible-through-common-data-models-and-fhir
Making Medicaid Data More Accessible Through Common Data Models and FHIR APIs
Methods, Data, & Tools
09/24/2021
Methods, Data, & Tools
09/24/2021
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/racial-differences-covid-19-outcomes-2020-2021
Racial Differences in COVID-19 Outcomes (2020-2021)
Assessments
12/08/2021
Assessments
12/08/2021
https://www.sentinelinitiative.org/methods-data-tools/methods/development-and-illustration-framework-conducting-nonrandomized-studies
Development and Illustration of a Framework for Conducting Nonrandomized Studies of Medication Safety and Effectiveness Using Healthcare Databases
Methods, Data, & Tools
12/10/2021
Methods, Data, & Tools
12/10/2021
https://www.sentinelinitiative.org/news-events/publications-presentations/racial-differences-us-covid-19-positivity-hospitalization
Racial Differences in U.S. COVID-19 Positivity, Hospitalization, and Mortality
Spotlight
08/28/2022
Spotlight
08/28/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-erenumab-use-signal
Outcome Monitoring Following Erenumab Use: A Signal Identification Analysis
Analyses
06/22/2023
Analyses
06/22/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/association-between-race-and-covid-19-outcomes-united-states
Association Between Race and COVID-19 Outcomes in the United States (2020-2021)
Publications and Presentations
08/25/2023
Publications and Presentations
08/25/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/incorporate-range-frequently-used-engineering-features-ehrs-sentinel
Incorporate a Range of Frequently Used Engineering Features from EHRs into the Sentinel Common Data Model in the Sentinel EHR and Claims Linked Data Partner Network
Methods, Data, & Tools
02/09/2024
Methods, Data, & Tools
02/09/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/hydrochlorothiazide-use-following-labeling-update-include-0
Hydrochlorothiazide Use Following Labeling Update to Include the Risk of Non-Melanoma Skin Cancer: An Interrupted Time Series Analysis
Analyses
04/23/2024
Analyses
04/23/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-0
Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Obesity: A Descriptive Analysis
Analyses
07/22/2024
Analyses
07/22/2024
https://www.sentinelinitiative.org/methods-data-tools/methods/evaluate-use-dance-algorithm-find-disconnected-negative-controls-and
Evaluate the Use of the DANCE Algorithm to Find Disconnected Negative Controls and Develop a Toolkit
Methods, Data, & Tools
12/18/2024
Methods, Data, & Tools
12/18/2024
https://www.sentinelinitiative.org/methods-data-tools/methods/subset-calibration-methods
Subset Calibration Methods
Methods, Data, & Tools
02/28/2025
Methods, Data, & Tools
02/28/2025
https://www.sentinelinitiative.org/methods-data-tools/methods/comparison-signal-detection-and-evaluation-study-designs-inform
Comparison of Signal Detection and Evaluation Study Designs to Inform Development of the Pregnancy Safety Framework
Methods, Data, & Tools
06/13/2025
Methods, Data, & Tools
06/13/2025
https://www.sentinelinitiative.org/methods-data-tools/methods/use-case-2-uc2-aim-5-plasmode-simulation-based-quantitative-bias
Use Case 2 (UC2) Aim 5: Plasmode Simulation Based Quantitative Bias Analysis (QBA) for Unmeasured Confounding
Methods, Data, & Tools
09/05/2025
Methods, Data, & Tools
09/05/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-syphilis-testing-and-treatment-infants
Characterization of Syphilis Testing and Treatment in Infants in the Mother-Infant Linkage Table in the Sentinel Distributed Database: A Descriptive Analysis
Analyses
09/12/2025
Analyses
09/12/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-syphilis-testing-and-treatment-pregnant
Characterization of Syphilis Testing and Treatment in Pregnant Women: A Descriptive Analysis
Analyses
09/12/2025
Analyses
09/12/2025
https://www.sentinelinitiative.org/studies/drugs/mounjaro-tirzepatide
Mounjaro (tirzepatide) & Arrhythmia
Studies
11/06/2025
Studies
11/06/2025
https://www.sentinelinitiative.org/methods-data-tools/methods/assessing-performance-major-congenital-malformations-composite-outcome
Assessing the Performance of Major Congenital Malformations as a Composite Outcome in Signal Detection and Evaluation
Methods, Data, & Tools
12/11/2025
Methods, Data, & Tools
12/11/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/renal-cell-carcinoma-following-least-180-days-canagliflozin
Renal Cell Carcinoma Following At Least 180 Days of Canagliflozin Use in Patients with Type 2 Diabetes Mellitus: A Clone-Censor-Weighted Analysis with Inverse Probability of Treatment Weighting for Active Comparators
Analyses
02/27/2026
Analyses
02/27/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-ozempic-use-patients-type-2-0
Outcome Monitoring Following Ozempic Use in Patients with Type 2 Diabetes: An Active Comparator Signal Identification Analysis
Analyses
04/06/2026
Analyses
04/06/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-prucalopride-and-plecanatide
Outcome Monitoring Following Prucalopride and Plecanatide Use: An Active Comparator Signal Identification Analysis with Alternating Exposure-Comparator Roles
Analyses
04/06/2026
Analyses
04/06/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/risk-gastrointestinal-hypomotility-constipation-or-gi
Risk of Gastrointestinal Hypomotility, Constipation, or GI Dysmotility with Serious Complications and Intentional Self-Harm in Individuals with Migraine Following Use of CGRP Inhibitors: A Propensity Score Matched Analysis
Analyses
04/07/2026
Analyses
04/07/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/association-between-race-and-covid-19-outcomes-during-pre
Association Between Race and COVID-19 Outcomes During the Pre-Vaccination Period in the United States (2020-2021)
Publications and Presentations
04/24/2026
Publications and Presentations
04/24/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-infliximab-biosimilar-product
Outcome Monitoring Following Infliximab Biosimilar Product Use: An Active Comparator Signal Identification Analysis
Analyses
05/08/2026
Analyses
05/08/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/dihydropyrimidine-dehydrogenase-dpyd-gene-variant-testing
Dihydropyrimidine Dehydrogenase (DPYD) Gene Variant Testing Rates and Fluoropyrimidine Use Following Pharmacogenetic Testing Among Incident Fluoropyrimidine Users: A Descriptive Analysis
Analyses
05/08/2026
Analyses
05/08/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/comparison-manual-and-automated-approaches-developing
A Comparison of Manual and Automated Approaches to Developing Computable Algorithms for Identifying Acute Pancreatitis
Publications and Presentations
06/08/2026
Publications and Presentations
06/08/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/safety-signal-identification-infliximab-biosimilars-exact
Safety Signal Identification for Infliximab Biosimilars: An Exact-and Propensity Score-Matched Cohort Study Using Variable Probability Tree-Based Scan Statistics
Publications and Presentations
06/14/2026
Publications and Presentations
06/14/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/real-world-evidence-post-marketing-drug-safety-outcomes-fda
Real World Evidence for Post-Marketing Drug Safety Outcomes: FDA’s Sentinel System
Publications and Presentations
06/14/2026
Publications and Presentations
06/14/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/prevalence-siponimod-exposure-among-females-childbearing-age
Prevalence of Siponimod Exposure Among Females of Childbearing Age in the U.S. Sentinel System
Publications and Presentations
06/15/2026
Publications and Presentations
06/15/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/prevalence-cutaneous-lupus-erythematosus-sentinel
Prevalence of Cutaneous Lupus Erythematosus in the Sentinel Distributed Database: A Descriptive Analysis
Analyses
06/16/2026
Analyses
06/16/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/using-natural-language-processing-clinical-notes-supplement
Using Natural Language Processing of Clinical Notes to Supplement Structured Electronic Health Record Data for Phenotyping Smoking and Obesity in a Healthcare System
Publications and Presentations
06/16/2026
Publications and Presentations
06/16/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/ketamine-use-patients-emergency-department-encounters
Ketamine Use in Patients with Emergency Department Encounters: A Descriptive Analysis
Analyses
06/30/2026
Analyses
06/30/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/ketamine-use-patients-emergency-department-encounters-second
Ketamine Use in Patients with Emergency Department Encounters: A Second Descriptive Analysis
Analyses
06/30/2026
Analyses
06/30/2026
https://www.sentinelinitiative.org/studies/drugs/covid-19-outcomes
COVID-19 Patients & Racial and Ethnic Differences
Studies
07/02/2026
Studies
07/02/2026
https://www.sentinelinitiative.org/studies/drugs/ketamine
Ketamine & Emergency Department and Pre-Hospital Use
Studies
07/02/2026
Studies
07/02/2026
https://www.sentinelinitiative.org/studies/drugs/hematopoietic-stem-cell-transplantation-hsct
Hematopoietic Stem Cell Transplantation (HSCT) and Thrombotic Microangiopathy (TMA) & Population Characterization
Studies
07/13/2026
Studies
07/13/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/etonogestrel-implant-insertions-and-removals-among-females
Etonogestrel Implant Insertions and Removals Among Females by Provider Specialty in the Sentinel Distributed Database: A Descriptive Analysis
Analyses
07/20/2026
Analyses
07/20/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/integrating-human-and-artificial-intelligence-robust
Integrating Human and Artificial Intelligence for Robust Postmarketing Safety Surveillance Systems: Reflections From the FDA Sentinel Innovation Center
Publications and Presentations
07/20/2026
Publications and Presentations
07/20/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/cautionary-note-plasmode-simulation-studies-setting-causal-0
A Cautionary Note for Plasmode Simulation Studies in the Setting of Causal Inference
Publications and Presentations
07/22/2026
Publications and Presentations
07/22/2026
https://www.sentinelinitiative.org/studies/drugs/calcitonin-gene-related-peptide-cgrp-inhibitors
Calcitonin Gene-Related Peptide (CGRP) Inhibitors & Gastrointestinal Hypomotility, Constipation or GI dysmotility with Serious Complications and Intentional Self-Harm
Studies
07/29/2026
Studies
07/29/2026
https://www.sentinelinitiative.org/studies/drugs/mayzent-siponimod
Mayzent (Siponimod) & Use in Pregnancy
Studies
08/05/2026
Studies
08/05/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/mycophenolate-use-during-pregnancy-descriptive-analysis
Mycophenolate Use During Pregnancy: A Descriptive Analysis
Analyses
08/14/2026
Analyses
08/14/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/frequency-blood-phosphate-monitoring-following-ferric
Frequency of Blood Phosphate Monitoring Following Ferric Carboxymaltose (FCM) Administration in Patients in the Sentinel Distributed Database: A Descriptive Analysis
Analyses
08/14/2026
Analyses
08/14/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-patterns-metformin-patients-polycystic-ovarian
Utilization Patterns of Metformin in Patients with Polycystic Ovarian Syndrome: A Descriptive Analysis
Analyses
08/24/2026
Analyses
08/24/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-metformin-users-polycystic-ovarian-syndrome
Characterization of Metformin Users with Polycystic Ovarian Syndrome: A Descriptive Analysis
Analyses
08/24/2026
Analyses
08/24/2026
https://www.sentinelinitiative.org/studies/drugs/motegrity-prucalopride
Motegrity (Prucalopride) & Signal Identification
Studies
08/26/2026
Studies
08/26/2026
https://www.sentinelinitiative.org/studies/drugs/trulance-plecanatide
Trulance (Plecanatide) & Signal Identification
Studies
08/26/2026
Studies
08/26/2026
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2026-ispe-annual-meeting
2026 ISPE Annual Meeting
Sentinel Initiative Events
08/29/2026
Sentinel Initiative Events
08/29/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/tree-based-safety-signal-identification-infliximab
Tree-Based Safety Signal Identification for Infliximab Biosimilar vs Reference Products
Publications and Presentations
08/31/2026
Publications and Presentations
08/31/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/combining-treatment-propensity-scores-and-clone-censor
Combining Treatment Propensity Scores and Clone-Censor-Weighting to Evaluate Treatment Duration in Active Comparator Studies
Publications and Presentations
08/31/2026
Publications and Presentations
08/31/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/evaluating-data-driven-automated-discovery-disconnected
Evaluating Data-Driven Automated Discovery of Disconnected Negative Controls Using Plasmode Simulations
Publications and Presentations
08/31/2026
Publications and Presentations
08/31/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/prevalence-cutaneous-lupus-erythematosus-us-populations
Prevalence of Cutaneous Lupus Erythematosus in U.S. Populations Using the FDA Sentinel Distributed Database
Publications and Presentations
09/01/2026
Publications and Presentations
09/01/2026
https://www.sentinelinitiative.org/news-events/fda-safety-communications-labeling-changes/fda-adds-boxed-warning-labeling-ferric
FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels
Regulatory Impact
09/01/2026
Regulatory Impact
09/01/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/finding-needles-same-haystack-comparing-designated-medical
Finding Needles in the Same Haystack: Comparing Designated Medical Event vs Untargeted Approach in Signal Identification
Publications and Presentations
09/01/2026
Publications and Presentations
09/01/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/descriptive-analysis-weight-loss-medication-use-including
A Descriptive Analysis of Weight Loss Medication Use, Including GLP-1 RA Products, and Intentional Self-Harm among Patients with Obesity in FDA's Sentinel Distributed Database
Publications and Presentations
09/01/2026
Publications and Presentations
09/01/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/risk-intentional-self-harm-after-glp-1-ra-use-among-patients
Risk of Intentional Self-Harm After GLP-1 RA Use Among Patients with Type 2 Diabetes in FDA’s Sentinel Distributed Database
Publications and Presentations
09/01/2026
Publications and Presentations
09/01/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/burden-cutaneous-lupus-erythematosus-commercial-vs-publicly
Burden of Cutaneous Lupus Erythematosus in Commercial vs. Publicly Insured Patients in the FDA’s Sentinel Distributed Database
Publications and Presentations
09/02/2026
Publications and Presentations
09/02/2026
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/cardiac-malformations-algorithm-defined-cardiac
Cardiac Malformations Algorithm Defined in "Cardiac Malformations and Oral Clefts Following in Utero Exposure to Cyclobenzaprine: A Propensity Score Stratified Analysis"
Methods, Data, & Tools
09/02/2026
Methods, Data, & Tools
09/02/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/development-and-evaluation-targeted-outcome-trees-safety
Development and Evaluation of Targeted Outcome Trees for Safety Surveillance using Tree-Based Scan Statistics in the Sentinel System
Publications and Presentations
09/02/2026
Publications and Presentations
09/02/2026
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/oral-clefts-algorithm-defined-cardiac-malformations-and
Oral Clefts Algorithm Defined in "Cardiac Malformations and Oral Clefts Following in Utero Exposure to Cyclobenzaprine: A Propensity Score Stratified Analysis"
Methods, Data, & Tools
09/02/2026
Methods, Data, & Tools
09/02/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/dihydropyrimidine-dehydrogenase-gene-testing-and
Dihydropyrimidine Dehydrogenase Gene Testing and Fluoropyrimidine Treatment in the United States – a Sentinel Distributed Database Study
Publications and Presentations
09/02/2026
Publications and Presentations
09/02/2026
https://www.sentinelinitiative.org/studies/drugs/cyclobenzaprine
Cyclobenzaprine & Cardiac Malformations and Oral Clefts
Studies
09/02/2026
Studies
09/02/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/risk-renal-cell-carcinoma-following-least-180-days-exposure
Risk of Renal Cell Carcinoma Following At Least 180 Days of Exposure to Canagliflozin in U.S. Patients with Type 2 Diabetes Mellitus
Publications and Presentations
09/02/2026
Publications and Presentations
09/02/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/cardiac-malformations-and-oral-clefts-following-utero
Cardiac Malformations and Oral Clefts Following in Utero Exposure to Cyclobenzaprine: A Propensity Score Stratified Analysis
Analyses
09/02/2026
Analyses
09/02/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/mycophenolate-use-during-pregnancy-analysis-sentinel
Mycophenolate Use During Pregnancy: An Analysis in the Sentinel Database
Publications and Presentations
09/02/2026
Publications and Presentations
09/02/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/assessing-performance-major-congenital-malformations
Assessing the Performance of Major Congenital Malformations as a Composite Outcome in Signal Detection and Evaluation
Publications and Presentations
09/02/2026
Publications and Presentations
09/02/2026
https://www.sentinelinitiative.org/studies/drugs/injectafer-ferric-carboxymaltose-fcm
Injectafer (ferric carboxymaltose, FCM) & Serum Phosphate Testing
Studies
09/03/2026
Studies
09/03/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/prenatal-care-and-congenital-syphilis-united-states
Prenatal Care and Congenital Syphilis in the United States: Characterizing Screening and Treatment
Publications and Presentations
09/03/2026
Publications and Presentations
09/03/2026
https://www.sentinelinitiative.org/studies/drugs/aimovig-erenumab-0
Aimovig (Erenumab) & Signal Identification
Studies
09/14/2026
Studies
09/14/2026
https://www.sentinelinitiative.org/studies/drugs/cutaneous-lupus-erythematosus
Cutaneous Lupus Erythematosus & Prevalence
Studies
09/14/2026
Studies
09/14/2026
https://www.sentinelinitiative.org/studies/drugs/fluoropyrimidine
Fluoropyrimidines & Dihydropyrimidine Dehydrogenase Testing
Studies
09/14/2026
Studies
09/14/2026
https://www.sentinelinitiative.org/studies/drugs/infliximab-biosimilars
Infliximab Biosimilars & Signal Identification
Studies
09/14/2026
Studies
09/14/2026
https://www.sentinelinitiative.org/studies/drugs/glucagon-peptide-1-receptor-agonists
Glucagon-Like Peptide-1 Receptor Agonists & Intentional Self-Harm
Studies
09/15/2026
Studies
09/15/2026
https://www.sentinelinitiative.org/studies/drugs/mycophenolate-mofetil-mycophenolic-acid
Mycophenolate & Use in Pregnancy
Studies
09/15/2026
Studies
09/15/2026
https://www.sentinelinitiative.org/studies/drugs/semaglutide-injectables
Semaglutide Injectables & Signal Identification
Studies
09/15/2026
Studies
09/15/2026
https://www.sentinelinitiative.org/studies/drugs/hydrochlorothiazide-1
Hydrochlorothiazide & Utilization
Studies
09/25/2026
Studies
09/25/2026