https://www.sentinelinitiative.org/news-events/publications-presentations/hydroxyurea-utilization-patterns-among-sickle-cell-disease
Hydroxyurea Utilization Patterns Among Sickle Cell Disease Patients in the United States, US FDA Sentinel Database
Publications and Presentations
11/29/2018
Publications and Presentations
11/29/2018
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2016
Duration of Follow Up for New Molecular Entities Approved in 2016
Analyses
04/16/2021
Analyses
04/16/2021
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2014-and
Duration of Follow Up for New Molecular Entities Approved in 2014 and 2015
Analyses
04/16/2021
Analyses
04/16/2021
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2010-2012
Duration of Follow Up for New Molecular Entities Approved in 2010, 2012, and 2013
Analyses
04/16/2021
Analyses
04/16/2021
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2008-and
Duration of Follow Up for New Molecular Entities Approved in 2008 and 2009
Analyses
04/16/2021
Analyses
04/16/2021
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2005-2006
Duration of Follow Up for New Molecular Entities Approved in 2005, 2006, and 2007
Analyses
04/16/2021
Analyses
04/16/2021
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2011
Duration of Follow Up for New Molecular Entities Approved in 2011
Analyses
04/16/2021
Analyses
04/16/2021
https://www.sentinelinitiative.org/methods-data-tools/methods/extending-machine-learning-methods-development-sentinel-follow-analyses
Extending Machine Learning Methods Development in Sentinel: Follow-up Analyses for Anaphylaxis Algorithm and Formalization of a General Phenotyping Framework (Phase 3)
Methods, Data, & Tools
05/17/2021
Methods, Data, & Tools
05/17/2021
https://www.sentinelinitiative.org/news-events/publications-presentations/who-gets-treated-influenza-surveillance-study-us-food-and
Who Gets Treated for Influenza: A Surveillance Study From the US Food and Drug Administration’s Sentinel System
Publications and Presentations
08/05/2021
Publications and Presentations
08/05/2021
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-drugs-approved-risk-evaluation-and-mitigation
Utilization of Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) That Employ Elements to Assure Safe Use (ETASU)
Assessments
08/23/2021
Assessments
08/23/2021
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/news-events/meetings-workshops-trainings/2021-13th-annual-sentinel-initiative-public-workshop
2021 13th Annual Sentinel Initiative Public Workshop
Sentinel Initiative Events
11/08/2021
Sentinel Initiative Events
11/08/2021
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/thromboembolic-stroke-algorithm-defined-1
Thromboembolic Stroke Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"
Methods, Data, & Tools
01/06/2022
Methods, Data, & Tools
01/06/2022
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/gastrointestinal-bleeding-algorithm-defined-0
Gastrointestinal Bleeding Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"
Methods, Data, & Tools
01/06/2022
Methods, Data, & Tools
01/06/2022
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/major-extracranial-bleeding-algorithm-defined-1
Major Extracranial Bleeding Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"
Methods, Data, & Tools
01/06/2022
Methods, Data, & Tools
01/06/2022
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/intracranial-hemorrhage-algorithm-defined-1
Intracranial Hemorrhage Algorithm Defined in "Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 and Older: An IPTW Analysis"
Methods, Data, & Tools
01/06/2022
Methods, Data, & Tools
01/06/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2019
Duration of Follow Up for New Molecular Entities Approved in 2019: A Descriptive Analysis
Analyses
01/26/2022
Analyses
01/26/2022
https://www.sentinelinitiative.org/engage-sentinel/quarterly-newsletter
Quarterly Newsletter
Spotlight
03/24/2022
Spotlight
03/24/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/hydroxyurea-use-among-patients-sickle-cell-disease-scd
Hydroxyurea Use Among Patients with Sickle Cell Disease (SCD): A Descriptive Analysis
Analyses
03/29/2022
Analyses
03/29/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/thromboembolic-stroke-major-extracranial-bleeding-0
Thromboembolic Stroke, Major Extracranial Bleeding, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Direct Oral Anticoagulant Use in Patients Aged 65 or Older: An Inverse Probability of Treatment Weighting (IPTW) Analysis
Analyses
04/25/2022
Analyses
04/25/2022
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2022-sentinel-public-training-day-inverse-probability
2022 Sentinel Public Training Day: Inverse Probability of Treatment Weighting & Innovation Day
Sentinel Initiative Events
04/28/2022
Sentinel Initiative Events
04/28/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-pediatric-demographics-and-enrollment
Characterization of Pediatric Demographics and Enrollment in the Sentinel Distributed Database: A Descriptive Analysis
Analyses
05/16/2022
Analyses
05/16/2022
https://www.sentinelinitiative.org/methods-data-tools/methods/approaches-handling-partially-observed-confounder-data-electronic-health
Approaches to Handling Partially Observed Confounder Data From Electronic Health Records (EHR) In Non-randomized Studies of Medication Outcomes
Methods, Data, & Tools
06/01/2022
Methods, Data, & Tools
06/01/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/bamlanivimab-bamlanivimab-and-etesevimab-and-casirivimab
Bamlanivimab, Bamlanivimab and Etesevimab, and Casirivimab-Imdevimab Use in Patients with COVID-19: A Descriptive Analysis
Analyses
06/14/2022
Analyses
06/14/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterizing-pregnant-women-and-without-evidence-heart
Characterizing Pregnant Women With and Without Evidence of Heart Failure and Non-Pregnant Women With Heart Failure: A Propensity Score Matched Analysis
Analyses
06/21/2022
Analyses
06/21/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/use-monoclonal-antibodies-mabs-under-emergency-use
Use of Monoclonal Antibodies (mAbs) Under an Emergency Use Authorization (EUA) in Patients with COVID-19 Diagnosis: A Descriptive Analysis
Analyses
06/24/2022
Analyses
06/24/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/hospitalization-and-anaphylaxis-following-monoclonal
Hospitalization and Anaphylaxis Following Monoclonal Antibodies (mAb) Use in Patients with COVID-19: A Descriptive Analysis
Analyses
07/14/2022
Analyses
07/14/2022
https://www.sentinelinitiative.org/studies/drugs/women-heart-failure
Women with Heart Failure & Pregnancy
Studies
08/10/2022
Studies
08/10/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/use-monoclonal-antibodies-mabs-under-emergency-use-0
Use of Monoclonal Antibodies (mAbs) Under an Emergency Use Authorization (EUA) in Patients with COVID-19 Diagnosis: An Updated Descriptive Analysis
Analyses
08/24/2022
Analyses
08/24/2022
https://www.sentinelinitiative.org/news-events/publications-presentations/characterizing-pediatric-members-sentinel-distributed
Characterizing Pediatric Members in the Sentinel Distributed Database
Publications and Presentations
08/28/2022
Publications and Presentations
08/28/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-ozempic-use-patients-type-2
Outcome Monitoring Following Ozempic Use in Patients with Type 2 Diabetes: A Signal Identification Analysis
Analyses
11/10/2022
Analyses
11/10/2022
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2022-14th-annual-sentinel-initiative-public-workshop
2022 14th Annual Sentinel Initiative Public Workshop
Sentinel Initiative Events
11/15/2022
Sentinel Initiative Events
11/15/2022
https://www.sentinelinitiative.org/news-events/publications-presentations/scalable-phenotyping-safety-outcomes-using-electronic-health
Scalable Phenotyping for Safety Outcomes Using Electronic Health Record Data
Publications and Presentations
11/17/2022
Publications and Presentations
11/17/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-zarxio-use-updated-signal
Outcome Monitoring Following Zarxio Use: An Updated Signal Identification Analysis
Analyses
03/08/2023
Analyses
03/08/2023
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2023-sentinel-public-training-signal-identification-among
2023 Sentinel Public Training: Signal Identification Among Infants Following Maternal Medication Use During Pregnancy & Innovation Day
Sentinel Initiative Events
04/11/2023
Sentinel Initiative Events
04/11/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/r-package-perform-routine-structural-missing-data
An R Package to Perform Routine Structural Missing Data Investigations in Real-World Data
Publications and Presentations
06/06/2023
Publications and Presentations
06/06/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/signal-detection-and-refinement-activities-within-fda-s-0
Signal Detection and Refinement Activities within FDA’s Sentinel System
Publications and Presentations
06/28/2023
Publications and Presentations
06/28/2023
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-cannabis-derived-product-users-trinetx-four
Characterization of Cannabis-Derived Product Users in TriNetX: Four Descriptive Analyses
Analyses
07/19/2023
Analyses
07/19/2023
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-beta-blockers-pediatric-population-descriptive
Utilization of Beta Blockers in the Pediatric Population: A Descriptive Analysis
Analyses
07/19/2023
Analyses
07/19/2023
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-beta-blockers-pediatric-population-updated
Utilization of Beta Blockers in the Pediatric Population: An Updated Descriptive Analysis
Analyses
07/19/2023
Analyses
07/19/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/utilization-single-and-multiple-inhaler-triple-therapy-among-patients
Utilization of Single and Multiple Inhaler Triple Therapy Among Patients with COPD in the Sentinel Distributed Database
Methods, Data, & Tools
07/31/2023
Methods, Data, & Tools
07/31/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/characterizing-medication-use-patterns-among-pregnant-and
Characterizing Medication Use Patterns Among Pregnant and Non-Pregnant Patients with COVID-19 in the Sentinel System
Publications and Presentations
08/25/2023
Publications and Presentations
08/25/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/utilization-beta-blockers-among-pediatric-population-united
Utilization of Beta-blockers Among the Pediatric Population in the United States: A Study in the FDA’s Sentinel System from 2008 to 2022
Publications and Presentations
08/25/2023
Publications and Presentations
08/25/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/variation-mother-infant-linkage-rates-jurisdiction-us
Variation in Mother-Infant Linkage Rates by Jurisdiction in U.S. Medicaid Data
Publications and Presentations
08/26/2023
Publications and Presentations
08/26/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/principled-approaches-handle-partially-observed-confounder
Principled Approaches to Handle Partially Observed Confounder Data from Electronic Health Records: A Plasmode Simulation Study
Publications and Presentations
08/27/2023
Publications and Presentations
08/27/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/expanding-capabilities-unapproved-cannabis-derived-product
Expanding Capabilities for Unapproved Cannabis-Derived Product Surveillance in the United States, TriNetX, July 1, 2018 – June 30, 2022
Publications and Presentations
08/27/2023
Publications and Presentations
08/27/2023
https://www.sentinelinitiative.org/news-events/publications-presentations/exploring-use-electronic-health-records-ehr-data-active
Exploring the Use of Electronic Health Records (EHR) Data for Active Safety Surveillance of Epidiolex in PCORnet, July 1, 2018 - July 1, 2022
Publications and Presentations
08/27/2023
Publications and Presentations
08/27/2023
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2023-public-workshop-optimizing-use-postapproval-pregnancy
2023 Public Workshop: Optimizing the Use of Postapproval Pregnancy Safety Studies
Sentinel Initiative Events
09/18/2023
Sentinel Initiative Events
09/18/2023
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-drugs-approved-risk-evaluation-and-mitigation-0
Utilization of Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) That Employ Elements to Assure Safe Use (ETASU): A Descriptive Analysis
Analyses
10/18/2023
Analyses
10/18/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/characterization-covid-19-vaccination-data-sdd-0
Characterization of COVID-19 Vaccination Data in the SDD
Methods, Data, & Tools
10/25/2023
Methods, Data, & Tools
10/25/2023
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2023-15th-annual-sentinel-initiative-public-workshop
2023 15th Annual Sentinel Initiative Public Workshop
Sentinel Initiative Events
11/08/2023
Sentinel Initiative Events
11/08/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/empirical-application-sentinel-electronic-health-record-ehr-and-claims
Empirical Application of the Sentinel Electronic Health Record (EHR) and Claims Data Partner Network to Address ARIA Insufficient Inferential Requests
Methods, Data, & Tools
11/17/2023
Methods, Data, & Tools
11/17/2023
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-cannabis-derived-product-users-national
Characterization of Cannabis-Derived Product Users in the National Patient-Centered Clinical Research Network (PCORnet): A Descriptive Analysis
Analyses
11/21/2023
Analyses
11/21/2023
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/bimzelx-bimekizumab-bkzx
Assessment of ARIA Sufficiency: Bimzelx (bimekizumab-bkzx)
Sufficiency Assessments
12/29/2023
Sufficiency Assessments
12/29/2023
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2024-sentinel-innovation-and-methods-seminar-series
2024 Sentinel Innovation and Methods Seminar Series
Sentinel Initiative Events
01/01/2024
Sentinel Initiative Events
01/01/2024
https://www.sentinelinitiative.org/methods-data-tools/methods/covid-19-pandemic-related-changes-healthcare-utilization-among-insured
COVID-19 Pandemic Related Changes in Healthcare Utilization Among Insured Persons in the US and its Impact on Pharmacoepidemiologic Research
Methods, Data, & Tools
01/11/2024
Methods, Data, & Tools
01/11/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-baloxavir-use-signal
Outcome Monitoring Following Baloxavir Use: A Signal Identification Analysis
Analyses
01/19/2024
Analyses
01/19/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/smdi-r-package-perform-structural-missing-data
smdi: An R Package to Perform Structural Missing Data Investigations on Partially Observed Confounders in Real-world Evidence Studies
Publications and Presentations
01/31/2024
Publications and Presentations
01/31/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/coding-trend-analyses-biopsy
Coding Trend Analyses: Biopsy
Methods, Data, & Tools
02/08/2024
Methods, Data, & Tools
02/08/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/coding-trend-analyses-crohns-disease
Coding Trend Analyses: Crohn's Disease
Methods, Data, & Tools
02/08/2024
Methods, Data, & Tools
02/08/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/coding-trend-analyses-colectomy-colostomy-and-ileostomy
Coding Trend Analyses: Colectomy, Colostomy, and Ileostomy
Methods, Data, & Tools
02/08/2024
Methods, Data, & Tools
02/08/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/coding-trend-analyses-diverticulitis-and-colitis
Coding Trend Analyses: Diverticulitis and Colitis
Methods, Data, & Tools
02/08/2024
Methods, Data, & Tools
02/08/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/coding-trend-analyses-endoscopy
Coding Trend Analyses: Endoscopy
Methods, Data, & Tools
02/08/2024
Methods, Data, & Tools
02/08/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/coding-trend-analyses-ulcerative-colitis
Coding Trend Analyses: Ulcerative Colitis
Methods, Data, & Tools
02/08/2024
Methods, Data, & Tools
02/08/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-dupilumab-use-signal
Outcome Monitoring Following Dupilumab Use: A Signal Identification Analysis
Analyses
02/15/2024
Analyses
02/15/2024
https://www.sentinelinitiative.org/methods-data-tools/methods/maintaining-and-expanding-reach-sentinel-ehr-and-claims-network-di8
Maintaining and Expanding the Reach of the Sentinel EHR and Claims Network (DI8)
Methods, Data, & Tools
03/01/2024
Methods, Data, & Tools
03/01/2024
https://www.sentinelinitiative.org/studies/drugs/singulair-montelukast-0
Singulair (Montelukast) & Intentional Self-Harm
Studies
03/21/2024
Studies
03/21/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/targeted-learning-undersmoothed-lasso-propensity-score-model
Targeted Learning with an Undersmoothed Lasso Propensity Score Model for Large-Scale Covariate Adjustment in Healthcare Database Studies
Publications and Presentations
03/21/2024
Publications and Presentations
03/21/2024
https://www.sentinelinitiative.org/studies/drugs/cannabinoid-products
Cannabinoid Products & Cohort Characterization
Studies
04/29/2024
Studies
04/29/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/rezdiffra-resmetirom
Assessment of ARIA Sufficiency: Rezdiffra (resmetirom)
Sufficiency Assessments
04/29/2024
Sufficiency Assessments
04/29/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/vafseo-vadadustat
Assessment of ARIA Sufficiency: Vafseo (vadadustat)
Sufficiency Assessments
04/30/2024
Sufficiency Assessments
04/30/2024
https://www.sentinelinitiative.org/studies/drugs/entyvio-vedolizumab-and-tysabri-natalizumab
Entyvio (Vedolizumab) and Tysabri (Natalizumab) & Interstitial Lung Disease
Studies
05/09/2024
Studies
05/09/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/interstitial-lung-disease-ild-patients-inflammatory-bowel
Interstitial Lung Disease (ILD) in Patients with Inflammatory Bowel Disease (IBD) and Following Vedolizumab or Natalizumab Initiation: A Descriptive Analysis
Analyses
05/09/2024
Analyses
05/09/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/interstitial-lung-disease-ild-rates-patients-inflammatory
Interstitial Lung Disease (ILD) Rates in Patients with Inflammatory Bowel Disease (IBD) and Following IBD Advanced Therapy: A Descriptive Analysis
Analyses
05/09/2024
Analyses
05/09/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/interstitial-lung-disease-algorithm-defined
Interstitial Lung Disease Algorithm Defined in "Interstitial Lung Disease (ILD) in Patients with Inflammatory Bowel Disease (IBD) and Following Vedolizumab or Natalizumab Initiation: A Descriptive Analysis"
Methods, Data, & Tools
05/09/2024
Methods, Data, & Tools
05/09/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/interstitial-lung-disease-algorithm-defined-0
Interstitial Lung Disease Algorithm Defined in "Interstitial Lung Disease (ILD) Rates in Patients with Inflammatory Bowel Disease (IBD) and Following IBD Advanced Therapy: A Descriptive Analysis"
Methods, Data, & Tools
05/09/2024
Methods, Data, & Tools
05/09/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/tryvio-aprocitentan
Assessment of ARIA Sufficiency: Tryvio (aprocitentan)
Sufficiency Assessments
05/13/2024
Sufficiency Assessments
05/13/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2007
Duration of Follow Up for New Molecular Entities Approved in 2007: A Descriptive Analysis
Analyses
05/14/2024
Analyses
05/14/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/voydeya-danicopan
Assessment of ARIA Sufficiency: Voydeya (danicopan)
Sufficiency Assessments
05/14/2024
Sufficiency Assessments
05/14/2024
https://www.sentinelinitiative.org/studies/drugs/new-molecular-entities-nmes
New Molecular Entities (NMEs) & Utilization Characterization
Studies
05/14/2024
Studies
05/14/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/general-framework-developing-computable-clinical-phenotype
A General Framework for Developing Computable Clinical Phenotype Algorithms
Publications and Presentations
05/15/2024
Publications and Presentations
05/15/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/finding-uncoded-anaphylaxis-electronic-health-records
Finding Uncoded Anaphylaxis in Electronic Health Records to Estimate the Sensitivity of ICD10 Codes
Publications and Presentations
05/16/2024
Publications and Presentations
05/16/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/duvyzat-givinostat
Assessment of ARIA Sufficiency: Duvyzat (givinostat)
Sufficiency Assessments
05/16/2024
Sufficiency Assessments
05/16/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-ibrexafungerp-pregnant-patients-updated
Utilization of Ibrexafungerp in Pregnant Patients: An Updated Descriptive Analysis in TriNetX
Analyses
05/17/2024
Analyses
05/17/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/concomitant-use-medications-drug-drug-interactions
Concomitant Use of Medications with Drug-Drug Interactions with Nirmatrelvir and Ritonavir Among Patients Treated with Nirmatrelvir and Ritonavir or Patients with COVID-19: A Descriptive Analysis
Analyses
05/17/2024
Analyses
05/17/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-beta-blockers-pediatric-population-follow
Utilization of Beta Blockers in the Pediatric Population: A Follow Up Updated Descriptive Analysis
Analyses
05/20/2024
Analyses
05/20/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/principled-approach-characterize-and-analyze-partially
A Principled Approach to Characterize and Analyze Partially Observed Confounder Data from Electronic Health Records
Publications and Presentations
05/21/2024
Publications and Presentations
05/21/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/transparency-reproducibility-and-replicability
Transparency, Reproducibility, and Replicability of Pharmacoepidemiology Studies in a Distributed Network Environment
Publications and Presentations
05/23/2024
Publications and Presentations
05/23/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-users-new-molecular-entities-approved-0
Characterization of Users of New Molecular Entities Approved in 2021 in TriNetX: An Updated Descriptive Analysis
Analyses
05/30/2024
Analyses
05/30/2024
https://www.sentinelinitiative.org/studies/drugs/enterovirus
Enterovirus & Neonatal Enteroviral Sepsis
Studies
05/31/2024
Studies
05/31/2024
https://www.sentinelinitiative.org/studies/drugs/hydroxyurea
Hydroxyurea & Use by Indication
Studies
05/31/2024
Studies
05/31/2024
https://www.sentinelinitiative.org/studies/characterization-influenza-complications-among-individuals-diagnosed-influenza-illness
Characterization of Influenza Complications Among Individuals Diagnosed with Influenza‐Like Illness, Pneumonia and Influenza, and Medically Attended Acute Respiratory Illness: A Descriptive Analysis
Analyses
06/04/2024
Analyses
06/04/2024
https://www.sentinelinitiative.org/methods-data-tools/sentinel-common-data-model/data-quality-review-and-characterization-programs
Data Quality Review and Characterization Programs
Methods, Data, & Tools
06/06/2024
Methods, Data, & Tools
06/06/2024
https://www.sentinelinitiative.org/methods-data-tools/sentinel-common-data-model/sentinel-common-components-sas-program-package
Sentinel Common Components SAS® Program Package
Common Data Model
06/06/2024
Common Data Model
06/06/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-pediatric-demographics-and-enrollment-0
Characterization of Pediatric Demographics and Enrollment in the Sentinel Distributed Database: An Updated Descriptive Analysis
Analyses
06/10/2024
Analyses
06/10/2024
https://www.sentinelinitiative.org/studies/drugs/angiotensin-converting-enzyme-ace-inhibitors-and-angiotensin-ii-receptor-blockers-0
Angiotensin-Converting Enzyme (ACE) Inhibitors and Angiotensin II Receptor Blockers (ARBs) & Pediatric Drug Utilization
Studies
06/13/2024
Studies
06/13/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/description-active-risk-identification-and-analysis-system
A Description of the Active Risk Identification and Analysis System of the U.S. Food and Drug Administration
Publications and Presentations
06/14/2024
Publications and Presentations
06/14/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/us-food-and-drug-administration-s-sentinel-system-post
The U.S. Food and Drug Administration’s Sentinel System: A Post-Market Active Drug Safety Surveillance System
Publications and Presentations
06/14/2024
Publications and Presentations
06/14/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/innovative-methods-evaluating-medical-product-safety-and
Innovative Methods for Evaluating Medical Product Safety and Effectiveness Using Real World Data: The U.S. Food and Drug Administration’s Sentinel Innovation Center
Publications and Presentations
06/14/2024
Publications and Presentations
06/14/2024
https://www.sentinelinitiative.org/studies/drugs/pharmacogenetic-testing
Pharmacogenetic Testing & Characteristics and Metrics
Studies
06/14/2024
Studies
06/14/2024
https://www.sentinelinitiative.org/studies/drugs/covid-19
COVID-19 & Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE)
Studies
06/20/2024
Studies
06/20/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/winrevair-sotatercept
Assessment of ARIA Sufficiency: Winrevair (sotatercept)
Sufficiency Assessments
06/20/2024
Sufficiency Assessments
06/20/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/voquezna-vonoprozan
Assessment of ARIA Sufficiency: Voquezna (vonoprozan)
Sufficiency Assessments
06/20/2024
Sufficiency Assessments
06/20/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/zepbound-tirzepatide
Assessment of ARIA Sufficiency: Zepbound (tirzepatide)
Sufficiency Assessments
06/20/2024
Sufficiency Assessments
06/20/2024
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/leqembi-lecanemab-irmb
Assessment of ARIA Sufficiency: Leqembi (lecanemab-irmb)
Sufficiency Assessments
06/20/2024
Sufficiency Assessments
06/20/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/triple-challenges-small-sample-size-both-exposure-and
Triple Challenges – Small Sample Size in Both Exposure and Control Groups to Scan Rare Maternal Outcomes in a Signal Identification Approach: A Simulation Study
Publications and Presentations
06/24/2024
Publications and Presentations
06/24/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/serious-infection-algorithm-defined-serious-infection
Serious Infection Algorithm Defined in "Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease: An Inverse Probability of Treatment Weighting Analysis"
Methods, Data, & Tools
06/24/2024
Methods, Data, & Tools
06/24/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/serious-infection-following-ustekinumab-use-patients-crohn-0
Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease: An Inverse Probability of Treatment Weighting Analysis
Analyses
06/24/2024
Analyses
06/24/2024
https://www.sentinelinitiative.org/studies/drugs/xofluza-baloxavir
Xofluza (Baloxavir) & Signal Identification
Studies
06/25/2024
Studies
06/25/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/use-sentinel-system-examine-medical-product-use-and-outcomes
Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy
Publications and Presentations
06/28/2024
Publications and Presentations
06/28/2024
https://www.sentinelinitiative.org/methods-data-tools/software-packages-toolkits/centers-medicare-and-medicaid-services-cms-medicaid
The Centers for Medicare and Medicaid Services (CMS): Medicaid and Children’s Health Insurance Program (CHIP) Claims in Sentinel Common Data Model (SCDM) Format
Methods, Data, & Tools
07/02/2024
Methods, Data, & Tools
07/02/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/simple-cox-approach-estimating-risk-ratios-without-sharing
A Simple Cox Approach to Estimating Risk Ratios Without Sharing Individual-Level Data in Multi-Site Studies
Publications and Presentations
07/05/2024
Publications and Presentations
07/05/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/distributed-regression-analysis-application-package-using
A Distributed Regression Analysis Application Package Using SAS
Publications and Presentations
07/09/2024
Publications and Presentations
07/09/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/counts-and-characteristics-dipeptidyl-peptidase-4-dpp-4
Counts and Characteristics of Dipeptidyl Peptidase-4 (DPP-4) Inhibitor or Sodium-Glucose Cotransporter-2 (SGLT-2) Inhibitor Users with Type 2 Diabetes: A Descriptive Analysis
Analyses
07/11/2024
Analyses
07/11/2024
https://www.sentinelinitiative.org/studies/drugs/dupixent-dupilumab
Dupixent (Dupilumab) & Signal Identification
Studies
07/12/2024
Studies
07/12/2024
https://www.sentinelinitiative.org/studies/drugs/brexafemme-ibrexafungerp
Brexafemme (Ibrexafungerp) & Use in Pregnancy
Studies
07/17/2024
Studies
07/17/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-ibrexafungerp-pregnant-patients-updated-0
Utilization of Ibrexafungerp in Pregnant Patients: An Updated Descriptive Analysis
Analyses
07/17/2024
Analyses
07/17/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-methotrexate-descriptive-analysis-trinetx
Utilization of Methotrexate: A Descriptive Analysis in TriNetX
Analyses
07/17/2024
Analyses
07/17/2024
https://www.sentinelinitiative.org/studies/drugs/glucagon-peptide-1-receptor-agonists
Glucagon-Like Peptide-1 Receptor Agonists & Intentional Self-Harm
Studies
07/22/2024
Studies
07/22/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/intentional-self-harm-algorithm-defined-intentional-2
Intentional Self-Harm Algorithm Defined in "Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Use in Patients with Obesity: A Descriptive Analysis"
Methods, Data, & Tools
07/22/2024
Methods, Data, & Tools
07/22/2024
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/intentional-self-harm-algorithm-defined-intentional-1
Intentional Self-Harm Algorithm Defined in "Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes: An Inverse Probability of Treatment Weighting Analysis"
Methods, Data, & Tools
07/22/2024
Methods, Data, & Tools
07/22/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-receptor
Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes: An Inverse Probability of Treatment Weighting Analysis
Analyses
07/22/2024
Analyses
07/22/2024
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/studies/drugs/drugs-risk-evaluation-and-mitigation-strategies-rems-employ-elements-assure-safe-use
Drugs with Risk Evaluation and Mitigation Strategies (REMS) That Employ Elements to Assure Safe Use (ETASU) & Utilization
Studies
07/23/2024
Studies
07/23/2024
https://www.sentinelinitiative.org/studies/drugs/makena-hydroxyprogesterone-caproate-injection-and-its-generics
Makena (Hydroxyprogesterone Caproate Injection) and Its Generics & Use in Pregnancy
Studies
07/23/2024
Studies
07/23/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/research-action-podcast-transforming-public-health
Research in Action Podcast: Transforming Public Health with Unstructured Data and NLP in FDA's Sentinel Initiative
Publications and Presentations
07/23/2024
Publications and Presentations
07/23/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/prevalence-selected-conditions-among-individuals
Prevalence of Selected Conditions Among Individuals with Childbearing Potential: A Descriptive Analysis
Analyses
07/26/2024
Analyses
07/26/2024
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/overview-cder-s-real-world-evidence-demonstration-projects
Overview of CDER’s Real-World Evidence Demonstration Projects
Sentinel Initiative Events
08/05/2024
Sentinel Initiative Events
08/05/2024
https://www.sentinelinitiative.org/news-events/meetings-workshops-trainings/2024-ispe-annual-meeting
2024 ISPE Annual Meeting
Sentinel Initiative Events
08/24/2024
Sentinel Initiative Events
08/24/2024