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Recent Sentinel Activity

This recent activity feed provides a list of the last 90 days of Sentinel activity across assessments, publications & presentations, projects, events, etc.

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URL Title Category Date Recent Activity
https://sentinelinitiative.org/news-events/fda-safety-communications-labeling-changes/fda-labeling-change-keppra-updated-include FDA Labeling Change: KEPPRA Updated to Include Risk of Anaphylaxis and Angioedema Regulatory Impact
FDA Labeling Change: KEPPRA Updated to Include Risk of Anaphylaxis and Angioedema
Regulatory Impact
https://sentinelinitiative.org/methods-data-tools/methods/covid-19-pregnancy-study-implementation COVID-19 Pregnancy Study Implementation Methods, Data, & Tools
COVID-19 Pregnancy Study Implementation
Methods, Data, & Tools
https://sentinelinitiative.org/studies/drugs/brilinta-ticagrelor Brilinta (Ticagrelor) & Concomitant Use with Lipitor (Atorvastatin) or Crestor (Rosuvastatin) Assessments
Brilinta (Ticagrelor) & Concomitant Use with Lipitor (Atorvastatin) or Crestor (Rosuvastatin)
Assessments
https://sentinelinitiative.org/studies/drugs/gimoti-metoclopramide Gimoti (Metoclopramide) & Duration of Use Assessments
Gimoti (Metoclopramide) & Duration of Use
Assessments
https://sentinelinitiative.org/methods-data-tools/methods/augmenting-date-death-cause-death-ascertainment-sentinel Augmenting Date of Death & Cause of Death Ascertainment in Sentinel Methods, Data, & Tools
Augmenting Date of Death & Cause of Death Ascertainment in Sentinel
Methods, Data, & Tools
https://sentinelinitiative.org/methods-data-tools/methods/inclusion-semi-structured-and-unstructured-electronic-health-record-ehr Inclusion of Semi-Structured and Unstructured Electronic Health Record (EHR) Data in Confounding Adjustment and Outcome Ascertainment Methods, Data, & Tools
Inclusion of Semi-Structured and Unstructured Electronic Health Record (EHR) Data in Confounding Adjustment and Outcome Ascertainment
Methods, Data, & Tools
https://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
2023 Public Workshop: Optimizing the Use of Postapproval Pregnancy Safety Studies
Sentinel Initiative Events
https://sentinelinitiative.org/methods-data-tools/methods/strengthening-inferential-studies-us-fda-sentinel-initiative Strengthening Inferential Studies in the U.S. FDA Sentinel Initiative: A Methodological Demonstration Project Methods, Data, & Tools
Strengthening Inferential Studies in the U.S. FDA Sentinel Initiative: A Methodological Demonstration Project
Methods, Data, & Tools
https://sentinelinitiative.org/methods-data-tools/methods/development-and-refinement-toolkit-large-scale-covariate-adjustment Development and Refinement of a Toolkit for Large Scale Covariate Adjustment in the Electronic Health Record and Claims Data Partner Network Methods, Data, & Tools
Development and Refinement of a Toolkit for Large Scale Covariate Adjustment in the Electronic Health Record and Claims Data Partner Network
Methods, Data, & Tools
https://sentinelinitiative.org/methods-data-tools/methods/empirical-application-sentinel-ehr-and-claims-data-partner-network Empirical Application of the Sentinel EHR and Claims Data Partner Network to Enhance ARIA Sufficient Inferential Requests and Atypical Descriptive Requests (Use Case Package 2) Methods, Data, & Tools
Empirical Application of the Sentinel EHR and Claims Data Partner Network to Enhance ARIA Sufficient Inferential Requests and Atypical Descriptive Requests (Use Case Package 2)
Methods, Data, & Tools
https://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
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
https://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
Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Obesity: A Descriptive Analysis
Analyses
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2021-first Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis Analyses
Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis
Analyses
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-products-labeling-changes-related-pregnancy Utilization of Products with Labeling Changes Related to Pregnancy Among Mothers with Live-Birth Deliveries: A Descriptive Analysis Analyses
Utilization of Products with Labeling Changes Related to Pregnancy Among Mothers with Live-Birth Deliveries: A Descriptive Analysis
Analyses
https://sentinelinitiative.org/studies/drugs/brintellix-vortioxetine-and-brilinta-ticragelor Brintellix (Vortioxetine) and Brilinta (Ticragelor) & Medication Errors Studies
Brintellix (Vortioxetine) and Brilinta (Ticragelor) & Medication Errors
Studies
https://sentinelinitiative.org/studies/drugs/covid-19-pregnancy COVID-19 in Pregnancy & Drug Utilization, Disease Severity, Adverse Neonatal Outcomes, and Adverse Maternal Outcomes Studies
COVID-19 in Pregnancy & Drug Utilization, Disease Severity, Adverse Neonatal Outcomes, and Adverse Maternal Outcomes
Studies
https://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
Comparison of Signal Detection and Evaluation Study Designs to Inform Development of the Pregnancy Safety Framework
Methods, Data, & Tools
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/rates-diabetic-ketoacidosis-dka-chronic-kidney-disease-ckd Rates of Diabetic Ketoacidosis (DKA) by Chronic Kidney Disease (CKD) Stage Among Patients with Type 1 Diabetes Mellitus (T1DM): A Propensity Score Matched Analysis Analyses
Rates of Diabetic Ketoacidosis (DKA) by Chronic Kidney Disease (CKD) Stage Among Patients with Type 1 Diabetes Mellitus (T1DM): A Propensity Score Matched Analysis
Analyses
https://sentinelinitiative.org/methods-data-tools/methods/chart-review-major-congenital-malformations Chart Review of Major Congenital Malformations Methods, Data, & Tools
Chart Review of Major Congenital Malformations
Methods, Data, & Tools
https://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
Use Case 2 (UC2) Aim 5: Plasmode Simulation Based Quantitative Bias Analysis (QBA) for Unmeasured Confounding
Methods, Data, & Tools
https://sentinelinitiative.org/methods-data-tools/methods/developing-prediction-model-estimate-magnitude-exposure Developing a Prediction Model to Estimate the Magnitude of Exposure Methods, Data, & Tools
Developing a Prediction Model to Estimate the Magnitude of Exposure
Methods, Data, & Tools
https://sentinelinitiative.org/studies/drugs/new-molecular-entities-nmes New Molecular Entities (NMEs) & Utilization Characterization Studies
New Molecular Entities (NMEs) & Utilization Characterization
Studies
https://sentinelinitiative.org/studies/drugs/products-converted-labeling-reference-studies-pregnancy-and-lactation-rule Products with Converted Labeling Reference Studies for the Pregnancy and Lactation Rule for the Development of the Pregnancy Safety Study Framework & Use in Pregnancy Studies
Products with Converted Labeling Reference Studies for the Pregnancy and Lactation Rule for the Development of the Pregnancy Safety Study Framework & Use in Pregnancy
Studies
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-faricimab-use-self-controlled Outcome Monitoring Following Faricimab Use: A Self-Controlled Risk Interval Signal Identification Analysis Analyses
Outcome Monitoring Following Faricimab Use: A Self-Controlled Risk Interval Signal Identification Analysis
Analyses
https://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
Assessing the Performance of Major Congenital Malformations as a Composite Outcome in Signal Detection and Evaluation
Methods, Data, & Tools
https://sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/rhapsido-remibrutinib Assessment of ARIA Sufficiency: Rhapsido (remibrutinib) Sufficiency Assessments
Assessment of ARIA Sufficiency: Rhapsido (remibrutinib)
Sufficiency Assessments
https://sentinelinitiative.org/studies/drugs/semaglutide-injectables Semaglutide Injectables & Signal Identification Studies
Semaglutide Injectables & Signal Identification
Studies
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-semaglutide-use-self-controlled Outcome Monitoring Following Semaglutide Use: A Self-Controlled Risk Interval Signal Identification Analysis Analyses
Outcome Monitoring Following Semaglutide Use: A Self-Controlled Risk Interval Signal Identification Analysis
Analyses
https://sentinelinitiative.org/methods-data-tools/routine-querying-tools/sentinel-routine-querying-system Sentinel Routine Querying System Methods, Data, & Tools
Sentinel Routine Querying System
Methods, Data, & Tools
https://sentinelinitiative.org/news-events/publications-presentations/strengthening-inferential-studies-fda-sentinel-initiative Strengthening Inferential Studies in the FDA Sentinel Initiative: Results from a Methodological Demonstration Project Publications and Presentations
Strengthening Inferential Studies in the FDA Sentinel Initiative: Results from a Methodological Demonstration Project
Publications and Presentations
https://sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/arakoda-tafenoquine-0 Assessment of ARIA Sufficiency: Arakoda (tafenoquine) Sufficiency Assessments
Assessment of ARIA Sufficiency: Arakoda (tafenoquine)
Sufficiency Assessments
https://sentinelinitiative.org/news-events/publications-presentations/adverse-outcomes-among-pregnant-women-covid-19-according Adverse Outcomes Among Pregnant Women with COVID-19 According to Hospitalization Status: A Prospective Individual Participant Data Meta-Analysis in Europe and North America Publications and Presentations
Adverse Outcomes Among Pregnant Women with COVID-19 According to Hospitalization Status: A Prospective Individual Participant Data Meta-Analysis in Europe and North America
Publications and Presentations
https://sentinelinitiative.org/news-events/publications-presentations/medications-used-among-nonhospitalized-pregnant-women-covid Medications Used Among Nonhospitalized Pregnant Women With COVID-19: A Prospective Individual Patient Data Meta-Analysis in Europe and North America Publications and Presentations
Medications Used Among Nonhospitalized Pregnant Women With COVID-19: A Prospective Individual Patient Data Meta-Analysis in Europe and North America
Publications and Presentations
https://sentinelinitiative.org/news-events/publications-presentations/augmenting-fact-and-date-death-electronic-health-records Augmenting Fact and Date of Death in Electronic Health Records Using Internet Media Sources: A Validation Study from Two Large Healthcare Systems Publications and Presentations
Augmenting Fact and Date of Death in Electronic Health Records Using Internet Media Sources: A Validation Study from Two Large Healthcare Systems
Publications and Presentations
https://sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/ocrevus-zunovo-ocrelizumab-and Assessment of ARIA Sufficiency: Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) Sufficiency Assessments
Assessment of ARIA Sufficiency: Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)
Sufficiency Assessments
https://sentinelinitiative.org/news-events/fda-safety-communications-labeling-changes/fda-requests-removal-suicidal-behavior-and FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications Regulatory Impact
FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications
Regulatory Impact
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-2 Intentional Self-Harm Following Glucagon-Like Peptide 1 Receptor Agonists (GLP-1RA) Use in Patients with Diabetes & Obesity: A Descriptive Analysis Analyses
Intentional Self-Harm Following Glucagon-Like Peptide 1 Receptor Agonists (GLP-1RA) Use in Patients with Diabetes & Obesity: A Descriptive Analysis
Analyses
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-glp-1 Intentional Self-Harm Following Glucagon-Like Peptide 1 (GLP-1) Receptor Agonists Use in Patients 18 Years and Older: A Descriptive Analysis Analyses
Intentional Self-Harm Following Glucagon-Like Peptide 1 (GLP-1) Receptor Agonists Use in Patients 18 Years and Older: A Descriptive Analysis
Analyses
https://sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/blujepa-gepotidacin Assessment of ARIA Sufficiency: Blujepa (gepotidacin) Sufficiency Assessments
Assessment of ARIA Sufficiency: Blujepa (gepotidacin)
Sufficiency Assessments
https://sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/nuzolvence-zoliflodacin Assessment of ARIA Sufficiency: Nuzolvence (zoliflodacin) Sufficiency Assessments
Assessment of ARIA Sufficiency: Nuzolvence (zoliflodacin)
Sufficiency Assessments
https://sentinelinitiative.org/methods-data-tools/health-outcomes-interest/intentional-self-harm-algorithm-defined-intentional-3 Intentional Self-Harm Algorithm Defined in "Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes, By Age and Sex Subgroups: An Inverse Probability of Treatment Weighting Analysis" Methods, Data, & Tools
Intentional Self-Harm Algorithm Defined in "Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes, By Age and Sex Subgroups: An Inverse Probability of Treatment Weighting Analysis"
Methods, Data, & Tools
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-1 Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes, By Age and Sex Subgroups: An Inverse Probability of Treatment Weighting Analysis Analyses
Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes, By Age and Sex Subgroups: An Inverse Probability of Treatment Weighting Analysis
Analyses
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2021-second Duration of Follow Up for New Molecular Entities Approved in 2021: Second Descriptive Analysis Analyses
Duration of Follow Up for New Molecular Entities Approved in 2021: Second Descriptive Analysis
Analyses
https://sentinelinitiative.org/news-events/publications-presentations/assessing-treatment-effects-observational-data-missing-0 Assessing Treatment Effects in Observational Data With Missing Confounders: A Comparative Study of Practical Doubly-Robust and Traditional Missing Data Methods Publications and Presentations
Assessing Treatment Effects in Observational Data With Missing Confounders: A Comparative Study of Practical Doubly-Robust and Traditional Missing Data Methods
Publications and Presentations
https://sentinelinitiative.org/news-events/publications-presentations/use-clinical-notes-assess-neuropsychiatric-events-after Use of Clinical Notes to Assess Neuropsychiatric Events After Montelukast Initiation Publications and Presentations
Use of Clinical Notes to Assess Neuropsychiatric Events After Montelukast Initiation
Publications and Presentations
https://sentinelinitiative.org/studies/drugs/vabysmo-faricimab Vabysmo (Faricimab) & Signal Identification Studies
Vabysmo (Faricimab) & Signal Identification
Studies
https://sentinelinitiative.org/news-events/publications-presentations/evaluating-unmeasured-confounding-factors-claims-data-using Evaluating Unmeasured Confounding Factors in Claims Data Using Linked Electronic Health Records: A Proof-of-Principle Analysis Publications and Presentations
Evaluating Unmeasured Confounding Factors in Claims Data Using Linked Electronic Health Records: A Proof-of-Principle Analysis
Publications and Presentations
https://sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/symbravo-meloxicam-and-rizatriptan Assessment of ARIA Sufficiency: Symbravo (meloxicam and rizatriptan) Sufficiency Assessments
Assessment of ARIA Sufficiency: Symbravo (meloxicam and rizatriptan)
Sufficiency Assessments
https://sentinelinitiative.org/methods-data-tools/health-outcomes-interest/renal-cell-carcinoma-algorithm-defined-renal-cell Renal Cell Carcinoma Algorithm Defined in "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" Methods, Data, & Tools
Renal Cell Carcinoma Algorithm Defined in "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"
Methods, Data, & Tools
https://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
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
https://sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/myqorzo-aficamten Assessment of ARIA Sufficiency: Myqorzo (aficamten) Sufficiency Assessments
Assessment of ARIA Sufficiency: Myqorzo (aficamten)
Sufficiency Assessments
https://sentinelinitiative.org/studies/drugs/fluoride Fluoride & Utilization Studies
Fluoride & Utilization
Studies
https://sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-orally-ingestible-systemic-sodium-fluoride Utilization of Orally Ingestible Systemic Sodium Fluoride: A Descriptive Analysis Analyses
Utilization of Orally Ingestible Systemic Sodium Fluoride: A Descriptive Analysis
Analyses
https://sentinelinitiative.org/studies/drugs/glucagon-peptide-1-receptor-agonists Glucagon-Like Peptide-1 Receptor Agonists & Intentional Self-Harm Studies
Glucagon-Like Peptide-1 Receptor Agonists & Intentional Self-Harm
Studies