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Individual Drug Analyses

This page contains a complete list of all FDA analyses conducted in the Sentinel System from the start of Mini-Sentinel in 2009 to the present. 

The table below is organized at the individual analysis level (e.g., Level 1, Level 2, Query Builder, protocol-based assessment, etc.). It is designed to support searches for a specific analysis. 

Alternatively, the Drug Studies table groups together related analyses that FDA conducted to address a safety concern, or set of related safety concerns. The Drug Studies page also provides important background information and describes the regulatory impact.

Note: The appearance of a drug in a Sentinel study does not mean that FDA has concluded that a causal relationship exists between the drug and the health outcome of interest. Patients and healthcare providers should refer to FDA.gov for further information about drug safety.

FDA Sentinel Analyses from ARIA and Other Sentinel Data Sources

Title Medical Product Outcomes Date
Duration of Follow Up for New Molecular Entities Approved in 2018: Third Descriptive Analysis
Descriptive
new molecular entities (NMEs)
Utilization of Amyloid Beta-Directed Monoclonal Antibodies: A Descriptive Analysis
Descriptive
amyloid beta-directed monoclonal antibodies
COVID-19 Hospitalization and Severe COVID-19 Infection Following Proton Pump Inhibitor (PPI) Use in Patients with Gastroesophageal Reflux Disease (GERD): An Updated Inverse Probability of Treatment Weighting Analysis
Retrospective Inferential
proton pump inhibitors
COVID-19 hospitalization
Severe COVID-19
Characterization of COVID-19 Vaccinations: A Descriptive Analysis
Descriptive
Characterization of Most Frequent Diagnoses, Procedures, Medications and Labs Associated with Use of Finerenone in TriNetX: A Descriptive Analysis
TriNetX Analysis
Utilization of Hormonal Contraceptives Following Live-Birth or Stillbirth Delivery: A Second Descriptive Analysis
Descriptive
combined hormonal contraceptives (CHCs),
progestin-only contraceptives (POCs)
Characterization of Syphilis Testing and Treatment in Pregnant Women: A Descriptive Analysis
Descriptive
syphilis testing
Characterization of Syphilis Testing and Treatment in Infants in the Mother-Infant Linkage Table in the Sentinel Distributed Database: A Descriptive Analysis
Descriptive
syphilis testing
syphilis treatment
Drug Utilization in Patients with Polyarticular Juvenile Idiopathic Arthritis (pJIA): A Descriptive Analysis
Descriptive
abatacept,
adalimumab,
etanercept,
tocilizumab
polyarticular juvenile idiopathic arthritis (pJIA)
Improving the Identification of Pregnancies in Claims Data: A Descriptive Analysis
Descriptive