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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
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
Characterization of Syphilis Testing and Treatment in Pregnant Women: A Descriptive Analysis
Descriptive
syphilis testing
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
Proportion of Incident Syndrome of Inappropriate Antidiuretic Hormone Secretion Cases with Evidence of Pulmonary Opportunistic Infections Among New Users of BIC/TC/TAF: A Descriptive Analysis
Descriptive
bictegravir/​emtricitabine/​tenofovir alafenamide
syndrome of inappropriate antidiuretic hormone secretion
Outcome Monitoring Following Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Use: A Self-Controlled Risk Interval Signal Identification Analysis
Signal Identification
bictegravir/​emtricitabine/​tenofovir alafenamide
Utilization of Biktarvy, Odefsey, Symtuza, and Genvoya: A Descriptive Analysis
Descriptive
Biktarvy,
Genvoya,
Odefsey,
Symtuza
Characterization of Confounding Covariates in the Sentinel Distributed Database (SDD): A Descriptive Analysis
Descriptive
Characterization of Use of Attention-Deficit/Hyperactivity Disorder (ADHD) Medications or Opioid Analgesics: A Descriptive Analysis
Descriptive
central nervous system stimulants
Characterization of Dosage of Attention-Deficit/Hyperactivity Disorder (ADHD) Stimulant Medications: A Descriptive Analysis
Descriptive
central nervous system stimulants