Pharmacovigilance Analysis of EGFR-TKIs

Four EGFR-TKIs, erlotinib, gefitinib, afatinib and osimertinib were selected as study drugs. Data from the FAERS database were fully anonymized by regulatory authorities. We extracted relevant data from the public release of the FAERS database for the pharmacovigilance disproportionality analysis, which covered the period from January 1, 2004 to March 31, 2018. OpenVigil FDA, a validated pharmacovigilance tool, is adapted to query FAERS data using the openFDA application programming interface (API) for accessing the FDA drug-event database with the additional openFDA drug mapping and duplicate detection functionality^{49 (link),50 (link)}, and it is used in many pharmacovigilance studies^{51 (link),52 (link)}. OpenVigil operates only on the cleaned FDA data by deleting duplicates or reports with missing data^{49 (link)}. After data cleaning by OpenVigil FDA, 6,106,629 reports from 2004 Q1 to 2018 Q1 remained. Among the drugs and AEs in the reports, we only selected reports with drug codes of “Primary Suspect or “Secondary Suspect”.

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Huang J., Meng L., Yang B., Sun S., Luo Z, & Chen H. (2020). Safety Profile of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Disproportionality Analysis of FDA Adverse Event Reporting System. Scientific Reports, 10, 4803.

Publication 2020

Afatinib Drug Egfr Erlotinib Gefitinib Osimertinib

Corresponding Organization :

Other organizations : First Affiliated Hospital of Chongqing Medical University, Chongqing Medical University, Western New England University, Shihezi University

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Variable analysis

independent variables

Four EGFR-TKIs: erlotinib, gefitinib, afatinib and osimertinib

dependent variables

Adverse events (AEs)

control variables

The FAERS database data was fully anonymized by regulatory authorities
OpenVigil FDA was used to clean the data by deleting duplicates or reports with missing data

positive controls

Not mentioned

negative controls

Not mentioned

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