3.1 Data source
The FAERS datasets comprises seven data tables, including patient
demographic and administrative information (DEMO), drug information
(DRUG), adverse events (REAC), patient outcomes (OUTC), report sources
(RPSR), therapy start states and end dates for reported drugs (THER),
and indications for drug administration (INDI). Raw FAERS data can be
downloaded for free from the FDA website. Data from the first quarter of
2004 to the end of 2021 were downloaded from the FAERS Quarterly Data
Extract Files [10]. Duplicate records were
excluded based on FDA recommendations. If the CASEIDs (a number for
identifying a FAERS case) were the same, the latest FDA_DT (date FDA
received the case) was selected. If the CASEID and FDA_DT were the
same, the higher PRIMARYID (a unique number for identifying a FAERS
report) was established. Deleted cases from 2019 were further removed
from the local database. FAERS data were managed
locally using Microsoft SQL
Server 2017.
3.2 Antipsychotic drugs
and venous thrombosis adverse event identification
Drug names in the DRUG table can be documented in various forms,
including generic, brand, synonymous, or abbreviations. Before
identifying target drugs, we standardized different names of the same
drug into a ”generic name” using
MedEx software (MedEx UIMA 1.3.8, Vanderbilt University, USA)[11, 12]. We attempted to identify 47
single-component antipsychotic drugs according to the WHO Anatomical
Therapeutic Chemical (ATC) classification (ATC code: J01AA) from the
local FAERS database. The 47
agents (ATC codes)( Supplementary Information for detail)