A 102 by 5 data matrix of a contingency table processed from the FDA Adverse Event Reporting System (FAERS) database from Q1 2021 to Q4 2023.
Details
A 102 by data matrix of a contingency table from the FDA Adverse Event Reporting System (FAERS) database, covering Q1 2021 to Q4 2023.
The 101 rows correspond to the AEs with the highest overall frequency (row marginals) reported during the period. The reported AEs - "Off label use" and "Drug ineffective" have been excluded.
The 5 columns include 4 statin medications and an "other" column. Marginal totals for each drug: 101,462 for Atorvastatin, 9,203 for Fluvastatin, 130,994 for Rosuvastatin, 87,841 for Simvastatin, and 57,393,834 for Other drugs.
Also refer to supplementary material of:
Ding, Y., Markatou, M., & Ball, R. (2020). An evaluation of statistical approaches to postmarketing surveillance. Statistics in Medicine, 39(7), 845-874
for the data generation process. The quarterly files can be found in https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.
Examples
data(statin101)
head(statin101)
#> Atorvastatin Fluvastatin Rosuvastatin Simvastatin Other
#> Fatigue 1064 123 975 948 762995
#> Pain 951 10 3365 794 749928
#> Nausea 1108 106 489 1450 592594
#> Arthralgia 1050 138 801 761 540673
#> Headache 1005 170 754 841 526625
#> Dyspnoea 1104 140 2653 1043 521640