Datasets#
statin49: FDA statin dataset with 49 adverse events#
Description#
A 50 by 7 data matrix of a contingency table processed from FDA Adverse Event Reporting System (FAERS) database from the third quarter of 2014 to the fourth quarter of 2020.
Format#
A data matrix with 50 rows and 7 columns.
Details#
A 50 by 7 data matrix of a contingency table processed from FDA Adverse Event Reporting System (FAERS) database from the third quarter of 2014 to the fourth quarter of 2020.
The 49 rows represent 49 important adverse events associated with the statin class, with the final row aggregating the remaining 5,990 adverse events. The 49 AEs are classified into three clusters:
AEs associated with signs and symptoms of muscle injury,
AEs associated with laboratory tests for muscle injury, and
AEs associated with kidney injury and its laboratory diagnosis and treatment.
The 7 columns include the six statin medications and an aggregate column for other drugs that also had occurrences of the 6,039 adverse events. The marginal totals for each drug column in the statin49 table are as follows: 197,390 for Atorvastatin, 5,742 for Fluvastatin, 3,230 for Lovastatin, 22,486 for Pravastatin, 122,450 for Rosuvastatin, 85,445 for Simvastatin, and 63,539,867 for Other drugs.
Data Source#
statin49: FDA statin dataset with 49 adverse events with Cluster Index#
Description#
A 50 by 7 data matrix of a contingency table processed from FDA Adverse Event Reporting System (FAERS) database from the third quarter of 2014 to the fourth quarter of 2020; this dataset also contains the cluster index of the various adverse events.
Format#
A data matrix with 50 rows and 7 columns.
Details#
A 50 by 7 data matrix of a contingency table processed from FDA Adverse Event Reporting System (FAERS) database from the third quarter of 2014 to the fourth quarter of 2020.
The 49 rows represent 49 important adverse events associated with the statin class, with the final row aggregating the remaining 5,990 adverse events. The 49 AEs are classified into three clusters:
AEs associated with signs and symptoms of muscle injury,
AEs associated with laboratory tests for muscle injury, and
AEs associated with kidney injury and its laboratory diagnosis and treatment.
The 7 columns include the six statin medications and an aggregate column for other drugs that also had occurrences of the 6,039 adverse events. The marginal totals for each drug column in the statin49 table are as follows: 197,390 for Atorvastatin, 5,742 for Fluvastatin, 3,230 for Lovastatin, 22,486 for Pravastatin, 122,450 for Rosuvastatin, 85,445 for Simvastatin, and 63,539,867 for Other drugs.
Data Source#
FDA statin dataset with 101 adverse events#
Description#
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.
Format#
A data matrix with 102 rows and 5 columns.
Details#
A 102 by 5 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 adverse events (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 5,739,383 for Other drugs.
Also refer to the 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.
Data Source#
The quarterly files can be found at FDA FAERS QDE.
FDA dataset for beta blockers with 500 adverse events#
Description#
A 501 by 9 data matrix of a contingency table processed from the FDA Adverse Event Reporting System (FAERS) database. This dataset covers a specific period from Q1 2021 to Q4 2023.
Format#
A data matrix with 501 rows and 9 columns.
Details#
A 501 by 9 data matrix of a contingency table from the FDA Adverse Event Reporting System (FAERS) database, covering the period from Q1 2021 to Q4 2023. The 500 rows correspond to the Adverse Events (AEs) with the highest overall frequency (row marginals) reported during the period, and 1 row for Other AEs. The reported AEs - “Off label use” and “Drug ineffective” have been excluded. The dataset includes the following 9 columns: Acebutolol, Atenolol, Bisoprolol, Carvedilol, Metoprolol, Nadolol, Propranolol, Timolol, and Other.
The marginal totals for each column are as follows:
Acebutolol: 62,164
Atenolol: 36,619
Bisoprolol: 134,297
Carvedilol: 35,922
Metoprolol: 88,387
Nadolol: 11,191
Propranolol: 56,444
Timolol: 16,077
Other: 76,926,859
Also refer to the 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.
Data Source#
The quarterly files can be found at FDA FAERS QDE.
FDA dataset for sedatives with 1000 adverse events#
Description#
A 1001 by 11 data matrix of a contingency table processed from the FDA Adverse Event Reporting System (FAERS) database. This dataset covers a specific period from Q1 2021 to Q4 2023.
Format#
A data matrix with 1001 rows and 11 columns.
Details#
A 1001 by 11 data matrix of a contingency table from the FDA Adverse Event Reporting System (FAERS) database, covering a specified period from Q1 2021 to Q4 2023.
The 1000 rows correspond to the adverse events (AEs) with the highest overall frequency (row marginals) reported during the period, and 1 row for Other AEs. The reported AEs, “Off label use” and “Drug ineffective”, have been excluded.
The dataset includes the following 10 columns: Clonazepam, Dexmedetomidine, Diazepam, Diphenhydramine, Doxepin, Lorazepam, Midazolam, Mirtazapine, Nitrazepam, Temazepam, and an Other column.
The marginal totals for each column are as follows: - Clonazepam: 110,453 - Dexmedetomidine: 4,262 - Diazepam: 74,859 - Diphenhydramine: 13,465 - Doxepin: 11,795 - Lorazepam: 101,969 - Midazolam: 26,264 - Mirtazapine: 54,273 - Nitrazepam: 3,473 - Temazepam: 20,523 - Other: 77,487,518
Also refer to the 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.
Data Source#
The quarterly files can be found at FDA FAERS QDE.