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Reported Adverse Drug Reactions for SARS Coronavirus 2 Treatments during the Pandemic: Evaluating and Comparing Disproportionality Analyses of FAERS Database

Chen, Xinyun (2022) Reported Adverse Drug Reactions for SARS Coronavirus 2 Treatments during the Pandemic: Evaluating and Comparing Disproportionality Analyses of FAERS Database. Master's Thesis, University of Pittsburgh. (Unpublished)

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The COVID-19 pandemic is one of the most serious health crises throughout the human history. With countless efforts of drug development and repurposing by the scientific community in a hope of finding safe and efficacious COVID-19 treatment, there is an emerging need for pharmacovigilance for these drugs indicated for COVID-19 treatment. For new drugs, clinical trials can only give limited knowledge about drug safety profiles which are not enough to guide the use of the drugs in large populations. Thus, potential risks of these drugs need to be quickly identified from data sources outside clinical trials. For repurposed drugs, change of indication may lead to unforeseeable risks even for drugs with well-established safety profiles. Thus, adverse events with elevated risks for repurposed drugs also need to be identified. This study set the aim of exploring the power of disproportionality analysis in extracting adverse drug reaction information from spontaneous reporting data to satisfy the pharmacovigilance need. For new drugs, the potential of identifying adverse reactions with limited report data was explored. For repurposed drugs, we focused on whether increase in disproportionality scores can be used to identify adverse drug events with elevated risks during the pandemic. The FDA Adverse Event Reporting System (FAERS) database was utilized, and the performance of two disproportionality scores ─ information component (IC) and reporting odds ratio (ROR) in signal detection and ranking were evaluated and compared. As a result, we found similar and seemingly plausible signal detection by both IC and ROR for a new drug Remdesivir. For repurposed drugs, we found that increase in IC and fold increase in ROR generally give plausible and comparable performance in signal detection and rankings especially for drug-adverse event combinations with large number of observations. This study explored the potentials of disproportionality analysis on identifying potential health risks for both new and repurposed drugs during the COVID-19 pandemic, which had lasting significance in case of a future public health crisis.


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Item Type: University of Pittsburgh ETD
Status: Unpublished
CreatorsEmailPitt UsernameORCID
Chen, Xinyunxic114@pitt.eduxic114
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairKirisci, Leventlevent@pitt.edulevent
Committee MemberKane-Gill, Sandra L.kane-gill@pitt.eduslk54
Committee MemberNewman, Terri Victoriatvn6@pitt.edutvn6
Date: 8 April 2022
Date Type: Publication
Defense Date: 25 March 2022
Approval Date: 8 April 2022
Submission Date: 8 April 2022
Access Restriction: 1 year -- Restrict access to University of Pittsburgh for a period of 1 year.
Number of Pages: 65
Institution: University of Pittsburgh
Schools and Programs: School of Pharmacy > Pharmaceutical Sciences
Degree: MS - Master of Science
Thesis Type: Master's Thesis
Refereed: Yes
Uncontrolled Keywords: COVID-19, Pharmacovigilance, Adverse Drug Reactions, Disproportionality Analysis, Food and Drug Administration Adverse Event Reporting System (FAERS)
Date Deposited: 08 Apr 2022 14:05
Last Modified: 08 Apr 2023 05:15


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