A Real-World Disproportionality Analysis of Olaparib: Data Mining of the Public Version of FDA Adverse Event Reporting System

Shu, Yamin; He, Xu‐Cheng; Liu, Yanxin; Wu, Pan; Zhang, Qilin

doi:10.2147/clep.s365513

Cited by 60 publications

(45 citation statements)

References 32 publications

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“…The data that were chosen for analysis in our study were AE signals that met four algorithm standards. The novelty signals are identified as any significant AE which was not listed in package inserts 51 .…”

Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

Yin

Shu

Zhu

et al. 2022

Sci Rep

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Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was to explore the adverse events (AEs) caused by osimertinib through data mining of the US FDA Adverse Event Reporting System (FAERS), and provide reference for clinical safety. Data of osimertinib were collected from the FAERS database covering the period from first quarter of 2016 to the fourth quarter of 2021. Disproportionality analyses was employed to quantify the associated AE signals of osimertinib and detect the risk signals from the data in the FAERS database. Reporting odds ratio (ROR) was used to detect the risk signals from the data in the FAERS database. The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). Totally, 9,704,33 reports were collected from the FAERS database, 10,804 reports of osimertinib were identified as the ‘primary suspected (PS)’ AEs. Osimertinib induced AEs occurred in 27 organ systems. 68 significant disproportionality PTs satisfying with the four algorithms were retained at the same time. Unexpected significant AEs such as scrotal volvulus, hepatic function abnormal, venous thromboembolisms might also occur. The median onset time of osimertinib-associated AEs was 58 days (interquartile range [IQR] 14–212 days), and the majority of the AEs occurred within the first 30 days after osimertinib initiation. Our study found significant new AEs signals of osimertinib and might provide support for clinical monitoring and risk identification of osimertinib.

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Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

Yin

Shu

Zhu

et al. 2022

Sci Rep

Self Cite

View full text Add to dashboard Cite

show abstract

“…The data that were chosen for analysis in our study were AE signals that met four algorithm standards. The novelty signals are identi ed as any signi cant AE which was not listed in package inserts (45).…”

Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Osimertinib

Yin

Shu

Zhu

et al. 2022

Preprint

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Background Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was to explore the adverse events (AEs) caused by osimertinib through data mining of the US FDA Adverse Event Reporting System (FAERS), and provide reference for clinical safety. Methods Data of osimertinib were collected from the FAERS database covering the period from first quarter of 2016 to the fourth quarter of 2021. Disproportionality analyses was employed to quantify the associated AE signals of osimertinib and detect the risk signals from the data in the FAERS database. ROR was used to detect the risk signals from the data in the FAERS database. The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). Results Totally, 9704338 reports were collected from the FAERS database, 10804 reports of osimertinib were identified as the ‘primary suspected (PS)’ AEs. Osimertinib induced AEs occurred in 27 organ systems. 68 significant disproportionality PTs satisfying with the four algorithms were retained at the same time. Unexpected significant AEs such as scrotal volvulus, hepatic function abnormal, VTEs might also occur. The median onset time of osimertinib-associated AEs was 58 days (interquartile range [IQR] 14–212 days), and the majority of the AEs occurred within the first 30 days after osimertinib initiation. Conclusion Our study found significant new AEs signals of osimertinib and might provide support for clinical monitoring and risk identification of osimertinib.

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“…Moreover, the cases deleted by FDA or manufacturers for various reasons were collected in Deleted files. Because multiple versions of a report would be reported, the deduplication process should be performed before statistical analysis, to ensure the uniqueness of the report 17 . The caseid and the primaryid were used as the key filters in our study to remove duplicate records.…”

Section: Methodsmentioning

confidence: 99%

Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system

et al. 2023

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Objective Quetiapine, an atypical second‐generation antipsychotic drug, is approved for treatment of schizophrenia, bipolar disorder, and depression. Due to the limitations of clinical trials, the association between quetiapine and rare cardiac adverse events (AEs) is still unclear. This study is to evaluate quetiapine‐associated cardiac AEs through data mining of FDA Adverse Event Reporting System (FAERS). Methods Reporting odds ratio (ROR) was used to quantify the signals of quetiapine‐related cardiac AEs from the first quarter (Q1) of 2018–2022 Q1. Serious and nonserious cases were compared, and signals were prioritized using a rating scale. Results A total of 1004 cases of quetiapine‐associated cardiac AEs were identified, with 31 signals being detected, among which 13 AEs were identified as new and unexpected signals. Besides, nine and 22 cardiac AEs were identified as moderate and weak clinical priority. The median TTO for moderate and weak clinical priority signals were 0 and 4 days, respectively. All of the cardiac AEs had early failure type characteristics, suggesting that most of the patients developed cardiac AEs in a few days after quetiapine treatment, and that the risk of cardiac AEs occurrence would be gradually decreased over time. Conclusion Our study provided valuable evidence for health‐care professionals to mitigate the risk of quetiapine‐associated cardiac AEs based on an extensive analysis of a real‐world, large‐sample FAERS database, and prioritize cardiac AE signals.

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A Real-World Disproportionality Analysis of Olaparib: Data Mining of the Public Version of FDA Adverse Event Reporting System

Cited by 60 publications

References 32 publications

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Osimertinib

Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system

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