PMID- 36380085
OWN - NLM
STAT- MEDLINE
DCOM- 20230106
LR  - 20230109
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 12
IP  - 1
DP  - 2022 Nov 15
TI  - A real-world pharmacovigilance study of FDA Adverse Event Reporting System 
      (FAERS) events for osimertinib.
PG  - 19555
LID - 10.1038/s41598-022-23834-1 [doi]
LID - 19555
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Yin, Yanchao
AU  - Yin Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China.
FAU - Shu, Yamin
AU  - Shu Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China.
FAU - Zhu, Junru
AU  - Zhu J
AD  - Department of Cardiac and Vascular Surgery, Tongji Hospital, Tongji Medical 
      College, Huazhong University of Science and Technology, Wuhan, 430030, China.
FAU - Li, Feie
AU  - Li F
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China. lifeie@tjh.tjmu.edu.cn.
FAU - Li, Juan
AU  - Li J
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China. lijuan@tjh.tjmu.edu.cn.
LA  - eng
PT  - Journal Article
DEP - 20221115
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 3C06JJ0Z2O (osimertinib)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Humans
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - *Lung Neoplasms/drug therapy
MH  - Pharmacovigilance
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
MH  - ErbB Receptors/antagonists & inhibitors
PMC - PMC9664039
COIS- The authors declare no competing interests.
EDAT- 2022/11/16 06:00
MHDA- 2022/11/19 06:00
PMCR- 2022/11/15
CRDT- 2022/11/15 23:42
PHST- 2022/08/09 00:00 [received]
PHST- 2022/11/07 00:00 [accepted]
PHST- 2022/11/15 23:42 [entrez]
PHST- 2022/11/16 06:00 [pubmed]
PHST- 2022/11/19 06:00 [medline]
PHST- 2022/11/15 00:00 [pmc-release]
AID - 10.1038/s41598-022-23834-1 [pii]
AID - 23834 [pii]
AID - 10.1038/s41598-022-23834-1 [doi]
PST - epublish
SO  - Sci Rep. 2022 Nov 15;12(1):19555. doi: 10.1038/s41598-022-23834-1.