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author:

Lin, Li (Lin, Li.) [1] | Zheng, Xinlei (Zheng, Xinlei.) [2] | Wu, Min (Wu, Min.) [3] | Chen, Yan (Chen, Yan.) [4] | Nian, Qichun (Nian, Qichun.) [5] | Lin, Yu (Lin, Yu.) [6] | Chen, Maohua (Chen, Maohua.) [7]

Indexed by:

SCIE

Abstract:

BackgroundRamucirumab (IMC-1121B) is a fully human immunoglobulin G1 monoclonal antibody, approved by the US Food and Drug Administration (FDA) for treating various cancers, including gastric, colorectal, liver, and non-small cell lung cancer. This study aimed to investigate the adverse events (AEs) associated with ramucirumab by utilizing data mining techniques on the FDA Adverse Event Reporting System (FAERS).MethodsWe collected ramucirumab-related data from the FAERS database, spanning from January 2014 to June 2023. Our analysis incorporated both Frequentist and Bayesian methodologies in disproportionality analysis to determine the relationship between the drug and specific AEs.ResultsAmong the 14,605,547 reports in FAERS database, 12,692,407 were identified as primary suspected AEs related to ramucirumab. These AEs involved 26 different organ systems, with 24 significant disproportionality Preferred Terms (PTs) identified across four algorithms. Notably, unexpected significant AEs, such as peripheral neuropathy, hemolytic uremic syndrome, rectal stenosis, anaphylactic shock, bladder tamponade, hydronephrosis, and spontaneous pneumothorax, were also observed.ConclusionThis study makes a significant contribution to the field by emphasizing the importance of long-term monitoring of approved agents to further expand on potential adverse events and to distinguish between events that are disease-related versus those more directly related to the particular treatment.

Keyword:

adverse event disproportionality analysis FAERS database pharmacovigilance Ramucirumab

Community:

  • [ 1 ] [Lin, Li]Fujian Med Univ, Fuzhou Univ, Fujian Prov Hosp, Shengli Clin Med Coll,Dept Med Oncol,Affiliated Pr, Fuzhou, Fujian, Peoples R China
  • [ 2 ] [Zheng, Xinlei]Pingtan Comprehens Expt Area Hosp, Dept Pharm, 2 Linhu 7th Rd, Fuzhou 350400, Peoples R China
  • [ 3 ] [Chen, Yan]Pingtan Comprehens Expt Area Hosp, Dept Pharm, 2 Linhu 7th Rd, Fuzhou 350400, Peoples R China
  • [ 4 ] [Nian, Qichun]Pingtan Comprehens Expt Area Hosp, Dept Pharm, 2 Linhu 7th Rd, Fuzhou 350400, Peoples R China
  • [ 5 ] [Chen, Maohua]Pingtan Comprehens Expt Area Hosp, Dept Pharm, 2 Linhu 7th Rd, Fuzhou 350400, Peoples R China
  • [ 6 ] [Wu, Min]Hangzhou Gongshu Dist Hlth Supervis Inst, Hangzhou Gongshu Dist Ctr Dis Control & Prevent, Hangzhou, Zhejiang, Peoples R China
  • [ 7 ] [Lin, Yu]Pingtan Comprehens Expt Area Hosp, Dept Orthoped, 2 Linhu 7th Rd, Fuzhou 350400, Fujian, Peoples R China
  • [ 8 ] [Lin, Yu]Fujian Med Univ Union Hosp, Dept Orthoped, Fuzhou, Peoples R China

Reprint 's Address:

  • [Chen, Maohua]Pingtan Comprehens Expt Area Hosp, Dept Pharm, 2 Linhu 7th Rd, Fuzhou 350400, Peoples R China;;[Lin, Yu]Pingtan Comprehens Expt Area Hosp, Dept Orthoped, 2 Linhu 7th Rd, Fuzhou 350400, Fujian, Peoples R China

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Source :

EXPERT OPINION ON DRUG SAFETY

ISSN: 1474-0338

Year: 2024

3 . 0 0 0

JCR@2023

CAS Journal Grade:3

Cited Count:

WoS CC Cited Count: 1

SCOPUS Cited Count:

ESI Highly Cited Papers on the List: 0 Unfold All

WanFang Cited Count:

Chinese Cited Count:

30 Days PV: 2

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