Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database
Abstract This study aims to monitor and identify adverse events (AEs) associated with cetuximab, a drug used to treat various late-stage (metastatic) tumors, to improve patient safety and guide drug use. This study retrospectively analyzed the cases reported in the FDA adverse event reporting system...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-02-01
|
| Series: | Scientific Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1038/s41598-025-88838-z |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1823862332508340224 |
|---|---|
| author | Shuai Zhao Yan Wang Xiaoli Deng Xi Chen Zhaoyi Lu |
| author_facet | Shuai Zhao Yan Wang Xiaoli Deng Xi Chen Zhaoyi Lu |
| author_sort | Shuai Zhao |
| collection | DOAJ |
| description | Abstract This study aims to monitor and identify adverse events (AEs) associated with cetuximab, a drug used to treat various late-stage (metastatic) tumors, to improve patient safety and guide drug use. This study retrospectively analyzed the cases reported in the FDA adverse event reporting system (FAERS) related to the application of cetuximab from 2013 Q1 to 2022 Q4. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) algorithms, were employed to quantify the signals of cetuximab-associated AEs. A total of 8364225 reports were contained in the FAERS database, of which 5186 reports of cetuximab were identified as ‘primary suspected (PS)’ AEs. The application of cetuximab resulted in AEs in 22 system organ classes (SOCs), which preserved 176 significant disproportionality preferred terms (PTs) through the computation of four algorithms. The main SOCs (Skin and subcutaneous tissue disorders, investigations, metabolism and nutrition disorders, and blood and lymphatic system disorders) accounted for 58.63%. Some AEs were not on the drug label: speech disorder, intervertebral discitis, glomerulonephritis rapidly progressive and disseminated intravascular coagulation. This study identified new signals of adverse drug reactions (ADRs) other than those mentioned in the specification associated with cetuximab, providing valuable insights into the relationship between ADRs and cetuximab use. The findings highlight the importance of continuous surveillance to detect and manage AEs effectively, ultimately improving patient safety during treatment with cetuximab. |
| format | Article |
| id | doaj-art-b501b992c88244d6b6f343dc927ae855 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-b501b992c88244d6b6f343dc927ae8552025-02-09T12:33:06ZengNature PortfolioScientific Reports2045-23222025-02-0115111110.1038/s41598-025-88838-zAnalysis of ADR reports of cetuximab based on the FDA adverse event reporting system databaseShuai Zhao0Yan Wang1Xiaoli Deng2Xi Chen3Zhaoyi Lu4Department of Galactophore, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical UniversityMedical Reproductive Center, Jiuquan Hospital, Shanghai General HospitalChangzhou Vocational Institute of Textile and Garment, Textile CollegeDepartment of Otorhinolaryngology, The First Affiliated Hospital, Nanjing Medical UniversityDepartment of Otorhinolaryngology, The First Affiliated Hospital, Nanjing Medical UniversityAbstract This study aims to monitor and identify adverse events (AEs) associated with cetuximab, a drug used to treat various late-stage (metastatic) tumors, to improve patient safety and guide drug use. This study retrospectively analyzed the cases reported in the FDA adverse event reporting system (FAERS) related to the application of cetuximab from 2013 Q1 to 2022 Q4. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) algorithms, were employed to quantify the signals of cetuximab-associated AEs. A total of 8364225 reports were contained in the FAERS database, of which 5186 reports of cetuximab were identified as ‘primary suspected (PS)’ AEs. The application of cetuximab resulted in AEs in 22 system organ classes (SOCs), which preserved 176 significant disproportionality preferred terms (PTs) through the computation of four algorithms. The main SOCs (Skin and subcutaneous tissue disorders, investigations, metabolism and nutrition disorders, and blood and lymphatic system disorders) accounted for 58.63%. Some AEs were not on the drug label: speech disorder, intervertebral discitis, glomerulonephritis rapidly progressive and disseminated intravascular coagulation. This study identified new signals of adverse drug reactions (ADRs) other than those mentioned in the specification associated with cetuximab, providing valuable insights into the relationship between ADRs and cetuximab use. The findings highlight the importance of continuous surveillance to detect and manage AEs effectively, ultimately improving patient safety during treatment with cetuximab.https://doi.org/10.1038/s41598-025-88838-zCetuximabHead and neck cancerAdverse events (AEs)Adverse drug reactions (ADRs)Preferred terms (PTs)System organ class (SOC) |
| spellingShingle | Shuai Zhao Yan Wang Xiaoli Deng Xi Chen Zhaoyi Lu Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database Scientific Reports Cetuximab Head and neck cancer Adverse events (AEs) Adverse drug reactions (ADRs) Preferred terms (PTs) System organ class (SOC) |
| title | Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database |
| title_full | Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database |
| title_fullStr | Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database |
| title_full_unstemmed | Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database |
| title_short | Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database |
| title_sort | analysis of adr reports of cetuximab based on the fda adverse event reporting system database |
| topic | Cetuximab Head and neck cancer Adverse events (AEs) Adverse drug reactions (ADRs) Preferred terms (PTs) System organ class (SOC) |
| url | https://doi.org/10.1038/s41598-025-88838-z |
| work_keys_str_mv | AT shuaizhao analysisofadrreportsofcetuximabbasedonthefdaadverseeventreportingsystemdatabase AT yanwang analysisofadrreportsofcetuximabbasedonthefdaadverseeventreportingsystemdatabase AT xiaolideng analysisofadrreportsofcetuximabbasedonthefdaadverseeventreportingsystemdatabase AT xichen analysisofadrreportsofcetuximabbasedonthefdaadverseeventreportingsystemdatabase AT zhaoyilu analysisofadrreportsofcetuximabbasedonthefdaadverseeventreportingsystemdatabase |