Characterizing ADRs of Enfortumab vedotin and Erdafitinib in bladder cancer treatment: a descriptive analysis from WHO-VigiAccess
2024

Safety Profiles of Enfortumab Vedotin and Erdafitinib in Bladder Cancer Treatment

Sample size: 3438 publication 10 minutes Evidence: high

Author Information

Author(s): Huang Yuanbin, Xu Meiqi, Ma Xinmiao, Wang Wei, Shen Chen, Liu Fei, Chen Zhiqi, Wang Jiawen, Guo Qian, Li Xiancheng

Primary Institution: Second Affiliated Hospital of Dalian Medical University

Hypothesis

This study assessed adverse drug reactions (ADRs) from both drugs, comparing their safety profiles to guide clinical use.

Conclusion

The study identified and compared potential and novel ADRs between EV and Erdafitinib, providing key insights into their safety profiles.

Supporting Evidence

  • 3,438 ADR reports were identified, with 2,257 for EV and 1,181 for Erdafitinib.
  • EV is linked to higher rates of skin and nervous system disorders compared to Erdafitinib.
  • Erdafitinib has a higher mortality rate associated with its ADRs compared to EV.

Takeaway

This study looked at the side effects of two cancer drugs, Enfortumab vedotin and Erdafitinib, to help doctors choose the best treatment for patients.

Methodology

A retrospective descriptive analysis was conducted on ADR reports for EV and Erdafitinib from the WHO-VigiAccess database.

Potential Biases

Reporting biases, including notoriety bias and selective reporting, may affect the interpretation of the data.

Limitations

The study is limited by potential reporting biases and the lack of accurate exposure population information.

Participant Demographics

{"gender_distribution":{"male":73.8,"female":23.3,"unknown":2.9},"age_distribution":{"65-74":25.4,"≥75":20.2,"unknown":37.6},"geographic_distribution":{"Americas":51.1,"Europe":44.6,"Asia":3.1,"Africa":0.1,"Oceania":1.1}}

Statistical Information

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.3389/fphar.2024.1503154

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