A real-world disproportionality analysis of the US Food and Drug Administration (FDA) adverse event reporting system (FAERS) events for Durvalumab
Ting Zou, Zhuoyang Li, Tianhong Wang, Shuang Deng, Siman Wang, Yusi Hua · 2024
Read A real-world disproportionality analysis of the US Food and Drug Administration (FDA) adverse event reporting system (FAERS) events for Durvalumab by Ting Zou, Zhuoyang Li, Tianhong Wang, Shuang Deng, Siman Wang, Yusi Hua (2024) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-11657981.txt.
Description
Ting Zou and co-authors mine the United States' adverse event database for the side effect profile of durvalumab, a cancer immunotherapy drug. Reports naming the drug as the prime suspect numbered 19,709 cases drawn from two decades of submissions. Four statistical methods, each hunting for events reported suspiciously often with this drug, were run in parallel for cross-checking.
Six event types passed all four tests at once. The familiar ones included pneumonitis, lung disorders, and lung inflammation after radiation, alongside death itself. Two findings stood out as warnings: spread of cancer to the central nervous system and drug-induced liver injury. The authors urge clinicians to watch for these events during treatment, arguing that spontaneous report mining can surface risks that trials are too small to catch.
Catalog record
| CREATOR | Ting Zou, Zhuoyang Li, Tianhong Wang, Shuang Deng, Siman Wang, Yusi Hua |
|---|---|
| YEAR | 2024 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 26 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |