ArticleEuropean journal of clinical pharmacology2025
A real-world pharmacovigilance study of FDA Adverse Event Reporting System events for gefitinib and docetaxel.
Article in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- A real-world pharmacovigilance study of dacomitinib based on FDA adverse event reporting system (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn recent years, gefitinib and docetaxel, as targeted and chemotherapeutic agents, respectively, have been widely used in the treatment of non-small cell lung cancer (NSCLC). However, the safety of these drugs remains a significant concern in clinical practice. Comparative studies on the safety of these two drugs have yet to be fully explored. This study aimed to analyze adverse event (AE) signals associated with gefitinib and docetaxel in the treatment of NSCLC using the FDA Adverse Event Reporting System (FAERS), providing insights for clinical practice and package insert.
methodsAdverse events for gefitinib and docetaxel were retrieved from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 (2004 Q1) through the fourth quarter of 2024 (2024 Q4). The reporting odds ratio method was used to identify risk signals. The results were standardized and classified using the System Organ Class (SOC) and Preferred Terms (PT) in the 26.1 version of the Medical Dictionary for Regulatory Activities (MedDRA) and compared with the package insert.
resultsThe FAERS received 8214 and 42,453 AE reports for gefitinib and docetaxel, respectively. An analysis of the top 100 AEs ranked by signal strength revealed 64 positive PTs for gefitinib, spanning 14 SOCs, 45 of which were not mentioned in the package insert. For docetaxel, 61 positive PTs were identified, involving 15 SOCs, with 33 AEs not mentioned in the package insert. The top 5 PTs with the highest signal strength for gefitinib were PRIDE syndrome, drug resistance, lymphangiosis carcinomatosa, xeroderma, and skin disorder. For docetaxel, the top 5 PTs were lacrimal structure injury, madarosis, hair disorder, variations in hair color, and psychological trauma.
conclusionThe potential adverse reactions of gefitinib and docetaxel are not fully covered in their package insert. The newly identified AE signals provide critical evidence for the improvement of the package insert. These findings have significant implications for individualized clinical treatment.
Indexed as
Identifiers
40913721What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.