ArticleTherapeutic innovation & regulatory science2025
Characterizing Gene Therapy Medicinal Products Post-Marketing Safety Reports Based on WHO Pharmacovigilance Database, VigiBase.
Article in Therapeutic innovation & regulatory science, 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
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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.
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Who cites it
1 citing paper in PubMed.
- Active monitoring vs. spontaneous reporting of antineoplastic drug-related adverse drug reactions: evidence from the Chinese hospital pharmacovigilance system.Frontiers in health services · 2025Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSafety assessments of gene therapy medicinal products (GTMPs) require comprehensive data collection from a variety of sources to ensure thorough evaluation. This study aimed to analyze the characteristics of adverse event (AE) reports for GTMPs, dividing them into Solicited Reports (SRs) and Unsolicited Reports (USRs), and to provide insights for developing effective pharmacovigilance strategies customized for GTMPs.
methodsIndividual case safety reports (ICSRs) collected from GTMPs were retrieved using VigiBase. We identified GTMPs approved by the United States Food and Drug Administration (US FDA) and/or European Medicines Agency (EMA) by December 31, 2022, and maintained their approval status as of July 28, 2023. Descriptive statistics were used to summarize the ICSRs’ characteristics. The reported AEs were classified into System Organ Classes (SOCs) and Preferred Terms (PTs).
resultsA total of 12,180 ICSRs for 13 GTMPs were retrieved from VigiBase. Of these, 27.6% were SR and 72.4% USR. As the number of ICSRs increased, the proportion of USR tended to increase. Compared to the SR, consumer reports were much less common in the USR. The majority of the reported events were serious in both groups. In the drug-AE pairs, cytokine release syndrome and pyrexia were the most commonly reported in both the SR and USR. Meanwhile the most frequently reported SOCs were “Investigations” in SR and “Nervous system disorders” in USR, respectively.
conclusionsOur study highlights the need for robust pharmacovigilance measures customized for GTMPs. The continued refinement of pharmacovigilance strategies customized for GTMPs is essential to ensure their safe and effective use.
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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.