ArticlePloS one2022
A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax.
Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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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
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- Venetoclax adverse event monitoring: a safety meta-analysis of randomized controlled trials and a retrospective evaluation of the FAERS.Annals of hematology · 2024Pooled it
- Disproportionality Analysis of Hematologic Adverse Event Signals Associated with Venetoclax in Combination with Senescence-Inducing Chemotherapy.Journal of clinical medicine · 2026Article
- [Rapid determination of venetoclax in plasma by ultra performance liquid chromatography-tandem mass spectrometry].Se pu = Chinese journal of chromatography · 2026Article
- Identifying high-risk drugs and demographic patterns in drug-induced liver injury from FAERS and CVARD analyses.Scientific reports · 2025Article
- Signal mining and risk analysis of tisotumab vedotin adverse events based on the FAERS database.Scientific reports · 2025Article
- Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System.Scientific reports · 2025Article
- Inhibition of anti-apoptotic Bcl-2 family members promotes synergistic cell death with ER stress inducers by disrupting autophagy in glioblastoma.Cell death discovery · 2025Article
- Disproportionality analysis of adverse events associated with ipilimumab and nivolumab combination therapy based on FAERS database.Scientific reports · 2025Article
- Disproportionality Analysis and Causal Inference in Drug Safety.Pharmaceutical medicine · 2025Review
- Real world pharmacovigilance assessment of drug related macular degeneration risks.Scientific reports · 2025Article
- Safety of venetoclax in real-world experience: data from the French national database of pharmacovigilance through all indications in hematological malignancies over 5 years.Therapeutic advances in hematology · 2025Article
- Real-world evidence of obinutuzumab and venetoclax in previously treated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.Leukemia & lymphoma · 2024Article
- Review
- Pharmacovigilance study of BCR-ABL1 tyrosine kinase inhibitors: a safety analysis of the FDA adverse event reporting system.BMC pharmacology & toxicology · 2024Article
- Drug-induced urinary retention: a real-world pharmacovigilance study using FDA and Canada vigilance databases.Frontiers in pharmacology · 2024Article
- Post-marketing safety evaluation of lurbinectedin: a pharmacovigilance analysis based on the FAERS database.Frontiers in pharmacology · 2024Article
- Signal detection of adverse events associated with gabapentinoid use for chronic pain.Pharmacoepidemiology and drug safety · 2024Article
- Adverse events in patients with advanced urothelial carcinoma treated with erdafitinib: a retrospective pharmacovigilance study.Frontiers in pharmacology · 2023Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVenetoclax (VEN) is the first selective small molecule Bcl-2 inhibitor approved by FDA and used in adult chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and some acute myeloid leukemia (AML). However, the long-term safety of VEN in large sample population was unknown. This study evaluated the adverse events (AEs) of VEN from FDA Adverse Event Reporting System (FAERS) since its approval in 2016 by data mining.
methodsThe disproportionality analyses, including four algorithms of reporting odd ratio (ROR), proportional reporting ratio (PRR), bayesian configuration promotion neural network (BCPNN), and multi item gamma poisson shrinker (MGPS), were employed to quantify the signals of VEN-associated AEs.
resultsFrom the FAERS database, a total of 8,379,682 reports were collected during the study period. After removing the duplication, the number of reports with VEN as the primary suspect (PS) was 19,107. The 19,107 cases of AEs involved 27 organ systems, 256 significant PTs which conforming to the four algorithms. Unexpected serious AEs, such as pleural effusion, splenic infarction, atrial fibrillation, skin squamous cell carcinoma, etc., have signals. The median time of occurrence of AEs related to VEN was 31 days (inter quartile range [IQR] 7-131 days), and half of the reported AEs occurred within 1 month after administration.
conclusionOur research has found new significant AEs signals of VEN, which improved its safety information in real-world after marketing approval, and contributed to its risk control of use in clinic.
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