ArticleClinical epidemiology2022
A Real-World Disproportionality Analysis of Olaparib: Data Mining of the Public Version of FDA Adverse Event Reporting System.
Article in Clinical epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 2 of them syntheses that pooled it.
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
93 citing papers in PubMed, 2 syntheses or guidelines pooled it, 150 citations in OpenAlex.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports.European journal of clinical pharmacology · 2025Pooled it
- Elucidating the mechanism of amikacin-induced acute kidney injury: a multilevel analysis based on the FAERS database and network toxicology.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Disproportionality analysis of adverse events associated with degarelix: a real-world study from the FDA Adverse Event Reporting System (FAERS) database.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Post-marketing safety profile of bictegravir/emtricitabine/tenofovir alafenamide: a FAERS pharmacovigilance study with EudraVigilance validation and mechanistic investigation of pancreatitis.Virology journal · 2026Article
- Real-world disproportionality analysis of trabectedin using the United States food and drug administration adverse event reporting system.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Hypophosphatemia as a Potential Class Effect of Histone Deacetylase Inhibitors: Evidence from Disproportionality Analysis and Mendelian Randomization Analysis of Drug Targets.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Tiopronin safety in cystinuria: first real-world pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS): an EAU YAU and Endourology sections review.Pediatric nephrology (Berlin, Germany) · 2026Article
- Evaluating adverse events of antibacterials in infants: insights from FDA adverse event reporting system (FAERS) data.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Postmarketing adverse events of biologics and Janus kinase inhibitors in patients with atopic dermatitis.Inflammopharmacology · 2026Article
- Disproportionality analysis of adverse events associated with bimekizumab: a real-world study based on FDA Adverse Event Reporting System (FAERS) Database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Article
- Real-world safety profile of opicapone: a comprehensive pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Association Between Irbesartan and Erectile Dysfunction: A Comprehensive Analysis Incorporating Real-World Pharmacovigilance and Mendelian Randomization.Hospital pharmacy · 2026Article
- SSRIs-induced liver injury adverse events: a data-based retrospective study and investigation of potential toxicological mechanisms.Frontiers in pharmacology · 2026Article
- Cross-national pharmacovigilance of drug-induced intestinal obstruction: disproportionality signals in FAERS and external validation in JADER.Frontiers in pharmacology · 2026Article
- Pemphigoid associated with quinolone antibiotics: a real-world pharmacovigilance study of the FDA adverse event reporting system and literature-based evidence.Frontiers in immunology · 2026Article
- The real-world safety profile of enfortumab vedotin with or without pembrolizumab: insights from a comparative analysis of FAERS.Frontiers in immunology · 2026Article
- Synergistic toxicity and clinical prioritization of docetaxel combined with nintedanib for non-small cell lung cancer: a real-world safety analysis using the FAERS database.Frontiers in oncology · 2026Article
- Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data.Frontiers in oncology · 2026Article
33 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Olaparib, the world's first poly ADP-ribose polymerase (PARP) inhibitor (PARPi), has been approved for treatment of ovarian cancer, breast cancer, pancreatic cancer and prostate cancer by FDA. The current study was to assess olaparib-related adverse events (AEs) of real-world through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were employed to quantify the signals of olaparib-associated AEs. Results: Out of 8,450,009 reports collected from the FAERS database, 6402 reports of olaparib-associated AEs were identified. A total of 118 significant disproportionality preferred terms (PTs) conforming to the four algorithms simultaneously were retained. The most common AEs included anemia, thrombocytopenia, nausea, decreased appetite, blood creatinine increased and dermatomyositis, which were corresponding to those reported in the specification and clinical trials. Unexpected significant AEs as interstitial lung disease, Conclusion: Results of our study were consistent with clinical observations, and we also found potential new and unexpected AEs signals for olaparib, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results could provide valuable evidence for further safety studies of olaparib.
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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.