Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery
Open accessAbstract
Large observational data sets are a great asset to better understand the effects of medicines in clinical practice and, ultimately, improve patient care. For an empirical pattern in observational data to be of practical relevance, it should represent a substantial deviation from the null model. For the purpose of identifying such deviations, statistical significance tests are inadequate, as they do not on their own distinguish the magnitude of an effect from its data support. The observed-to-expected (OE) ratio on the other hand directly measures strength of association and is an intuitive basis to identify a range of patterns related to event rates, including pairwise associations, higher order interactions and temporal associations between events over time. It is sensitive to random fluctuations for rare events with low expected counts but statistical shrinkage can protect against spurious associations. Shrinkage OE ratios provide a simple but powerful framework for large-scale pattern discovery. In this article, we outline a range of patterns that are naturally viewed in terms of OE ratios and propose a straightforward and effective statistical shrinkage transformation that can be applied to any such ratio. The proposed approach retains emphasis on the practical relevance and transparency of highlighted patterns, while protecting against spurious associations.
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Cites
Estimation with Quadratic Loss
James, W., & Stein, C. M. (1992) · Springer series in statistics · doi:10.1007/978-1-4612-0919-5_30 · Cited by 2,319 · see citing works
Evans, S., WALLER, P. C., & Davis, S. (2001) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.677 · Cited by 1,808 · see citing works
A Bayesian neural network method for adverse drug reaction signal generation
Bate, A., Lindquist, M., Edwards, I. R., Olsson, S., Orre, R., Lansner, A., & Freitas, R. M. D. (1998) · European Journal of Clinical Pharmacology · doi:10.1007/s002280050466 · Cited by 1,492 · see citing works
Self-citationDuMouchel, W. (1999) · The American Statistician · doi:10.1080/00031305.1999.10474456 · Cited by 883 · see citing works
Selecting the right interestingness measure for association patterns
Tan, P., Kumar, V., & Srivastava, J. (2002) · ACM SIGKDD International Conference on Knowledge Discovery and Data Mining (KDD) · doi:10.1145/775047.775053 · Cited by 868 · see citing works
ROTHMAN, K. J., GREENLAND, S., & WALKER, A. M. (1980) · American Journal of Epidemiology · doi:10.1093/oxfordjournals.aje.a113015 · Cited by 851 · cited 1× · see citing works
“The additive baseline model has clear advantages as a basis for both individual decision-making and public policy-making.(13) Moreover, empirical results suggest that it is better suited to detect some patterns indicative of adverse drug interactions, at least in individual case safety reports.”
BackgroundLarge-Scale Bayesian Logistic Regression for Text Categorization
Genkin, A., Lewis, D. D., & Madigan, D. (2007) · Technometrics · doi:10.1198/004017007000000245 · Cited by 812 · see citing works
VigiBase, the WHO Global ICSR Database System: Basic Facts
Lindquist, M. (2008) · Drug Information Journal · doi:10.1177/009286150804200501 · Cited by 599 · see citing works
Sanz, E. J., Cuevas, C. D. L., Kiuru, A., Bate, A., & Edwards, R. (2005) · The Lancet · doi:10.1016/s0140-6736(05)17865-9 · Cited by 379 · see citing works
Self-citationProceedings of the Third Berkeley Symposium on Mathematical Statistics and Probability:
F., D. D., & Neyman, J. (1957) · Journal of the American Statistical Association · doi:10.2307/2280857 · Cited by 351 · see citing works
Statistical significance tests.
Cox, D. (1982) · British Journal of Clinical Pharmacology · doi:10.1111/j.1365-2125.1982.tb01987.x · Cited by 335 · see citing works
Empirical bayes screening for multi-item associations
DuMouchel, W., & Pregibon, D. (2001) · ACM SIGKDD Conference on Knowledge Discovery and Data Mining (KDD) · doi:10.1145/502512.502526 · Cited by 268 · see citing works
Norén, G. N., Bate, A., Orre, R., & Edwards, I. R. (2005) · Statistics in Medicine · doi:10.1002/sim.2473 · Cited by 208 · see citing works
Self-citationDiscovering significant patterns
Webb, G. I. (2008) · Machine Learning · doi:10.1007/s10994-008-5045-y · Cited by 203 · see citing works
Discovering Significant Patterns
Webb, G. I. (2007) · Machine Learning · doi:10.1007/s10994-007-5006-x · Cited by 203 · see citing works
A statistical methodology for drug–drug interaction surveillance
Norén, G. N., Sundberg, R., Bate, A., & Edwards, I. R. (2008) · Statistics in Medicine · doi:10.1002/sim.3247 · Cited by 202 · see citing works
Self-citationTemporal pattern discovery in longitudinal electronic patient records
Norén, G. N., Hopstadius, J., Bate, A., Star, K., & Edwards, I. R. (2009) · Data Mining and Knowledge Discovery · doi:10.1007/s10618-009-0152-3 · Cited by 170 · see citing works
Self-citationDuplicate detection in adverse drug reaction surveillance
Norén, G. N., Orre, R., Bate, A., & Edwards, I. R. (2007) · Data Mining and Knowledge Discovery · doi:10.1007/s10618-006-0052-8 · Cited by 142 · see citing works
Self-citationSanz, E. J., DELASCUEVAS, C., KIURU, A., et al. (2005) · The Lancet · doi:10.1016/s0140-6736(05)70271-3 · Cited by 81 · see citing works
Caster, O., Norén, G. N., Madigan, D., & Bate, A. (2010) · Statistical Analysis and Data Mining The ASA Data Science Journal · doi:10.1002/sam.10078 · Cited by 67 · see citing works
Self-citationImpact of Stratification on Adverse Drug Reaction Surveillance
Hopstadius, J., Norén, G. N., Bate, A., & Edwards, I. R. (2008) · Drug Safety · doi:10.2165/00002018-200831110-00008 · Cited by 59 · see citing works
Self-citationAhmed, I., Thiessard, F., Miremont‐Salamé, G., Bégaud, B., & Tubert‐Bitter, P. (2010) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2010.111 · Cited by 46 · see citing works
Pattern Discovery and Detection: A Unified Statistical Methodology
Hand, D. J., & Bolton, R. J. (2004) · Journal of Applied Statistics · doi:10.1080/0266476042000270518 · Cited by 24 · see citing works
Gould, A. L. (2006) · Biometrical Journal · doi:10.1002/bimj.200610296 · Cited by 21 · see citing works
Data Mining in Pharmacovigilance
Hauben, M., Madigan, D., Hochberg, A. M., Reisinger, S. J., & O’Hara, D. J. (2007) · International Journal of Pharmaceutical Medicine · doi:10.2165/00124363-200721050-00001 · Cited by 5 · see citing works
Abacavir and increased risk of myocardial infarction
Edwards, R., Bate, A., & Lindquist, M. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61333-1 · Cited by 3 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Salem, J.-E., Manouchehri, A., Moey, M., Lebrun-Vignes, B., Bastarache, L., Pariente, A., Gobert, A., Spano, J.-P., Balko, J. M., Bonaca, M. P., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30608-9 · Cited by 1,271 · see citing works
Cohen, M. E., Ko, C. Y., Bilimoria, K. Y., Zhou, L., Huffman, K., Wang, X., Liu, Y., Kraemer, K., Meng, X., Merkow, R., et al. (2013) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2013.02.027 · Cited by 583 · see citing works
Neurologic toxicity associated with immune checkpoint inhibitors: a pharmacovigilance study
Johnson, D. B., Manouchehri, A., Haugh, A. M., Quach, H. T., Balko, J. M., Lebrun‐Vignes, B., Mammen, A. L., Moslehi, J. J., & Salem, J. (2019) · Journal for ImmunoTherapy of Cancer · doi:10.1186/s40425-019-0617-x · Cited by 368 · see citing works
Cardiovascular Toxicities Associated With Ibrutinib
Salem, J., Manouchehri, A., Bretagne, M., Lebrun‐Vignes, B., Groarke, J. D., Johnson, D. B., Yang, T., Reddy, N. M., Funck‐Brentano, C., Brown, J. R., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2019.07.056 · Cited by 269 · see citing works
Ibrutinib-Mediated Atrial Fibrillation Attributable to Inhibition of C-Terminal Src Kinase
Xiao, L., Salem, J., Clauß, S., Hanley, A., Bapat, A. C., Hulsmans, M., Iwamoto, Y., Wojtkiewicz, G. R., Çetinbaş, M., Schloss, M. J., et al. (2020) · Circulation · doi:10.1161/circulationaha.120.049210 · Cited by 251 · see citing works
Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems
Cutroneo, P. M., Sartori, D., Tuccori, M., Crisafulli, S., Battini, V., Carnovale, C., Rafaniello, C., Capuano, A., Poluzzi, E., Moretti, U., et al. (2024) · Frontiers in Drug Safety and Regulation · doi:10.3389/fdsfr.2023.1323057 · Cited by 224 · see citing works
Bergvall, T., Norén, G. N., & Lindquist, M. (2013) · Drug Safety · doi:10.1007/s40264-013-0131-x · Cited by 207 · see citing works
Self-citationHoisnard, L., Lebrun‐Vignes, B., Maury, S., Mahévas, M., Karoui, K. E., Roy, L., Zarour, A., Michel, M., Cohen, J. L., Amiot, A., et al. (2022) · Scientific Reports · doi:10.1038/s41598-022-10777-w · Cited by 192 · see citing works
Zhai, Y., Ye, X., Hu, F., Xu, J., Guo, X., Zhuang, Y., & He, J. (2019) · Journal for ImmunoTherapy of Cancer · doi:10.1186/s40425-019-0754-2 · Cited by 191 · see citing works
Caster, O., Aoki, Y., Gattepaille, L. M., & Grundmark, B. (2020) · Drug Safety · doi:10.1007/s40264-020-00911-w · Cited by 187 · see citing works
Adverse Cardiovascular and Pulmonary Events Associated With Chimeric Antigen Receptor T-Cell Therapy
Goldman, A., Maor, E., Bomze, D., Liu, J. E., Herrmann, J., Fein, J. A., Steingart, R. M., Mahmood, S., Schaffer, W. L., Perales, M., et al. (2021) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.08.044 · Cited by 157 · see citing works
Good Signal Detection Practices: Evidence from IMI PROTECT
Wisniewski, A. F. Z., Bate, A., Cédric Bousquet, B., Brueckner, A., Candore, G., Juhlin, K., Maciá, M. A., Manlik, K., Quarcoo, N., Seabroke, S., et al. (2016) · Drug Safety · doi:10.1007/s40264-016-0405-1 · Cited by 152 · see citing works
Self-citationComparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases
Candore, G., Juhlin, K., Manlik, K., Thakrar, B. T., Quarcoo, N., Seabroke, S., Wisniewski, A. F. Z., & Slattery, J. (2015) · Drug Safety · doi:10.1007/s40264-015-0289-5 · Cited by 149 · see citing works
A Standardized Dataset of a Spontaneous Adverse Event Reporting System
Khaleel, M. A., Khan, A. H., Ghadzi, S. M. S., Adnan, A. S., & Abdallah, Q. (2022) · Healthcare · doi:10.3390/healthcare10030420 · Cited by 143 · see citing works
Nguyen, L. S., Cooper, L. T., Kerneis, M., Funck-Brentano, C., Silvain, J., Brechot, N., Hekimian, G., Ammirati, E., Ben M’Barek, B., Redheuil, A., et al. (2022) · Nature Communications · doi:10.1038/s41467-021-27631-8 · Cited by 136 · see citing works
Davidson, L., van den Reek, J. M. P. A., Bruno, M., van Hunsel, F. P. A. M., Herings, R. M. C., Matzaraki, V., Boahen, C. K., Kumar, V., Groenewoud, H., van de Veerdonk, F. L., et al. (2021) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2021.100266 · Cited by 124 · see citing works
Ang, P. S., Chen, Z., Chan, C. L., & Tai, B. C. (2016) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2016.1167184 · Cited by 111 · see citing works
Arnaud, L., Mertz, P., Gavand, P., Martin, T., Chasset, F., Tebacher‐Alt, M., Lambert, A., Müller, C., Sibilia, J., Lebrun‐Vignes, B., et al. (2019) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2018-214598 · Cited by 107 · see citing works
Caster, O., Juhlin, K., Watson, S., & Norén, G. N. (2014) · Drug Safety · doi:10.1007/s40264-014-0204-5 · Cited by 106 · see citing works
Self-citationAli, A. K., Heran, B. S., & Etminan, M. (2015) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.1612 · Cited by 97 · see citing works
Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase®
Aldea‐Perona, A., García-Sáiz, M., & Sanz, E. J. (2015) · Drug Safety · doi:10.1007/s40264-015-0360-2 · Cited by 95 · see citing works
Zhu, J., Chen, G., He, Z., Zheng, Y., Gao, S., Li, J., Ling, Y., Yu, X., Qiu, K., & Wu, J. (2021) · EClinicalMedicine · doi:10.1016/j.eclinm.2021.100951 · Cited by 86 · see citing works
Sarangdhar, M., Tabar, S., Schmidt, C., Kushwaha, A., Shah, K., Dahlquist, J., Jegga, A. G., & Aronow, B. J. (2016) · Nature Biotechnology · doi:10.1038/nbt.3623 · Cited by 84 · see citing works
Zhou, J., Zheng, Y., Xu, B., Long, S., Zhu, L.-E., Liu, Y., Li, C., Zhang, Y., Liu, M., & Wu, X. (2024) · BMC Medicine · doi:10.1186/s12916-024-03274-6 · Cited by 85 · see citing works
Waliany, S., Zhu, H., Wakelee, H. A., Padda, S. K., Das, M. S., Ramchandran, K. J., Myall, N. J., Chen, T., Witteles, R. M., & Neal, J. W. (2021) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2021.07.030 · Cited by 83 · see citing works
Valproic Acid and Fatalities in Children: A Review of Individual Case Safety Reports in VigiBase
Star, K., Edwards, I. R., & Choonara, I. (2014) · PLoS ONE · doi:10.1371/journal.pone.0108970 · Cited by 78 · see citing works
Cuevas, C. D. L., Sanz, E. J., Ruan, C., & de León, J. (2021) · Revista de Psiquiatría y Salud Mental · doi:10.1016/j.rpsm.2021.07.004 · Cited by 65 · see citing works
Caster, O., Dietrich, J., Kürzinger, M., Lerch, M., Maskell, S. R., Norén, G. N., Tcherny‐Lessenot, S., Vroman, B., Wisniewski, A. F. Z., & van Stekelenborg, J. (2018) · Drug Safety · doi:10.1007/s40264-018-0699-2 · Cited by 64 · see citing works
Self-citationSandberg, L., Taavola, H., Aoki, Y., Chandler, R. E., & Norén, G. N. (2020) · Drug Safety · doi:10.1007/s40264-020-00957-w · Cited by 63 · see citing works
Self-citationPerformance of Stratified and Subgrouped Disproportionality Analyses in Spontaneous Databases
Seabroke, S., Candore, G., Juhlin, K., Quarcoo, N., Wisniewski, A. F. Z., Arani, R. B., Painter, J. L., Tregunno, P. M., Norén, G. N., & Slattery, J. (2016) · Drug Safety · doi:10.1007/s40264-015-0388-3 · Cited by 60 · see citing works
Self-citationBai, X., Lin, X., Zheng, K., Chen, X., Wu, X., Huang, Y., & Zhuang, Y. (2020) · Endocrine · doi:10.1007/s12020-020-02355-9 · Cited by 61 · see citing works
Chen, C., Chen, T., Liang, J., Guo, X., Xu, J., Zheng, Y., Guo, Z., Chi, L., Wei, L., Chen, X., et al. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.616505 · Cited by 59 · see citing works
Fusaroli, M., Isgrò, V., Cutroneo, P. M., Ferrajolo, C., Cirillo, V., Bufalo, F. D., Raschi, E., Poluzzi, E., & Trifirò, G. (2022) · Drug Safety · doi:10.1007/s40264-022-01194-z · Cited by 59 · see citing works
Hou, Y., Ye, X., Gui-zhi, W., Cheng, G., Du, X., & He, J. (2014) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2014.915938 · Cited by 57 · see citing works
Zhao, B., Fu, Y., Cui, S., Chen, X., Liu, S., & Luo, L. F. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1333662 · Cited by 53 · see citing works
van Hunsel, F. P. A. M., van de Koppel, S., van Puijenbroek, E., & Kant, A. C. (2018) · Drug Safety · doi:10.1007/s40264-018-0664-0 · Cited by 48 · see citing works
Wakao, R., Taavola, H., Sandberg, L., Iwasa, E., Soejima, S., Chandler, R. E., & Norén, G. N. (2019) · Drug Safety · doi:10.1007/s40264-019-00861-y · Cited by 48 · see citing works
Self-citationCoste, A., Wong, A. Y. S., Bokern, M. P., Bate, A., & Douglas, I. (2022) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.5548 · Cited by 47 · see citing works
Self-citationThe evolving role of disproportionality analysis in pharmacovigilance
Fusaroli, M., Raschi, E., Poluzzi, E., & Hauben, M. (2024) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2024.2368817 · Cited by 47 · see citing works
Gérard, A. O., Merino, D., Obberghen, E. K. V., Rocher, F., Destère, A., Lantéri‐Minet, M., & Drici, M. (2022) · The Journal of Headache and Pain · doi:10.1186/s10194-022-01424-w · Cited by 45 · see citing works
Star, K., Iessa, N., Almandil, N. B., Wilton, L., Curran, S. R., Edwards, I. R., & Wong, I. C. K. (2012) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2011.0134 · Cited by 44 · see citing works
Goldman, A., Fishman, B., Twig, G., Raschi, E., Cukierman‐Yaffe, T., Moshkovits, Y., Pomerantz, A., Ben‐Zvi, I., Dankner, R. S., & Maor, E. (2023) · Cardiovascular Diabetology · doi:10.1186/s12933-023-01743-5 · Cited by 42 · see citing works
Safety of SGLT2 Inhibitors: A Pharmacovigilance Study from 2013 to 2021 Based on FAERS
Zhou, X., Ye, X., Guo, X., Liu, D., Xu, J., Hu, F., Zhai, Y., Gao, Y., Xu, X., Dong, Z., et al. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.766125 · Cited by 43 · see citing works
Ferrajolo, C., Capuano, A., Trifirò, G., Moretti, U., Rossi, F., & Santuccio, C. (2014) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2014.939581 · Cited by 41 · see citing works
Cherkas, Y., Ide, J., & van Stekelenborg, J. (2022) · Drug Safety · doi:10.1007/s40264-022-01163-6 · Cited by 40 · see citing works
Norén, G. N., Bergvall, T., Ryan, P. B., Juhlin, K., Schuemie, M. J., & Madigan, D. (2013) · Drug Safety · doi:10.1007/s40264-013-0095-x · Cited by 39 · see citing works
Self-citationZoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance
Norén, G. N., Caster, O., Juhlin, K., & Lindquist, M. (2014) · Drug Safety · doi:10.1007/s40264-014-0198-z · Cited by 40 · see citing works
Self-citationVaughn, S., Strawn, J., Poweleit, E., Sarangdhar, M., & Ramsey, L. (2021) · Journal of Personalized Medicine · doi:10.3390/jpm11070615 · Cited by 40 · see citing works
Zhai, Y., Ye, X., Hu, F., Xu, J., Guo, X., Cao, Y., Lin, Z., Zhou, X., Guo, Z., & He, J. (2021) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2021.735466 · Cited by 40 · see citing works
Jung, S. Y., Kim, M. S., Li, H. J., Lee, K. H., Koyanagi, A., Solmi, M., Kronbichler, A., Dragioti, E., Tizaoui, K., Cargnin, S., et al. (2021) · Clinical and Translational Science · doi:10.1111/cts.13168 · Cited by 39 · see citing works
Pokladníková, J., Meyboom, R. H. B., Meincke, R., Niedrig, D., & Russmann, S. (2016) · Drug Safety · doi:10.1007/s40264-016-0401-5 · Cited by 38 · see citing works
Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study
Hilmi, M., Éderhy, S., Waintraub, X., Funck‐Brentano, C., Cohen, A. A., Vozy, A., Lebrun‐Vignes, B., Moslehi, J. J., Nguyen, L. S., & Salem, J. (2020) · Pharmaceuticals · doi:10.3390/ph13100325 · Cited by 38 · see citing works
Bai, X., Chen, X., Wu, X., Huang, Y., Zhuang, Y., & Lin, X. (2019) · European Journal of Endocrinology · doi:10.1530/eje-19-0535 · Cited by 37 · see citing works
Bai, X., Chen, X., Wu, X., Huang, Y., Zhuang, Y., Chen, Y., Feng, C., & Lin, X. (2020) · Journal of Endocrinological Investigation · doi:10.1007/s40618-020-01226-4 · Cited by 37 · see citing works
Hyperglycaemic disorders associated with PCSK9 inhibitors: a real-world, pharmacovigilance study
Goldman, A., Raschi, E., Cukierman‐Yaffe, T., Dankner, R. S., Shouval, R., Shechter, M., Ben‐Zvi, I., Gerstein, H. C., & Maor, E. (2021) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwab209 · Cited by 37 · see citing works
Dong, Z., Ye, X., Chen, C., Wang, R., Liu, D., Xu, X., Zhou, X., & He, J. (2022) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15361 · Cited by 37 · see citing works
Cuevas, C. D. L., Sanz, E. J., Rohde, C., & de León, J. (2022) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2022.2032659 · Cited by 35 · see citing works
de León, J., Baldessarini, R. J., Balon, R., Bilbily, J., Caroff, S. N., Citrome, L., Correll, C. U., Cotes, R. O., Davis, J. M., DeLisi, L. E., et al. (2025) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000001990 · Cited by 35 · see citing works
Gosho, M., Maruo, K., Tada, K., & Hirakawa, A. (2017) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-017-2233-3 · Cited by 34 · see citing works
Caster, O., Sandberg, L., Bergvall, T., Watson, S., & Norén, G. N. (2017) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.4247 · Cited by 34 · see citing works
Self-citationCardiovascular toxicity induced by SSRIs: Analysis of spontaneous reports submitted to FAERS
Chen, Y., Fan, Q., Liu, Y., Shi, Y., & Luo, H. (2023) · Psychiatry Research · doi:10.1016/j.psychres.2023.115300 · Cited by 34 · see citing works
Evaluation of Disproportionality Safety Signaling Applied to Healthcare Databases
DuMouchel, W., Ryan, P. B., Schuemie, M. J., & Madigan, D. (2013) · Drug Safety · doi:10.1007/s40264-013-0106-y · Cited by 34 · see citing works
Xia, S., Gong, H., Zhao, Y., Guo, L., Wang, Y., Ma, R., Zhang, B., Sarangdhar, M., Noguchi, Y., & Yan, M. (2023) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.2920 · Cited by 33 · see citing works
An evaluation of statistical approaches to postmarketing surveillance
Ding, Y., Markatou, M., & Ball, R. (2020) · Statistics in Medicine · doi:10.1002/sim.8447 · Cited by 33 · see citing works
Chimeric antigen receptor T ‐cells safety: A pharmacovigilance and meta‐analysis study
Dolladille, C., Éderhy, S., Ezine, E., Choquet, S., Nguyen, L. S., Alexandre, J., Moslehi, J. J., Dechartres, A., & Salem, J. (2021) · American Journal of Hematology · doi:10.1002/ajh.26259 · Cited by 33 · see citing works
Zhou, J., Wei, Z., Xu, B., Liu, M., Xu, R., & Wu, X. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.1039867 · Cited by 32 · see citing works
Goldman, A., Bomze, D., Dankner, R. S., Fourey, D., Boursi, B., Arad, M., & Maor, E. (2021) · Targeted Oncology · doi:10.1007/s11523-021-00817-2 · Cited by 32 · see citing works
Juhlin, K., Ye, X., Star, K., & Norén, G. N. (2013) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.3474 · Cited by 32 · see citing works
Self-citationJozwiak, M., Géri, G., Laghlam, D., Boussion, K., Dolladille, C., & Nguyen, L. S. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.826446 · Cited by 31 · see citing works
Waliany, S., Caswell-Jin, J. L., Riaz, F., Myall, N. J., Zhu, H., Witteles, R. M., & Neal, J. W. (2023) · JACC CardioOncology · doi:10.1016/j.jaccao.2022.09.007 · Cited by 33 · see citing works
Hlavaty, A., Roustit, M., Montani, D., Chaumais, M., Guignabert, C., Humbert, M. J. C., Cracowski, J., & Khouri, C. (2022) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15436 · Cited by 30 · see citing works
Song, Z., Tu, D.-Y., Tang, G., Liu, N., Tai, Z.-G., Yang, J.-M., & Wang, Y. (2023) · Haematologica · doi:10.3324/haematol.2022.281455 · Cited by 22 · see citing works
Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre
Star, K., Sandberg, L., Bergvall, T., Choonara, I., Caduff‐Janosa, P., & Edwards, I. R. (2019) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.4734 · Cited by 29 · see citing works
Fusaroli, M., Giunchi, V., Battini, V., Gringeri, M., Rimondini, R., Menchetti, M., Radice, S., Pozzi, M., Nobile, M., Clementi, E., et al. (2022) · Psychiatry and Clinical Neurosciences · doi:10.1111/pcn.13511 · Cited by 29 · see citing works
Pacaci, A., Gönül, S., Sınacı, A. A., Yüksel, M., & Ertürkmen, G. B. L. (2018) · Frontiers in Pharmacology · doi:10.3389/fphar.2018.00435 · Cited by 29 · see citing works
Wang, F., Qi, W., & Wu, X. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.986357 · Cited by 28 · see citing works
Anquetil, C., Salem, J., Lebrun‐Vignes, B., Touhami, S., Desbois, A. C., Maalouf, G., Domont, F., Allenbach, Y., Cacoub, P., Bodaghi, B., et al. (2020) · Journal of Autoimmunity · doi:10.1016/j.jaut.2020.102454 · Cited by 28 · see citing works
Robust discovery of local patterns
Hopstadius, J., & Norén, G. N. (2012) · International Health Informatics Symposium · doi:10.1145/2110363.2110395 · Cited by 28 · see citing works
Self-citationWang, Q., Liu, J., Sun, H., Dong, Y., Tan, W., Tang, Z., & Jiang, Y. (2023) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2023.2250720 · Cited by 27 · see citing works
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Lacroix, C., Maurier, A., Largeau, B., Destère, A., Thillard, E.-M., Drici, M., Micallef, J., & Jonville‐Béra, A. ‐. (2022) · Therapies · doi:10.1016/j.therap.2022.10.002 · Cited by 27 · see citing works
Spetz, J. K. E., Florido, M. H. C., Fraser, C. S., Qin, X., Choiniere, J., Yu, S. J., Singh, R., Friesen, M., Rubin, L. L., Salem, J., et al. (2022) · Science Advances · doi:10.1126/sciadv.abn6579 · Cited by 26 · see citing works
de León, J., Ruan, C., Schoretsanitis, G., Tezanos, A. G. V., Spina, E., Sanz, E. J., Betancort, M., & Cuevas, C. D. L. (2024) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2024.2373111 · Cited by 26 · see citing works
He, L., Yu, Y., Wei, Y., Huang, J., Shen, Y., & Li, H. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.815151 · Cited by 26 · see citing works
Balcerac, A., Bihan, K., Psimaras, D., Lebrun‐Vignes, B., Salem, J., & Weiss, N. (2022) · Journal of Neurology · doi:10.1007/s00415-022-11450-y · Cited by 26 · see citing works
Zhou, J., Huang, W., Xie, Y., Shen, H., Liu, M., & Wu, X. (2024) · Endocrine · doi:10.1007/s12020-024-04112-8 · Cited by 25 · see citing works
Wang, Y., Cui, C., Ren, X., Dong, X., & Cui, W. (2022) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2022.988013 · Cited by 25 · see citing works
Rodríguez, A. J., Nerlekar, N., & Ebeling, P. R. (2022) · Bone · doi:10.1016/j.bone.2022.116647 · Cited by 24 · see citing works
Charting and Sidestepping the Pitfalls of Disproportionality Analysis
Fusaroli, M., Sartori, D., van Puijenbroek, E., & Norén, G. N. (2025) · Drug Safety · doi:10.1007/s40264-025-01604-y · Cited by 31 · see citing works
Self-citationYang, K., Li, J., Sun, Z., Bai, C., & Zhao, L. (2023) · Clinical and Experimental Medicine · doi:10.1007/s10238-023-01055-8 · Cited by 25 · see citing works
Zhou, J., Wei, Z., Lai, W., Liu, M., & Wu, X. (2024) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.16354 · Cited by 23 · see citing works
Brand, J. S., Gauffin, O., Sartori, D., Fusaroli, M., Sköld, H., Bergvall, T., Sandberg, L., Wallberg, M., Hjelmström, P., & Norén, G. N. (2026) · Drug Safety · doi:10.1007/s40264-025-01642-6 · Cited by 23 · see citing works
Self-citationDrug-associated hyperammonaemia: a Bayesian analysis of the WHO Pharmacovigilance Database
Balcerac, A., Bihan, K., Lebrun‐Vignes, B., Thabut, D., Salem, J., & Weiss, N. (2022) · Annals of Intensive Care · doi:10.1186/s13613-022-01026-4 · Cited by 23 · see citing works
Gómez-Lumbreras, A., Boyce, R. D., Zapata, L. V., Tan, M. S., Hansten, P. D., Horn, J. R., & Malone, D. C. (2023) · Annals of Pharmacotherapy · doi:10.1177/10600280221148031 · Cited by 23 · see citing works
Wang, Y., Cui, C., Deng, L., Wang, L., & Ren, X. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1127128 · Cited by 23 · see citing works
Gauffin, O., Brand, J. S., Vidlin, S. H., Sartori, D., Asikainen, S., Català, M., Chalabi, E., Dedman, D., Danilović, A., Duarte‐Salles, T., et al. (2023) · Drug Safety · doi:10.1007/s40264-023-01353-w · Cited by 23 · see citing works
Self-citationHu, F., Zhai, Y., Yuan, L., Liang, J., Xu, J., Guo, X., Zhou, X., Lin, Z., Jin-hai, S., Ye, X., et al. (2021) · Cancer Medicine · doi:10.1002/cam4.4343 · Cited by 23 · see citing works
Li, X., Ndungu, P., Taneja, S. B., Chapin, M. R., Egbert, S., Akenapalli, K., Paine, M. F., Kane‐Gill, S. L., & Boyce, R. D. (2023) · Clinical and Translational Science · doi:10.1111/cts.13505 · Cited by 22 · see citing works
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Cuevas, C. D. L., Sanz, E. J., & de León, J. (2024) · Patient Preference and Adherence · doi:10.2147/ppa.s495254 · Cited by 22 · see citing works
CTLA-4 Pathway Is Instrumental in Giant Cell Arteritis
Régnier, P., Joncour, A. L., Maciejewski‐Duval, A., Darrasse-Jèze, G., Dolladille, C., Meijers, W. C., Bastarache, L. A., Fouret, P. J., Bruneval, P., Arbaretaz, F., et al. (2023) · Circulation Research · doi:10.1161/circresaha.122.322330 · Cited by 22 · see citing works
Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites
Juhlin, K., Karimi, G., Andér, M., Camilli, S., Dheda, M., Tan, S. H., Isahak, R., Lee, S. J., Vaughan, S. M., Caduff‐Janosa, P., et al. (2015) · Drug Safety · doi:10.1007/s40264-015-0271-2 · Cited by 22 · see citing works
Self-citation
- Authors
- Norén, G. N., Hopstadius, J., & Bate, A.
- Affiliations
- Uppsala Monitoring Centre (SE)
- Corresponding author
- Norén, G Niklas
- Venue
- Statistical Methods in Medical Research
- Publisher
- SAGE Publications
- Published
- 2011-06-24
- Volume
- 22
- Issue
- 1
- Pages
- 57-69
- ISSN
- 0962-2802 (ISSN-L)
- 1477-0334
- PMC
- PMC6331976
- OpenAlex
- W2005366883
- Cited by
- 336
- References
- 26
- Citations by year
- 2026: 45 · 2025: 45 · 2024: 48 · 2023: 46 · 2022: 53 · 2021: 21 · 2020: 17 · 2019: 9 · 2018: 11 · 2017: 5 · 2016: 5 · 2015: 8 · 2014: 10 · 2013: 7 · 2012: 6
- FWCI
- 6.43
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Statistical Methods in Medical Research (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- observed-to-expected ratio, pattern discovery, observational data, spurious association, rare events, higher-order interactions, temporal association, associative strength, clinical practice
- MeSH terms
- Models, Statistical
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