{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T05:52:54Z","timestamp":1791006774699,"version":"4.1.0"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"DOI":"10.1007\/s40264-026-01711-4","type":"journal-article","created":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T12:43:50Z","timestamp":1790858630000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Value of Time-to-Onset for Signal Validation: Experience from the Reporting of COVID-19 Vaccines and Glomerular Diseases in VigiBase"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2360-7174","authenticated-orcid":false,"given":"Annette","family":"Rudolph","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3959-0944","authenticated-orcid":false,"given":"Monica","family":"Tarapues","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1593-356X","authenticated-orcid":false,"given":"Oskar","family":"Gauffin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2475-2621","authenticated-orcid":false,"given":"Qun-Ying","family":"Yue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,1]]},"reference":[{"issue":"6","key":"1711_CR1","doi-asserted-by":"publisher","first-page":"603","DOI":"10.1002\/pds.3226","volume":"21","author":"L Van Holle","year":"2012","unstructured":"Van Holle L, Zeinoun Z, Bauchau V, Verstraeten T. Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study. Pharmacoepidemiol Drug Saf. 2012;21(6):603\u201310. https:\/\/doi.org\/10.1002\/pds.3226.","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"12","key":"1711_CR2","doi-asserted-by":"publisher","first-page":"1361","DOI":"10.1002\/pds.4115","volume":"25","author":"JHG Scholl","year":"2016","unstructured":"Scholl JHG, van Puijenbroek EP. The value of time-to-onset in statistical signal detection of adverse drug reactions: a comparison with disproportionality analysis in spontaneous reports from the Netherlands. Pharmacoepidemiol Drug Saf. 2016;25(12):1361\u20137. https:\/\/doi.org\/10.1002\/pds.4115.","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"4","key":"1711_CR3","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1007\/s40264-016-0503-0","volume":"40","author":"T Zhang","year":"2017","unstructured":"Zhang T, Ye X, Guo X, Wu G, Hou Y, Xu J, et al. Signal detection based on time to onset algorithm in spontaneous reporting system of China. Drug Saf. 2017;40(4):343\u201350. https:\/\/doi.org\/10.1007\/s40264-016-0503-0.","journal-title":"Drug Saf"},{"key":"1711_CR4","unstructured":"SCOPE. SCOPE Signal management processes at Member State level vs. centralised European level. https:\/\/www.ema.europa.eu\/en\/documents\/other\/scope-training-signal-management-best-practice-guide_en.pdf. Accessed 9 June 2025."},{"key":"1711_CR5","unstructured":"European Medicines Agency (EMA). Good pharmacovigilance practices (GVP). 2012. https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/good-pharmacovigilance-practices-gvp. Accessed 9 June 2025."},{"issue":"5","key":"1711_CR6","doi-asserted-by":"publisher","first-page":"959","DOI":"10.1016\/j.kint.2021.09.002","volume":"100","author":"NL Li","year":"2021","unstructured":"Li NL, Coates PT, Rovin BH. COVID-19 vaccination followed by activation of glomerular diseases: does association equal causation? Kidney Int. 2021;100(5):959\u201365. https:\/\/doi.org\/10.1016\/j.kint.2021.09.002.","journal-title":"Kidney Int"},{"issue":"3","key":"1711_CR7","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1093\/ndt\/17.3.359","volume":"17","author":"J Rossert","year":"2002","unstructured":"Rossert J, McClellan WM, Roger SD, Verbeelen DL. Epoetin treatment: what are the arguments to expect a beneficial effect on renal disease progression? Nephrol Dial Transplant. 2002Mar;17(3):359\u201362. https:\/\/doi.org\/10.1093\/ndt\/17.3.359.","journal-title":"Nephrol Dial Transplant"},{"issue":"5","key":"1711_CR8","doi-asserted-by":"publisher","first-page":"1002","DOI":"10.4103\/1319-2442.270254","volume":"30","author":"C Patel","year":"2019","unstructured":"Patel C, Shah H. Vaccine-associated kidney diseases: a narrative review of the literature. Saudi J Kidney Dis Transpl. 2019;30(5):1002. https:\/\/doi.org\/10.4103\/1319-2442.270254.","journal-title":"Saudi J Kidney Dis Transpl"},{"key":"1711_CR9","unstructured":"European Medicines Agency. Summary of product characteristics for Comirnaty. 2025. https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/comirnaty. Accessed 3 Feb 2025."},{"key":"1711_CR10","unstructured":"European Medicines Agency. Summary of product characteristics for Spikevax. 2025. https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/spikevax#overview. Accessed 7 Feb 2025."},{"key":"1711_CR11","unstructured":"European Medicines Agency. Summary of product characteristics for Vaxzevria. 2024. https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/vaxzevria. Accessed 7 Feb 2025."},{"issue":"12","key":"1711_CR12","doi-asserted-by":"publisher","first-page":"2969","DOI":"10.1016\/j.ekir.2021.09.008","volume":"6","author":"N Klomjit","year":"2021","unstructured":"Klomjit N, Alexander MP, Fervenza FC, Zoghby Z, Garg A, Hogan MC, et al. COVID-19 vaccination and glomerulonephritis. Kidney Int Rep. 2021;6(12):2969\u201378. https:\/\/doi.org\/10.1016\/j.ekir.2021.09.008.","journal-title":"Kidney Int Rep"},{"issue":"3","key":"1711_CR13","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0297568","volume":"19","author":"KS Kechagias","year":"2024","unstructured":"Kechagias KS, Laleye JD, Drmota J, Geropoulos G, Kyrtsonis G, Zafeiri M, et al. Minimal change disease following COVID-19 vaccination: a systematic review. PLoS ONE. 2024;19(3):e0297568. https:\/\/doi.org\/10.1371\/journal.pone.0297568.","journal-title":"PLoS ONE"},{"issue":"5","key":"1711_CR14","doi-asserted-by":"publisher","first-page":"317","DOI":"10.1093\/qjmed\/hcad159","volume":"117","author":"Y Li","year":"2024","unstructured":"Li Y, Gong Y, Xu G. New insights into kidney disease after COVID-19 infection and vaccination: histopathological and clinical findings. QJM Mon J Assoc Physicians. 2024;117(5):317\u201337. https:\/\/doi.org\/10.1093\/qjmed\/hcad159.","journal-title":"QJM Mon J Assoc Physicians"},{"issue":"3","key":"1711_CR15","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1007\/s10157-022-02299-6","volume":"27","author":"Y Ota","year":"2023","unstructured":"Ota Y, Kuroki R, Iwata M, Taira H, Matsuo S, Kamijo M, et al. Association between COVID-19 vaccination and relapse of glomerulonephritis. Clin Exp Nephrol. 2023;27(3):236\u201342. https:\/\/doi.org\/10.1007\/s10157-022-02299-6.","journal-title":"Clin Exp Nephrol"},{"issue":"5","key":"1711_CR16","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1007\/s40264-020-00911-w","volume":"43","author":"O Caster","year":"2020","unstructured":"Caster O, Aoki Y, Gattepaille LM, Grundmark B. Disproportionality analysis forpharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations.Drug Saf. 2020;43(5):479\u201387. https:\/\/doi.org\/10.1007\/s40264-020-00911-w.","journal-title":"Drug Saf"},{"issue":"302","key":"1711_CR17","doi-asserted-by":"publisher","first-page":"601","DOI":"10.3233\/SHTI230213","volume":"18","author":"L Quirant","year":"2023","unstructured":"Quirant L, Sandberg L, Barrett JW, Ellenius J. Decision support for signal assessment of large case series in pharmacovigilance. Stud Health Technol Inform. 2023May;18(302):601\u20132. https:\/\/doi.org\/10.3233\/SHTI230213.","journal-title":"Stud Health Technol Inform."},{"key":"1711_CR18","unstructured":"Turesson E. Free-text informed duplicate detection of COVID-19 vaccine adverse event reports. 2022. https:\/\/urn.kb.se\/resolve?urn=urn:nbn:se:uu:diva-477319. Accessed 9 July 2024."},{"issue":"1","key":"1711_CR19","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-17","volume":"14","author":"F Leroy","year":"2014","unstructured":"Leroy F, Dauxois JY, Th\u00e9ophile H, Haramburu F, Tubert-Bitter P. Estimating time-to-onset of adverse drug reactions from spontaneous reporting databases. BMC Med Res Methodol. 2014;14(1):17. https:\/\/doi.org\/10.1186\/1471-2288-14-17.","journal-title":"BMC Med Res Methodol"},{"key":"1711_CR20","doi-asserted-by":"publisher","first-page":"456","DOI":"10.1201\/9780429246593","volume-title":"An introduction to the bootstrap","author":"B Efron","year":"1994","unstructured":"Efron B, Tibshirani RJ. An introduction to the bootstrap. New York (NY): Chapman and Hall\/CRC; 1994. p. 456. https:\/\/doi.org\/10.1201\/9780429246593."},{"issue":"397","key":"1711_CR21","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1080\/01621459.1987.10478410","volume":"82","author":"B Efron","year":"1987","unstructured":"Efron B. Better bootstrap confidence intervals. J Am Stat Assoc. 1987;82(397):171\u201385. https:\/\/doi.org\/10.1080\/01621459.1987.10478410.","journal-title":"J Am Stat Assoc"},{"issue":"10","key":"1711_CR22","doi-asserted-by":"publisher","first-page":"1508","DOI":"10.1016\/j.ekir.2019.07.019","volume":"4","author":"N Nobakht","year":"2019","unstructured":"Nobakht N, Nguyen HA, Kamgar MK, Abdelnour L, Rastogi A, Hanna RM. Development of collapsing focal and segmental glomerulosclerosis after receiving intravitreal vascular endothelial growth factor blockade. Kidney Int Rep. 2019;4(10):1508\u201312. https:\/\/doi.org\/10.1016\/j.ekir.2019.07.019.","journal-title":"Kidney Int Rep"},{"issue":"5","key":"1711_CR23","doi-asserted-by":"publisher","first-page":"860","DOI":"10.1016\/j.xkme.2021.05.002","volume":"3","author":"M Abramson","year":"2021","unstructured":"Abramson M, Mon-Wei Yu S, Campbell KN, Chung M, Salem F. IgA nephropathy after SARS-CoV-2 vaccination. Kidney Med. 2021;3(5):860\u20133. https:\/\/doi.org\/10.1016\/j.xkme.2021.05.002.","journal-title":"Kidney Med"},{"issue":"7","key":"1711_CR24","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0068938","volume":"8","author":"G Karimi","year":"2013","unstructured":"Karimi G, Star K, Nor\u00e9n GN, H\u00e4gg S. The impact of duration of treatment on reported time-to-onset in spontaneous reporting systems for pharmacovigilance. PLoS ONE. 2013;8(7):e68938. https:\/\/doi.org\/10.1371\/journal.pone.0068938.","journal-title":"PLoS ONE"},{"issue":"9","key":"1711_CR25","doi-asserted-by":"publisher","first-page":"909","DOI":"10.1007\/s10157-022-02231-y","volume":"26","author":"N Nakagawa","year":"2022","unstructured":"Nakagawa N, Maruyama S, Kashihara N, Narita I, Isaka Y. New-onset and relapse of nephrotic syndrome following COVID-19 vaccination: a questionnaire survey in Japan. Clin Exp Nephrol. 2022;26(9):909\u201316. https:\/\/doi.org\/10.1007\/s10157-022-02231-y.","journal-title":"Clin Exp Nephrol"},{"issue":"4","key":"1711_CR26","doi-asserted-by":"publisher","first-page":"299","DOI":"10.2165\/11588490-000000000-00000","volume":"34","author":"MJ Klepper","year":"2011","unstructured":"Klepper MJ, Edwards B. Individual case safety reports: how to determine the onset date of an adverse reaction. Drug Saf. 2011;34(4):299\u2013305. https:\/\/doi.org\/10.2165\/11588490-000000000-00000.","journal-title":"Drug Saf"},{"issue":"7","key":"1711_CR27","doi-asserted-by":"publisher","first-page":"1291","DOI":"10.2215\/CJN.00860115","volume":"10","author":"GS Markowitz","year":"2015","unstructured":"Markowitz GS, Bomback AS, Perazella MA. Drug-induced glomerular disease: direct cellular injury. Clin J Am Soc Nephrol. 2015;10(7):1291\u20139. https:\/\/doi.org\/10.2215\/CJN.00860115.","journal-title":"Clin J Am Soc Nephrol"},{"issue":"13","key":"1711_CR28","doi-asserted-by":"publisher","first-page":"204209862211189","DOI":"10.1177\/20420986221118972","volume":"1","author":"A Rudolph","year":"2022","unstructured":"Rudolph A, Mitchell J, Barrett J, Sk\u00f6ld H, Taavola H, Erlanson N, et al. Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge. Ther Adv Drug Saf. 2022;1(13):20420986221118972. https:\/\/doi.org\/10.1177\/20420986221118972.","journal-title":"Ther Adv Drug Saf."},{"issue":"12","key":"1711_CR29","doi-asserted-by":"publisher","first-page":"2247","DOI":"10.1681\/ASN.2022030258","volume":"33","author":"M Canney","year":"2022","unstructured":"Canney M, Atiquzzaman M, Cunningham AM, Zheng Y, Er L, Hawken S, et al. A population-based analysis of the risk of glomerular disease relapse after COVID-19 vaccination. J Am Soc Nephrol. 2022;33(12):2247\u201357. https:\/\/doi.org\/10.1681\/ASN.2022030258.","journal-title":"J Am Soc Nephrol"},{"issue":"7","key":"1711_CR30","doi-asserted-by":"publisher","first-page":"328","DOI":"10.4103\/1947-2714.161252","volume":"7","author":"P Tandon","year":"2015","unstructured":"Tandon P, Wong N, Zaltzman JS. Lithium-induced minimal change disease and acute kidney injury. North Am J Med Sci. 2015;7(7):328\u201331. https:\/\/doi.org\/10.4103\/1947-2714.161252.","journal-title":"North Am J Med Sci"},{"issue":"3","key":"1711_CR31","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1177\/23993693251356093","volume":"9","author":"RB Chowdhury","year":"2025","unstructured":"Chowdhury RB, Mohan A, Charkviani M, Mignano SE, Alexander MP, Buglioni A, et al. Glomerular pathology of vascular endothelial growth factor inhibition: a 12-year review at the Mayo Clinic. J Onco-Nephrol. 2025;9(3):51\u201361. https:\/\/doi.org\/10.1177\/23993693251356093.","journal-title":"J Onco-Nephrol"}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-026-01711-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-026-01711-4","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-026-01711-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T05:02:41Z","timestamp":1791003761000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-026-01711-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,1]]},"references-count":31,"alternative-id":["1711"],"URL":"https:\/\/doi.org\/10.1007\/s40264-026-01711-4","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,1]]},"assertion":[{"value":"12 December 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 July 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 October 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This work was conducted by the authors as part of their regular work tasks and has not received any additional funding.","order":1,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Annette Rudolph, Monica Tarapues, Oskar Gauffin and Qun-Ying Yue have no conflicts of interest that are directly relevant to the content of this article.","order":2,"name":"Ethics","label":"Conflicts of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The presented analysis is based on anonymised spontaneous reports in VigiBase and, thus, did not require ethics approval.","order":3,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The presented analysis did not include any data directly collected from patients and, therefore, did not require consent for participation by patients or legal guardians.","order":4,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The presented analysis did not include any data directly collected from patients and, therefore, did not require consent for publication by patients or legal guardians.","order":5,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The data supporting the findings of this study are not publicly available. Access to the data is restricted based on the conditions for access within the WHO Programme for International Drug Monitoring. Subject to these conditions, data are available from the authors upon reasonable request.","order":6,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":7,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"AR, MT and QYY performed the qualitative review and cleaning of the data and performed data characterisation. OG performed statistical analyses of the data. All authors were involved in drafting and revising the manuscript, providing critical feedback and approving the final version.","order":8,"name":"Ethics","label":"Authors\u2019 Contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}