{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T02:08:42Z","timestamp":1783908522661,"version":"3.55.0"},"reference-count":14,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T00:00:00Z","timestamp":1775606400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T00:00:00Z","timestamp":1775606400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Naunyn-Schmiedeberg's Arch Pharmacol"],"published-print":{"date-parts":[[2026,6]]},"DOI":"10.1007\/s00210-026-05307-8","type":"journal-article","created":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T11:39:24Z","timestamp":1775648364000},"page":"14595-14599","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Post-marketing safety evaluation and objective benefit-risk assessment of sublingual immunotherapy tablets in allergic rhinitis"],"prefix":"10.1007","volume":"399","author":[{"given":"Eleonora","family":"Castellana","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Rachele","family":"Chiappetta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,8]]},"reference":[{"key":"5307_CR1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2024.107966","volume":"196","author":"M Chen","year":"2024","unstructured":"Chen M, Huang Y, Jiang S, Ke C (2024) Safety assessment of KRAS (G12C) inhibitors based on the FDA adverse event reporting system (FAERS) database: a real-world pharmacovigilance study. Lung Cancer 196:107966. https:\/\/doi.org\/10.1016\/j.lungcan.2024.107966","journal-title":"Lung Cancer"},{"issue":"2","key":"5307_CR2","doi-asserted-by":"publisher","first-page":"144","DOI":"10.1159\/000500524","volume":"180","author":"L Cui","year":"2019","unstructured":"Cui L, Li J, Li Y, Xia Z (2019) Long-term efficacy of sublingual mite immunotherapy in monosensitized and polysensitized children with allergic rhinitis: a 7-year prospective study. Int Arch Allergy Immunol 180(2):144\u2013149. https:\/\/doi.org\/10.1159\/000500524","journal-title":"Int Arch Allergy Immunol"},{"key":"5307_CR3","doi-asserted-by":"publisher","DOI":"10.1016\/j.rcsop.2026.100719","volume":"22","author":"S Ghubade","year":"2026","unstructured":"Ghubade S, Shukla S (2026) Assessing safety trends of withdrawn medications: a data-driven pharmacovigilance approach using growth models. Explor Res Clin Soc Pharm 22:100719. https:\/\/doi.org\/10.1016\/j.rcsop.2026.100719","journal-title":"Explor Res Clin Soc Pharm"},{"key":"5307_CR4","doi-asserted-by":"publisher","DOI":"10.1177\/2042098620976951","volume":"11","author":"ML K\u00fcrzinger","year":"2020","unstructured":"K\u00fcrzinger ML, Douarin L, Uzun I et al (2020) Structured benefit-risk evaluation for medicinal products: review of quantitative benefit-risk assessment findings in the literature. Ther Adv Drug Saf 11:2042098620976951. https:\/\/doi.org\/10.1177\/2042098620976951","journal-title":"Ther Adv Drug Saf"},{"key":"5307_CR5","doi-asserted-by":"publisher","DOI":"10.35629\/4494-100225952601","author":"WM Wasiullah","year":"2025","unstructured":"Mohd. Wasiullah WM, Yadav YP, Maury SM, vishwakarma M, vishwakarma M, Yadav AY (2025a) \u201cA report on-from clinical trials to post marketing surveillance: the evaluation of safety data generation in pharmacovigilance,.\u201d Int J Pharm Res Appl. https:\/\/doi.org\/10.35629\/4494-100225952601","journal-title":"Int J Pharm Res Appl"},{"key":"5307_CR6","doi-asserted-by":"publisher","DOI":"10.35629\/4494-100225202528","author":"WM Wasiullah","year":"2025","unstructured":"Mohd. Wasiullah WM, Yadav YP, vishwakarma M, vishwakarma M, dubey LS, yadav A (2025b) \u201cA comprehensive review of pharmacovigilance: present, past, and future perspectives in patient safety,.\u201d Int J Pharm Res Appl. https:\/\/doi.org\/10.35629\/4494-100225202528","journal-title":"Int J Pharm Res Appl"},{"key":"5307_CR7","doi-asserted-by":"publisher","DOI":"10.35629\/4494-100224132417","author":"YP Yadav","year":"2025","unstructured":"Mohd. Wasiullah WM, Yadav YP, Yadav GKY, vishwakarma M, vishwakarma M, Yadav RY (2025c) \u201cEnhancing vaccine safety: the role of pharmacovigilance in public health,.\u201d Int J Pharm Res Appl. https:\/\/doi.org\/10.35629\/4494-100224132417","journal-title":"Int J Pharm Res Appl"},{"issue":"1","key":"5307_CR8","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-023-00789-3","volume":"25","author":"JN Mutanga","year":"2023","unstructured":"Mutanga JN, Nukala U, Rodriguez Messan M et al (2023) A retrospective review of center for biologics evaluation and research advisory committee meetings in the context of the FDA\u2019s benefit-risk framework. AAPS J 25(1):24. https:\/\/doi.org\/10.1208\/s12248-023-00789-3","journal-title":"AAPS J"},{"issue":"1","key":"5307_CR9","doi-asserted-by":"publisher","first-page":"33","DOI":"10.2500\/aap.2024.45.230068","volume":"45","author":"HS Nelson","year":"2024","unstructured":"Nelson HS, Bernstein DI, Biedermann T, Nolte H (2024) Sublingual immunotherapy tablets in monosensitized and polysensitized adults with allergic rhinoconjunctivitis. Allergy Asthma Proc 45(1):33\u201336. https:\/\/doi.org\/10.2500\/aap.2024.45.230068","journal-title":"Allergy Asthma Proc"},{"issue":"16","key":"5307_CR10","doi-asserted-by":"publisher","first-page":"1401","DOI":"10.2217\/imt-2023-0100","volume":"15","author":"Y Okamoto","year":"2023","unstructured":"Okamoto Y, Kato M, Ishii K, Sato Y, Hata T, Asaka Y (2023) Safety and effectiveness of a 300 IR house dust mite sublingual tablet: descriptive 4-year final analysis of a post-marketing surveillance in Japan. Immunotherapy 15(16):1401\u20131414. https:\/\/doi.org\/10.2217\/imt-2023-0100","journal-title":"Immunotherapy"},{"key":"5307_CR11","doi-asserted-by":"publisher","DOI":"10.12775\/QS.2026.51.68476","author":"T Pietrucha","year":"2026","unstructured":"Pietrucha T, Go\u0142dyn M, Kubala K, Grabi\u0144ska M, Halik P, Jusiak J (2026) Subcutaneous versus sublingual allergen immunotherapy in allergic rhinitis and asthma: a comparative narrative review. Quality in Sport. https:\/\/doi.org\/10.12775\/QS.2026.51.68476","journal-title":"Quality in Sport"},{"key":"5307_CR12","doi-asserted-by":"publisher","DOI":"10.1177\/20420986241285927","volume":"15","author":"TY Sree Sudha","year":"2024","unstructured":"Sree Sudha TY, Meena B, Pareek S, Singh H (2024) Enhancing pharmacovigilance for robust drug safety monitoring: addressing underreporting and collaborative solutions. Ther Adv Drug Saf 15:20420986241285927. https:\/\/doi.org\/10.1177\/20420986241285927","journal-title":"Ther Adv Drug Saf"},{"issue":"6","key":"5307_CR13","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjoto.2024.104476","volume":"45","author":"J Wang","year":"2024","unstructured":"Wang J, Cai L, Huang C, Pei J, Shi X, Tao Y (2024) Individualized sublingual immunotherapy with dynamic maintenance dose ascending for house dust mite-induced allergic rhinitis. Am J Otolaryngol 45(6):104476. https:\/\/doi.org\/10.1016\/j.amjoto.2024.104476","journal-title":"Am J Otolaryngol"},{"issue":"7","key":"5307_CR14","doi-asserted-by":"publisher","DOI":"10.1016\/j.waojou.2024.100924","volume":"17","author":"M Worm","year":"2024","unstructured":"Worm M, Demoly P, Okamoto Y et al (2024) Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J 17(7):100924. https:\/\/doi.org\/10.1016\/j.waojou.2024.100924","journal-title":"World Allergy Organ J"}],"container-title":["Naunyn-Schmiedeberg's Archives of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-026-05307-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00210-026-05307-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-026-05307-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T01:44:53Z","timestamp":1783907093000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00210-026-05307-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,8]]},"references-count":14,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["5307"],"URL":"https:\/\/doi.org\/10.1007\/s00210-026-05307-8","relation":{},"ISSN":["0028-1298","1432-1912"],"issn-type":[{"value":"0028-1298","type":"print"},{"value":"1432-1912","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,8]]},"assertion":[{"value":"26 March 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 April 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 April 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Since all adverse events have been processed from sources with anonymized data and the study does not include any information that could make the patient identifiable, approval from the Ethics Review Board was not deemed necessary.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}