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Primary endpoint was incidence of\u2009\u2265\u2009grade 2 IRRs based on the National Cancer Institute Common Terminology Criteria for Adverse Events. Secondary endpoints included IRRs severity, time to IRR onset, and H1RA-induced drowsiness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Incidence of\u2009\u2265\u2009grade 2 IRRs was 52.4% and 31.6% for the hydroxyzine (n\u2009=\u200921) and bepotastine (n\u2009=\u200919) groups, respectively (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.184). Distribution of initial and maximum IRR grades in the two groups was not statistically significant (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.846 and 0.555). Median time (range) to IRR onset in the two groups was 67 (12\u2013112) and 62 (10\u2013119) min, respectively (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.981). Median visual analog scale score (range and 75th percentile) for drowsiness was 37 (0\u2013100, 46) and 12 (0\u2013100, 29) mm in the two groups, respectively (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.138). Incidence of\u2009\u2265\u2009grade 2 IRRs in the absence of bone marrow infiltration was\u00a043.8% and 14.3% in the two groups, respectively (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.118), and no group differences were observed with bone marrow infiltration.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Bepotastine did not show significant superiority over hydroxyzine in preventing rituximab-induced IRRs due to the small sample size. Nevertheless, this exploratory study provides insight for further confirmatory studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number and date of registration<\/jats:title>\n                    <jats:p>jRCTs051220169; February 14, 2023.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-026-03012-3","type":"journal-article","created":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T13:04:32Z","timestamp":1776344672000},"page":"979-988","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy of bepotastine compared with hydroxyzine in preventing rituximab-induced infusion-related reactions in non-hodgkin lymphoma patients: a phase II, double-blind, multicenter, and randomized trial"],"prefix":"10.1007","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0263-5726","authenticated-orcid":false,"given":"Yumi","family":"Kitahiro","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironobu","family":"Minami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimikazu","family":"Yakushijin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiji","family":"Kurata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rina","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miki","family":"Saeki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuri","family":"Okazoe-Hirakawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kotaro","family":"Iida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natsuko","family":"Murase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isamu","family":"Harima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoko","family":"Kitamura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kotaro","family":"Itohara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Omura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Sugimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidetomo","family":"Takakura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihito","family":"Kitao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masako","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manabu","family":"Shimoyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamoru","family":"Okuno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ikuko","family":"Yano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,16]]},"reference":[{"issue":"22","key":"3012_CR1","doi-asserted-by":"publisher","first-page":"5027","DOI":"10.1200\/JCO.2005.09.137","volume":"23","author":"LH Sehn","year":"2005","unstructured":"Sehn LH, Donaldson J, Chhanabhai M et al (2005) Introduction of combined CHOP plus rituximab therapy dramatically improved outcome of diffuse large B-cell lymphoma in British Columbia. 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KYakushijin received honoraria from Pfizer. The other authors declare that they have no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was performed in line with the principles of the Declaration of Helsinki. This study was approved by Kobe University Clinical Research Ethical Committee (Reference number: C220009) and registered with the Japan Registry of Clinical Trials (jRCTs051220169).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients were required to provide written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}