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After its approval, a prospective, non-interventional, observational post-marketing surveillance was initiated to evaluate the safety and effectiveness of nivolumab treatment for up to 12\u00a0months in patients with relapsed\/refractory cHL. Of 304 registered patients, 288 were included in safety analyses and 282 in effectiveness analyses. There were 191 (66.3%) male patients, median age was 64.0\u00a0years, and 54 patients (18.8%) had performance status\u2009\u2265\u20092. Treatment-related adverse events (TRAEs) were reported in 183 (63.5%) patients, with grade 3\u20135 TRAEs in 86 (29.9%). The most common TRAEs were infusion reaction (14.6%), hepatic function abnormal (5.9%), interstitial lung disease (ILD) (5.6%), and hypothyroidism (5.2%). TRAEs of special interest in\u2009\u2265\u20095% of patients were infusion reaction (15.6%), hepatic failure\/hepatic dysfunction\/hepatitis\/cholangitis sclerosing (13.2%), thyroid dysfunction (9.7%), and ILD (7.3%). In multivariable analyses, prior allogeneic hematopoietic stem cell transplantation was a risk factor for hepatic failure\/hepatic dysfunction\/hepatitis\/cholangitis sclerosing, and prior thyroid gland disorders was a risk factor for thyroid dysfunction. The overall response rate was 61.7%. In conclusion, nivolumab showed a similar safety profile and comparable effectiveness to that reported in clinical trials for relapsed\/refractory cHL (CheckMate 205, ONO-4538-15).<\/jats:p>","DOI":"10.1007\/s12185-024-03734-y","type":"journal-article","created":{"date-parts":[[2024,3,23]],"date-time":"2024-03-23T17:01:30Z","timestamp":1711213290000},"page":"667-676","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan"],"prefix":"10.1007","volume":"119","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-9586-5084","authenticated-orcid":false,"given":"Akira","family":"Kawasaki","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyohiko","family":"Hatake","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Itaru","family":"Matsumura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomohiro","family":"Hoshino","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ayumi","family":"Akamatsu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akito","family":"Kakuuchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kensei","family":"Tobinai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,3,23]]},"reference":[{"issue":"3","key":"3734_CR1","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1111\/j.1440-1827.2007.02207.x","volume":"58","author":"R Aoki","year":"2008","unstructured":"Aoki R, Karube K, Sugita Y, Nomura Y, Shimizu K, Kimura Y, et al. 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Kiyohiko Hatake reported research funding from Ono Pharmaceutical in relation to this work; consulting fees from Meiji Seika Pharma; and honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing or educational events from Towa Pharmaceutical, Meiji Seika Pharma, Otsuka Pharmaceutical, Janssen Pharmaceutical, Aioi Nissay Dowa Insurance, Yakult Honsha, Daiichi Sankyo, and Chugai Pharmaceutical. Itaru Matsumura reported research funding from Ono Pharmaceutical in relation to this work; research grants from Ono Pharmaceutical, Janssen Pharmaceutical, Nippon Shinyaku, Kyowa Kirin, Sumitomo Dainippon Pharma, Shionogi & Co, Teijin Pharma, Boehringer Ingelheim, Sanofi, Chugai Pharmaceutical, Eisai, MSD, Asahi Kasei Pharma, Astellas Pharma, Takeda Pharmaceutical, Nihon Pharmaceutical, Daiichi Sankyo, AbbVie, Taiho Pharmaceutical, Mitsubishi Tanabe Pharma Corporation, Nippon Kayaku, CSL Behring, Mundipharma, AYUMI Pharmaceutical, Eli Lilly Japan, Actelion Pharmaceuticals Japan, and Amgen BioPharma; consulting fees from Otsuka Pharmaceutical; and speakers\u2019 fees from Bristol-Myers Squibb (Celgene), Novartis, Otsuka, Pfizer Japan, Janssen, Astellas Pharma, Takeda Pharmaceutical, Daiichi Sankyo, Ono Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, SymBio Pharmaceuticals, AbbVie, and Amgen BioPharma. Koji Izutsu reported research funding from Ono Pharmaceutical in relation to this work; grants from MSD, AstraZeneca, AbbVie, Eisai, Incyte, Bristol-Myers Squibb, Novartis, Pfizer, Janssen Pharmaceutical, Yakult, Kyowa Kirin, Ono Pharmaceutical, and Daiichi Sankyo; consulting fees from Bristol-Myers Squibb, AstraZeneca, Zenyaku, Kyowa Kirin, MSD, Nihon Shinyaku, AbbVie, Ono Pharmaceutical, Genmab, Mitsubishi Tanabe Pharma, and Nihon Kayaku; and honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Bristol-Myers Squibb, AstraZeneca, Janssen, Eisai, Kyowa Kirin, Takeda Pharmaceutical, Chugai, Novartis, MSD, Symbio, Abbvie, Ono Pharmaceutical, Pfizer, Eli Lily, and Daiichi Sankyo. Kensei Tobinai reported research funding from Ono Pharmaceutical in relation to this work; consulting fees from Zenyaku Kogyo, Daiichi Sankyo, HUYA Bioscience International, and Mundipharma; honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing or educational events from Zenyaku Kogyo, Daiichi Sankyo, Celgene\/Bristol-Myers Squibb, HUYA Bioscience International, Mundipharma, and Solasia Pharma.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This PMS conformed to Japanese Good Post-Marketing Study Practice regulations. Each participating hospital agreed to contracts for this PMS with the study sponsor. Since all treatments were at the physician\u2019s discretion in actual clinical practice and no interventions were made for the purpose of this study, written informed consent was not required under Good Post-Marketing Study Practice.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and consent to participate"}},{"value":"The participating institutions provided consent for reporting data in this article.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}