{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T21:30:10Z","timestamp":1775597410966,"version":"3.50.1"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,2,20]],"date-time":"2018-02-20T00:00:00Z","timestamp":1519084800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A postmarketing surveillance study is ongoing to evaluate nivolumab treatment for Japanese patients with malignant melanoma and accumulate data on all adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>) and efficacy. In this interim analysis, we evaluated data from approximately 100 Japanese medical institutions obtained from the nivolumab approval date in Japan (4 July 2014) through 3 July 2016. Patients were monitored during the first 12 months of treatment. Nivolumab was administrated by i.v. infusion (2 mg\/kg every 3 weeks). A total of 680 and 610 patients were evaluated for safety and efficacy, respectively. The incidences of adverse drug reactions (<jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content>) and grade 3 or higher <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content> were 53.53% and 12.35%, respectively. Predominant <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content> included hypothyroidism (11.32%) and abnormal enzyme activity, such as increase of aspartate aminotransferase (7.79%), alanine aminotransferase (6.76%), alkaline phosphatase (6.18%) and \u03b3\u2010glutamyltransferase (5.44%). Grade 3 or higher <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content> of special interest with an incidence of 1% or higher were hepatic function disorder (2.50%), colitis\/diarrhea (2.06%) and infusion reaction (1.32%). No cases of encephalitis or venous thromboembolism, other <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content> of special interest, were observed. The estimated median overall survival was 379 days (95% confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>], 290\u2013not reached [<jats:styled-content style=\"fixed-case\">NR<\/jats:styled-content>]) in the overall population, <jats:styled-content style=\"fixed-case\">NR<\/jats:styled-content> (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 305\u2013<jats:styled-content style=\"fixed-case\">NR<\/jats:styled-content>) for cutaneous melanoma and 340 days (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 275\u2013<jats:styled-content style=\"fixed-case\">NR<\/jats:styled-content>) for mucosal melanoma. The improvement rate based on the antitumor response at the last evaluation was 22.2% (131\/590 patients). No new safety concerns were raised, and serious <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content> of special interest were infrequent. Nivolumab showed equivalent efficacy in patients with mucosal melanoma and those with cutaneous melanoma.<\/jats:p>","DOI":"10.1111\/1346-8138.14227","type":"journal-article","created":{"date-parts":[[2018,2,21]],"date-time":"2018-02-21T20:07:16Z","timestamp":1519243636000},"page":"408-415","source":"Crossref","is-referenced-by-count":41,"title":["Safety and efficacy of nivolumab in Japanese patients with malignant melanoma: An interim analysis of a postmarketing surveillance"],"prefix":"10.1111","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7335-4617","authenticated-orcid":false,"given":"Yoshio","family":"Kiyohara","sequence":"first","affiliation":[{"name":"Dermatology Division Shizuoka Cancer Center Hospital Shizuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hisashi","family":"Uhara","sequence":"additional","affiliation":[{"name":"Department of Dermatology Sapporo Medical University School of Medicine Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshihiko","family":"Ito","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division Ono Pharmaceutical Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noritake","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division Ono Pharmaceutical Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuya","family":"Tsuchida","sequence":"additional","affiliation":[{"name":"Department of Dermatology Saitama Medical University Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9638-0428","authenticated-orcid":false,"given":"Naoya","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Department of Dermatologic Oncology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,2,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.17554\/j.issn.1819-6187.2016.04.84"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-007-0751-1"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-014-0234-4"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1200690"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.53.0105"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)70076-8"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1412082"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504627"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1507643"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1510665"},{"key":"e_1_2_7_12_1","first-page":"155","article-title":"Oral and cutaneous melanoma: similarities and differences","volume":"2","author":"Moreira RN","year":"2010","journal-title":"J Clin Med Res"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/jop.12526"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1254\/fpj.140.81"},{"key":"e_1_2_7_15_1","unstructured":"Ono Pharmaceutical Co. 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