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Bayesian network meta\u2010analysis (NMA) was conducted, and odds ratios (ORs) with 95% credible intervals (95%CrI) were calculated. A pharmacovigilance analysis was performed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. ICI\u2010associated AEs in patients with melanoma were obtained for the period from the first quarter (Q1) of 2004 to Q1 of 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The NMA included 31 RCTs, comprising 11,937 patients with melanoma. Ipilimumab (Ipi), nivolumab (Nivo), and pembrolizumab (Pem) were ranked as having the lowest risk of any grade as well as grade 3\u20135 trAEs. Chemotherapy (Chemo) was associated with the lowest risk of any grade or grade 3\u20135 irAEs. Compared to other ICIs, Chemo, Ipi, and Ipi\u2010Chemo were associated with the lowest risk of any irAEs. Based on the results of the FAERS pharmacovigilance analysis, we identified 5974 AEs in 4599 melanoma patients treated with ICIs. ICIs were associated with statistically significant indications involving 236 preferred terms (PTs). Thoroughly examined and pinpointed AEs were strongly correlated with ICIs. Pem treatment was associated with 166 significant PTs. Apart from malignant neoplasm progression and death, the most common PT was an immune\u2010mediated adverse reaction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The results of this study indicated that ICI safety profiles vary. These findings provide comparative safety signals that may help inform AE monitoring and risk assessment in patients with melanoma receiving ICIs, but they should not be interpreted as definitive prescribing guidance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/hsr2.72865","type":"journal-article","created":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T21:22:51Z","timestamp":1785273771000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The Real\u2010World Safety Profile of Immune Checkpoint Inhibitors in Melanoma: FAERS Pharmacovigilance Analysis Complemented by Randomized Trial Evidence"],"prefix":"10.1002","volume":"9","author":[{"given":"Yiwei","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Pharmacy Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region Nanning People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xueyan","family":"Liang","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trial Laboratory, Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region Nanning People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoyu","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Scientific Research and Discipline Development Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region Nanning People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3901-0727","authenticated-orcid":false,"given":"Yan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Guangxi Academy of Medical Sciences and the People's Hospital of Guangxi Zhuang Autonomous Region Nanning People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,28]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lanepe.2021.100024"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.1611"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1104621"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2022.109657"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.27145"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.7326\/M14-2385"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/JOP.18.00005"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2024.1396752"},{"key":"e_1_2_14_11_1","unstructured":"National Cancer Institute \u201cCommon Terminology Criteria for Adverse Events (CTCAE) v5.0 \u201d accessed May 12 2024 https:\/\/ctep.cancer.gov\/protocolDevelopment\/electronic_applications\/ctc.htm#ctc_50."},{"key":"e_1_2_14_12_1","unstructured":"Medical Dictionary for Regulatory Activities \u201cWelcome to MedDRA. 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