{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T02:24:29Z","timestamp":1773887069211,"version":"3.50.1"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2022,10,27]],"date-time":"2022-10-27T00:00:00Z","timestamp":1666828800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,10,27]],"date-time":"2022-10-27T00:00:00Z","timestamp":1666828800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development, LLC","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ann Hematol"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract\n<\/jats:title><jats:p>Daratumumab monotherapy demonstrated favorable safety and efficacy in relapsed\/refractory multiple myeloma (RRMM) patients in the global phase 1\/2 GEN501 and phase 2 SIRIUS studies. MMY1003 evaluated daratumumab monotherapy specifically in Chinese patients with RRMM. This 3-part, open-label, phase 1, dose-escalation study included patients with\u2009\u2265\u20092 prior lines of therapy. Part 3 included patients who had received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) and experienced disease progression on their last regimen. Patients received intravenous daratumumab 8\u00a0mg\/kg or 16\u00a0mg\/kg in part 1 and 16\u00a0mg\/kg in parts 2\u2009+\u20093. Primary endpoints were dose-limiting toxicity (DLT; part 1), pharmacokinetics (parts 1\u2009+\u20092), and adverse events (AEs). Fifty patients enrolled. The first 3 patients in part 1 received daratumumab 8\u00a0mg\/kg; remaining patients in parts 1\u20133 received daratumumab 16\u00a0mg\/kg. In the daratumumab 16\u00a0mg\/kg group (<jats:italic>n<\/jats:italic>\u2009=\u200947), patients received a median of 4 prior lines of therapy; 32% were refractory to a PI and IMiD, and 79% were refractory to their last prior therapy. No DLTs occurred. Thirty-six (77%) patients reported grade 3\/4 treatment-emergent AEs. Thirteen (28%) patients experienced infusion-related reactions. At an 18.5-month median follow-up, overall response rate was 43%. Median progression-free survival (PFS) and overall survival (OS) were 6.7\u00a0months and not reached, respectively; 12-month PFS and OS rates were 35% and 70%. Pharmacokinetic results (<jats:italic>n<\/jats:italic>\u2009=\u200922) were consistent with other studies. Safety, pharmacokinetics, and efficacy of daratumumab monotherapy were confirmed in Chinese patients with RRMM. This trial is registered on ClinicalTrials.gov (NCT02852837).<\/jats:p>","DOI":"10.1007\/s00277-022-04951-3","type":"journal-article","created":{"date-parts":[[2022,10,27]],"date-time":"2022-10-27T06:04:35Z","timestamp":1666850675000},"page":"2679-2690","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Safety and efficacy of daratumumab in Chinese patients with relapsed or refractory multiple myeloma: a phase 1, dose-escalation study (MMY1003)"],"prefix":"10.1007","volume":"101","author":[{"given":"Hongmei","family":"Jing","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junyuan","family":"Qi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lugui","family":"Qiu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chengcheng","family":"Fu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junmin","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ming","family":"Qi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ni","family":"Fan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia","family":"Ji","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiajia","family":"Lu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunan","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4617-2601","authenticated-orcid":false,"given":"Jie","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,10,27]]},"reference":[{"key":"4951_CR1","doi-asserted-by":"publisher","first-page":"1513","DOI":"10.3389\/fonc.2019.01513","volume":"9","author":"S Wang","year":"2020","unstructured":"Wang S, Xu L, Feng J, Liu Y, Liu L, Wang J, Liu J, Huang X, Gao P, Lu J, Zhan S (2020) Prevalence and incidence of multiple myeloma in urban area in China: a national population-based analysis. Front Oncol 9:1513","journal-title":"Front Oncol"},{"key":"4951_CR2","doi-asserted-by":"publisher","first-page":"2516","DOI":"10.1182\/blood-2007-10-116129","volume":"111","author":"SK Kumar","year":"2008","unstructured":"Kumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Zeldenrust SR, Dingli D, Russell SJ, Lust JA, Greipp PR, Kyle RA, Gertz MA (2008) Improved survival in multiple myeloma and the impact of novel therapies. Blood 111:2516\u20132520","journal-title":"Blood"},{"key":"4951_CR3","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1038\/leu.2011.196","volume":"26","author":"SK Kumar","year":"2012","unstructured":"Kumar SK, Lee JH, Lahuerta JJ, Morgan G, Richardson PG, Crowley J, Haessler J, Feather J, Hoering A, Moreau P, Leleu X, Hulin C, Klein SK, Sonneveld P, Siegel D, Blad\u00e9 J, Goldschmidt H, Jagannath S, Miguel JS, Orlowski R, Palumbo A, Sezer O, Rajkumar SV, Durie BG (2012) Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter International Myeloma Working Group study. Leukemia 26:149\u2013157","journal-title":"Leukemia"},{"key":"4951_CR4","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1586\/17474086.2014.882764","volume":"7","author":"JP Laubach","year":"2014","unstructured":"Laubach JP, Voorhees PM, Hassoun H, Jakubowiak A, Lonial S, Richardson PG (2014) Current strategies for treatment of relapsed\/refractory multiple myeloma. Expert Rev Hematol 7:97\u2013111","journal-title":"Expert Rev Hematol"},{"key":"4951_CR5","doi-asserted-by":"publisher","first-page":"1355","DOI":"10.1634\/theoncologist.2016-0104","volume":"21","author":"S Usmani","year":"2016","unstructured":"Usmani S, Ahmadi T, Ng Y, Lam A, Desai A, Potluri R, Mehra M (2016) Analysis of real-world data on overall survival in multiple myeloma patients with \u22653 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or double refractory to a PI and an IMiD. Oncologist 21:1355\u20131361","journal-title":"Oncologist"},{"key":"4951_CR6","doi-asserted-by":"publisher","first-page":"1840","DOI":"10.4049\/jimmunol.1003032","volume":"186","author":"M de Weers","year":"2011","unstructured":"de Weers M, Tai YT, van der Veer MS, Bakker JM, Vink T, Jacobs DC, Oomen LA, Peipp M, Valerius T, Slootstra JW, Mutis T, Bleeker WK, Anderson KC, Lokhorst HM, van de Winkel JG, Parren PW (2011) Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol 186:1840\u20131848","journal-title":"J Immunol"},{"key":"4951_CR7","doi-asserted-by":"publisher","first-page":"3474","DOI":"10.1182\/blood.V124.21.3474.3474","volume":"124","author":"J Lammerts van Bueren","year":"2014","unstructured":"Lammerts van Bueren J, Jakobs D, Kaldenhoven N, Roza M, Hiddingh S, Meesters J, Voorhorst M, Gresnigt E, Wiegman L, Buijsse O, Andringa G, Overdijk MB, Doshi P, Sasser K, de Weers M, Parren PWHI (2014) Direct in vitro comparison of daratumumab with surrogate analogs of CD38 antibodies MOR03087, SAR650984 and Ab79. Blood 124:3474","journal-title":"Blood"},{"key":"4951_CR8","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1080\/19420862.2015.1007813","volume":"7","author":"MB Overdijk","year":"2015","unstructured":"Overdijk MB, Verploegen S, B\u00f6gels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, Parren PWHI (2015) Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs 7:311\u2013321","journal-title":"MAbs"},{"key":"4951_CR9","doi-asserted-by":"publisher","first-page":"807","DOI":"10.4049\/jimmunol.1501351","volume":"197","author":"MB Overdijk","year":"2016","unstructured":"Overdijk MB, Jansen JH, Nederend M, Lammerts van Bueren JJ, Groen RW, Parren PW, Leusen JH, Boross P (2016) The therapeutic CD38 monoclonal antibody daratumumab induces programmed cell death via Fc\u03b3 receptor-mediated cross-linking. J Immunol 197:807\u2013813","journal-title":"J Immunol"},{"key":"4951_CR10","doi-asserted-by":"publisher","first-page":"384","DOI":"10.1182\/blood-2015-12-687749","volume":"128","author":"J Krejcik","year":"2016","unstructured":"Krejcik J, Casneuf T, Nijhof IS, Verbist B, Bald J, Plesner T, Syed K, Liu K, van de Donk NWCJ, Weiss BM, Ahmadi T, Lokhorst HM, Mutis T, Sasser AK (2016) Daratumumab depletes CD38+ immune-regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood 128:384\u2013394","journal-title":"Blood"},{"key":"4951_CR11","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1002\/cyto.a.23693","volume":"95","author":"HC Adams III","year":"2019","unstructured":"Adams HC III, Stevenaert F, Krejcik J, Van der Borght K, Smets T, Bald J, Abraham Y, Ceulemans H, Chiu C, Vanhoof G, Usmani SZ, Plesner T, Lonial S, Nijhof I, Lokhorst HM, Mutis T, van de Donk N, Sasser AK, Casneuf T (2019) High-parameter mass cytometry evaluation of relapsed\/refractory multiple myeloma patients treated with daratumumab demonstrates immune modulation as a novel mechanism of action. Cytometry A 95:279\u2013289","journal-title":"Cytometry A"},{"key":"4951_CR12","doi-asserted-by":"publisher","first-page":"573","DOI":"10.1038\/s41375-020-0855-4","volume":"35","author":"T Casneuf","year":"2021","unstructured":"Casneuf T, Adams HC III, van de Donk NWCJ, Abraham Y, Bald J, Vanhoof G, Van der Borght K, Smets T, Foulk B, Nielsen KC, Rusbuldt J, Axel A, Lysaght A, Ceulemans H, Stevenaert F, Usmani SZ, Plesner T, Avet-Loiseau H, Nijhof I, Mutis T, Schecter JM, Chiu C, Bahlis NJ (2021) Deep immune profiling of patients treated with lenalidomide and dexamethasone with or without daratumumab. Leukemia 35:573\u2013584","journal-title":"Leukemia"},{"key":"4951_CR13","doi-asserted-by":"publisher","first-page":"754","DOI":"10.1056\/NEJMoa1606038","volume":"375","author":"A Palumbo","year":"2016","unstructured":"Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, Mark TM, Qi M, Schecter J, Amin H, Qin X, Deraedt W, Ahmadi T, Spencer A, Sonneveld P (2016) Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med 375:754\u2013766","journal-title":"N Engl J Med"},{"key":"4951_CR14","doi-asserted-by":"publisher","first-page":"1319","DOI":"10.1056\/NEJMoa1607751","volume":"375","author":"MA Dimopoulos","year":"2016","unstructured":"Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis N, Usmani SZ, Rabinovic A, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoo SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O\u2019Rourke DM, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P (2016) Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 375:1319\u20131331","journal-title":"N Engl J Med"},{"key":"4951_CR15","unstructured":"DARZALEX\u00ae (daratumumab) injection, for intravenous use [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2021"},{"key":"4951_CR16","unstructured":"European Medicines Agency. DARZALEX 20 mg\/mL concentrate for solution for infusion [summary of product characteristics]. (2016) http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/004077\/WC500207296.pdf. Accessed 2 December 2021"},{"key":"4951_CR17","doi-asserted-by":"publisher","first-page":"1207","DOI":"10.1056\/NEJMoa1506348","volume":"373","author":"HM Lokhorst","year":"2015","unstructured":"Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NWCJ, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG (2015) Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med 373:1207\u20131219","journal-title":"N Engl J Med"},{"key":"4951_CR18","doi-asserted-by":"publisher","first-page":"1551","DOI":"10.1016\/S0140-6736(15)01120-4","volume":"387","author":"S Lonial","year":"2016","unstructured":"Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis N, Belch A, Krishnan A, Vescio R, Mateos MV, Mazumder A, Orlowski RZ, Sutherland H, Blad\u00e9 J, Scott EC, Oriol A, Berdeja JG, Gharibo M, Stevens DA, LeBlanc R, Sebag M, Callander N, Jakubowiak A, White D, De La Rubia J, Richardson PG, Lisby S, Feng H, Uhlar CM, Khan I, Ahmadi T, Voorhees P (2016) Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet 387:1551\u20131560","journal-title":"Lancet"},{"key":"4951_CR19","doi-asserted-by":"publisher","first-page":"e447","DOI":"10.1016\/S2352-3026(20)30081-8","volume":"7","author":"SZ Usmani","year":"2020","unstructured":"Usmani SZ, Nahi H, Plesner T, Weiss BM, Bahlis NJ, Belch A, Voorhees PM, Laubach JP, van de Donk N, Ahmadi T, Uhlar CM, Wang J, Feng H, Qi M, Richardson PG, Lonial S (2020) Daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma: final results from the phase 2 GEN501 and SIRIUS trials. Lancet Haematol 7:e447\u2013e455","journal-title":"Lancet Haematol"},{"key":"4951_CR20","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1182\/blood-2016-03-705210","volume":"128","author":"SZ Usmani","year":"2016","unstructured":"Usmani SZ, Weiss BM, Plesner T, Bahlis NJ, Belch A, Lonial S, Lokhorst HM, Voorhees PM, Richardson PG, Chari A, Sasser AK, Axel A, Feng H, Uhlar CM, Wang J, Khan I, Ahmadi T, Nahi H (2016) Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood 128:37\u201344","journal-title":"Blood"},{"key":"4951_CR21","unstructured":"U.S. Department of Health and Human Sercives, National Institutes of Health, National Cancer Institute (2020) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. 14 June\u00a02010. https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03\/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed 2 Decemeber 2021"},{"key":"4951_CR22","doi-asserted-by":"publisher","first-page":"1467","DOI":"10.1038\/sj.leu.2404284","volume":"20","author":"BGM Durie","year":"2006","unstructured":"Durie BGM, Harousseau JL, Miguel JS, Blad\u00e9 J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV (2006) International uniform response criteria for multiple myeloma. Leukemia 20:1467\u20131473","journal-title":"Leukemia"},{"key":"4951_CR23","doi-asserted-by":"crossref","unstructured":"Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blad\u00e9 J, Richardson P, Orlowski R, Siegel D, Jagannath S, Facon T, vet-Loiseau H, Lonial S, Palumbo A, Zonder J, Ludwig H, Vesole D, Sezer O, Munshi NC, San MJ (2011) Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood 117:4691-4695","DOI":"10.1182\/blood-2010-10-299487"},{"key":"4951_CR24","doi-asserted-by":"publisher","first-page":"721","DOI":"10.1002\/cpt.577","volume":"101","author":"XS Xu","year":"2017","unstructured":"Xu XS, Yan X, Puchalski T, Lonial S, Lokhorst HM, Voorhees PM, Plesner T, Liu K, Khan I, Jansson R, Ahmadi T, Perez Ruixo JJ, Zhou H, Clemens PL (2017) Clinical implications of complex pharmacokinetics for daratumumab dose regimen in patients with relapsed\/refractory multiple myeloma. Clin Pharmacol Ther 101:721\u2013724","journal-title":"Clin Pharmacol Ther"},{"key":"4951_CR25","doi-asserted-by":"publisher","first-page":"915","DOI":"10.1007\/s40262-016-0477-1","volume":"56","author":"PL Clemens","year":"2017","unstructured":"Clemens PL, Yan X, Lokhorst HM, Lonial S, Losic N, Khan I, Jansson R, Ahmadi T, Lantz K, Zhou H, Puchalski T, Xu XS (2017) Pharmacokinetics of daratumumab following intravenous infusion in relapsed or refractory multiple myeloma after prior proteasome inhibitor and immunomodulatory drug treatment. Clin Pharmacokinet 56:915\u2013924","journal-title":"Clin Pharmacokinet"},{"key":"4951_CR26","doi-asserted-by":"publisher","first-page":"529","DOI":"10.1007\/s40262-017-0598-1","volume":"57","author":"X Yan","year":"2018","unstructured":"Yan X, Clemens PL, Puchalski T, Lonial S, Lokhorst H, Voorhees PM, Usmani S, Richardson PG, Plesner T, Liu K, Orlowski RZ, Losic N, Jansson R, Ahmadi T, Lantz K, Ruixo JJP, Zhou H, Xu XS (2018) Influence of disease and patient characteristics on daratumumab exposure and clinical outcomes in relapsed or refractory multiple myeloma. Clin Pharmacokinet 57:529\u2013538","journal-title":"Clin Pharmacokinet"},{"key":"#cr-split#-4951_CR27.1","doi-asserted-by":"crossref","unstructured":"Lancman G, Sastow D, Aslanova M, Moshier E, Cho HJ, Jagannath S, Madduri D, Parekh SS, Richard S, Richter J, Sanchez L, Chari A (2020) Effect of intravenous immunoglobulin on infections in multiple myeloma (MM) patients receiving daratumumab. Presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology (ASH)","DOI":"10.1182\/blood-2020-140056"},{"key":"#cr-split#-4951_CR27.2","unstructured":"Lancman G, Sastow D, Aslanova M, Moshier E, Cho HJ, Jagannath S, Madduri D, Parekh SS, Richard S, Richter J, Sanchez L, Chari A (2020) Effect of intravenous immunoglobulin on infections in multiple myeloma"},{"key":"#cr-split#-4951_CR27.3","unstructured":"(MM) patients receiving daratumumab. Presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology (ASH); December 5-8, 2020"}],"container-title":["Annals of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00277-022-04951-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00277-022-04951-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00277-022-04951-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,9]],"date-time":"2022-11-09T08:11:33Z","timestamp":1667981493000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00277-022-04951-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10,27]]},"references-count":29,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["4951"],"URL":"https:\/\/doi.org\/10.1007\/s00277-022-04951-3","relation":{},"ISSN":["0939-5555","1432-0584"],"issn-type":[{"value":"0939-5555","type":"print"},{"value":"1432-0584","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,27]]},"assertion":[{"value":"3 December 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 July 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 October 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study protocol and amendments were reviewed and approved by affiliated independent ethics committees and institutional review boards. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent to participate in this study.","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":"Hongmei Jing, Li Yang, Junyuan Qi, Lugui Qiu, Chengcheng Fu, Junmin Li, Min Yang, and Jie Jin have no conflicts of interest to disclose. Ming Qi is an employee of Janssen and owns stock in Johnson & Johnson. Ni Fan, Jia Ji, and Jiajia Lu are employees of Janssen. Yunan Li is a former employee of Janssen.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}