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The aim of the real-world, retrospective Orbit study was to describe long-term clinical outcomes and management in adults (aged\u2009\u2265\u200920\u00a0years) with CLL\/SLL treated with ibrutinib, either as first-line (1L) treatment or for relapsed or refractory (RR) disease, in routine clinical practice in Japan between July 2018 and December 2020. A total of 246 patients were registered, and the safety and per-protocol sets included 237 and 234 patients, respectively. After a median follow-up of 35.7\u00a0months, the 36-month progression-free survival rate was 80.9% in the 1L CLL cohort and 67.2% in the RR CLL cohort, and the 36-month overall survival rates were 90.8% and 83.7%, respectively. Common Terminology Criteria for Adverse Events (CTCAE) Grade\u2009\u2265\u20093 adverse events of special interest were atrial fibrillation (2.1%), infections (herpesvirus infection, fungal infection, or <jats:italic>Pneumocystis jiroveci<\/jats:italic> pneumonia; 1.7%), bleeding (3.8%), and second primary malignancy (2.5%). 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Ltd., Kyowa Kirin Co., Ltd., Janssen Pharmaceutical K.K., SymBio Pharmaceuticals Ltd., Bristol-Myers Squibb K.K., AstraZeneca K.K., Sanofi K.K., Asahi Kasei Pharma Corporation, Yamasa Corporation, Meiji Seika Pharma Co., Ltd., Daiichi Sankyo Co., Ltd., and PharmaEssentia Japan K.K.; has received honoraria for manuscript writing from Janssen Pharmaceutical K.K. and AstraZeneca K.K.; and has participated in data safety monitoring of AbbVie GK and Janssen Pharmaceutical K.K. Go Yamamoto has received honoraria for lectures from Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Eisai Co., Ltd., Daiichi Sankyo Co., Ltd., Sanofi, Nippon kayaku Co., Ltd., Janssen Pharmaceutical K.K., Novartis Pharma K.K., Bristol-Myers Squibb K.K., Meiji Seika Pharma Co., Ltd., Mundipharma K.K., AstraZeneca K.K., and Genmab K.K. Yoshihiro Kameoka has received research funding and honoraria for lectures from Janssen Pharmaceutical K.K. Shuichi Ota has received honoraria from Novartis Pharma K.K., Takeda Pharmaceutical Co. Ltd., AstraZeneca K.K., AbbVie GK, Bristol-Myers Squibb K.K., Janssen Pharmaceutical K.K., Amgen K.K., and Sanofi K.K. Eri Matsuki has received research funding and honoraria from Janssen Pharmaceutical K.K.; and has received consulting fee from Janssen Asia Pacific. Kazutaka Ozeki has received honoraria for lectures from Janssen Pharmaceutical K.K. Takahiro Kumode has received honoraria for lectures from Janssen Pharmaceutical K.K. and Ono Pharmaceutical Co., Ltd. Hideto Tamura has received honoraria for lectures from Sanofi K.K., Bristol-Myers Squibb K.K., and Ono Pharmaceutical Co., Ltd. Ai Omi is an employee of Janssen Pharmaceutical K.K. Kazuhiro Shibayama and Aki Watanabe are employees of Janssen Pharmaceutical K.K.; and own stocks of Johnson & Johnson. Yasushi Isobe has received consulting fees from LSI Medience Corporation. Kensuke Kojima has received honoraria for lectures from Janssen Pharmaceutical K.K., AstraZeneca K.K., and AbbVie GK.; and has received scholarship from Daiichi Sankyo Co., Ltd. and Eisai Co., Ltd. Jun Takizawa has received consulting fees from Janssen Pharmaceutical K.K., AstraZeneca K.K., and AbbVie GK; has received honoraria from Janssen Pharmaceutical K.K., AstraZeneca K.K., AbbVie GK, Novartis Pharma K.K., Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., and Nippon Kayaku Co., Ltd.; and his institution has received research grant from Janssen Pharmaceutical K.K., AstraZeneca K.K., AbbVie GK, Novartis Pharma K.K., Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Nippon Kayaku Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Eli Lilly Co., Ltd., and Asahi Kasei Corporation. Hirokazu Nagai has received honoraria from AbbVie GK, AstraZeneca K.K., Genmab K.K., Janssen Pharmaceutical K.K., Eli Lilly Co., Ltd., Takeda Pharmaceutical Co. Ltd., Kyowa Kirin Co., Ltd., MSD, Eisai Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Chugai Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., Mundipharma K.K., GlaxoSmithKline K.K., Bristol-Myers Squibb K.K., Nippon Kayaku Co., Ltd., Nippon Shinyaku Co., Ltd., and BeiGene Ltd.; and his institute has received research grant from AbbVie GK, AstraZeneca K.K., BeiGene Ltd., Genmab K.K., HUYABIO international, Janssen Pharmaceutical K.K., Eli Lilly Co., Ltd., Takeda Pharmaceutical Co. Ltd., Kyowa Kirin Co., Ltd., MSD, Mitsubishi Tanabe Pharma Corporation, Chugai Pharmaceutical Co., Ltd., Haihe Biopharma, Daiichi Sankyo Co., Ltd, Celgene K.K. Zenyaku Kogyo Co., Ltd., Solasia Pharma K.K., Ono Pharmaceutical Co., Ltd., and Regeneron Pharmaceuticals Inc. Junji Suzumiya has received research grant from Eisai Co., Ltd.; has received consulting fees from Eli Lilly Co., Ltd., Zenyaku Kogyo Co., Ltd., Kyowa Kirin Co., Ltd., Nippon Shinyaku Co., Ltd., and Otsuka Pharmaceutical Co., Ltd.; and has received honoraria for lectures from Janssen Pharmaceutical K.K., AstraZeneca K.K., Chugai Pharmaceutical Co., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Kyowa Kirin Co., Ltd., Zenyaku Kogyo Co., Ltd., Novartis Pharma K.K., AbbVie Inc., and SymBio Pharmaceuticals Ltd. Sadao Aoki has received honoraria for lectures from Janssen Pharmaceutical K.K., AbbVie GK, AstraZeneca K.K., and Chugai Pharmaceutical Co., Ltd. Tsuyoshi Muta, Shingo Kurahashi, Takanori Toyama, Naoki Takahashi, Nobuyuki Aotsuka, and Takuro Yoshimura have no conflicts of interests to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}