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Randomization stratification factors included geographic region (Japan versus North America or rest of the world). Primary end point was investigator-assessed median progression-free survival. Efficacy, safety, and pharmacokinetics were evaluated in a subgroup of Japanese patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Seventy-eight Japanese patients were randomized to control (<jats:italic>n<\/jats:italic>\u2009=\u200923), veliparib-combination-only (<jats:italic>n<\/jats:italic>\u2009=\u200930), and veliparib-throughout (<jats:italic>n<\/jats:italic>\u2009=\u200925) arms. In the Japanese subgroup, median progression-free survival for veliparib-throughout versus control was 27.4 and 19.1\u00a0months (hazard ratio, 0.46; 95% confidence interval, 0.18\u20131.16; <jats:italic>p<\/jats:italic>\u2009=\u20090.1 [not significant]). In the veliparib-throughout arm, grade 3\/4 leukopenia, neutropenia, and thrombocytopenia rates were higher for Japanese (32%\/88%\/32%) versus non-Japanese (17%\/56%\/28%) patients. Grade 3\/4 anemia rates were higher in non-Japanese (65%) versus Japanese (48%) patients. Early introduction of olanzapine during veliparib monotherapy maintenance phase may help prevent premature discontinuation of veliparib, via its potent antiemetic efficacy.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Median progression-free survival was numerically longer in Japanese patients in the veliparib-throughout versus control arm, consistent with results in the overall study population. Pharmacokinetics were comparable between Japanese and non-Japanese patients. Data for the subgroup of Japanese patients were not powered to show statistical significance but to guide further investigation.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10147-022-02258-x","type":"journal-article","created":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T08:03:08Z","timestamp":1671436988000},"page":"163-174","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Veliparib with frontline chemotherapy and as maintenance in Japanese women with ovarian cancer: a subanalysis of efficacy, safety, and antiemetic use in the phase 3 VELIA trial"],"prefix":"10.1007","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3151-8315","authenticated-orcid":false,"given":"Mika","family":"Mizuno","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimihiko","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidekatsu","family":"Nakai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidenori","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoji","family":"Kamiura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimio","family":"Ushijima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoji","family":"Nagao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirokuni","family":"Takano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masao","family":"Okadome","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Munetaka","family":"Takekuma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Tokunaga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Nagase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Aoki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert L.","family":"Coleman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuko","family":"Nishimura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine K.","family":"Ratajczak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideyuki","family":"Hashiba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Xiong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriyuki","family":"Katsumata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Enomoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aikou","family":"Okamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,12,19]]},"reference":[{"key":"2258_CR1","unstructured":"International Agency for Research on Cancer. 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K.I.: speakers\u2019 bureau (AstraZeneca); research grants (AbbVie Inc, Takeda Pharmaceutical, Ono Pharmaceutical). H.N.: research grants (AbbVie, AstraZeneca, Takeda Pharmaceutical). H.K.: research grants (AbbVie); donations (Chugai Pharmaceutical). S.K.: manuscript fees and other (Kinpodo, Johnson & Johnson); research grants (AbbVie GK, Merck, Genmab, Clovis, AstraZeneca, Zeria Pharmaceutical). K.U.: research grants (AbbVie, Chugai, AstraZeneca, Pfizer, Takeda Pharmaceutical, Kaken Pharmaceutical, Nippon Kayaku, Taiho Pharmaceutical, Eisai, Mochida Pharmaceutical, Ono Pharmaceutical, MSD, Tsumura Pharmaceuticals); speakers\u2019 bureau (Chugai, AstraZeneca, Kyowa Kirin, Bayer, Tsumura Pharmaceuticals, MSD). Sh.Na.: speakers\u2019 bureau (Chugai Pharmaceutical, Mochida Pharmaceutical, Asahi Kasei Medical, Terumo Corporation); research grants (AbbVie, Takeda Pharmaceutical, Pfizer, AstraZeneca, Taiho Pharmaceutical). Hi.Ta.: research grants (AbbVie). M.O.: research grants (AbbVie). M.T.: research grants (AbbVie, Takeda Pharmaceutical, Chugai Pharmaceutical, MSD). Hi.To.: Research grants (AbbVie). Sa.Na.: Speakers\u2019 bureau (Chugai Pharmaceutical, AstraZeneca); research grants (AbbVie, Ono Pharmaceutical). D.A.: speakers\u2019 bureau (AbbVie, AstraZeneca, Chugai Pharmaceutical, MSD, Myriad Genetics, Takeda Pharmaceutical); consultancy (AstraZeneca, Chugai Pharmaceutical, MSD, Myriad Genetics, Takeda Pharmaceutical); research grants (AbbVie, Takeda Pharmaceutical). R.L.C.: research grants (Merck, AstraZeneca, Roche, AbbVie, Esperance, Clovis, Gateway, V Foundation); scientific steering committee (AbbVie, AstraZeneca, Clovis, GamaMabs, Genmab, ImmunoGen, Janssen, Merck, Roche\/Genentech, GSK, Gradalis). Y.N., C.R., H.H., and H.X.: employees of AbbVie and may hold stock or stock options. N.K.: research grants (AbbVie). T.E.: speakers\u2019 bureau (AstraZeneca, MSD, Chugai). A.O.: speakers\u2019 bureau (Takeda Pharmaceutical Company Ltd., Zeria Pharmaceutical Co., Ltd., AstraZeneca K.K., Eisai Co., Ltd., Kaken Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Bayer Holding Ltd., ASKA Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., MSD K.K., Fuji Pharma Co., Ltd.); research grants (Meiji Holdings Co., Ltd., Fuji Pharma Co., Ltd., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Kaken Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd., ASKA Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd.).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}