Cited 9 times in
Ramucirumab Safety in East Asian Patients: A Meta-Analysis of Six Global, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trials.
DC Field | Value | Language |
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dc.contributor.author | 손주혁 | - |
dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2018-11-16T16:52:47Z | - |
dc.date.available | 2018-11-16T16:52:47Z | - |
dc.date.issued | 2018 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/165426 | - |
dc.description.abstract | Purpose Several ramucirumab trials have reported a higher incidence of selected adverse events (AEs) in East Asian (EA) patients with cancer versus non-EA patients. A meta-analysis was conducted across six completed phase III trials to establish the safety parameters of ramucirumab in EA compared with non-EA patients. Materials and Methods Six global, randomized, double-blind, placebo-controlled, phase III registration trials investigating ramucirumab were assessed. Relative risks (RRs) and 95% CIs were calculated for selected all-grade and grade ≥ 3 AEs using fixed-effects and mixed-effects models. Ratio of RR and number needed to harm were calculated for AEs (all grade and grade ≥ 3) between EA and non-EA patients. Results Of 4,996 randomly assigned patients receiving ramucirumab or placebo, 802 (16.1%) were EA (ramucirumab, n = 411; placebo, n = 391) and 4,194 were non-EA (ramucirumab, n = 2,337; placebo, n = 1,857). Patient baseline characteristics were generally balanced between treatment arms in EA and non-EA patients, excluding sex and body weight. Grade ≥ 3 AEs possibly associated with ramucirumab, which were increased in EA versus non-EA patients, included neutropenia (42.1% v 25.5%, respectively) and proteinuria (3.9% v 0.6%, respectively). There was an increase in the RR of several grade ≥ 3 AEs, including hypertension and proteinuria, in ramucirumab-treated EA and non-EA patients compared with placebo. The ratio of RR revealed no significant differences between EA and non-EA patients for all-grade and grade ≥ 3 AEs. Conclusion Despite the enhanced propensity of selected AEs in EA patients relative to non-EA patients, there were no substantial differences in the RR for AEs possibly associated with ramucirumab in these phase III trials. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF GLOBAL ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | Ramucirumab Safety in East Asian Patients: A Meta-Analysis of Six Global, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trials. | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Chia-Jui Yen | - |
dc.contributor.googleauthor | Kei Muro | - |
dc.contributor.googleauthor | Tae-Won Kim | - |
dc.contributor.googleauthor | Masatoshi Kudo | - |
dc.contributor.googleauthor | Jin-Yuan Shih | - |
dc.contributor.googleauthor | Keun-Wook Lee | - |
dc.contributor.googleauthor | Yee Chao | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Kentaro Yamazaki | - |
dc.contributor.googleauthor | JooHyuk Sohn | - |
dc.contributor.googleauthor | Rebecca Cheng | - |
dc.contributor.googleauthor | Yawei Zhang | - |
dc.contributor.googleauthor | Polina Binder | - |
dc.contributor.googleauthor | Gu Mi | - |
dc.contributor.googleauthor | Mauro Orlando | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.identifier.doi | 10.1200/JGO.17.00227 | - |
dc.contributor.localId | A01995 | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J03517 | - |
dc.identifier.eissn | 2378-9506 | - |
dc.identifier.pmid | 30085888 | - |
dc.identifier.url | http://ascopubs.org/doi/abs/10.1200/JGO.17.00227 | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.citation.volume | 4 | - |
dc.citation.startPage | 1 | - |
dc.citation.endPage | 12 | - |
dc.identifier.bibliographicCitation | JOURNAL OF GLOBAL ONCOLOGY, Vol.4 : 1-12, 2018 | - |
dc.identifier.rimsid | 58891 | - |
dc.type.rims | ART | - |
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