@article{742d34f7ec4a43ed86e18cabfc984ccb,
title = "Real-world adverse events with niraparib 200 mg/day maintenance therapy in ovarian cancer: A retrospective study",
abstract = "Aim: To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. Materials & methods: This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Results: Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%). In the ENGOT-OV16/NOVA trial, these respective AEs occurred in 74, 61 and 59% of patients. Conclusion: Incidence of common clinical trial-reported AEs was lower among patients initiating niraparib 200 mg/day in real-world practice versus patients initiating niraparib 300 mg/day in ENGOT-OV16/NOVA.",
keywords = "PARP inhibitor, adverse events, niraparib, ovarian cancer, real-world occurrence",
author = "Gallagher, {Jack R.} and Heap, {Kylee Jean} and Susan Carroll and Karin Travers and Brooke Harrow and Westin, {Shannon N.}",
note = "Funding Information: SN Westin has served in a consulting or advisory role for AstraZeneca, BioAscend, Casdin Capital, Clovis Oncology, Genentech, Gerson Lehrman Group, Medivation, Medscape, Merck, Novartis, Ovation Sciences, Pfizer, Roche, Takeda, TESARO, Vaniam Group, and Watermark Research Partners; and has received research funding from ArQule, AstraZeneca, Bayer, Clovis Oncology, Cotinga Pharmaceuticals, Novartis, Roche/Genentech, and TESARO. JR Gallagher, KJ Heap, and S Carroll are employees of Clarity Pharma Research, LLC. K Travers is an employee of TESARO and owns stock/has other ownership with TESARO. B Harrow was an employee of TESARO at the time the study was conducted and owned stock/had other ownership with TESARO at that time; she is no longer employed with TESARO. This study was sponsored by TESARO: a GSK Company and conducted by Clarity Pharma Research, LLC. Medical writing support, funded by TESARO and coordinated by H Ostendorff-Bach, PhD, of TESARO, was provided by S Ghat-pande, PhD, of Team 9 Science, LLC (Vaniam Group LLC). The authors have no other relevant affiliationsor financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. AM Schreiber of TESARO copy edited and styled the manuscript. Publisher Copyright: {\textcopyright} 2019 Jack R. Gallagher.",
year = "2019",
doi = "10.2217/fon-2019-0471",
language = "English (US)",
volume = "15",
pages = "4197--4206",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "36",
}