ArticleDrugs - real world outcomes2019
Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study.
Article in Drugs - real world outcomes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Rehospitalisation risk by hypnotics class in older patients with heart failure: a cohort study utilizing administrative claims data in Japan.Open heart · 2024Article
- Association between the Use of Suvorexant and Hip Fracture in Older Adults in Japan Using a Nationwide Administrative Claims Database: A Matched Case-Control Study.Drugs & aging · 2023Article
- Post-marketing analysis for biosimilar CT-P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan.Journal of gastroenterology and hepatology · 2021Article
- Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies.BMC medical informatics and decision making · 2021Observational
- Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database.ClinicoEconomics and outcomes research : CEOR · 2021Article
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo understand the extent to which a large-scale healthcare claims database (DB) captures the safety profile of eribulin mesylate (Halaven
methodsWe descriptively summarized patient characteristics and AEs of 551 and 951 patients retrieved from DB and PMS, respectively, during 2011‒2013. Using 2814 patient data from the DB during 2011‒2016, the drug use and AE incidence over time were assessed.
resultsIn both datasets, 99.8% were females, and the mean age was 57.8 ± 10.7 years. The mean number of eribulin administration was 11.1 ± 10.9 and 10.1 ± 7.8 in DB and PMS, respectively. Although, overall, the difference in AE incidence between the two datasets was moderate, gaps were larger for nausea (DB: 73.32% vs. PMS: 15.77%), neutropenia (20.87% vs. 66.67%), stomatitis (37.39% vs. 10.94%), and alopecia (0.36% vs. 12.09%). During 2011‒2016, the observed incidence of anemia or pyrexia significantly decreased (trend test, p = 0.0009 for both).
conclusionGenerally, patient characteristics, drug use, and AE incidence between the DB and PMS were comparable; however, AEs such as neutropenia may require defining based on the laboratory data to achieve more comparable results in DBs. Besides the usefulness of healthcare claims DBs for long-term assessments, they may also serve as a good complementary to PMS in the pharmacovigilance of eribulin.
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