PMID- 30847841
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 6
IP  - 1
DP  - 2019 Mar
TI  - 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.
PG  - 27-35
LID - 10.1007/s40801-019-0150-8 [doi]
AB  - BACKGROUND: To understand the extent to which a large-scale healthcare claims 
      database (DB) captures the safety profile of eribulin mesylate (Halaven((R)), Eisai 
      Co., Ltd., Japan), we compared patient characteristics, drug use, and adverse 
      events (AEs) between data for patients treated with eribulin retrieved from a DB 
      and data for metastatic breast cancer patients from a conventional prospective 
      post-marketing surveillance (PMS). METHODS: We 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. RESULTS: In 
      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). CONCLUSION: 
      Generally, 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.
FAU - Sakata, Yukinori
AU  - Sakata Y
AD  - Clinical Planning and Development Department, Eisai Co., Ltd., 4-6-10, 
      Koishikawa, Bunkyo-ku, Tokyo, 112-8088, Japan. y2-sakata@hhc.eisai.co.jp.
FAU - Matsuoka, Toshiyuki
AU  - Matsuoka T
AD  - Clinical Planning and Development Department, Eisai Co., Ltd., 4-6-10, 
      Koishikawa, Bunkyo-ku, Tokyo, 112-8088, Japan.
FAU - Ohashi, Satoshi
AU  - Ohashi S
AD  - Clinical Planning and Development Department, Eisai Co., Ltd., 4-6-10, 
      Koishikawa, Bunkyo-ku, Tokyo, 112-8088, Japan.
FAU - Koga, Tadashi
AU  - Koga T
AD  - Clinical Study Support, Inc., Daiei Bldg, 2F, 1-11-20 Nishiki, Naka-ku, Nagoya, 
      460-0003, Japan.
FAU - Toyoda, Tetsumi
AU  - Toyoda T
AD  - Clinical Study Support, Inc., Daiei Bldg, 2F, 1-11-20 Nishiki, Naka-ku, Nagoya, 
      460-0003, Japan.
FAU - Ishii, Mika
AU  - Ishii M
AD  - Clinical Planning and Development Department, Eisai Co., Ltd., 4-6-10, 
      Koishikawa, Bunkyo-ku, Tokyo, 112-8088, Japan.
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC6423272
COIS- CONFLICT OF INTEREST: YS, HT, TM, SO, and MI are/were employees of Eisai Co. 
      Ltd., Tokyo, Japan. TK and TT are employees of Clinical Study Support, Inc., 
      Nagoya, Japan, and were involved in the study based on the contract with Eisai 
      Co. Ltd. ETHICAL APPROVAL AND INFORMED CONSENT: For this retrospective database 
      study, all data for analysis were extracted from a pre-existing anonymized 
      database. For the usage of de-identified secondary data, ethical approval and 
      informed consent do not apply, according to the Japanese Ethical Guidelines for 
      Medical and Health Research Involving Human Subjects. DATA AVAILABILITY: The MDV 
      data that support the findings of this study are available from Medical Data 
      Vision Co., Ltd. (MDV; Tokyo, Japan) upon purchase. Restrictions do apply to the 
      availability of these data, and are thus unavailable to the public. For inquiries 
      on the dataset analyzed in this study, please contact MDV 
      (https://www.mdv.co.jp/). The PMS data that support the findings of this study 
      are available upon request from the corresponding author, YS. The data are not 
      publicly available due to the absence of consent from the participating 
      institutions.
EDAT- 2019/03/09 06:00
MHDA- 2019/03/09 06:01
PMCR- 2019/03/07
CRDT- 2019/03/09 06:00
PHST- 2019/03/09 06:00 [pubmed]
PHST- 2019/03/09 06:01 [medline]
PHST- 2019/03/09 06:00 [entrez]
PHST- 2019/03/07 00:00 [pmc-release]
AID - 10.1007/s40801-019-0150-8 [pii]
AID - 150 [pii]
AID - 10.1007/s40801-019-0150-8 [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2019 Mar;6(1):27-35. doi: 10.1007/s40801-019-0150-8.