Scientific publications


  1. 1. Kubota K.  A Design for Prescription-Event Monitoring in Japan (J-PEM). Pharmacoepidemiol Drug Saf. 1999; 8(6): 447-456,;2-I
  2. 2. Yokotsuka M, Aoyama M, Kubota K.  The Use of a Medical Dictionary for Regulatory Activities Terminology (MedDRA) in Prescription-Event Monitoring in Japan(J-PEM). Int J Med Inform. 2000; 57: 139-153,
  3. 3. Kubota K, Kawabe E, Hinotsu S, Hamada C, Ohashi Y, Kurokawa K.  Pilot Study of Prescription-Event Monitoring in Japan (J-PEM) Comparing Troglitazone with Alternative Oral Hypoglycaemics. Eur J Clin Pharmacol. 2001; 56: 831-838,
  4. 4. Tanaka K, Morita Y, Kawabe E, Kubota K.  Drug Use Investigation (DUI) and Prescription-Event Monitoring in Japan (J-PEM). Pharmacoepidemiol Drug Saf. 2001; 10(7): 653-658,
  5. 5. Kubota K,  Prescription-Event Monitoring in Japan (J-PEM). Drug Saf. 2002; 25(6): 441-444,
  6. 6. Samizo K, Kawabe E, Hinotsu S, Sato T, Kageyama S, Hamada C, Ohashi Y, Kubota K.  Comparison of losartan with ACE inhibitors and dihydropyridine calcium channel angtagonists. A pilot study of Prescription-Event Monitoring in Japan. Drug Saf. 2002; 25(11): 811-821,

B. Case-control study

  1. 7. Sakamoto C, Sugano K, Ota S, Sakaki N, Takahashi S, Yoshida Y, Tsukui T, Osawa H, Sakurai Y, Yoshino J, Mizokami Y, Mine T, Arakawa T, Kuwayama H, Saigenji K, Yakabi K, Chiba T, Shimosegawa T, Sheehan JE, Perez-Gutthann S, Yamaguchi T, Kaufman DW, Sato T, Kubota K, Terano A.  Case-control study on the association of upper gastrointestinal bleeding and nonsteroidal anti-inflammatory drugs in Japan. Eur J Clin Pharmacol. 2006; 62(9): 765-772,

C. Research on the background incidence of possible adverse drug reaction

  1. 8. Nojiri S, Gemba K, Aoe K, Kato K, Yamaguchi T, Sato T, Kubota K, Kishimoto T.  Survival and prognostic factors in malignant pleural mesothelioma: a retrospective study of 314 patients in the west part of Japan. Jpn J Clin Oncol. 2011; 41(1): 32-39.
  2. 9. Nojiri S, Gemba K, Aoe K, Kato K, Yamaguchi T, Sato T, Kubota K, Kishimoto T.  Incidence of interstitial lung disease in patients with mesothelioma in the west part of Japan. Pharmacoepidemiol Drug Saf. 2011; 20(6): 643-652,

D. Japan Statin Study (JSS)

  1. 10. Kageyama S, Kitamura M, Kokan A, Kubota K, Matsui K, Ooba N, Orii T, Sato T, Shimodozono Y, Uehara H, Yagame M, Yaju Y, Yamaguchi T.  Japan Statin Study (JSS), a prospective case-cohort study for monitoring multiple adverse events: rationale, design and characteristics of study subjects. Pharmacoepidemiol Drug Saf. 2010; 19: S169,
  1. 11. N Ooba, T Sato, A Wakana, T Orii, M Kitamura, A Kokan, H Kurata, Y Shimodozono, K Matsui, H Yoshida, T Yamaguchi, S Kageyama, K Kubota.  A Prospective Stratified Case-Cohort Study on Statins and Multiple Adverse Events in Japan. PLOS ONE 9(5): e96919,

E. Therapeutic Risk Management

  1. 12. Ooba N, Sato T, Watanabe H, Kubota K.  Resolving a Double Standard for Risk Management of Thalidomide: An Evaluation of Two Different Risk Management Programmes in Japan. Drug Saf. 2010; 33(1): 35-45,

F. Support for Clinical Researches

  1. 13. Ando K, Ohtsu H, Arakawa Y, Kubota K, Yamaguchi T, Nagase M, Yamada A, Fujita T.  Rationale and design of the Eplerenone combination Versus conventional Agents to Lower blood pressure on Urinary Antialbuminuric Treatment Effect (EVALUATE) trial: a double-blinded randomized placebo-controlled trial to evaluate the antialbuminuric effects of an aldosterone blocker in hypertensive patients with albuminuria. Hypertens Res. 2010; 33(6): 616-621,

G. Disproportionality measures for signal detection from Japanese Spontaneous Reports

  1. 14. Ooba N, Kubota K.  Selected control events and reporting odds ratio in signal detection methodology. Pharmacoepidemiol Drug Saf. 2010; 19(11): 1159-1165,
  2. 15. Kamijima Y, Kubota K.  Potential roles of standardized MedDRA Queries in capturing patterns of adverse drug reactions and reporting; a exploratory study in Japanese data. ACPE Beijing 2011.

H. Database studies in Japan

  1. 16. Ooba N, Setoguchi S, Ando T, Sato T, Yamaguchi T, Mochizuki M, Kubota K.  Climas-based definition of death in Japanese claims database: validity and implcations. PLOS ONE 2013; 8(5): e66116,
  1. 17. Kubota K, Kamijima Y, Sato T, Ooba N, Koide D, Iizuka H, Nakagawa H.  Epidemiology of psoriasis and palmoplantar pustulosis: a nationwide study using the Japanese national claims database. BMJ Open 2015; 5: e006450,

I. Asian Pharmacoepidemiology Network (AsPEN)

  1. 18. Andersen M, Bergman U, Choi NK, Gerhard T, Huang C, Jalbert J, Kimura M, Kimura T, Kubota K, Lai ECC, Ooba N, Ösby U, Park BJ, Pratt N, Roughead EE, Sato T, Setoguchi S, Shin JY, Sundström A, Yang YHK.  The Asian Pharmacoepidemiology Network (AsPEN): Promoting multi-national collaboration for pharmacoepidemiologic research in Asia. Pharmacoepidemiol Drug Saf. 2013; 22(7): 700-704,
  1. 19. Pratt N, Andersen M, Bergman U, Choi NK, Gerhard Y, Huang C, Kimura M, Kimura T, Kubota K, Lai ECC, Ooba N, Ösby U, Park BJ, Sato T, Shin JY, Sundström A, Yang YHK, Roughead EE.  Multi-country rapid adverse drug event assessment: The Asian Pharmacoepidemiology Network (AsPEN) antipsychoticand acute hyperglycaemia study. Pharmacoepidemiol Drug Saf. 2013; 22(9): 915-924,
  1. 20. Pratt N, Chan EW, Choi NK, Kimura M, Kimura T, Kubota K, Lai EC, Man KK, Ooba N, Park BJ, Sato T, Shin JY, Wong IC, Kao Yang YH, Roughead EE.  Prescription sequence symmetry analysis: assessing risk, temporality, and consistency for adverse drug reactions across datasets in five countries. Pharmacoepidemiol Drug Saf. 2015; 24(8): 858-864,
  1. 21. Roughead EE, Chan EW, Choi NK, Kimura M, Kimura T, Kubota K, Lai EC, Man KK, Nguyen TA, Ooba N, Park BJ, Sato T, Shin JY, Wang T, Griffiths J, Wong IC, Yang YH, Pratt NL  Variation in Association Between Thiazolidinediones and Heart Failure Across Ethnic Groups: Retrospective analysis of Large Healthcare Claims Databases in Six Countries. Drug Saf. 2015; 38(9): 823-831,
  1. 22. Lai EC, Man KK, Chaiyakunapruk N, Cheng CL, Chien HC, Chui CS, Dilokthornsakul P, Hardy NC, Hsieh CY, Hsu CY, Kubota K, Lin TC, Liu Y, Park BJ, Pratt N, Roughead EE, Shin JY, Watcharathanakij S, Wen J, Wong IC, Yang YK, Zhang Y, Setoguchi S.  Brief Report: Databases in the Asia-Pacific Region: The Potential for a Distributed Network Approach. Epidemiology 2015; 26(6): 815-820,
  1. 23. Lai ECC, Stang P, Yang YHK, Kubota K, Wong ICK, Setoguchi S.  International Multi-database Pharmacoepidemiology: Potentials and Pitfalls. Curr Epidemiol Rep. 2015; 2: 229-238,

J. Pharmacoepidemiology study design

  1. 24. Kubota K.  Symmetry analysis for monitoring safety of newly marketed drugs. Pharmacoepidemiol Drug Saf. 6 Oct 2015 [Epub ahead of print],