<b>2. Comparison of the Onset Time Profile among the Interferon Formulations in Adverse Drug Reaction of Suicide- or Diabetes-Related</b>

DOI 19 Citations 1 References
  • YAMADA Masayuki
    Clinical Development Division, Kissei Pharmaceutical Co. LTD.
  • HANDA Jun
    Pharmaceutical Development Division, Nippon Kayaku Co., LTD.

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  • <b>2. 自殺または糖尿病関連副作用における各種インターフェロン製剤間の発現時期プロファイルの比較</b>
  • 2. Comparison of the Onset Time Profile among the Interferon Formulations in Adverse Drug Reaction of Suicide- or Diabetes-Related

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Japanese Adverse Drug Event Report database (Abbreviation; JADER) was disclosed April 2012 and will be expected to have a major role in the establishment of the adequate information for the proper usage of drugs. In this paper, we were compared using the shape parameters that were estimated by fitting the Weibull distribution, whether the adverse drug reaction of suicide- or diabetes-related onset time profiles vary depending on the type of interferon formulations. The data were used JADER of August 2013. The combined number of adverse drug reaction and drug that duplicates removed was 702,925. In diabetes-related side effects, the distribution of adverse drug reaction time was different among formulations. The shape parameters of the Weibull distribution are 1.49 (1.09-1.94), 0.84 (0.66-1.05) and 1.07 (0.92-1.23)(point estimates and two-sided 95% confidence interval) in interferon-α,-β and peginterferon, respectively. Interferon-α is categorized as the wear-out failure type adverse drug reaction onset time profile from which its 95% confidence interval exceeds 1. Peginterferon is classified as the random failures type from which its point estimates is almost 1. Since the upper 95% confidence interval is near 1, the time profile of interferon-β is close to the early failures type. We conclude that the combination of the shape parameter of the Weibull distribution and the visual inspection, like histogram and box plot, is useful in the monitoring of adverse drug reaction onset time profile.

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