| Budget Amount *help |
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2015: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2014: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2013: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
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| Outline of Final Research Achievements |
The purpose of this study was to identify the method to compensate for the weaknesses of the spontaneous adverse event reporting system database. Associations with adverse events were analyzed for various drugs, using PRR, ROR, IC, and EBGM. These results were suggested that the ROR method was more appropriate for pharmacovigilance and the EBGM method was more suitable for pharmacoepidemiological studies. In addition, these results became clear that it is necessary to perform stratified analysis by age and gender according to the actual clinically adapted patient layer of the drug to be analyzed. Furthermore, these results were shown that the number of adverse events registered in JADER was affected by the marketed order of drugs and the seriousness of adverse events among the same drug efficacy. By considering these points, it was suggested that analysis by signal detection method and interpretation of the results can be appropriately implemented.
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