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Signal Detection and Management Examples

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SJ Pharma is a leading expert in Signal Detection, Management, & Consulting. View some signaling examples here or visit SJ Pharma online to learn more about the benefits our signaling and data mining services can bring to your business.

Published in: Data & Analytics
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Signal Detection and Management Examples

  1. 1. Steve Jolley SJ Pharma Consulting, LLC
  2. 2. Source Data from PSUR •Prior to analysis •208 cases •459 adverse events © SJ Pharma Consulting, LLC 2
  3. 3. Sector Map by SOC © SJ Pharma Consulting, LLC 3
  4. 4. Sector Map by PT © SJ Pharma Consulting, LLC 4
  5. 5. Cause of Death (coded) Count of Events Analysis by Cause of Death © SJ Pharma Consulting, LLC 5
  6. 6. MedDRA Preferred term Count of Events Analysis by Preferred Term © SJ Pharma Consulting, LLC 6
  7. 7. MedDRA Preferred term Count of Events Shows high reporting rate of liver events Analysis by Preferred Term © SJ Pharma Consulting, LLC 7
  8. 8. Shows high reporting rate of • Hepatic function abnormal • Hepatic disorder Analysis by Preferred Term, Liver SOC only © SJ Pharma Consulting, LLC 8
  9. 9. Analysis by Age Range Shows some correlation between liver problems and age range 60 to 80 years © SJ Pharma Consulting, LLC 9
  10. 10. Analysis by Sex Shows no obvious correlation between liver problems and patient sex © SJ Pharma Consulting, LLC 10
  11. 11. Analysis by Country Shows high correlation to liver problems in Japan © SJ Pharma Consulting, LLC 11
  12. 12. Analysis by concomitant medications (all events) © SJ Pharma Consulting, LLC 12
  13. 13. Analysis by concomitant medications (liver events only) Shows greater correlation with Flovent when look at liver events only Increases strength of correlation between company drug, Flovent and liver events © SJ Pharma Consulting, LLC 13
  14. 14. Hypothesis  Potential signal with liver events  Hepatic function abnormal  Hepatic disorder  Correlation to  Country: Japan  Age range: 60 to 80 years  Concomitant medication: Flovent © SJ Pharma Consulting, LLC 14

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