Signal Detection and Management Examples

SIGNALING EXAMPLES

Steve JolleySJ Pharma Consulting, LLC

© SJ Pharma Consulting, LLC 2

Source Data from PSUR•Prior to analysis•208 cases•459 adverse events


Sector Map by SOCSector Map by SOC


Sector Map by PTSector Map by PT


Cause of Death(coded)

Count of Events Analysis by Cause of Death


MedDRAPreferred term

Count of Events Analysis by Preferred Term


MedDRAPreferred term

Count of Events

Shows high reporting rate of liver events

Analysis by Preferred Term


Shows high reporting rate of • Hepatic function abnormal• Hepatic disorder

Analysis by Preferred Term,Liver SOC only


Analysis by Age Range

Shows some correlation between liver problems and age range 60 to 80 years


Analysis by Sex

Shows no obvious correlation between liver problems and patient sex


Analysis by Country

Shows high correlation to liver problems in Japan


Analysis by concomitant medications (all events)


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

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Hypothesis Potential signal with liver events

Hepatic function abnormalHepatic disorder

Correlation toCountry: JapanAge range: 60 to 80 yearsConcomitant medication: Flovent

© SJ Pharma Consulting, LLC

Signal Detection and Management Examples

Data & Analytics

Transcript of Signal Detection and Management Examples