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1. Steve Jolley
SJ Pharma Consulting, LLC

2. Source Data from PSUR
•Prior to analysis
•208 cases
•459 adverse events
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3. Sector Map by SOC
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4. Sector Map by PT
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5. Cause of
Death
(coded)
Count of
Events Analysis by Cause of Death
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6. MedDRA
Preferred
term
Count of
Events Analysis by Preferred Term
© SJ Pharma Consulting, LLC 6

7. MedDRA
Preferred
term
Count of
Events
Shows high reporting
rate of liver events
Analysis by Preferred Term
© SJ Pharma Consulting, LLC 7

8. Shows high reporting rate of
• Hepatic function abnormal
• Hepatic disorder
Analysis by Preferred Term,
Liver SOC only
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9. Analysis by Age Range
Shows some correlation
between liver problems and
age range 60 to 80 years
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10. Analysis by Sex
Shows no obvious
correlation between
liver problems and
patient sex
© SJ Pharma Consulting, LLC 10

11. Analysis by Country
Shows high correlation to liver
problems in Japan
© SJ Pharma Consulting, LLC 11

12. Analysis by concomitant
medications (all events)
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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. 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