1.
Steve Jolley
SJ Pharma Consulting, LLC

2.
Source Data from PSUR
•Prior to analysis
•208 cases
•459 adverse events
© SJ Pharma Consulting, LLC 2

3.
Sector Map by SOC
© SJ Pharma Consulting, LLC 3

4.
Sector Map by PT
© SJ Pharma Consulting, LLC 4

5.
Cause of
Death
(coded)
Count of
Events Analysis by Cause of Death
© SJ Pharma Consulting, LLC 5

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
© SJ Pharma Consulting, LLC 8

9.
Analysis by Age Range
Shows some correlation
between liver problems and
age range 60 to 80 years
© SJ Pharma Consulting, LLC 9

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)
© SJ Pharma Consulting, LLC 12

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