Mais conteúdo relacionado Semelhante a Signal Detection and Management Examples (12) Signal Detection and Management Examples2. Source Data from PSUR
•Prior to analysis
•208 cases
•459 adverse events
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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
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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
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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
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