MED Watch Dashboard Big Data Mining on Safety Information and Adverse Event Reports http://medwatch.co.nf Budapest Users of R Network, 2014.01.15

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3. Data Source (FDA)
•
•
2012 Q4 Safety Alerts for Human Medical
Products (Drugs, Biologics, Medical Devices,
Special Nutritionals, and Cosmetics)
The alerts contain actionable information that
may impact both treatment and diagnostic
choices for healthcare professional and
patient.
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4. MED Watch Dashboard Viewers
http://medwatch.co.nf
December of 2013
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6. Data Clean - 1
•
•
The raw reported data have been cleaned
according to the International Conference on
Harmonisation (ICH) of Technical
Requirements for Registration of
Pharmaceuticals for Human Use.
The verbatim reactions/indications have been
coded into the system organ class (SOC)
using the Medical Dictionary for Regulatory
Activities (MedDRA version 13.1) for coding of
diseases/medical conditions.
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7. Data Clean - 2
●
The raw reported datasets have been
transferred into CDISC SDTM datasets, and
also into CDISC ADaM datasets which are the
basis for production of statistical graphs in R
statistical package including:
–
Shiny,
–
vcd (The conditional density plot - Hofmann and Theus
2005),
–
Basic Hexagon Binning Functions (hexbin)
–
rworldmap(joinCountryData2Map, mapCountryData),
–
ggplot2.
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8. ￭
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14. LIE Factor - Edward Tufte
Define the maximum ideas to the audience:
•
In the shortest time,
•
Minimize the number of "ink", with the smallest optimal
representation.
• Tell the truth about the data.
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