1. 1 Click to edit Master title style Demographic Analysis Panel Current and Future State FDA/PhUSE CSS - Working Group 5 - Analysis Standards Script Examples

2. 22 Current State: Demographic Analysis Panel Observed Datasets CODE Analysis Datasets CODE Tables, Figures and Listings Program and Dataset Flow SDTM Spreadsheet - 15 analyses Tables and Charts demographics.sas data_checks.sas -- Generic variable checks err_output.sas -- Error output when missing vars sl_gs_output.sas -- Script Launcher settings output Demographics_Template.xls -- Excel template DM.sas7bdat DS.sas7bdat Demographics.xls Industry Standard

3. 33 Analysis 1: Overview

4. 44 Analysis 2: Age Groups

5. 55 Analysis 3: Age Groups by Disposition

6. 66 Analysis 4: Age Statistics

7. 77 Future State: Demographic Analysis Panel Observed Datasets CODE Analysis Datasets CODE Tables, Figures and Listings Program and Dataset Flow SDTM ADaM create_adsl.sas DM.sas7bdat DS.sas7bdat RTF Documents Analyses Tables and Charts TFL SAS programs ADSL.sas7bdatage_analysis.rtf agegroup_analysis.rtf race_analysis.rtf Industry Standard

8. 88 Analysis 1: Age Analysis Treatment Group Total Drug ADrug B Age (Days)N 301303604 Mean 78.8378.7078.76 Std 15.8116.2116.00 Mode 66.0063.00 Min 55.0054.00 Q1 66.0065.00 Median 75.0074.0075.00 Q3 91.0090.0090.50 Max 123.00125.00

9. 99 Analysis 2: Age Group Analysis Treatment Group Total Drug ADrug B n%n%n% Age Category 6320.97524.813822.8 <65 days >=65 days 23979.122875.246777.2 Total 302100.0303100.0605100.0

10. 10 Analysis 2: Race Analysis Treatment Group Total Drug ADrug B n%n%n% Race 31.03 6 Asian Black or A 10.31 2 Other 62.072.3132.2 White 29196.729296.458396.5 Total 301100.0303100.0604100.0