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

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

33 Analysis 1: Overview

44 Analysis 2: Age Groups

55 Analysis 3: Age Groups by Disposition

66 Analysis 4: Age Statistics

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

88 Analysis 1: Age Analysis Treatment Group Total Drug ADrug B Age (Days)N Mean Std Mode Min Q Median Q Max

99 Analysis 2: Age Group Analysis Treatment Group Total Drug ADrug B n%n%n% Age Category <65 days >=65 days Total

10 Analysis 2: Race Analysis Treatment Group Total Drug ADrug B n%n%n% Race Asian Black or A Other White Total