Findings Shift Plots

This process displays shift plots to compare test measurements for a specified findings domain at baseline versus on-therapy values and performs a matched pairs analysis on average score during baseline and a summary score during the trial. A separate analysis is done for each findings measurement.

What do I need?

This process requires several demographic-, electrocardiogram -, laboratory-, and vital sign -related variables . These include:

•

USUBJID ,

•	a treatment variable ( the actual treatment received by each subject ( TRT01A )),

•	the planned treatment (intent-to-treat) for each subject ( TRT01P ), or the description of the planned treatment arm ( ARM ), and

•	variables for the EG ( EGTEST, EGTESTCD , EGSTRESN , EGBLFL , and EGDTC ), LB ( LBTEST, LBTESTCD , LBSTRESN , LBBLFL , LBDTC, LBSTNRHI , and LBSTNRLO ), or VS ( VSTEST , VSTESTCD , VSSTRESN , VSBLFL , and VSDTC ) domains.

Variables can be taken either from the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) folder or from the DM , EG , LB , and VS domains in SDTM .

Data from the Basic Data Structure (BDS) ADaM data sets can also be used for selected JMP Clinical Findings Reports. BDS variables are required and equated with SDTM variables, as follows: PARAMCD = xxTESTCD , AVAL = xxSTRESN , where xx indicates the specific two letter SDTM findings domain ( LB , EG , or VS ). In addition, when BDS is used, AVALC substitutes for xxSTRESC .

Refer to Localization-Specific Value Specification for more information about these data sets.

Output/Results

The output generated by this process is summarized by a tabbed report. Refer to the Findings Shift Plots output documentation for detailed descriptions and guides to interpreting your results.