Findings Waterfall Plots

This process creates waterfall plots to show the distribution of changes in test measurements for a given Findings domain across subjects (ordered by their magnitude of change). The Findings measurements are summarized based on a specified summary statistic and a waterfall plot is created for each Findings test.

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 LBSTRNRHI and LBSTNRLO variables for LB domain if the data are normalized by either the lower or upper reference limits, and

•	variables for the EG ( EGTEST , EGSTRESN , EGBLFL , and EGDTC ), LB ( LBTEST , LBSTRESN , LBBLFL , LBDTC , LBSTNRHI , and LBSTNRLO ), or VS ( VSTEST , VSSTRESN , VSBLFL , and VSDTC ) domains, when calculating changes from baseline.

•	DM/ADSL variables AGE , SEX , RACE , SITEID (when available) to be entered in data filter.

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 Waterfall Plots output documentation for detailed descriptions and guides to interpreting your results.