Findings Time Trends

This process enables you to visualize findings measurements across the time line of the study.

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 ),

•	variables from either EG ( EGTESTCD , EGSTRESN , and EGDTC), LB ( LBTESTCD , LBSTRESN , and LBDTC), or VS ( VSTESTCD , VSSTRESN , and VSDTC ), and

•	the LBSTRNRHI and LBSTNRLO variables if the data are normalized by either the lower or upper reference limits.

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 Time Trends output documentation for detailed descriptions and guides to interpreting your results.