Findings Time to Event

This process enables you to define events using one or more findings tests to be analyzed in a Time-to-Event analysis.

For events defined with more than one test code, it is assumed that these tests are scheduled on the same date/time. If a subject does not experience an event, they are censored on the date of their last available findings data.

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

•	the Date/Time of Last Exposure to Treatment ( TRTEDTM ), and

•	variables for the EG ( EGTTESTCD , EGSTRESN , and EGDTC ), LB ( LBTESTCD , LBSTRESN , and LBDTC ), or VS ( VSTESTCD , VSSTRESN , 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 Time to Event output documentation for detailed descriptions and guides to interpreting your results.