Appendixes | Clinical | Findings Box Plots
Findings Box Plots
This process displays the box plots by treatment group representing the change from baseline in measurements for each test for specified findings domain across various time windows or points in the study. Time windows can be specified using a list of bracketed times or, alternatively, a number of time windows can be set to create time windows that span across the entire study.
If the variable xxBLCHG (where xx is substituted with the chosen domain 2 letter code) exists, this variable is used in plotting change from baseline. Otherwise, a measurement is determined to be a baseline measurement by the ABLFL or xxBLFL variable where xx is substituted with the 2 letter code for the chosen domain for analysis. If this variable does not exist, baseline is calculated from measurements taken on or before day 1 of the study. A time window can be specified to determine baseline measurements.
What do I need?
This process requires several demographic-, electrocardiogram -, laboratory-, and vital sign -related variables. These include:
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USUBJID ,
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a treatment variable ( the actual treatment received by each subject ( TRT01A )),
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the planned treatment (intent-to-treat) for each subject ( TRT01P ), or the description of the planned treatment arm ( ARM ), and
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variables for the EG ( EGTESTCD , EGSTRESN , EGBLFL , and EGDTC ), LB ( LBTESTCD , LBSTRESN , LBBLFL , and LBDTC ) , or VS ( 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 Box Plots output documentation for detailed descriptions and guides to interpreting your results.