Findings ANOVA

This process screens all findings measurements for a specified domain one at a time by performing a repeated-measures analysis of variance . The baseline measurements can be considered as a covariate or as a response. A measurement is determined to be a baseline measurement by the 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. A compound symmetry covariance structure is assumed within each subject. A separate model is fit for each lab measurement. You can also separate the data into time windows. A volcano plot of the interaction effect and other output enable efficient screening of lab scores that differ between treatment groups.

For the LB domain, lab measurements are standardized by a reference range derived from the lower limit of normal (LLN) and upper limit of normal (ULN) to facilitate comparisons.

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 ),

•	AGE , SEX , RACE , SITEID , and

•	variables for the EG ( EGTEST, EGTESTCD , EGSTRESN , EGBLFL , and EGDTC ), LB ( LBTEST, LBTESTCD , LBSTRESN , LBBLFL , and LBDTC ) , 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 ANOVA output documentation for detailed descriptions and guides to interpreting your results.