PK Findings panel

Specify the data from PK Findings tests.

Map the data by dragging the dataset from the Data folder to the Setup tab or use the icon_select_source icon in the Setup tab. Once a dataset is mapped, use the option buttons in the Mappings panels to assign the columns in the dataset to the appropriate context associations. Required context mappings are colored orange.

None: Columns mapped to this context are not included in any analysis or output.

Test Identifier: Identifiers for unique PK Findings test. The unique tests are displayed in the PK Findings properties tab.

Row: Data to include and represent the unique set of rows. All unique combinations of Row and Join columns determine the number of sample rows in the result dataset.

Carry: Data to carry over unchanged in the output worksheets.

Each column selected as a Join column in the EX domain will appear as a column mapping context for the PC domain. This allows specifying what column in the PC domain corresponds to what column in the EX domain. In most cases, the EXSTDTC (Start Date/Time of Treatment) context will be mapped to the PCRFTDTC (Date/Time of Reference Point) field in the PC domain.

PCELTM column requirement

Although PCTPT (Planned Time Point Name), PCTPTNUM (Planned Time Point Number), and PCELTM (Planned Elapsed Time from Time Point Ref) tabulate the same information, they each have a different format and only PCELTM has a defined standard format. Therefore, PCELTM is the variable that CDISC Data Preparer uses to calculate Relative Nominal Times for the Sample result dataset. If your datasets usually have PCTPT or PCTPTNUM instead of PCELTM, you will need to create a PCELTM column from the other column. If PCELTM is not in the dataset, or not carried along, or not in the proper format, CDISC Data Preparer generates a warning.

The PCELTM column values need to be in hours and have units of “hr” specified in the header. The column type must be text.

To create the PCELTM column from a PCTPTNUM or PCTPT column:

Use the Data Wizard object’s Transformation action to copy the contents of the column to a new PCELTM column. You can use the arithmetic formula “x-n” and set “n” to 0.

Create a Properties step to specify the column units as “hr” and, if the data is from a PCTPTNUM column, set the column’s data type to Text.

If the data is from a PCTPT column, create a Filter step involving multiple filters to replace “PREDOSE” with “0”, “15MIN” with “0.25”, “30MIN” with “0.5”, “45MIN” with “0.75”, “1H” with “1”, etc.


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