In this lesson,
| VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT |
|---|---|---|---|
| STUDYID | Study Identifier | _ | RS.STUDYID |
| USUBJID | Unique Subject Identifier | _ | RS.USUBJID |
| SUBJID | Subject Identifier for the Study | _ | ADSL.SUBJID |
| PARAM | Parameter | _ | Populate as 'Target Response' when PARAMCD='TRGRESP'. Populate as 'Non-target Response' when PARAMCD='NTRGRESP'. Populate as 'New Lesion Progression' when PARAMCD='NEWLPROG'. Populate as 'Overall Response' when PARAMCD='OVRLRESP'. Populate as 'Best Overall Response' when PARAMCD='BESTRESP'. |
| PARAMCD | Parameter Code | _ | Source parameters: Populate with values from RS.RSTESTCD. Derived parameter: Create a new parameter with PARAMCD=BESTRESP. |
| PARAMN | Parameter (N) | _ | Populate as 1 when PARAMCD='TRGRESP'. Populate as 2 when PARAMCD='NTRGRESP'. Populate as 3 when PARAMCD='NEWLPROG'. Populate as 4 when PARAMCD='OVRLRESP'. Populate as 5 when PARAMCD='BESTRESP'. |
| ADT | Analysis Date | _ | Populate using RS.RSDTC. |
| ADY | Analysis Relative Day | _ | Populate using ADSL.TRTSDT and ADRS.ADT. If ADT is on or after treatment start date then populate as the difference between ADT and TRTSDT and add one to the difference. Else if ADT is before TRTSDT then populate as the difference between ADT and TRTSDT. |
| AVISIT | Analysis Visit | _ | Populate using RS.VISIT. |
| AVISITN | Analysis Visit (N) | _ | Populate using RS.VISITNUM . |
| AVALC | Analysis Value (C) | _ | Source parameters: Populate with values from RS.RSSTRESC. Derived parameter: Populate with the best overall response seen across all records where PARAMCD="OVRLRESP" within a subject. The order of response to consider as best. CR > PR > SD > PD > NE. If there exists more than one record with the same best response, use the earliest record. |