myCSG © |Area: ADaM| Concept: ADRS : Full ADRS - Response Analysis Dataset | Lesson: L1101 : ADRS dataset - Best overall response |

In this lesson, 

  • We will see how to obtain the best overall response and add it as a new parameter.
VARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_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.
Complete SAS code to generate the output is available for registered users!

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