ROWORDER VARIABLE_NAME VARIABLE_LABEL TYPE GENERAL_COMMENT
001 STUDYID Study Identifier ADSL.STUDYID
002 USUBJID Unique Subject Identifier ADSL.USUBJID
003 AVISITN Analysis Visit (N) Part 1:
Populate as 112 when AVISIT='Upto Week 12'.
Populate as 124 when AVISIT='Upto Week 24'.
Populate as 136 when AVISIT='Upto Week 36'.
Populate as 148 when AVISIT='Upto Week 48'.
Populate as 160 when AVISIT='Upto Week 60'.
Populate as 200 when AVISIT='Upto EOS'.
004 AVISIT Analysis Visit
Create a record for each postbaseline VISIT available in SV dataset for each subject (VISITNUM >1).
Concatenate the text "Upto " to the value in VISIT variable and assign it to AVISIT.
Create a additional record with visit "Upto EOS" for each subject.
005 ASTDT Analysis Start Date On all records, populate with the value from TRTSDT.
006 AENDT Analysis End Date For the records of the visits coming from SV, populate with the value from SVSTDTC of that visit.
For the additonal record of AVISIT="Upto EOS", populate with the value from ADSL.EOSDT.
007 PARAM Parameter Populate as 'Lack of Efficacy' when PARAMCD='LACKEFF'.
Populate as 'Other Intercurrent Event' when PARAMCD='OTHEVNT'.
Populate as 'Any Intercurrent Event' when PARAMCD='ANYEVNT'.
008 PARAMCD Parameter Code Create 3 parameters "LACKEFF", "OTHEVNT", "ANYEVNT" for each of the records of AVISIT defined in AVISIT derivation.
009 PARAMN Parameter (N) Populate as 101 when PARAMCD='LACKEFF'.
Populate as 102 when PARAMCD='OTHEVNT'.
Populate as 103 when PARAMCD='ANYEVNT'.
010 AVALC (PARAMCD=LACKEFF) Analysis Value (C) Populate as "Y" if there exists a record in DS where DSDECOD='LACK OF EFFICACY' and ASTDT<= DSSTDTC <=AENDT of that visit. Populate as "N" otherwise.
011 AVALC (PARAMCD=OTHEVNT) Analysis Value (C) Populate as "Y" if there exists a record in DS where DSDECOD is not in ('LACK OF EFFICACY', 'COMPLETED') and ASTDT<= DSSTDTC <=AENDT of that visit. Populate as "N" otherwise.
012 AVALC (PARAMCD=ANYEVNT) Analysis Value (C) Populate as "Y" if there exists a record in DS where DSDECOD is not in ('COMPLETED') and ASTDT<= DSSTDTC <=AENDT of that visit. Populate as "N" otherwise.
013 TRTSDT Date of First Exposure to Treatment ADSL.TRTSDT
014 EOSDT Date of End of Study ADSL.EOSDT