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 |