ROWORDER	VARIABLE_NAME	VARIABLE_LABEL	TYPE	GENERAL_COMMENT
001	STUDYID	Study Identifier		IS.STUDYID
002	USUBJID	Unique Subject Identifier		IS.USUBJID
003	ISSEQ	Sequence Number		IS.ISSEQ
004	ADT	Analysis Date		Populate using IS.ISDTC
005	ADY	Analysis Relative Day		Populate using ADSL.TRTSDT and ADIS.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.
006	VISITNUM	Visit Number		IS.VISITNUM
007	VISIT	Visit Name		IS.VISIT
008	AVISIT	Analysis Visit		Part 1: Populate as 'Screening' when ADY <=-1. Populate as 'Visit 1' when 1<= ADY <=1. Populate as 'Visit 2' when 7<= ADY <=9. Populate as 'Visit 3' when 25<= ADY <=33. Populate as 'Visit 4' when 78<= ADY <=92. Populate as 'Visit 5' when 166<= ADY <=194. Populate as 'Visit 6' when 351<= ADY <=379. Part 2: Populate as 'Baseline' on the record where ABLFL is 'Y'.
009	AVISITN	Analysis Visit (N)		Part 1: Populate as -1 when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 2 when AVISIT='Visit 2'. Populate as 3 when AVISIT='Visit 3'. Populate as 4 when AVISIT='Visit 4'. Populate as 5 when AVISIT='Visit 5'. Populate as 6 when AVISIT='Visit 6'. Part 2: Populate as 0 on the record where ABLFL is 'Y'.
010	PARAM	Parameter		Populate as 'Titer (GCE/ml)' when PARAMCD='TITER'.
011	PARAMCD	Parameter Code		For the source records: set to ISTESTCD
012	PARAMN	Parameter (N)		Populate as 1 when PARAMCD='TITER'.
013	AVAL	Analysis Value		A. For the source records: Set to ISSTRESN
014	BASE	Baseline Value		Populate using ADIS.AVAL on the record where ADIS.ABLFL="Y" of each parameter and subject on all records that subject and parameter.
015	CHG	Change from Baseline		Populate as the difference between ADIS.AVAL and ADIS.BASE on postbaseline records (ADIS.ANL02FL="Y").
016	R2BASE	Ratio to Baseline		On postbaseline records (ANL02FL="Y") where PARAMCD="TITER": Populate with the ratio of AVAL to BASE (AVAL/BASE). Round the ratio to two decimal places.
017	CRIT1	Analysis Criterion 1		Populate as "Seroresponse - Titer >=200" on records where PARAMCD="TITER".
018	CRIT1FL	Criterion 1 Evaluation Result Flag		On records where PARAMCD="TITER": Populate as "Y" when AVAL>=200. Else if AVAL is not null, then populate as "N".
019	CRIT2	Analysis Criterion 2		Populate as "Seroconversion - > 4 fold increase from baseline" on records where PARAMCD="TITER".
020	CRIT2FL	Criterion 2 Evaluation Result Flag		On postbaseline records (ANL02FL="Y") where PARAMCD="TITER": Populate as "Y" when R2BASE > 4. Else if R2BASE is not null then populate as "N".
021	AWTARGET	Analysis Window Target		Populate as null when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 8 when AVISIT='Visit 2'. Populate as 29 when AVISIT='Visit 3'. Populate as 85 when AVISIT='Visit 4'. Populate as 180 when AVISIT='Visit 5'. Populate as 365 when AVISIT='Visit 6'.
022	AWTDIFF	Analysis Window Diff from Target		Populate as the absolute difference between AWTARGET and ADY
023	AWLO	Analysis Window Beginning Timepoint		Populate as null when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 7 when AVISIT='Visit 2'. Populate as 25 when AVISIT='Visit 3'. Populate as 78 when AVISIT='Visit 4'. Populate as 166 when AVISIT='Visit 5'. Populate as 351 when AVISIT='Visit 6'.
024	AWHI	Analysis Window Ending Timepoint		Populate as -1 when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 9 when AVISIT='Visit 2'. Populate as 33 when AVISIT='Visit 3'. Populate as 92 when AVISIT='Visit 4'. Populate as 194 when AVISIT='Visit 5'. Populate as 379 when AVISIT='Visit 6'.
025	AWU	Analysis Window Unit		Populate as "DAYS" when AVISIT is not null.
026	ABLFL	Baseline Record Flag		Populate as "Y" on the latest record with non-missing result on or prior to treatment start date (ADSL.TRTSDT) for each subject and parameter.
027	ANL01FL	Analysis Flag 01		Populate as "Y" on the records which is closet to the target day within each analysis visit (ADIS.AVISIT) per subject and parameter. If there exists multiple records which are equally close to the target day, choose the latest record.
028	ANL02FL	Analysis Flag 02		Populate as "Y" on postbaseline records (ADIS.ADT>ADSL.TRTSDT).