VARIABLE_NAME	VARIABLE_LABEL	TYPE	GENERAL_COMMENT
STUDYID	Study Identifier	_	EG.STUDYID
USUBJID	Unique Subject Identifier	_	EG.USUBJID
SUBJID	Subject Identifier for the Study	_	ADSL.SUBJID
PARAM	Parameter	_	Populate as 'Heart Rate (beats/min)' when PARAMCD='HR'. Populate as 'PR Interval (msec)' when PARAMCD='PR'. Populate as 'QT Interval (msec)' when PARAMCD='QT'. Populate as 'RR Interval (msec)' when PARAMCD='RR'. Populate as 'QRS Interval (msec)' when PARAMCD='QRS'. Populate as 'Interpretation' when PARAMCD='INTP'.
PARAMCD	Parameter Code	_	Populate with values from EG.EGTESTCD.
PARAMN	Parameter (N)	_	Populate as 1 when PARAMCD='HR'. Populate as 2 when PARAMCD='PR'. Populate as 3 when PARAMCD='QT'. Populate as 4 when PARAMCD='RR'. Populate as 5 when PARAMCD='QRS'. Populate as 6 when PARAMCD='INTP'.
ADT	Analysis Date	_	Populate using EG.EGDTC
ADY	Analysis Relative Day	_	Populate using ADSL.TRTSDT and ADEG.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 ADEG.ADY and ADEG.ABLFL. 1) Populate as "Week 12" if ADY is in between 2 and 127. 2) Populate as "Week 24" if ADY is in between 128 and 210. 3) Populate as "Baseline" if ABLFL="Y".
AVISITN	Analysis Visit (N)	_	Populate using ADEG.AVISIT. 1) Populate as 12 when AVISIT="Week 12". 2) Populate as 24 when AVISIT="Week 24". 3) Populate as 0 when AVISIT="Baseline".
AVAL	Analysis Value	_	Populate using EG.EGSTRESN.
AVALC	Analysis Value (C)	_	Populateusing EG.EGSTRESC. Populate only on the records where PARAMCD="INTP". Leave null for all other parameters.
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.
ANL01FL	Analysis Flag 01	_	Populate as "Y" on the record that is closest to the target day within each analysis visit (ADEG.AVISIT) per subject and parameter. If there exists multiple records that are equally closest then choose the record with latest date.
ANL02FL	Analysis Flag 02	_	Populate as "Y" on postbaseline records (ADEG.ADT>ADSL.TRTSDT).
AVALCAT1	Analysis Value Category 1	_	Populate using ADEG.AVAL on the records where AVAL is not null. For PARAMCD="HR": Populate as "< 50 bpm" when AVAL is less than 50. Populate as "50 - 100 bpm" when AVAL is in between 50 and 100 (inclusive). Populate as "> 100 bpm" when AVAL is greater than 100. For PARAMCD in ("PR", "QRS"): Populate as "< 200 msec" when AVAL is less than 200. Populate as ">= 200 msec" when AVAL is greater than or equals to 200. For PARAMCD="QT": Populate as "< 450 msec" when AVAL is less than 450. Populate as ">= 450 - < 480 msec" when AVAL is greater than or equals to 450 and AVAL is less than 480 . Populate as ">=480 - < 500 msec" when AVAL is greater than or equals to 480 and AVAL is less than 500. Populate as ">= 500 msec" when AVAL is greater than or equals to 500.
AVALCA1N	Analysis Value Category 1 (N)	_	For PARAMCD in ("HR"): Populate as 1 when AVALCAT1='< 50 bpm'. Populate as 2 when AVALCAT1='50 -100 bpm'. Populate as 3 when AVALCAT1='> 100 bpm'. For PARAMCD in ("PR", "QRS"): Populate as 1 when AVALCAT1='< 200 msec'. Populate as 2 when AVALCAT1='>= 200 msec'. For PARAMCD in ("QT"): Populate as 1 when AVALCAT1='< 450 msec'. Populate as 2 when AVALCAT1='>= 450 - <480 msec'. Populate as 3 when AVALCAT1='>= 480 - < 500 msec'. Populate as 4 when AVALCAT1='>= 500 msec'.
BASE	Baseline Value	_	Populate using ADEG.AVAL on the record where ADEG.ABLFL="Y" of each parameter and subject on all records that subject and parameter.
BASEC	Baseline Value (C)	_	Populate using ADEG.AVALC on the record where ADEG.ABLFL="Y" of each parameter and subject on all records that subject and parameter.
BASECAT1	Baseline Category 1	_	Populate using ADEG.AVALCAT1 on the record where ADEG.ABLFL="Y" of each parameter and subject on all records that subject and parameter.
BASECA1N	Baseline Category 1 (N)	_	Populate using ADEG.AVALCA1N on the record where ADEG.ABLFL="Y" of each parameter and subject on all records that subject and parameter.
CHG	Change from Baseline	_	Populate as the difference between ADEG.AVAL and ADEG.BASE on postbaseline records (ADEG.ANL02FL="Y").
CHGCAT1	Change from Baseline Category 1	_	Populate using ADEG.CHG For PARAMCD="QT": Populate as "<= 30 msec" when CHG is less than or equals to 30. Populate as "> 30 - 60 msec" when CHG is greater than 30 and less than or equals to 60. Populate as "> 60 msec" when AVAL is greater than 60.
CHGCAT1N	Change from Baseline Category 1 (N)	_	For PARAMCD in ("QT"): Populate as 1 when CHGCAT1='<= 30 msec'. Populate as 2 when CHGCAT1='> 30 - 60 msec'. Populate as 3 when CHGCAT1='> 60 msec'.
PCHG	Percent Change from Baseline	_	Populate using ADEG.CHG and ADEG.BASE, as CHG/BASE*100 when BASE is not null and is not 0.
SHIFT1	Shift 1	_	Populate using ADEG.BASEC and ADEG.AVALC for the records where PARAMCD="INTP" on the records where ANL02FL="Y". 1) If AVALC is null then temporarliy consider it as "Missing". 2) If BASEC is null then temporarily consider it as "Missing". 3) Concatenate the values of BASEC and AVALC with the word " to " in between.
SHIFT2	Shift 2	_	Populate using ADEG.BASECAT1 and ADEG.AVALCAT1 for the records where PARAMCD in ("HR", "PR", "QRS", "QT") on the records where ANL02FL="Y". 1) If AVALCAT1 is null then temporarily consider it as "Missing". 2) If BASECAT1 is null then temporarily consider it as "Missing". 3) Concatenate the values of BASECAT1 and AVALCAT1 with the word " to " in between.
AWTARGET	Analysis Window Target	_	Populate as 85 when AVISIT='Week 12'. Populate as 169 when AVISIT='Week 24'.
AWTDIFF	Analysis Window Diff from Target	_	Populate using ADEG.AWTARGET and ADEG.ADY, as absolute difference between AWTARGET and ADY.
AWLO	Analysis Window Beginning Timepoint	_	Populate as 2 when AVISIT='Week 12'. Populate as 128 when AVISIT='Week 24'.
AWHI	Analysis Window Ending Timepoint	_	Populate as 127 when AVISIT='Week 12'. Populate as 210 when AVISIT='Week 24'.
AWU	Analysis Window Unit	_	Populate as "DAYS" when AVISIT is not null and AWTDIFF is not null.
EGSEQ	Sequence Number	_	EG.EGSEQ
VISITNUM	Visit Number	_	EG.VISITNUM
VISIT	Visit Name	_	EG.VISIT
SITEID	Study Site Identifier	_	ADSL.SITEID
AGE	Age	_	ADSL.AGE
AGEU	Age Units	_	ADSL.AGEU
SEX	Sex	_	ADSL.SEX
RACE	Race	_	ADSL.RACE
SAFFL	Safety Population Flag	_	ADSL.SAFFL
RANDFL	Randomized Population Flag	_	ADSL.RANDFL
ENRLFL	Enrolled Population Flag	_	ADSL.ENRLFL

Complete SAS code to generate the output is available for registered users!

Already registered! Login
Not registered, you can signup here! Signup

Dont want to register?
You can directly purchase this lesson (code+input data) here

You can purchase this lesson (code+input data) here

If you are looking to purchase subscription for full access to data and programs for all lessons (TASKS+SDTM+ADaM+TFLs), you can send us a message on +91-7330--77--66--49-- on Whatsapp.

R data is available only for R subscribers.
You can contact us on +91-7330--77--66---49 for purchasing subscription to R programs and data

R codes are available only for R subscribers.
You can contact us on +91-7330--77--66---49 for purchasing subscription to R programs and data

---