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The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The ADSL draws from the DM dataset, which shows 4 subjects. The CV dataset shows two visits for the first subject, DMD-EF-01-101. It contains 16 rows, 1-8 for visit 1 and 9-16 for visit 6. Of these rows, the CVTESTCD = "LVEF_C" and CVTESTCD = "RVEF_C" representing the Ventricular Ejection Fraction, Calculated (%) for left and right were selected for the analysis. The LB dataset test where LBTESTCD = "BNPPRONT" was used to add the value of BNPPRONT to compute the percent change over time, and then was added as a potential covariate in each row for the last analysis.

Example Analysis Datasets

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This is a simplified example ADSL dataset; it is expected that the Foundational standards are followed to include all the core variablesADaMIG is referenced. Analysis age (AAGE) was computed included to provide age with more precision. The Body Surface Area (BSA) at screening is named BSASC as per the ADAMIG v1.2. There are many possible calculations for BSA. For ; for this example, the Du Bois method was used (footnoteref: https://www.calculator.net/body-surface-area-calculator.html).

Definexmltable

Dataset	ADSL
Level	Variable
Purpose	Analysis
Name	Variable

Variable Name	Variable Label	Type	Codelist/Controlled Terms/Format	Source	Derivation/Comment
STUDYID	Study Identifier	Char		DM.STUDYID
USUBJID	Unique Subject Identifier	Char		DM.USUBJID
BRTHDT	Date of Birth	Num	date9.		Date portion of DM.BRTHDTC converted to numeric and displayed in a format such as date9.from ISO 8601 format to numeric date.9
AAGE	Analysis Age	Num			Age as screening, computed by DM.RFICDTC - BRTHDTC as continuous variable. Note that some countries do not allow capturing date of birth, so this could be computed by capturing age in years and months on a CRF.
AGE	Age	Num		DM.AGE
AGEU	Age Units	Char	YEARS	DM.AGEU
SEX	Sex	Char	(SEX)	DM.SEX
RACE	Race	Num	(RACE)	DM.RACE
TRTSDT	Date of First Exposure to Treatment	Num	date9.		Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9.
RFICDT	Date of Informed Consent	Num	date9.		Date portion of DM.RFICDTC converted to numeric and displayed in a format such as date9.
DTHDT	Date of Death	Num	date9.		Date portion of DM.RFSTDTC converted to numeric and displayed in a format such as date9.
DTHFL	Subject Death Flag	Char	Y	DM.DTHFL
TRT01P	Planned Treatment for Period 01	Char	Drug A, Drug B		Predecessor ; : DM.ARM. May be changed to lower case or more descriptive term for use in tables and listings.
TRT01A	Actual Treatment for Period 01	Char	Drug A, Drug B		Predecessor ; : DM.ACTARM. Note: Actual treatment treatment matches planned treatment unless there is a reason subject does not take planned drug.
ITTFL	Intent-To-Treat Population Flag	Char	Y; N		Derive the intent-to-treat population as per the protocol and SAP.
ACEINHFL	ACE Inhibitor Medications Flag	Char	Y; N		Select a list of ACE inhibitor medications from concomitant medications (CM) domain as per Statistical Analysis Plan or Protocol. Set to "Y" if these medications were taken during the study, and "N" if they are absent. Can be used to subset or to exclude the population who took ACE inhibitors.
HEIGHTSC	Height (cm) at Screening	Num			Set to VS.VSSTRESN where VS.VSTESTCD = "HEIGHT" and VISITNUM= 1 (or screening visit for your study).
WEIGHTSC	Weight (kg) at Screening	Num			Set to VS.VSSTRESN where VS.VSTESTCD = "WEIGHT" and VISITNUM = 1 (or screening visit for your study).
BSASC	Body Surface Area at Screening	Num			Select where VISITNUM = 1 (or screening visit for your study). Compute from HEIGHT and WEIGHT, using the Du Bois method. BSA = 0.007184 × W^0.425 × H^0.725 Note that there are multiple methods and the study protocol should describe which one to use (e.g., Du Bois, Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, and Schlich).

Dataset wrap

Show	true
Name	ADSL

Dataset2

tableid	adsl

Row	STUDYID	USUBJID	BRTHDT	AAGE	AGE	AGEU	SEX	RACE	TRTSDT	RFICDT	DTHDT	DTHFL	TRT01P	ITTFL	ACENHFL	HEIGHTSC	WEIGHTSC	BSASC
1	DMD-EFLGE	DMD-EF-01-101	07FEB2010	12.3	12	YEARS	M	BLACK OR AFRICAN AMERICAN	16JUN2022	16JUN2022			Drug A	Y	Y	119	20	0.82
2	DMD-EFLGE	DMD-EF-01-101	01MAY2008	14.1	14	YEARS	M	ASIAN	13JUN2022	13JUN2022			Drug A	Y	Y	115	30	0,95
3	DMD-EFLGE	DMD-EF-01-101	10JUL2003	19.0	19	YEARS	M	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	15JUL22022	15JUL2022			Drug B	Y	N	140	45	1,30
4	DMD-EFLGE	DMD-EF-01-101	15JAN1999	23.7	23	YEARS	M	WHITE	06SEP2022	06SEP2022	23NOV2023	Y	Drug B	Y	Y	132	42	1,21

ADCVNTP Analysis Dataset

In this example, columns for derived variables BASE, CHG, PCHG and CHGCAT1 have been added to facilitate analyses of the efficacy endpoints. Specifically, example demographic data for ADSL were created for an 8 year old male. Also, a custom variable for BSA at baseline (BSABL), and an example of a stratification variable for subjects with was added from ADSL.

Definexmltable

Dataset	ADCVNTP
Level	Value
Purpose	Analysis
OID	AVAL

Dataset	Variable	Where	Type	Origin	Derivation/Comment
ADCVNTP	AVAL	PARAMCD in ("LVEF_C", "RVEF_C")	Num	Predecessor	Set to CV.CVSTRESN
ADCVNTP	AVAL	PARAMCD = "BNPPRONT"	Num	Predecessor	Set to LB.LBSTRESN where LB.LBTESTCD = "BNPPRONT"
ADCVNTP	CHGCAT1	PARAMCD in ("LVEF_C", "RVEF_C")	Char		Categorize the value of CHGCAT1 as follows: If CHG >= 5.00 THEN CHGCAT1 = "Decline >=5%". Else if CHG not missing and CHG < 5.00 THEN CHGCAT1 = "Decline <5%"
ADCVNTP	CHGCAT1	PARAMCD = "BNPPRONT"	Char		Categorize the value of CHCAT1 as follows: "Increase >100 pg/mL", ; "Increase <=100 pg/mL"; "No increase"

Definexmltable

Dataset	ADCVNTP
Level	Variable
Purpose	Analysis
Name	Variable

Variable Name	Variable Label	Type	Codelist/Controlled Terms/Format	Source	Derivation/Comment
STUDYID	Study Identifier	Char		CV.STUDYID
USUBJID	Unique Subject Identifier	Char		CV.USUBJID
BRTHDT	Date of Birth	Num	Date9.	ADSL.BRTHDT
AGE	Age	Num		ADSL.AAGE
AGEU	Age Unit	Char	YEARS	ADSL.AGEU
SEX	Sex	Char	(SEX)	DM.SEX
RACE	Race	Num	(RACE)	DM.RACE
TRTSDT	Date of First Exposure to Treatment	Num	date9	ADSL.TRTSDT
TRT01P	Planned Treatment for Period 01	Char	Drug A, ; Drug B	ADSL.TRT01P
TRT01A	Actual Treatment for Period 01	Char	Drug A, ; Drug B	ADSL.TRT01A
ITTFL	Intent-To-Treat Population Flag	Char	Y; N	ADSL.ITTFL
BSASC	Body Surface Area at Screening	Num		ADSL.BSASC
HEIGHT	Height (cm)	Num			Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" by visit.
WEIGHT	Weight (kg)	Num			Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" by visit.
BSA	Body Surface Area (m2)	Num			Compute from HEIGHT and WEIGHT at each visit, using the Du Bois method. BSA = 0.007184 × W^0.425 × H^0.725 Note that there are multiple methods and the study protocol should describe which one to use (e.g., Mosteller, Haycock, Gehan & George, Boyd, Fujimoto, Takahira, and Schlich).
ACEINHFL	ACE Inhibitor Medications Flag	Char	Y; N	ADSL.ACEINHFL
PARAM	Parameter	Char	Left Ventricular Ejection Fraction, Calculated (%); Right Ventricular Ejection Fraction, Calculated (%); N-Terminal ProB-type Natriuretic Peptide (pg/mL)		For tests from CV, set to the values of CV.CVTEST plus CV.CVTESTU with spaces and parentheses as shown. For tests from LB, set to the value of LB.LBTEST plus LB.LBTESTU with spaces and parentheses as shown.
PARAMCD	Parameter Code	Char	LVEF_C; RVEF_C; BNPPRONT	CV.CVTESTCD LB.LBTESTCD	Note: for this example dataset, select the records where the test values shown at left are included.
PARAMN	Parameter (N)	Num			Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3"
AVAL	Analysis Value	Num			See Parameter Value List Metadata
AVISIT	Analysis Visit	Char	Visit 1 (Baseline); Visit 6 (1 Year)		If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". Else if If CV.VISIT = "VISIT 6" then AVISIT = "Visit 6 (1 Year)".
AVISITN	Analysis Visit (N)	Num	1, ; 6	CV.VISITNUM LB.VISITNUM
VISIT	Visit	Num	VISIT 1; VISIT 6	CV.VISIT LB.VISIT
ADT	Analysis Date	Num	date9.		Date portion of CV.CVDTC or LB.LBDTC converted to numeric and displayed in a format such as date9.
ABLFL	Baseline Record Flag	Char	Y		If CV.VISIT = "VISIT 1" then ABLFL = "Y".
BASE	Baseline Value	Num			Set BASE to AVAL from the record for that subject and parameter where ABLFL = "Y". Populate BASE for additional visits by merging the value of BASE in the baseline record by USUBJID and PARAMCD.
CHG	Change from Baseline	Num			Compute CHG = AVAL - BASE for that record. Only compute for post-baseline records.
PCHG	Percent Change from Baseline	Num			Compute PCHG = (CHG / BASE) * 100. Only compute for post-baseline records.
CHGCAT1	Change from Baseline Category 1	Char	Decline >=5% ; Decline <5% Increase GT 100 pg/mL		See PVLM table.Parameter Value Metadata
SRCDOM	Source Data	Char	CV; LB		Set to the SDTM domain name that relates to the analysis value.
SRCVAR	Source Variable	Char			Set to the SDTM variable that relates to the analysis value.
SRCSEQ	Source Sequence Number	Num		CV.CVSEQ LB.LBSEQ	Set to the SDTM domain sequence number that relates to the analysis value.

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Dataset wrap

Show	true
Name	adcvntp

Rowcaps

Rows 1-2:	Show the baseline ejection fraction measurements at VISIT 1.
Row 3:	Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 1.
Rows 4-5:	Show the baseline ejection fraction measurements at VISIT 6.
Row 6:	Shows the baseline N-Terminal ProB-type Natriuretic Peptide test results at VISIT 6.

Dataset2

tableid	adcvntp

Row	STUDYID	USUBJID	AGE	AGEU	SEX	RACE	TRT01P	TRT01A	ITTFL	BSASC	HEIGHT	WEIGHT	BSA	ACEINHFL	PARAM	PARAMCD	PARAMN	AVAL	AVISIT	AVISITN	VISIT	ADT	ABLFL	BASE	CHG	PCHG	CHGCAT1	SRCDOM	SRCVAR	SRCSEQ
1	DMD-EFLGE	DMD-EF-01-101	12	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	0.82	119	20	0.82	Y	Left Ventricular Ejection Fraction, Calculated (%)	LVEF_C	1	67	Visit 1 (Baseline)	1	VISIT 1	16MAY2022	Y	67				CV	CVTESTCD	3
2	DMD-EFLGE	DMD-EF-01-101	12	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	0.82	119	20	0.82	Y	Right Ventricular Ejection Fraction, Calculated (%)	RVEF_C	2	74	Visit 1 (Baseline))	1	VISIT 1	16MAY2022	Y	74				CV	CVTESTCD	7
3	DMD-EFLGE	DMD-EF-01-101	12	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	0.82	119	20	0.82	Y	N-Terminal ProB-type Natriuretic Peptide (IU/L)	BNPPRONT	3	40	Visit 1 (Baseline)	1	VISIT 1	16MAY2022	Y	40				LB	LBTESTCD	1
4	DMD-EFLGE	DMD-EF-01-101	12	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	0.82	132	32	1.08	Y	Left Ventricular Ejection Fraction, Calculated (%)	LVEF_C	1	60	Visit 6 (1 Year)	6	VISIT 6	06APR2023		67	-7	-10.447761	Decline >=5.0%	CV	CVTESTCD	11
5	DMD-EFLGE	DMD-EF-01-101	12	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	0.82	132	32	1.08	Y	Right Ventricular Ejection Fraction, Calculated (%)	RVEF_C	2	61	Visit 6 (1 Year)	6	VISIT 6	06APR2023		74	-13	-17.567568	Decline >=5.0%	CV	CVTESTCD	15
6	DMD-EFLGE	DMD-EF-01-101	12	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	0.82	132	32	1.08	Y	N-Terminal ProB-type Natriuretic Peptide (IU/L)	BNPPRONT	3	900	Visit 6 (1 Year)	6	VISIT 1	06APR2023		40	860	2,150	Increase GT 100 pg/mL	LB	LBTESTCD	2

ADCVCMR Analysis Dataset

Efficacy Example 2

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Definexmltable

Dataset	ADCVCMR
Level	Variable
Purpose	Analysis
Name	Variable

Variable Name	Variable Label	Type	Codelist/Controlled Terms/Format	Source	Derivation/Comment
STUDYID	Study Identifier	Char		ADCVNTP.STUDYID
USUBJID	Unique Subject Identifier	Char		ADCVNTP.USUBJID
BRTHDT	Date of Birth	Num	Date9.	ADCVNTP.BRTHDT
AGE	Age	Num		ADCVNTP.AGE
AGEU	Age Unit	Char	YEARS	ADCVNTPL.AGEU
TRTSDT	Date of First Exposure to Treatment	Num	date9.	ADCVNTP.TRTSDT
TRT01P	Planned Treatment for Period 01	Char	Drug A, ; Drug B	ADCVNTP.TRT01P
ITTFL	Intent-To-Treat Population Flag	Char	Y; N	ADCVNTP.ITTFL
BSASC	Body Surface Area at Screening	Num		ADCVNTP.BSASC
BSA	Body Surface Area (m2)	Num		ADCVNTP.BSA
ACEINHFL	ACE Inhibitor Medications Flag	Char	Y; N	ADCVNTP.ACEINHFL
BNPPRONT		Num			BNPPRONT = AVAL where PARAMCD = ADCVNTP.BNPPRONT, and merge by USUBJID and AVISITN. Note: there are many ways to add this including transposing the data.
PARAM	Parameter	Char	Left Ventricular Ejection Fraction, Calculated (%); Right Ventricular Ejection Fraction, Calculated (%); N-Terminal ProB-type Natriuretic Peptide (pg/mL)	ADCVNTP.PARAM
PARAMCD	Parameter Code	Char	LVEF_C; RVEF_C; BNPPRONT	ADCVNTP.PARAMCD
PARAMN	Parameter (N)	Num		ADCVNTP.PARAMN
AVAL	Analysis Value	Num		ADCVNTP.AVAL
AVISIT	Analysis Visit	Char	Visit 1 (Baseline); Visit 6 (1 Year)	ADCVNTP.AVISIT
AVISITN	Analysis Visit (N)	Num	1, ; 6	ADCVNTP.AVISITN
ADT	Analysis Date	Num	date9.	ADCVNTP.ADT
ABLFL	Baseline Record Flag	Char	Y	ADCVNTP.ABLFL
BASE	Baseline Value	Num		ADCVNTP.BASE
CHG	Change from Baseline	Num		ADCVNTP.CHG
PCHG	Percent Change from Baseline	Num		ADCVNTP.PCHG
CHGCAT1	Change from Baseline Category 1	Char	Decline >=5% ; Decline <5% Increase GT 100 pg/mL	ADCVNTP.CHGCAT1

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Example Analysis Datasets

ADCVNTP Analysis Dataset

ADCVCMR Analysis Dataset