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Definexmltable

Multiple	true
Level	Dataset
Purpose	Analysis

Dataset Name	Dataset Description	Class of Dataset	Structure	Keys	Documentation	Location
ADSL	Subject-Level Analysis Dataset	SUBJECT LEVEL ANALYSIS DATASET	One record per subject	USUBJID	ADaMIG	adsl.xpt
ADCVNTP	Cardiac Ejection Fraction and NTproBNP Analysis Dataset	BASIC DATA STRUCTURE	One record per subject per analysis visit per parameter	USUBJID, AVISITN, PARAMN	Analysis Dataset	adcvntp.xpt
ADCVCMR	Cardiovascular CMR Ejection Fraction Analysis Dataset	BASIC DATA STRUCTURE	One record per subject per analysis visit per parameter	USUBJID, AVISITN, PARAMN	Analysis Dataset	adcvcmr.xpt

The ADSL was combined with other SDTM datasets to create the analysis datasets. More than one SDTM dataset can be combined in this wayADaM model requires a one-record-per-subject analysis dataset, ADSL, which contains subject characteristics and covariates that are important for analyses. Also, stratification variables can be created in the ADSL to subset by, or to add variables needed in the analyses. For the data. More than one SDTM dataset is used as input to the ADSL. As an example, a flag (ACEMEDFL) could be added for ACE inhibitors. Another variable, body surface area indicating concomitant medication use of ACE inhibitors (ACEINHFL) was derived from CM. Body surface area at screening (BSASC), was derived from the VS dataset ( using height and weight ) at the screening visit and added to ADSL. Note that based on the dates shown in DM, the screening visit and visit 1 have occurred at the same dates for time in this example.

The ADCVNTP dataset includes tests pertinent to these analyses. The records from CV where CVTESTCD = "LVEF_C" and "RVEF_C" and the records from LB where LBTESTCD = "BNPPRONT" were selected. Many lab draws may occur throughout the year, but only those linked to a specific visit were included. By subsetting the LB dataset by LBLNKID not missing, laboratory data that aligns with CV data can be filtered out and sorted using USUBJID and VISIT. If LBLNKID is not available, a windowing strategy could be used to select the laboratory draw closest to that visit for merging with CV, computed in AVISIT.

The ADCVMR dataset is an efficacy analysis dataset with only a few records for more complex modeling of changes in ejection fraction, plus the ProB-type test results. It is an ADaM Basic Data Structure (BDS) dataset, with additional variables added from ADCVNTP.

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This is a simplified example ADSL dataset; it is expected that additional variables for stratification, or of interest for analysis, would be includedthe Foundational standards are followed to include all the core variables. Analysis age was computed from date of birth and (AAGE) was computed to provide age with more precision. The Body Surface Area (BSA) at screening is calculated for screening, and named BSASC as per the ADAMIG v1.2. There are many possible calculations for BSA. For this example, the Du Bois method was used (footnote: 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 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 , and from treatment (EX or EC) domains as as per Statistical Analysis Plan or Protocol. Code Set to "Y" if the medication was 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

RFICDTC

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.

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Definexmltable

Dataset	ADCVNTP
Level	Variable
Purpose	Analysis
Name	Variable

ADSLBSASC

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 Select for records with RE data.
BRTHDT	Date of Birth	Num	Date9.	ADSL.BRTHDT
AAGEAGE	Analysis Age	Num		ADSL.AAGE
AGEU	Age Unit	Char	YEARS	ADSL.AGEU
TRTSDT SEX	RFICDTSex	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	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	HEIGHT	Height (cm)	Num			Set to VS.VSSTRESN where VS.VSTEST = "HEIGHT" and merge by visit.
WEIGHT	Weight (kg)	Num			Set to VS.VSSTRESN where VS.VSTEST = "WEIGHT" and merge by visit.	BSASC	Body Surface Area at Screening	Num	.
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	If CV.CVTESTCD = "LVEF_C" then PARAMCD = "LVEF_C" If CV.CVTESTCD = "RVEF_C" then PARAMCD = "RVEF_C" If LB.LBTESTDC = "BNPPRONT" then PARAMCD = "BNPPRONT" LB.LBTESTCD	NoteNote: for this example dataset, select the records where the test values shown above 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
AVISIT	Analysis Visit	Char	Visit 1 (Baseline) Visit 6 (1 Year)		If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". Else 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.
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.

Efficacy Analysis Example 1 1

This example dataset shows the findings and additional analysis variables associated with:

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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

BRTHDT

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

07FEB2010

12

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

0.82

119

20

1

0.

09

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

07FEB2010

12

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

Drug A

Y

0.82

119

20

1

0.

09

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

07FEB2010

12

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

0.82

119

20

1

0.

09

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

07FEB2010

12

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

0.82

132

32

1.

33

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

07FEB2010

12

Drug A

YEARS

Y

132

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

0.82

132

32

1.

33

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

07FEB2010

12

YEARS

M

BLACK OR AFRICAN AMERICAN

Drug A

Y

0.82

132

32

1.

33

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

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ADCVNTP Analysis Dataset

ADCVCMR Analysis Dataset

Example Analysis Results Metadata (ARM) Tables