Ejection Fraction Endpoints

Ejection Fraction

change in ejection fraction, would expect a decline in EF of 2-3% per year, concerning if rapid progression~~, i.e., 10% decline or more~~ - Use absolute change, updated to 5% decline for 1 year

NTproBNP

% change over a period of time – a decrease is correlated with improvement, measured annually

This section illustrates example analysis datasets for the following endpoints:

Percent change in ejection fraction over time (1 year)
Decline in ejection fraction over time (1 year) grouped by a decline greater than 5%
Percent change in NT-proBNP over time (1 year)

Source Data

The SDTM examples used as the source data are from Section 2.1, Basic Systolic Function. The ADSL draws from the DM dataset. The CV dataset shows two visits for subject DMD-EF-01-101. The records for which CVTESTCD = "LVEF_C" and "RVEF_C" were selected for analysis. The records in the LB dataset where LBTESTCD = "BNPPRONT" were used to compute the percent change over time and as a potential covariate.

Example Analysis Datasets

The tables below show the analysis dataset metadata and parameters used for this example.

Analysis Datasets

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 ADaM 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 the data. More than one SDTM dataset is used as input to the ADSL. As an example, a flag 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. Note that based on the dates shown in DM, the screening visit and visit 1 occurred at the same 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.

ADSL Analysis Dataset

This is a simplified example ADSL dataset; it is expected that the ADaMIG is referenced. Analysis age (AAGE) was 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 this example, the Du Bois method was used (ref: https://www.calculator.net/body-surface-area-calculator.html).

ADSL Variable Metadata

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 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 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).

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adsl.xpt

Row	STUDYID	USUBJID	BRTHDT	AAGE	AGE	AGEU	SEX	RACE	TRTSDT	RFICDT	DTHDT	DTHFL	TRT01P	ITTFL	ACEINHFL	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

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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.

Parameter Value List - ADCVNTP [ADCVNTP]

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"

ADCVNTP Variable Metadata

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
AAGE	Analysis 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
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 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)	CV.CVTEST LB.LBTEST
PARAMCD	Parameter Code	Char	LVEF_C; RVEF_C; BNPPRONT	CV.CVTESTCD LB.LBTESTCD
PARAMN	Parameter (N)	Num			Number PARAMCD as follows: LVEF_C = "1" RVEF_C = "2" BNPPRONT = "3"
AVAL	Analysis Value	Num			See Parameter Value Metadata
AVISIT	Analysis Visit	Char	Visit 1 (Baseline); Visit 6 (1 Year)		If CV.VISIT = "VISIT 1" then AVISIT = "Visit 1 (Baseline)". 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 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.

Efficacy Analysis Example 1

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

Left Ventricular Ejection Fraction, Calculated (%)
Right Ventricular Ejection Fraction, Calculated (%)
N-Terminal ProB-type Natriuretic Peptide (pg/mL)

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

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adcvntp.xpt

Row	STUDYID	USUBJID	AAGE	AGEU	SEX	RACE	TRT01P	TRT01A	ITTFL	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	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	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	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	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	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	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	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	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	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	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	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Drug A	Y	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

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ADCVCMR Analysis Dataset

The dataset above can also be set up to provide multivariate analyses by taking the lab tests of interest (Paramcd = BNPPRONT) or other analysis datasets, and merging variables of interest with the ADCVNTP dataset. This summary dataset is created from other ADaM datasets as the source and only variable used in the analysis are kept.

ADCVCMR Variable Metadata

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
AAGE	Analysis Age	Num		ADCVNTP.AAGE
AGEU	Age Unit	Char	YEARS	ADCVNTPL.AGEU
SEX	Sex	Char	(SEX)	ADCVNTPL.SEX
RACE	Race	Num	(RACE)	ADCVNTPL.RACE
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
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 (%);	ADCVNTP.PARAM
PARAMCD	Parameter Code	Char	LVEF_C; RVEF_C;	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

Efficacy Analysis Example 2

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adcvcmr.xpt

Row	STUDYID	USUBJID	BRTHDT	TRT01P	AAGE	AGU	SEX	RACE	TRT01A	ITTFL	BSA	ACEINHFL	BNPPRONT	PARAM	PARAMCD	PARAMN	AVAL	AVISIT	AVISITN	ADT	ABLFL	BASE	CHG	PCHG	CHGCAT1
1	DMD-EFLGE	DMD-EF-01-101	07FEB2010	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	0.82	Y	40	Left Ventricular Ejection Fraction, Calculated (%)	LVEF_C	1	70	Visit 1 (Baseline)	1	16MAY2022	Y	70
2	DMD-EFLGE	DMD-EF-01-101	07FEB2010	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	0.82	Y	40	Right Ventricular Ejection Fraction, Calculated (%)	RVEF_C	2	75	Visit 1 (Baseline)	1	16MAY2022	Y	75
3	DMD-EFLGE	DMD-EF-01-101	07FEB2010	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	1.08	Y	900	Left Ventricular Ejection Fraction, Calculated (%)	LVEF_C	1	65	Visit 6 (1 Year)	6	06APR2023		70	-5	-10.447761	Decline >=5.0%
4	DMD-EFLGE	DMD-EF-01-101	07FEB2010	Drug A	12.3	YEARS	M	BLACK OR AFRICAN AMERICAN	Drug A	Y	1.08	Y	900	Right Ventricular Ejection Fraction, Calculated (%)	RVEF_C	2	70	Visit 6 (1 Year)	6	06APR2023		75	-5	-17.567568	Decline >=5.0%

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Example Analysis Results Metadata (ARM) Tables

For more details on ARM, see the ADaMIG and the Analysis Results Metadata (ARM) v1.0 for Define-XML v2.0 (https://www.cdisc.org/standards/foundational/adam).

Table 1. A simple comparison of change by treatment groups over one year.

Display	Table 14.xx.xx Change in Left Ventricular Ejection Fraction Percent Over 1 Year
Analysis Result	Comparison of Change of Ejection Fraction Percent for the Treatment Groups (1 Year)
Analysis Variables(s)	CHG
Analysis Reason	Primary efficacy endpoint as prespecified in the SAP
Analysis Purpose	Primary outcome measure
Data References (incl. selection criteria)	PARAMCD = "LVEF_C" Where ITTFL = "Y" and AVISITN = 6;
Documentation	Comparison of Means with 95% confidence interval
Programming Statements (Add programming language statements here: SAS, R, etc.)	Proc means DATA=ADCVNTP N MEAN clm STDERR; /* Subset the data. Can run again selecting for paramcd="RVEF_C"*/ Where PARAMCD = 'LVEF_C' and ITTFL = "Y" and AVISITN = 6 ; Class TRT01P; Var CHG; run;

Table 2. This table demonstrates a model over multiple time points.

Display	Table 14.xx.xx Percent Change in Left Ventricular Ejection Fraction Percent Over Time (Yearly)
Analysis Result	Comparison of Percent Change of Ejection Fraction for the Treatment Groups Over Time ( yearly)
Analysis Variables(s)	CHG
Analysis Reason	Primary efficacy endpoint as prespecified in the SAP
Analysis Purpose	Primary outcome measure
Data References (incl. selection criteria)	PARAMCD = "LVEF_C" Where ITTFL = "Y"
Documentation	The mixed model using lsmeans to compare treatment groups
Programming Statements (Add programming language statements here: SAS, R, etc.)	/* Note that CHG is only computed post-baseline, so subset for the yearly visits, i.e. 6, 12, 18 etc. / Proc mixed DATA=ADCVNTP; Class TRT01P AVISITN; / Subset by param, as there are two parameters with CHG calculated/ Where ITTFL = "Y" and AVISITN IN(6,12,18,24,36,48) and PARAMCD = "LVEF_C"; Model PCHG=AVISITNTRT01P/Solution; RANDOM INTERCEPT / SUBJECT=STUYDID TYPE=UN; LSMEANS TRT01P*AVISITN/ CL PDIFF; RUN;

Table 3. This example uses the dataset ADCVCMR, with AGE, SEX, RACE, and BNPPRONT as covariates.

Display	Table 14.xx.xx Percent change in NTproBNP over 1 Year
Analysis Result	Comparison of Percent Change of NTproBNP for the Treatment Groups Over a period of time.
Analysis Variables(s)	PCHG
Analysis Reason	Primary efficacy endpoint as prespecified in the SAP
Analysis Purpose	Primary outcome measure
Data References (incl. selection criteria)	PARAMCD = L_VEFC; ITTFL = "Y" and AVISITN GE 6;
Documentation	Multiple Regression Model
	Proc reg data=ADCVCMR ; Where PARAMCD = L_VEFC and ITTFL = "Y" and AVISITN GE 6; Model PCHG = AAGE SEX RACE BNPPRONT; run;

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Source Data

Example Analysis Datasets

ADSL Analysis Dataset

ADCVNTP Analysis Dataset

ADCVCMR Analysis Dataset

Example Analysis Results Metadata (ARM) Tables