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The data from the SDTM examples for ejection fraction can be used for multiple endpoint analyses. For this example we show the following endpoints:

  • From CV domain
    • Percent change in ejection fraction
    • Decline in ejection fraction over a time period (yearly) grouped by a decline greater than x.x%.
  • From the LB domain
    • Percent change in NTproBNP over a period of time (yearly).

The SDTM examples are in the section Basic CMR tests -Systolic Function (make link) . The example datasets show visits 1 and 6 for one subject. As mentioned in the SDTM text, for the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every two months. Visit 1 represents the visit at day 1 of the study, and visit 6 represents the visit at month 12 of the study. 

Questions. 

Is screening considered visit 1, or is it to include the subject into the study?

Are these Real World Evidence (RWE) studies only or clinical trials?

Should both endpoints be shown in one efficacy dataset or two?


Analysis Datasets

ADCV Analysis Dataset

This example analysis dataset used the SDTM CV dataset for input which shows the findings associated with a Cardiac Magnetic Resonance Imaging procedure related to ejection fraction. 

CVDTC is the date of the CMR procedure, CVDY is the study. For the purposes of this example, the participant was enrolled in the study on 20-May-2021 and the study visits were every twp months.The CVLNKID variable is used to identify a record to show a relationship between records in separate domains.




The following are the parameters for the example ADaM datasets. Note that the columns for derived variables, BASE, and CHG have been added, as well as selected variables from ADSL. The rows needed from the spirometry and 6MWT for ranking change from baseline were created in the safety analysis datasets. These derived rows were then copied to ADCOMPOS. The ADCOMPOS example shows the final rows required. 

ADSPIRO Variable Metadata

Parameter Value List - ADSPIRO, AD6MWT, ADCOMPOS

Rows 1-8:Show the baseline CMR ejection fraction measurements for participant 101 at Screening.
Rows 9-16:Show the CMR ejection fraction measurements for participant 101 at VISIT 6.
$titleHtml

cv.xpt

RowSTUDYIDUSUBJID



PARAMCDPARAMAVALCVMETHODVISITNUMVISITADTABLFLBASECHGPCHGCHGCATSRCDOMSRCSEQ
1DMD-EFLGE101



LVEF_CLeft Ventricular Ejection Fraction, Calculated (%)67CARDIAC MAGNETIC RESONANCE IMAGING1SCREENING2022-05-16Y67


CV3
2DMD-EFLGE101



LVCO

LV Cardiac Output (L/min)

5.4

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16Y5.4


CV4
3DMD-EFLGE101



RVEF_CRight Ventricular Ejection Fraction, Calculated (%)74

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16Y74


CV7
4DMD-EFLGE101



RVCORV Cardiac Output (L/min)5.6

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16Y67


CV8
5DMD-EFLGE101



BNPPRONTN-Terminal ProB-type Natriuretic Peptide (pg/mL)


1SCREENING2022-05-16Y



LB1
6DMD-EFLGE101



LVEF_CLeft Ventricular Ejection Fraction, Calculated (%)60CARDIAC MAGNETIC RESONANCE IMAGING6VISIT 62023-06-01Y5.4


CV11
7DMD-EFLGE101



LVCOLV Cardiac Output (L/min)4.0

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01Y74


CV12
8DMD-EFLGE101



RVEF_CRight Ventricular Ejection Fraction, Calculated (%)61

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01Y



CV15
9DMD-EFLGE101



RVCORV Cardiac Output (L/min)4.0

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01Y



CV16
10DMD-EFLGE101



BNPPRONTN-Terminal ProB-type Natriuretic Peptide (pg/mL)


6VISIT 62023-06-01Y



LB2

Dataset Debug Messages

Dataset Wrapper Debug Message

Please add a row column to your dataset.



(Copied from the SDTM page for reference until I create the sample ADaM dataset


Rows 1-8:Show the baseline CMR ejection fraction measurements for participant 101 at Screening.
Rows 9-16:Show the CMR ejection fraction measurements for participant 101 at VISIT 6.

cv.xpt

cv.xpt

RowSTUDYIDDOMAINUSUBJIDCVSEQCVLNKIDCVTESTCDCVTESTCVORRESCVORRESUCVSTRESCCVSTRESNCVSTRESUCVMETHODVISITNUMVISITCVDTCCVDY
1DMD-EFLGECV1011

LVESV

Left Ventricle End Systolic Volume32mL3232mLCARDIAC MAGNETIC RESONANCE IMAGING1SCREENING2022-05-16
2DMD-EFLGECV1012

LVEDV

Left Ventricle End Diastolic Volume95mL9595mL

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16
3DMD-EFLGECV10132LVEF_CLeft Ventricular Ejection Fraction, Calculated67%6767%CARDIAC MAGNETIC RESONANCE IMAGING1SCREENING2022-05-16
4DMD-EFLGECV10142LVCOLV Cardiac Output5.4L/min5.45.4L/min

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16
5DMD-EFLGECV1015

RVESV

Right Ventricle End Systolic Volume24mL2424mL

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16
6DMD-EFLGECV1016

RVEDV

Right Ventricle End Diastolic Volume90mL9090mLCARDIAC MAGNETIC RESONANCE IMAGING1SCREENING2022-05-16
7DMD-EFLGECV10172RVEF_CRight Ventricular Ejection Fraction, Calculated74%7474%

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16
8DMD-EFLGECV10182RVCORV Cardiac Output5.6L/min5.65.6L/min

CARDIAC MAGNETIC RESONANCE IMAGING

1SCREENING2022-05-16
9DMD-EFLGECV1019

LVESV

Left Ventricle End Systolic Volume37mL3737mLCARDIAC MAGNETIC RESONANCE IMAGING6VISIT 62023-06-01376
10DMD-EFLGECV10110

LVEDV

Left Ventricle End Diastolic Volume94mL9494mL

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01376
11DMD-EFLGECV101112LVEF_CLeft Ventricular Ejection Fraction, Calculated60%6060%CARDIAC MAGNETIC RESONANCE IMAGING6VISIT 62023-06-01376
12DMD-EFLGECV101122LVCOLV Cardiac Output4.0L/min4.04.0L/min

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01376
13DMD-EFLGECV10113

RVESV

Right Ventricle End Systolic Volume36mL3636mL

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01376
14DMD-EFLGECV10114

RVEDV

Right Ventricle End Diastolic Volume93mL9393mLCARDIAC MAGNETIC RESONANCE IMAGING6VISIT 62023-06-01376
15DMD-EFLGECV101152RVEF_CRight Ventricular Ejection Fraction, Calculated61%6161%

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01376
16DMD-EFLGECV101162RVCORV Cardiac Output4.0L/min4.04.0L/min

CARDIAC MAGNETIC RESONANCE IMAGING

6VISIT 62023-06-01376
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.





Ejection Fraction

  • change in ejection fraction, would expect a decline in EF 2-3% per year, would prefer an improvement or no change. Concerning if rapid progression, 10% decline or more, for example.

NTproBNP

  • % change over a period of time – a decrease would mean improvement, annually is appropriate

SDTM Examples: Basic CMR tests - Systolic Function



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