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The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests - Systolic Function. The example datasets show visits 1 and 6 for one subject. The subject 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. The associated laboratory test, N-Terminal ProB-type Natriuretic Peptide, is used in conjunction with ejection fraction as a biomarker and is important for diagnosis and treatment. It is also used separately to identify the percent change over a period of timeCV dataset 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 it was added as a ptential covariate in each row for the last analysis. As in all ADaM datasets, the Subject Level Analysis Dataset (ADSL) was merged in to the SDTM datasets to capture all the necessary demographics, treatments and other required variables for analysis of the data.
Analysis Datasets
The example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the Metadata Table below. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown . One variable mentioned for illustrative purposes. For example, one variable added; body surface area at baseline (BSA), can be computed and added to BSABL) was computed for baseline records in ADSL. However, since the subjects are children, the body surface area changes over time. Therefore, it would probably be better necessary to have a separate dataset to represent this over time.
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