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The data Analysis dataset (ADaM) is created from the SDTM examples for ejection fraction can be used for multiple endpoint analysescollected data stored in SDTM. It should have full traceability back to the input datasets. 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 example datasets from which this data is drawn 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 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 time.

The analysis dataset also includes treatment and demographic information drawn from the ADSL. In this example, we only show some of the required variables plus important stratification variables from ADSL. One variable mentioned body surface area (BSA), can be computed and added to ADSL. However, since the subjects are children their body surface area changes over time. Therefore it would probably be better to have a separate dataset to capture this. In this example, we will show one variable for BSA with the label "BASELINE Body Surface Area".

Questions. 

Is screening considered visit 1, or is it to include the subject into the study? SDTM team agreed to change to VISIT 1 instead of SCREENING.

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

Should both endpoints be shown in one efficacy dataset or two?  I will be showing 3 datasets.

bWhat is a good surface area to use for the child subject?

Should i use Male and 6 years? please advise.

Analysis Datasets

Below is the table of analysis datasets and unique parameters created for the example. The ADSL is required as part of the process of creating the subsequent analysis datasets.

ADCVEF is a dataset capturing only the tests required for this analysis, selecting for CVTESTCD equal to "LVEF_C" or "LVCO".  The relationship dataset RELREC is merged in with ADCVEF in preprarion to add the tests from LB to the efficacy dataset.
ADLBNTRP is a subset of LB selecting for LBTESTCD  equal to "BNPPRONT", and LBLINKID not missing. In this case, many lab draws may occur throughout the year, but we are only interested in the ones linked to a specific visit.

ADCMRI 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 a Basic Structure dataset with additional variables added from ADCVEF.

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.

Analysis Datasets

The following are the data structures for the example ADaM datasetThe following are the parameters for the example ADaM datasets. Note that the columns for derived variables, BASE, and CHG, PCHG and CHGCAT1 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. the efficacy analysis of endpoints. The example demographics for ADSL were created for a xx year old male child.