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This example illustrates In this section, example analysis datasets are shown for the following endpoints:

• From CV domain
  • Percent change in ejection fraction over time
  • Decline in ejection fraction over a time period (yearly) grouped by a decline greater than 10.0%.
• From the LB domain
  • Percent change in NTproBNP over a period of time (yearly).

Source Data

The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests - Systolic Function. The CV dataset contains 16 rows, 1-8 for visit 1 and 9-16 for visit 6. Of these rows, the ones where 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 were used for analysis. In the LB dataset, the records where LBTESTCD = "BNPPRONT" was were used to add the value of BNPPRONT to compute the percent percentage change over time, and then it was added as a ptential potential covariate in each row for the last analysis.   As in all ADaM datasets, the The SDTM datasets were merged with a Subject Level Analysis Dataset (ADSL) was merged in dataset to record the SDTM datasets to capture all the necessary demographics, treatments and other required appropriate variables for analysis of the data.

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ADaM Datasets

The example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the Metadata Table metadata table below. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown for illustrative purposes. For example, one variable added; body surface area at baseline (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 necessary to have a separate dataset to represent this over time.

The table below shows the example analysis datasets and unique parameters for this exampleendpoint. The Subject Level Analysis Dataset (ADSL)   is a necessary component in the creation process of subsequent analysis datasets for human trials. The ADSL incorporates demographics, treatment groups, study dates, and stratification variables. In this example, the ADSL is not illustrated, but serves as a source for standard ADaM variables. Additional information can be found in Section 2.3.1 of the ADaM Implementation Guide (ADaMIG) v1.3.

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ADSL Analysis Dataset

ADCVNTP Analysis Dataset

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The subsequent section provides the data structures for the example ADaM datasets. 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 (BSABASE), was added from ADSL.

Example 1 1

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

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Example Analysis Results Metadata (ARM) Tables

This table may be included in the submission package for regulatory agencies. It describes the analyses conducted for the study (usually limited to primary and secondary  endpoints) with details on data and analysis procedures used. The first example uses the dataset ADCVNTPR, selecting for the parameter "N-Terminal ProB-type Natriuretic Peptide (IU/L)"is an example ARM table for the selected endpoint. Other endpoints can be represented in the same way describing the variables and procedures used. For more details on ARM, see the ADaMIG and the ARM implementation in Define-XML (available at https://www.cdisc.org/standards/foundational/define-xml/).

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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

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