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

• From CV domain
  • Percent change in ejection fraction

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• • over time
  • Decline in ejection fraction

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• • over a

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• • time period (yearly) grouped by a decline greater than 10.0%.
• From the LB domain
  • Percent change in NTproBNP

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• • over a period of

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• • 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" were used for analysis. In the LB dataset, the records representing the Ventricular Ejection Fraction, Calculated (%) for left and right were selected for the analysis. The LB dataset test where LBTESTCD = "BNPPRONT" were used was used to add the value of BNPPRONT to compute the percentage percent change over time, and then it was added as a potential ptential covariate in each row for the last analysis. The SDTM datasets were merged with a   As in all ADaM datasets, the Subject Level Analysis Dataset (ADSL) dataset was merged in to record the SDTM datasets to capture all the necessary demographics, treatments and other appropriate required variables for analysis of the data.

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Analysis Datasets

The tables below show the example analysis datasets and unique parameters for this endpointdataset 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 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.

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Dataset Name

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Dataset Description

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Structure

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Location

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Keys

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ADSL

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BASIC DATA STRUCTURE

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ADSL Analysis Dataset

The ADSL includes The table below shows the example analysis datasets and unique parameters for this example. 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. For In this example, the ADSL is not shown other than illustrated, but serves as a source for standard ADaM variables. See Additional information can be found in Section 2.3.1 of the ADaM Implementation Guide (ADaMIG) v1.3 for additional information.

ADCVNTP Analysis Dataset

The ADCVEF dataset includes tests pertinent to this analysis, those for which CVTESTCD is equal to "LVEF_C" or "RVEF_C". The relationship dataset RELREC illustrates the relationship between datasets. 

The ADCVNTRP dataset is a subset of the Laboratory Results (LB) SDTM dataset, for which LBTESTCD is equal to "BNPPRONT". ADCVNTP dataset is a subset of the Laboratory Results (LB) SDTM dataset, for which LBTESTCD is equal to "BNPPRONT". In this case, many lab draws may be conducted occur throughout the year, but only those linked to a specific visit are included. By subsetting the LB dataset with 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.

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 an ADaM Basic Data Structure (BDS) dataset, with additional variables added from ADCVEF.

Analysis Datasets

The subsequent section provides 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.at baseline (BSABASE), was added from ADSL.

Example 11 

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)