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- Percent change in ejection fraction over time
- Decline in ejection fraction over a time period (1 year) grouped by a decline greater than 10.0%.
- Percent change in NTproBNP over a period of time (1 year)
Source Data
The SDTM examples used as the source data are from Section 2.1, Basic CMR Tests for Systolic Function. The CV 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 potential 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.
Example Analysis Datasets
The analysis datasets for this example include treatment and demographic information drawn from the Subject Level Analysis Dataset (ADSL), defined in the Metadata Tables below. Only some of the required variables from ADSL are shown for illustrative purposes. The ADSL incorporates demographics, treatment groups, study dates, and stratification variables. Additional information on the ADSL can be found in Section 2.3.1 of the ADaM Implementation Guide (ADaMIG) v1.3.
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Analysis Datasets
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), and an example of a stratification variable for subjects with was added from ADSL.
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Example Analysis Results Metadata (ARM) Tables
These tables may be included in the submission package for regulatory agencies. They describe the analyses conducted for the study (usually limited to primary and secondary endpoints) with details on data and analysis procedures used.
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