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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 "RVEF_C" were used for analysis. In the LB dataset, the records where LBTESTCD = "BNPPRONT" were used to compute the percentage change over time, then added as a potential covariate in each row for the last analysis. The SDTM datasets were merged with a Subject Level Analysis Dataset (ADSL) dataset to record the demographics, treatments and other appropriate variables for analysis.
ADaM Datasets
The tables below show the example analysis dataset includes treatment and demographic information drawn from the ADSL, defined in the metadata table belowdatasets and unique parameters for this endpoint. In this example, only some of the required variables, plus important stratification variables from ADSL, are shown for illustrative purposes. For example, 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 endpoint. 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.
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". In this case, many lab draws may 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.
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Dataset Description
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Structure
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ADSL
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Subject-Level Analysis Dataset
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BASIC DATA STRUCTURE
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Analysis Dataset
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ADSL Analysis Dataset
The ADSL includes demographics, treatment groups, study dates and stratification variables. For this example, the ADSL is not shown other than as a source for standard ADaM variables. See Section 2.3.1 of the ADaMIG v1.3 for additional information.
ADCVNTP Analysis Dataset
The 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 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.
ADSL Analysis Dataset
The ADSL includes demographics, treatment groups, study dates and stratification variables. For this example, the ADSL is not shown other than as a source for standard ADaM variables. See Section 2.3.1 of the ADaMIG v1.3 for additional information.
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ADCVEF 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.
ADCVMRI Analysis Dataset
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.
Example Analysis Results Metadata (ARM) Tables
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