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For the ADSL here is an additional SDTM dataset showing variables needed for ADSL.
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| Show | true |
|---|---|
| Name | dm |
Shows the demographics for one subject. RFSTDTC represents the beginning of the trial, or subject registration date.
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Analysis Datasets
The example analysis dataset 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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