ADaM ADSL

Illustrates Domains

ADSL

Illustrates Variables

STRATAR
STRAT1D
STRAT1R
STRAT2D
STRAT2R


Content

The following is an example of an abbreviated ADSL dataset. The variables presented are those that may be of specific interest to the analysis of Crohn's disease trials. Stratification factors indicating prior treatment with a biologic and disease severity were included as a covariates; these stratification factors are optional. The proposed variable names follow ADaM naming conventions. The following tables provide examples of an ADSL dataset metadata and ADSL variable metadata. The source derivation metadata for the variables are provided for illustrative purposes and are not intended to represent standard derivation logic. Additional text in the Source/Derivation/Comment column provides further discussion for the variable and would not be present in an actual define.xml document.  

This ADSL includes 2 stratification factors used to determine randomization balance: prior anti-TNF-alpha usage baseline and disease severity. These would most like come from the randomization file and may be checked against the collected SDTM data.

adsl.xpt

adsl.xpt

RowSTUDYIDUSUBJIDTRT01PITTFLFASFL

STRATAR

STRAT1DSTRAT1RSTRAT2DSTRAT2R
1CR123CR123-001Drug AYYY, Non-SeverePrior anti-TNF-alpha UsageYDisease SeverityNon-Severe
2CR123CR123-002Drug BYYN, SeverePrior anti-TNF-alpha UsageNDisease SeveritySevere

ADSL Dataset Metadata

ADSL Variable Metadata