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.
|1||CR123||CR123-001||Drug A||Y||Y||Y, Non-Severe||Prior anti-TNF-alpha Usage||Y||Disease Severity||Non-Severe|
|2||CR123||CR123-002||Drug B||Y||Y||N, Severe||Prior anti-TNF-alpha Usage||N||Disease Severity||Severe|
ADSL Dataset Metadata
Subject-Level Analysis Dataset
|SUBJECT LEVEL ANALYSIS DATASET||One record per subject||Analysis||STUDYID, USUBJID||ADSL.xpt||ADSL.SAS|
ADSL Variable Metadata
|Variable Name||Variable Label||Type||Codelist||Source/Derivation/Comment|
|USUBJID||Unique Subject Identifier||text||DM.USUBJID|
Planned Treatment for Period 01
Intent-To-Treat Population Flag
Y if the subject has been assigned a Randomization number.
Full Analysis Population Flag
Y if the subject has met the criteria defined in the SAP.
|STRATAR||Strata Used for Randomization||text||Prior TNF-alpha Usage (Y vs N), Disease Severity (Severe vs Non-Severe)|
Subject level values used at randomization to determine a subject's treatment group
|STRAT1D||Description of Stratification Factor 1||text||Prior anti-TNF-alpha Usage||First factor captured in STRATAR|
|STRAT1R||Strat Factor 1 Value Used for Rand||text||Y; N||First factor subject value|
|STRAT2D||Description of Stratification Factor 2||text||Disease Severity|
Second factor captured in STRATAR
|STRAT2R||Strat Factor 2 Value Used for Rand||text||Severe; Non-Severe||Second factor subject value|