The following is an example of an abbreviated ADSL dataset. The variables presented may be of specific interest to the analysis of psoriasis trials. A flag variable indicating prior treatment with a biologic was included as a covariate; this flag variable is optional. The baseline values of several variables were also included, as analyses may be performed to investigate the efficacy results based on the severity of disease at baseline. The proposed variable names follow ADaM naming conventions. The 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. 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 the baseline PASIBL score. A sponsor may derive this in a pre-ADSL dataset. If this process is utilized, the pre-ADSL dataset should follow ADaM principles but may not contain all required ADSL variables. See the ADaMIG for additional information (https://www.cdisc.org/standards/foundational/adam).
ADSL Dataset Metadata
|ADSL||Subject-level Analysis||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.
|Prior Biologic Usage Flag||text||Y; N||Y if the subject had received a biologic therapy before start of the study.|
|PASIBL||Baseline PASI Score||float|
The source for this variable may be a pre-ADSL dataset or the source SDTM domain and associated record identification. This would be study-specific.
|Baseline Static Physician Global Assessment||integer||The source of this would be the SDTM QS domain and the associated record identification. This would be study-specific.|
Baseline Percent BSA Affected
|integer||The source of this would be the SDTM FA domain and the associated record identification. This would be study-specific.|