Illustrates Domains
ADEFF
Illustrates Variables
ITTFL
FASFL
CRIT1
CRIT1FL
CRIT1FN
BASE
CHG
PCHG
ABLFL
Content
The following is an example of a Basic Data Structure (BDS) analysis dataset and analysis-variable metadata for the endpoints in Section 7.2, Analysis of Selected Efficacy Variables. Note that some variables are not shown; only variables for the most important concepts were included in this example. For handling of missing data, the protocol-specified primary imputation method was to impute the missing PASI90, PASI75, and sPGA responses as non-response. Sponsors may use other methods for handling missing data, and other sensitivity analyses may be used that are not illustrated in this example. In this example, the PASISCO score was reported in the SDTM, because these were calculated by a vendor and not the investigator. Complete traceability should be implemented if practical and feasible; some traceability information is provided below, for illustration purposes only.
The display of the parameter-level metadata included on this page is intended to indicate the set of variables impacted by each parameter. It does not match the way the Define-XML would be displayed.
ADEFF Dataset Metadata
Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|---|---|---|---|---|---|---|
ADEFF | Efficacy Analysis Data | BASIC DATA STRUCTURE | 1 record per subject per parameter per visit | Analysis | STUDYID, USUBJID, PARAMCD, AVISIT | ADEFF.xpt | ADEFF.SAS/SAP |
ADEFF Variable Metadata
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|
| STUDYID | Study Identifier | text | ADSL.STUDYID | |
USUBJID | Unique Subject Identifier | text | ADSL.USUBJID | |
PARAM | Parameter | text | PASI Score; Static Physician Global Assessment | See parameter-value metadata. |
PARAMCD | Parameter Code | text | PASISCO; SPGA | See parameter-value metadata. |
AVISIT | Analysis Visit | text | Week 0; Week 12; Week 16 | Set to the visit as define by the SAP. |
| TRTP | Planned Treatment | text | ||
ITTFL | Intent-To-Treat Population Flag | text | Y; N | ADSL.ITTFL |
FASFL | Full Analysis Set Population Flag | text | Y; N | ADSL.FASFL |
AVAL | Analysis Value | integer | Derivations are described per parameter in the parameter value level metadata. | |
| CRIT1 | Analysis Criterion 1 | text | Derivations are described per parameter in the parameter value level metadata. | |
| CRIT1FL | Criterion 1 Evaluation Result Flag | text | Y; N | |
| CRIT1FN | Criterion 1 Evaluation Result Flag (N) | integer | 1; 0 | This variable is optional, IF CRIT1FL ="Y" then 1, else 0. |
| CRIT2 | Analysis Criterion 2 | text | Derivations are described per parameter in the parameter value level metadata. | |
| CRIT2FL | Criterion 1 Evaluation Result Flag | text | Y; N | |
| CRIT2FN | Criterion 1 Evaluation Result Flag (N) | integer | 1; 0 | This variable is optional, IF CRIT2FL ="Y" then 1, else 0. |
BASE | Baseline Value | integer | BASE = AVAL where ABLFL = "Y" | |
| CHG | Change from Baseline | integer | AVAL-BASE | |
PCHG | Percent Change from Baseline | float | ((AVAL-BASE)/BASE)*100. Populated (when calculable) for all post-baseline records of that PARAM regardless of whether that record is used for analysis. The decision on how to populate pre-baseline and baseline values of PCHG is left to producer choice. This is the percent from baseline. Negative number represent improvement. | |
ABLFL | Baseline Record Flag | text | Y | Set to "Y" when AVISIT = "Week 0". |
SRCDOM | Source Data | text | This is the source SDTM domain or ADaM dataset to which the record being used for the analysis value can be traced. This will be study-specific. | |
| SRCVAR | Source Variable | text | This is the source SDTM domain or ADaM dataset to which the record being used for the analysis value can be traced. This will be study-specific. | |
| SRCSEQ | Source Sequence Number | float | This is the source SDTM domain or ADaM dataset to which the record being used for the analysis value can be traced. This will be study-specific. |
Parameter Value Level List - ADEFF - PASISCO
Variable | Where | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|
AVAL | PARAMCD = "PASISCO" | integer | AVAL=RS.RSSTRESN where RS.RSTESTCD="PASI0129" at the corresponding visit. Subjects with missing data at the corresponding visit (e.g., AVISIT=Week 0, Week 12 and Week 16) are null. | |
| CRIT1 | PARAMCD = "PASISCO" | text | PASI75 | |
CRIT1FL | PARAMCD = "PASISCO" | text | Y; N | CRIT1FL="Y" where "PASISCO PCHG is not null and <=-75%, "N" if PCHG >-75 or PCHG is missing. |
| CRIT2 | PARAMCD = "PASISCO" | text | PASI90 | |
CRIT2FL | PARAMCD = "PASISCO" | text | Y; N | CRIT2FL="Y" where PASISCO PCHG is not null and <=-90%, "N" if PCHG >-90 or PCHG is missing. |
Parameter Value Level List - ADEFF - SPGA
| Variable | Where | Type | Codelist/Controlled Terms | Source/Derivation/Comment |
|---|---|---|---|---|
| AVAL | PARAMCD = "SPGA" | integer | AVAL=QS.QSSTRESN where QS.QSTESTCD="CGI02-Severity" and QSCAT="PSORIASIS" at the corresponding visit. Subjects with missing data at the corresponding visit (e.g., AVISIT=Week 0, Week 12 and Week 16) are null. | |
| CRIT1 | PARAMCD = "SPGA" | text | sPGA 0 or 1 with a minimum 2 category improvement | |
| CRIT1FL | PARAMCD = "SPGA" | text | Y; N | CRIT1FL="Y" where AVAL= 0 or 1 and CHG is not null and <=-2, otherwise "N". |