ADSL Composite Endpoint

Illustrates Domains

ADSL

Illustrates Variables

DCSREAS
CREATBL
GFREBL
DTHDT
DTHCAUS

Content

This is a simplified example ADSL dataset for an AKI trial. It is anticipated that, for many studies, other variables of interest would be included. The dataset includes information needed to derive the study's composite primary endpoint. Not all ADSL variables are shown; this example focuses on specific variables useful for AKI analysis. See the ADaMIG for required ADSL variables.

adsl.xpt

adsl.xpt

Row	USUBJID	EOSSTT	DCSREAS	CREATBL	GFREBL	DTHDT	DTHCAUS	EOSDT	TRTSDT
1	XYZ-001-001	DISCONTINUED	DEATH	1.1	95	2013-11-02	SEPSIS	2013-11-02	2013-08-10
2	XYZ-001-002	DISCONTINUED	DEATH	1.2	58.5	2015-03-20	SUDDEN CARDIAC DEATH	2015-03-20	2014-12-29
3	XYZ-001-003	COMPLETED	COMPLETED	0.8	105			2010-10-12	2010-07-11
4	XYZ-001-004	DISCONTINUED	DEATH	0.9	78.9	2015-04-03	RENAL FAILURE	2015-04-03	2015-01-31
5	XYZ-001-005	COMPLETED	COMPLETED	1.4	68.3			2015-01-23	2014-10-26
6	XYZ-001-006	COMPLETED	COMPLETED	1.3	93.5			2015-01-25	2014-10-28

ADSL Dataset Metadata

Dataset Name	Dataset Description	Dataset Location	Dataset Structure	Keys	Class	Documentation
ADSL	Subject-Level Analysis Dataset	ADSL.XPT	One record per subject	STUDYID, USUBJID	ADSL	ADSL.SAS/SAP

ADSL Variable Metadata

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Source/Derivation/Comment
USUBJID	Unique Subject Identifier	text		Predecessor: DM.USUBJID
EOSSTT	End of Study Status	text	COMPLETED;DISCONTINUED	Derived: If DS.DSCAT = "DISPOSITION EVENT" and DS.DSDECOD = "COMPLETED" set to "COMPLETED". If DS.DSCAT = "DISPOSITION EVENT" and DS.DSDECOD is not "COMPLETED" set to "DISCONTINUED".
DCSREAS	Reason for Discontinuation from Study	text	COMPLETED;DEATH	Derived: Set to DS.DSDECOD where DS.DSCAT = "DISPOSITION EVENT".
CREATBL	Baseline Creatinine (mg/dL)	float		Derived: Set to LB.LBORRES where LB.LBTESTCD = "CREAT" and LB.LBLOBXFL = "Y".
GFREBL	Baseline GFRE (mL/min/1.73m2)	float		Derived: Set to LB.LBORRES where LB.LBTESTCD = "GFRE" and LB.LBLOBXFL = "Y".
DTHDT	Date of Death	integer		Derived: DM.DTHDTC converted from ISO to numeric.
DTHCAUS	Cause of Death	text		Derived: Set to DD.DDSTRESC where DD.DDTEST = "Primary Cause of Death".
EOSDT	End of Study Date	integer		Derived: DS.DSSTDTC where DS.DSCAT="DISPOSITION EVENT". ISO date should be converted to numeric.
TRTSDT	Date of First Exposure to Treatment	integer		Derived: DM.RFXSTDTC converted from ISO to numeric.