ADAKIEP Composite Endpoint

Illustrates Domains

ADSL

Illustrates Variables

SRCDOM
SRCSEQ

Content

This is an example of a BDS dataset with summary occurrence and date information about the composite endpoint.

adakiep.xpt

adakiep.xpt

Row	USUBJID	PARAM	PARAMCD	AVALC	ADY	ADT	SRCDOM	SRCSEQ
1	XYZ-001-001	Death	DEATH	Y	85	2013-11-02	DS	1
2	XYZ-001-001	Dialysis	DIALYSIS	Y	80	2013-10-29	PR	2
3	XYZ-001-001	eGFR 25 Percent Decrease	EGFRDEC	N	85	2013-11-02
4	XYZ-001-001	Composite AKI Endpoint	AKIEP	Y	80	2013-10-29
5	XYZ-001-002	Death	DEATH	Y	82	2015-03-20	DS	1
6	XYZ-001-002	Dialysis	DIALYSIS	Y	73	2015-03-11	PR	2
7	XYZ-001-002	eGFR 25 Percent Decrease	EGFRDEC	N	82	2015-03-20
8	XYZ-001-002	Composite AKI Endpoint	AKIEP	Y	73	2015-03-11
9	XYZ-001-003	Death	DEATH	N	94	2010-10-12	DS	1
10	XYZ-001-003	Dialysis	DIALYSIS	Y	64	2010-09-12	PR	2
11	XYZ-001-003	eGFR 25 Percent Decrease	EGFRDEC	Y	93	2010-10-11	ADLB	6
12	XYZ-001-003	Composite AKI Endpoint	AKIEP	Y	64	2010-09-12
13	XYZ-001-004	Death	DEATH	Y	63	2015-04-03	DS	1
14	XYZ-001-004	Dialysis	DIALYSIS	N	63	2015-04-03	PR	1
15	XYZ-001-004	eGFR 25 Percent Decrease	EGFRDEC	N	63	2015-04-03
16	XYZ-001-004	Composite AKI Endpoint	AKIEP	Y	63	2015-04-03
17	XYZ-001-005	Death	DEATH	N	89	2015-01-23	DS	1
18	XYZ-001-005	Dialysis	DIALYSIS	N	89	2015-01-23	PR	1
19	XYZ-001-005	eGFR 25 Percent Decrease	EGFRDEC	N	89	2015-01-23
20	XYZ-001-005	Composite AKI Endpoint	AKIEP	N	89	2015-01-23
21	XYZ-001-006	Death	DEATH	N	89	2015-01-25	DS	1
21	XYZ-001-006	Dialysis	DIALYSIS	N	89	2015-01-25	PR	1
22	XYZ-001-006	eGFR 25 Percent Decrease	EGFRDEC	N	89	2015-01-25
23	XYZ-001-006	Composite AKI Endpoint	AKIEP	N	89	2015-01-25

The analysis dataset metadata, as well as the analysis variable metadata, for ADAKIEP are presented in the first 2 tables that follow. The remainder of the tables represent parameter value-level lists for applicable variables.

ADAKIEP Dataset Metadata

Dataset Name	Description	Class	Structure	Keys	Location	Documentation
ADAKIEP	Composite AKI Endpoints Analysis Data	BASIC DATA STRUCTURE	One record per subject per parameter	USUBJID, PARAMCD	adakiep.xpt	See SAP, Section X.X.X

ADAKIEP Variable Metadata

Variable Name	Variable Label	Type	Length	Codelist/Controlled Terms	Source/Derivation/Comment
USUBJID	Unique Subject Identifier	text	8		Predecessor: ADSL.USUBJID
PARAM	Parameter	text	20	Death; Dialysis; eGFR 25 Percent Decrease; Composite AKI Endpoint	Assigned
PARAMCD	Parameter Code	text	8	DEATH; DIALYSIS; EGFRDEC; AKIEP	Assigned
AVALC	Analysis Value (C)	text	1	Y; N	Assigned: See parameter value metadata
ADY	Analysis Day	integer	4		Derived: ADAKIEP.ADT-ADSL.TRTSDT+1
ADT	Analysis Date	integer	8		Assigned: See parameter value metadata
SRCDOM	Source Data	text	4		Derived: See parameter value level metadata
SRCSEQ	Source Sequence Number	integer	2		Derived: See parameter value level metadata

These tables represent parameter value level lists for applicable variables.

ADAKIEP Parameter [CL.PARAM.ADAKIEP]

Permitted Value (Code)
Death
Dialysis
eGFR 25 Percent Decrease
Composite AKI Endpoint

ADAKIEP Parameter Code [CL.PARAMCD.ADAKIEP]

Permitted Value (Code)	Display Value (Decode)
DEATH	Death
DIALYSIS	Dialysis
EGFRDEC	eGFR 25 Percent Decrease
AKIEP	Composite AKI Endpoint

Parameter Value Level List - ADAKIEP [AVALC]

Variable	Where	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
AVALC	PARAMCD="DEATH"	text	1	Y;N	Derived	Set to "Y" where DS.DSDECOD="DEATH" and ADSL.DTHDT<ADSL.TRTSDT+90 Otherwise set to "N"
AVALC	PARAMCD="DIALYSIS"	text	1	Y;N	Derived	Set to "Y" if there are any records where PR.PRDECOD="RENAL REPLACEMENT THERAPY" and PR.PRCAT="RENAL REPLACEMENT THERAPY" and PR.PROCCUR = 'Y" Otherwise set to "N"
AVALC	PARAMCD="EGFRDEC"	text	1	Y;N	Derived	Set to "Y" If if there are any records where ADGFR.CONFRMFL is Y Otherwise set to "N"
AVALC	PARAMCD="AKIEP"	text	1	Y;N	Derived	Set to "Y" if there are any records where PR.PRDECOD="RENAL REPLACEMENT THERAPY" and PR.PRCAT="RENAL REPLACEMENT THERAPY" and PR.PROCCUR="Y" OR ADGFR.CONFRMFL is Y OR DS.DSDECOD="DEATH" Otherwise set to "N"

Parameter Value Level List - ADAKIEP [ADT]

Variable	Where	Type	Length	Controlled Terms or Format	Origin	Derivation/Comment
ADT	PARAMCD="DEATH"	integer	8	date9.	Derived	Derived: Set to DS.DSSTDTC where DS.DSDECOD="DEATH" and ADSL.DTHDT<ADSL.TRTSDT+90 Otherwise set to ADSL.EOSDT
ADT	PARAMCD="DIALYSIS"	integer	8	date9.	Derived	Derived: Earliest value of PR.PRSTDTC converted to numeric where PR.PRCAT="RENAL REPLACEMENT THERAPY" Otherwise set to ADSL.EOSDT
ADT	PARAMCD="EGFRDEC"	integer	8	date9.	Derived	Derived: Set to the earliest ADGFR.ADT where ADGFR.CONFRMFL = "Y" Otherwise set to ADSL.EOSDT
ADT	PARAMCD="AKIEP"	integer	8	date9.	Derived	Derived: Set to earliest value of ADSL.DTHDT when ADSL.DTHDT<ADSL.TRTSDT+90 PR.PRSTDTC where PR.PRCAT="RENAL REPLACEMENT THERAPY" ADGFR.ADT where ADGFR.CONFRMFL = "Y"

Parameter Value Level List - ADAKIEP [SRCDOM]

Variable	Where	DataType	Length	Origin	Derivation/Comment
SRCDOM	PARAMCD="DEATH"	text	2	Assigned	Set to "DS"
SRCDOM	PARAMCD="DIALYSIS"	text	2	Assigned	Set to "PR"
SRCDOM	PARAMCD="EGFRDEC"	text	4	Assigned	Set to "ADGFR" if CONFRMFL = 'Y" otherwise null
SRCDOM	PARAMCD="AKIEP"	text	2	Assigned	Set to null

Parameter Value Level List - ADAKIEP [SRCSEQ]

Variable	Where	DataType	Length	Origin	Derivation/Comment
SRCSEQ	PARAMCD="DEATH"	integer	2	Derived	Set to DS.DSSEQ where DSCAT = "DISPOSITION EVENT"
SRCSEQ	PARAMCD="DIALYSIS"	integer	2	Derived	If PR.PRCAT = "RENAL REPLACEMENT THERAPY" and PR.PROCCUR = "Y" set to value of PR.PRSEQ corresponding to the earliest value of PR.PRSTDTC If PR.PRCAT = "RENAL REPLACEMENT THERAPY" and PR.PROCCUR = "N" set to PR.PRSEQ
SRCSEQ	PARAMCD="EGFRDEC"	integer	2	Derived	Set to ADGFR.ASEQ where CONFRMFL = "Y" otherwise null
SRCSEQ	PARAMCD="AKIEP"	integer	2	Derived	Set to null