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Title	ASSIGN Risk Score (ASSIGN CVD 10-YEAR RISK)
CDISC Reference	Clinical Classifications Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name	(ASSIGN CVD 10-YEAR RISK)
QRS Permission Status	Public Domain
Team	Dyslipidemia Standards Team and CDISC QRS Sub-Team
Supplement Version	2.0
Status	FINALREVISION DRAFT
Date	2023-XX04-XX22
Notes	This supplement is intended to be used with other CDISC User Guides for specific Therapeutic/Disease Areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical trials.

Revision History

Date	Version	Summary of Changes
2023-XX-XX	2.0	ASSIGN CVD 10-YEAR RISK Final Converted the supplement to the current WIKI QRS supplement template. Updated RSTEST name
2016-07-14	1.0	ASSIGN CVD 10-YEAR RISK Final Based on the SDS Team decision to not release the draft CC domain, but include its definition in the RS domain, all references to the CC domain were revised to the RS domain throughout this document.
from Supp V1.0 from "ASSG01-ASSIGN CVD Risk Score" to "ASSG01-ASSIGN Score" based on the published controlled terminology. Replace the RSBLFL variable with the current RSLOBXFL variable. The original QSEVAL assumption 3 and the variable was removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values. Added a missing visit to the examples.
2016-07-142015-10-07	1.0	ASSIGN CVD 10-YEAR RISK Draft
2015-01-05	1.0	ASSIGN CVD 10-YEAR RISK Draft
Final Based on the SDS Team decision to not release the draft CC domain, but include its definition in the RS domain, all references to the CC domain were revised to the RS domain throughout this document.

1 Introduction

This document describes the CDISC implementation of the Acute Physiology and Chronic Health Evaluation II (APACHE II) instrument. CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standardsthe ASSIGN CVD 10-YEAR RISK instrument.

The ASSIGN CVD 10-YEAR RISK does not have a CRF and the algorithm to calculate the ASSIGN CVD 10-YEAR RISK is in the public domain.

The representation of data collected for this instrument is this clinical classification is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument clinical classification are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages clinical classifications documentation can be found on the CDISC website CDISC web site at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website web site at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG Study Data Tabulation Model Implementation Guide for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

2 Copyright Status

CDISC believes this instrument is to be in the public domain, but you should perform your own assessment. CDISC CDISC has included the APACHE II in ASSIGN CVD 10-YEAR RISK in the CDISC inventory library of QRS data standards supplements. Hence Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrumentthis instrument. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument measure consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. .

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the APACHE IIASSIGN: Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical Care Medicine 1985; 13(10):818–29.

Woodward M, Brindle P, Tunstall-Pedoe H, for the SIGN group on risk estimation. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart 2007; 93: 172-176.

3 The RS Domain Model

3.1 Assumptions for

...

Disease Response and Clin Classification Domain Model

All assumptions and business rules described in the SDTMIG RS SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the APACHE II are listed below.

The QRS APACHE II is a severity-of-disease classification system that uses a point score based on the initial values of 12 routine physiologic measurements, age, and previous health status. Scores range from 0 to 71 and higher scores correspond to more severe disease and a higher risk of death. The composite score is based on findings represented in other SDTM domains such as Laboratory Test Results (LB) and Vital Signs (VS).

The APACHE II provides weightings for 12 physiology measures, the sum of which yields a total acute physiology score (APS). This weighting system for 11 of the physiology measures is based on a numeric rating scale (0-4) where 0 reflects values within the normal range and an increase in the numeric rating scale represents an increase in the abnormality of the physiology measure in either the high or low direction.
1. For example, the rating of 4 for heart rate (ventricular response) may coincide with multiple definitions depending on whether the abnormality is in the high or low direction (e.g., 4 = ">=180" or 4 = "<=39", respectively).
2. Note that the score for the Glasgow Coma Score (GCS), the final physiology measure, is the reverse; lower scores indicate mild or no head injury and higher scores represent more severe head injury.
3. Age and severe chronic health problems reflect diminished physiologic reserve; these have been directly incorporated into APACHE II. Chronological age is a well-documented risk factor for death from acute illness that is independent of severity of disease. This item includes a numeric rating (0, 2, 3, 5, 6) and a definition of what is represented by the rating (e.g., 6 = ">=75" years in age).
4. Severe chronic organ system insufficiency or immunocompromised state markedly influenced outcome. Nonoperative and emergency surgery admissions had a substantially higher risk for death from prior chronic conditions than did elective surgical admissions. This indicates that patients with the most severe chronic conditions are not considered to be candidates for elective surgery. For patients with a history of severe organ system insufficiency or who are immunocompromised, a numeric rating of 2 or 5 is assigned for chronic health points, where 2 is assigned “for elective postoperative patients” and 5 is assigned “for nonoperative or emergency postoperative patients”.
5. For the APACHE II, RSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
Records are created in rs.xpt (or in split rsap.xpt) for every item on the instrument.
1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE". If the reason is known then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND is missing.
Some items on the QRS APACHE II may be not done due to conditional branching per the instrument instructions.
1. The equation for computing the alveolar-arterial O₂ gradient is heavily dependent on inspired O₂ levels, so there are 2 methods for calculating oxygenation. When inspired O₂ levels ≥ 0.5 use the alveolar-arterial O₂ gradient and complete RSTESTCD = "APCH105A". When inspired O₂ levels < 0.5 use the partial pressure of oxygen (PaO₂) and complete RSTESTCD = "APCH105B". The other will be treated as not done due to conditional branching.
2. In addition, arterial pH (RSTESTCD = "APCH106A") is preferred but in cases where oxygenation is normal and blood gases are not measured, serum HCO₃ (RSTESTCD = "APCH106B") can be substituted. Only 1 of these 2 physiological parameters will be measured and the other will be treated as not done due to conditional branching.
3. In addition, a chronic health response, item RSTESTCD = "APCH115", is only assigned (along with the points) when the patient has a history of severe organ system insufficiency or is immunocompromised. Otherwise it will be not done due to conditional branching.
4. A record is created in rs.xpt for all items. When an item is considered conditionally branched, it is represented as follows:
  1. RSSTAT = "NOT DONE"
  2. RSDRVFL = "Y" (the record is derived as a "NOT DONE" record)
  3. QNAM = “RSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y” (RS supplemental qualifier variable)
  4. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing)
The APACHE II instrument includes a total APS and total APACHE II score which are considered as captured data on the CRF and not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions on the CRF. If scores are received by the sponsor,
1. It is recommended that they are submitted to SDTM and verified in ADaM.
Terminology
1. RSCAT, RSTESTCD, RSTEST, and RSORRESU values are included in CDISC Controlled Terminology.
2. A full list of value sets for the result and unit fields are provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the QRS APACHE II RS Domain Model

The rsap.xpt dataset represents the items from the APACHE II. The RS domain was split into 2 physically separate datasets: the APACHE II instrument (rsap.xpt) and the GCS (rsgc.xpt). Each dataset represents a subset of the RS domain. Note: In this example, the vital sign and lab values used to answer the APACHE II items were also collected and represented separately in the VS and LB domains. RSLNKID is used to link the APACHE II records to their corresponding findings in their respective source domains. This relationship is defined in the RELREC table.

The APACHE II example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 2 subjects collected at visit 1 for the APACHE II instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, RSCAT, and RSORRESU. All original results, matching the CRF item response text, are represented in RSORRES. This result is then represented as a standard numeric score in RSSTRESN and as a standard character representation in RSSTRESC

The table represents the items from the APACHE II instrument.

...

Name	rs

...

Show that this subject was evaluated for oxygenation (mmHg) where FIO₂ is less than 0.5, so PaO₂ is recorded. Oxygenation (mmHg) for A-aDO₂,where FIO₂ is greater than or equal to 0.5, is shown as not done due to conditional branching.

...

Show that this subject was evaluated for arterial pH. Serum HCO₃ (venous mmol/L) is shown as not done due to conditional branching since arterial pH is preferred when arterial blood gases are available.

...

Show the subject was not evaluated on this instrument at visit 1. A record for each item on the instrument is created with a status of "NOT DONE". Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. No assumptions are made about which items were not done based on conditional branching.

...

tableid	rs.xpt

...

The following dataset represents source-data GCS scores which were input into the APACHE II. Note that RSSEQ is set to start at 101 for each subject within this split RS domain as APACHE II is only collected once during the study (at VISITNUM=1). RSGRPID in the split domain below matches RSGRPID for the corresponding record in the preceding RS domain example.

Dataset wrap

Name	dm

Dataset2

tableid	dm.xpt

Row	STUDYID	DOMAIN	USUBJID	SUBJID	SEX	BRTHDTC	AGE	AGEU
1	1001	DM	1001-001	1	F	6/24/1972	39	YEARS
2	1001	DM	1001-002	2	M	2/2/1947	65	YEARS

The following dataset represents source-data vital signs tests that were input into the APACHE II. Note that the result values fall within the ranges contained in RSORRES in the corresponding RS record. VSLNKID matches RSLNKID for each corresponding record in the RS domain example above.

...

Name	vs

...

Row

...

STUDYID

...

DOMAIN

...

USUBJID

...

VSSEQ

...

VSLNKID

...

VSTESTCD

...

VSTEST

...

VSORRES

...

VSORRESU

...

VSSTRESC

...

VSSTRESN

...

VSSTRESU

...

VSLOC

...

VSBLFL

...

VISITNUM

...

VSDTC

...

the ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) are listed below.

The ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) describes the cardiovascular risk of the subject. The score is expressed as a percentage.

The ASSIGN Cardiovascular Disease 10-Year Risk Score is derived via an algorithm that includes labs, vital signs, medical history, substance use, social deprivation and demography. Please refer to Appendix 1 of the reference cited above for the algorithm calculation. This is considered captured data and not a derivation.
Social deprivation is represented with the Scottish Index of Multiple Deprivation (SIMD) and comes from a database which uses the postal code of the subject. The SIMD is collected and used to calculate the ASSIGN, however is considered to be a possible privacy issue. Therefore it is not submitted and is not represented in the example below.
Terminology:
1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
2. The value sets for the result field are not provided in Section 4, SDTM Mapping Strategy, since there is only a single numeric percentage result.

3.2 Example for the RS Domain Model

The ASSIGN CVD 10-YEAR RISK Score example below shows the terminology used to implement this clinical classification measure in the RS domain. This example shows data collected for the ASSIGN CVD 10-YEAR RISK Score for two subjects, one has only one visit and the other has two visits. The example uses CDISC controlled terminology for RSTESTCD, RSTEST, and RSCAT. SCTESTCD and SCTEST are not represented here for the SIMD per assumption 2. Data that is used for input to the composite scores such as labs, vital signs, substance use, social deprivation and medical history are included in its original domain and the relationship to the RS domain should be defined using the RELREC domain. The ASSIGN CVD 10-YEAR RISK is represented in the RS domain and is linked to the other domains in RELREC by the RSLNKID.

The table represents the items from the ASSIGN CVD 10-YEAR RISK instrument. The USUBJID = "1001-002" was not evaluated for this instrument at visit 5. Since the visit was missed, the reason for not completing the visit was not collected, so no date is assumed for when the visit would have occurred.

Dataset wrap

Name	rs

Dataset2

tableid	rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKID	RSTESTCD	RSTEST	RSCAT	RSORRES	RSORRESU	RSSTRESC	RSSTRESN	RSSTRESU	RSSTAT	RSLOBXFL	VISITNUM	VISIT	RSDTC
1	1001	RS	1001-001	1	1	ASSG0101	ASSG01-ASSIGN Score	ASSIGN CVD 10-YEAR RISK	3	%	3	3	%		Y	1	Visit 1	2012-05-10
2	1001	RS	1001-001	2	2	ASSG0101	ASSG01-ASSIGN Score	ASSIGN CVD 10-YEAR RISK	8	%	8	8	%			5	Visit 5	2012-10-08
3	1001	RS	1001-002	1	1	ASSG0101	ASSG01-ASSIGN Score	ASSIGN CVD 10-YEAR RISK	55	%	55	55	%		Y	1	Visit 1	2012-04-30
4	1001	RS	1001-002	2		ASSG0101	ASSG01-ASSIGN Score	ASSIGN CVD 10-YEAR RISK						NOT DONE		5	Visit 5

The table represents the lab items from the ASSIGN CVD 10-YEAR RISK instrument.

Dataset wrap

Name	lb

Dataset2

tableid	lb.xpt

LBSPECVISITNUM

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBLNKID	LBTESTCD	LBTEST	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	VISITNUM	LBBLFL	VISIT	LBDTC
1	STUDYX	LB	P0001	1	AP05	PO2	Partial Pressure Oxygen	65	mmHg	65	65	mmHg	ARTERIAL BLOOD	Y	1	2014-06-24	2	STUDYX1001	LBP0001	1001-001	21	AP061	PHCHOL	pHCholesterol	8.7.12	7.12	7.12	ARTERIAL BLOOD	Y	1	2014-06-24		mmol/L	8.7	8.7	mmol/L	1	Visit 1	2012-05-10
2	1001	LB	1001-001	2	1	CHOLHDL	HDL Cholesterol	1.7	3	STUDYX	LB	P0001	3	AP07	SODIUM	Sodium	150	mmol/L	150	1.7	1.7150	mmol/L	SERUM1	Y	Visit 1	2014 2012- 06 05- 24 10
43	STUDYX1001	LBP0001	1001-001	43	AP082	KCHOL	PotassiumCholesterol	8.3.7	mmol/L	8.3	8.73.7	mmol/L	SERUM5	Y	1	2014-06-24	5	Visit 5	2012-10-08
4	1001STUDYX	LBP0001	1001-001	54	AP092	CREATCHOLHDL	Creatinine	0.5	mg/dL	0.5	0.5	mg/dL	SERUM	Y	1	2014-06-24	6	STUDYX	LB	P0001	6	AP10	HCT	Hematocrit	24.6	%	24.6	24.6	%	Y	1	2014-06-24	7	STUDYX	LB	P0001	7	AP11	WBC	Leukocytes	42	10^9/L	42	42	10^9/L	Y	1	2014-06-24

The following dataset represents the one-to-one relationship (as defined in RELTYPE) between the RS and VS domains and between the RS and LB domains for the APACHE II.

...

Name	relrec

...

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, RSSTRESN, and RSORRESU) should be populated.

RSTESTCD = "APCH101" RSTEST = "APCH1-Temperature - Rectal"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH102" RSTEST = "APCH1-Mean Arterial Pressure"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH103" RSTEST = "APCH1-Heart Rate"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH104" RSTEST = "APCH1-Respiratory Rate"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH105A" RSTEST = "APCH1-Oxygenation: A-aDO2"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH105B" RSTEST = "APCH1-Oxygenation: PaO2"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH106A" RSTEST = "APCH1-Arterial pH"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

HDL Cholesterol	2	mmol/L	2	2	mmol/L	5	Visit 5	2012-10-08
5	1001	LB	1001-002	1	1	CHOL	Cholesterol	6.5	mmol/L	6.5	6.5	mmol/L	1	Visit 1	2012-04-30
6	1001	LB	1001-002	2	1	CHOLHDL	HDL Cholesterol	2.1	mmol/L	2.1	2.1	mmol/L	1	Visit 1	2012-04-30

The table represents the demographic items from the ASSIGN CVD 10-YEAR RISK instrument.

Dataset wrap

Name	dm

Dataset2

tableid	dm.xpt

Row	STUDYID	DOMAIN	USUBJID	SUBJID	SEX	BRTHDTC	AGE	AGEU
1	1001	DM	1001-001	1	F	1972-06-24	39	YEARS
2	1001	DM	1001-002	2	M	1947-02-02	65	YEARS

The table represents the vital signs items from the ASSIGN CVD 10-YEAR RISK instrument.

Dataset wrap

Name	vs

Dataset2

tableid	vs.xpt

Row	STUDYID	DOMAIN	USUBJID	VSSEQ	VSLNKID	VSTESTCD	VSTEST	VSORRES	VSORRESU	VSORRESC	VSSTRESN	VSSTRESU	VISITNUM	VISIT	VSDTC
1	1001	VS	1001-001	1	1	SYSBP	Systolic Blood Pressure	140	mmHg	140	140	mmHg	1	VISIT 1	2012-05-10
2	1001	VS	1001-001	2	2	SYSBP	Systolic Blood Pressure	145	mmHg	145	145	mmHg	5	VISIT 5	2012-10-08
3	1001	VS	1001-002	1	1	SYSBP	Systolic Blood Pressure	142	mmHg	142	142	mmHg	1	VISIT 1	2012-04-30

The table represents the medical history items from the ASSIGN CVD 10-YEAR RISK instrument.

Dataset wrap

Name	mh

Dataset2

tableid	mh.xpt

Row	STUDYID	DOMAIN	USUBJID	MHSEQ	MHLNKID	MHTERM	MHPRESP	MHOCCUR	VISITNUM	VISIT	MHDTC	MHSTDC	MHENRTPT	MHENTPT
1	1001	MH	1001-001	1	1	DIABETES	Y	N	1	Visit 1	2012-05-10	2011-01-15	ONGOING	2012-05-10
2	1001	MH	1001-001	2	1	RHEUMATOID ARTHRITIS	Y	N	1	Visit 1	2012-05-10	2011-06-15	ONGOING	2012-05-10
3	1001	MH	1001-002	1	1	DIABETES	Y	Y	1	Visit 1	2012-04-30	2011-02-15	ONGOING	2012-04-30
4	1001	MH	1001-002	2	1	RHEUMATOID ARTHRITIS	Y	N	1	Visit 1	2012-04-30	2011-05-15	ONGOING	2012-04-30

The table represents the associated person's family history of stroke and coronary heart disease items used to calculate the risk scores for the ASSIGN CVD 10-YEAR RISK instrument.

Dataset wrap

Name	apmh

Dataset2

tableid	apmh.xpt

Row	STUDYID	DOMAIN	APID	RSUBJID	MHSEQ	MHLNKID	SREL	MHTERM	MHPRESP	MHOCCUR	VISITNUM	VISIT	MHDTC	MHSTDC	MHENRTPT	MHENTPT
1	1001	APMH	AP-01	1001-001	1	1	FAMILY MEMBER, BIOLOGICAL	STROKE	Y	N	1	Visit 1	2012-05-10	2010-02-20	ONGOING	2012-05-10
2	1001	APMH	AP-01	1001-001	2	1	FAMILY MEMBER, BIOLOGICAL	CORONARY HEART DISEASE	Y	N	1	Visit 1	2012-05-10	2010-10-20	ONGOING	2012-05-10
3	1001	APMH	AP-01	1001-002	1	1	FAMILY MEMBER, BIOLOGICAL	STROKE	Y	Y	1	Visit 1	2012-04-30	2010-06-20	ONGOING	2012-04-30
4	1001	APMH	AP-01	1001-002	2	1	FAMILY MEMBER, BIOLOGICAL	CORONARY HEART DISEASE	Y	Y	1	Visit 1	2012-04-30	2010-10-20	ONGOING	2012-04-30

The table represents the substance use items from the ASSIGN CVD 10-YEAR RISK instrument.

Dataset wrap

Name	su

Dataset2

tableid	su.xpt

Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SULNKID	SUTRT	SUCAT	SUDOSE	SUDOSU	SUDOSFRQ	SUSTRTPT	SUSTTPT	SUENRTPT	SUENTPT	SUPRESP	SUOCCUR	VISITNUM	VISIT	SUDTC
1	1001	SU	1001-001	1	1	CIGARETTES	TOBACCO	0	CIGARETTE	PER DAY					Y	N	1	VISIT 1	2012-05-10
2	1001	SU	1001-001	2	2	CIGARETTES	TOBACCO	5	CIGARETTE	PER DAY	BEFORE	2012-10-08	ONGOING	2012-10-08	Y	Y	5	VISIT 5	2012-10-08
3	1001	SU	1001-002	1	1	CIGARETTES	TOBACCO	20	CIGARETTE	PER DAY	BEFORE	2012-04-30	ONGOING	2012-04-30	Y	Y	1	VISIT 1	2012-04-30

The RELREC table below shows how to define the one-to-one relationship (as defined in RELTYPE), or the one-to-many relationship between the RS domain and the LB, VS, SU, and the MH domains for the ASSIGN Risk Score.

Dataset wrap

Name	relrec

Dataset2

tableid	relrec.xpt

Row	STUDYID	RDOMAIN	IDVAR	RELTYPE	RELID
1	1001	RS	RSLNKID	ONE	A
2	1001	LB	LBLNKID	MANY	A
3	1001	RS	RSLNKID	ONE	B
4	1001	VS	VSLNKID	ONE	B
5	1001	RS	RSLNKID	ONE	C
6	1001	SU	SULNKID	ONE	C
7	1001	RS	RSLNKID	ONE	D
8	1001	MH	MHLNKID	MANY	D
9	1001	RS	RSLNKID	ONE	E
10	1001	APMH	MHLNKID	MANY	E

RSTESTCD = "APCH106B" RSTEST = "APCH1-Serum HCO3"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH107" RSTEST = "APCH1-Serum Sodium"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH108" RSTEST = "APCH1-Serum Potassium"

RSORRES	RSSTRESC	RSSTRESN
>=7	4	4
6-6.9	3	3
5.5-5.9	1	1
3.5-5.4	0	0
3-3.4	1	1
2.5-2.9	2	2
<2.5	4	4

...

RSTESTCD = "APCH109" RSTEST = "APCH1-Serum Creatinine"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH110" RSTEST = "APCH1-Hematocrit"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH111" RSTEST = "APCH1-White Blood Count"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH114" RSTEST = "APCH1-B: Age Points"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

RSTESTCD = "APCH115" RSTEST = "APCH1-C: Chronic Health Points"

...

RSORRES

...

RSSTRESC

...

RSSTRESN

...

End of Document

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Versions Compared

Old Version 9

New Version Current

Key

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for

Disease Response and Clin Classification Domain Model

3.2 Example for the QRS APACHE II RS Domain Model

3.2 Example for the RS Domain Model

4 SDTM Mapping Strategy

Page tree

Page History

Versions Compared

Old Version 9

New Version Current

Key

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for

Disease Response and Clin Classification Domain Model

3.2 Example for the QRS APACHE II RS Domain Model

3.2 Example for the RS Domain Model

4 SDTM Mapping Strategy