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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 StatusPublic Domain
Team

Dyslipidemia Standards Team and CDISC QRS Sub-Team

Supplement Version2.0
StatusREVISION DRAFT
Date2023-04-2022
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.

...

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 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.

2016-07-14

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.

...

The table represents the items from the ASSIGN CVD 10-YEAR RISK instrument 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
Namers
Dataset2
tableidrs.xpt
RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKIDRSTESTCDRSTESTRSCATRSORRESRSORRESURSSTRESCRSSTRESNRSSTRESURSSTATRSBLFLRSLOBXFLVISITNUMVISITRSDTC
11001RS1001-00111ASSG0101

ASSG01-ASSIGN

CVD Risk

Score

ASSIGN CVD 10-YEAR RISK3%33%
Y1Visit 1

2012-05-10

21001RS1001-00122ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK8%88%

5Visit 5

2012-10-08

31001RS1001-00211ASSG0101ASSG01-ASSIGN CVD Risk ScoreASSIGN CVD 10-YEAR RISK55%5555%
Y1Visit 1

2012-04-30

41001RS1001-0022
ASSG0101ASSG01-ASSIGN ScoreASSIGN CVD 10-YEAR RISK




NOT DONE
5Visit 5


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

...

Dataset wrap
Namemh
Dataset2
tableidmh.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

5

3

1001

MH

1001-002

1

1

DIABETES

Y

Y

1

Visit 1

2012-04-30

6

2011-02-15

ONGOING

2012-04-30

4

1001

MH

1001-002

2

1

RHEUMATOID ARTHRITIS

Y

N

1

Visit 1

2012-04-30

2011-05-15ONGOING2012-04-30

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
Nameapmh
Dataset2
tableidapmh.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

53

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

46

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
Namesu
Dataset2
tableidsu.xpt
RowSTUDYIDDOMAINUSUBJIDSUSEQSULNKIDSUTRTSUCATSUDOSESUDOSUSUDOSFQSUDOSFRQSUSTRTPTSUSTTPTSUENRTPTSUENTPTSUPRESPSUOCCURVISITNUMVISITSUDTC
11001SU1001-00111CIGARETTESTOBACCO0CIGARETTEPER DAY



YN1VISIT 12012-05-10
21001SU1001-00122CIGARETTESTOBACCO5CIGARETTEPER DAYBEFORE2012-10-08ONGOING2012-10-08YY5VISIT 52012-10-08
31001SU1001-00211CIGARETTESTOBACCO20CIGARETTEPER DAYBEFORE2012-04-30ONGOING2012-04-30YY1VISIT 1

2012-04-30

...