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Date | Version | Summary of Changes |
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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.
- Reoplace 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.
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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.
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The table represents the items from the ASSIGN CVD 10-YEAR RISK instrument. Since the 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.
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTESTCD | RSTEST | RSCAT | RSORRES | RSORRESU | RSSTRESC | RSSTRESN | RSSTRESU | RSSTAT | RSLOBXFL | VISITNUM | VISIT | RSDTC |
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| 1 | 1001 | RS | 1001-001 | 1 | 1 | ASSG0101 | CVD Risk | 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 CVD Risk Score | ASSIGN CVD 10-YEAR RISK | 8 | % | 8 | 8 | % |
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| 5 | Visit 5 | 2012-10-08 | | 3 | 1001 | RS | 1001-002 | 1 | 1 | ASSG0101 | ASSG01-ASSIGN CVD Risk 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 CVD Risk Score | ASSIGN CVD 10-YEAR RISK |
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| NOT DONE |
| 5 | Visit 5 |
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| Dataset2 |
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| 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 | 53 | 1001 | MH | 1001-002 | 1 | 1 | DIABETES | Y | Y | 1 | Visit 1 | 2012-04-30 | 2011-02-15 | ONGOING | 2012-04-30 | 64 | 1001 | MH | 1001-002 | 2 | 1 | RHEUMATOID ARTHRITIS | Y | N | 1 | Visit 1 | 2012-04-30 | 2011-05-15 | ONGOING | 2012-04-30 |
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| Dataset2 |
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| 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 | 64 | 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 |
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SULNKID | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFQSUDOSFRQ | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT | SUPRESP | SUOCCUR | VISITNUM | VISIT | SUDTC |
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| 1 | 1001 | SU | 1001-001 | 1 | 1 | CIGARETTES | TOBACCO | 0 | CIGARETTE | PER DAY |
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| 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 | |
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