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| Rows 1-4: | Represent lab values used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Rows 5-6: | Represent lab values used to calculate the risk score for subject 1001-002 shown in the RS domain above. |
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBLNKID | LBTESTCD | LBTEST | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | VISITNUM | VISIT | LBDTC | | 1 | 1001 | LB | 1001-001 | 1 | 1 | CHOL | Cholesterol | 8.7 | 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 | mmol/L | 1.7 | 1.7 | mmol/L | 1 | Visit 1 | 2012-05-10 | | 3 | 1001 | LB | 1001-001 | 3 | 2 | CHOL | Cholesterol | 8.3 | mmol/L | 8.3 | 8.3 | mmol/L | 5 | Visit 5 | 2012-10-08 | | 4 | 1001 | LB | 1001-001 | 4 | 2 | CHOLHDL | 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 |
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| Row 1: | Represents sex and age values used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Row 2: | Represents sex and age values used to calculate the risk score for subject1001-002 shown in the RS domain above. |
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | SUBJID | SEX | BRTHDTC | AGE | AGEU | | 1 | 1001 | DM | 1001-001 | 1 | F6 | /24/19721972-06-24 | 39 | YEARS | | 2 | 1001 | DM | 1001-002 | 2 | M2 | /2/19471947-02-02 | 65 | |
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| Rows 1-2: | Represent blood pressure values used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Row 3: | Represents blood pressure values used to calculate the risk score for subject 1001-002 shown in the RS domain above. |
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| Dataset2 |
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| | STUDYID | DOMAIN | USUBJID | VSSEQ | VSLNKID | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSORRESC |
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Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSLNKID | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOCVISITNUM | VSBLFL | VISITNUMVISIT | VSDTC |
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| 1 | STUDYX1001 | VSP0001 | 1001-001 | 1 | AP011 | TEMPSYSBP | Temperature | 38.9 | C | 38.9 | 38.9 | C | RECTUM | Y | 1 | 2014-06-24 | 2 | STUDYX | VS | P0001 | 2 | AP02 | MAP | Mean Arterial Pressure | 117 | mmHg | 117 | 117 | mmHg | Y | 1 | 2014-06-24 | 3 | STUDYX | VS | P0001 | 3 | AP03 | HR | Heart Rate | 98 | beats/min | 98 | 98 | beats/min | Y | 1 | 2014-06-24 | 4 | STUDYX | VS | P0001 | 4 | AP04 | RESP | Respiratory Rate | 54 | breaths/min | 54 | 54 | breaths/min | Y | 1 | 2014-06-24Systolic 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 |
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| Rows 1-4: | Represent diabetes and rheumatoid arthritis medical history used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Rows 5-6: | Represent diabetes and rheumatoid arthritis medical history used to calculate the risk score for subject1001-002 shown in the RS domain above. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHLNKID | MHTERM | MHPRESP | MHOCCUR | VISITNUM | VISIT | MHDTC | 1 | 1001 | MH | 1001-001 | 1 | 1 | DIABETES | Y | N | 1 | Visit 1 | 2012-05-10 | 2 | 1001 | MH | 1001-001 | 2 | 1 | RHEUMATOID ARTHRITIS | Y | N | 1 | Visit 1 | 2012-05-10 | 3 | 1001 | MH | 1001-001 | 3 | 2 | DIABETES | Y | Y | 5 | Visit 5 | 2012-10-08 | 4 | 1001 | MH | 1001-001 | 4 | 2 | RHEUMATOID ARTHRITIS | Y | N | 5 | Visit 5 | 2012-10-08 | 5 | 1001 | MH | 1001-002 | 1 | 1 | DIABETES | Y | Y | 1 | Visit 1 | 2012-04-30 | 6 | 1001 | MH | 1001-002 | 2 | 1 | RHEUMATOID ARTHRITIS | Y | N | 1 | Visit 1 | 2012-04-30 |
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| Rows 1-4: | Represent family history of stroke and coronary heart disease used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Rows 5-6: | Represent family history of stroke and coronary heart disease used to calculate the risk score for subject1001-002 shown in the RS domain above. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | RSUBJID | MHSEQ | MHLNKID | SREL | MHTERM | MHPRESP | MHORSUR | VISITNUM | VISIT | MHDTC | 1 | 1001 | APMH | 1001-001 | 1 | 1 | FAMILY MEMBER, BIOLOGICAL | STROKE | Y | N | 1 | Visit 1 | 2012-05-10 | 2 | 1001 | APMH | 1001-001 | 2 | 1 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASE | Y | N | 1 | Visit 1 | 2012-05-10 | 3 | 1001 | APMH | 1001-001 | 3 | 2 | FAMILY MEMBER, BIOLOGICAL | STROKE | Y | N | 5 | Visit 5 | 2012-10-08 | 4 | 1001 | APMH | 1001-001 | 4 | 2 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASE | Y | N | 5 | Visit 5 | 2012-10-08 | 5 | 1001 | APMH | 1001-002 | 1 | 1 | FAMILY MEMBER, BIOLOGICAL | STROKE | Y | Y | 1 | Visit 1 | 2012-04-30 | 6 | 1001 | APMH | 1001-002 | 2 | 1 | FAMILY MEMBER, BIOLOGICAL | CORONARY HEART DISEASE | Y | Y | 1 | Visit 1 | 2012-04-30 |
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| Rows 1-2: | Represent smoking information used to calculate the risk scores for subject 1001-001 shown in the RS domain above. | | Row 3: | Represents smoking information used to calculate the risk score for subject1001-002 shown in the RS domain above. |
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SULNKID | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFQ | 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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| Dataset2 |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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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 | |
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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.
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