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This example shows different cardiovascular endpoints collected for 1 subject, including examples of both collected and derived baseline measurements. |
These endpoints were measured at a single point in time at 8 hours post-dose (CVELTM = "PT8H"), per the study protocol. Since the time point is not an interval with a planned start and end, CVSTINT and CVENINT are null.
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Rows 1-2, 4-5: | Show measurements performed at a specific time. Note that the same test was performed multiple times on the same day for a subject. In this example, CVDTC is part of the natural key of the dataset (CVDTC contains both date and time), distinguishing one record from the next. | Rows 3, 6: | Represent the mean of the 2 previous rows, which make them derived records (CVDRVFL="Y"), and at the same time serve as baseline values (CVBLFL="Y"). CVDTC now contains information about the date (not time). | Row 7: | Shows an example of a measured baseline value. It is not derived (CVDRVFL is null). |
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVPOS | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | CVCSTATE | CVBLFL | CVDRVFL | CVDTC | CVDY | CVNOMDY | CVTPT | CVTPTNUM | CVELTM | CVTPTREF | CVSTINT | CVENINT |
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1 | ABC | CV | ABC-001-001 | 1 | SYSBP | Systolic Blood Pressure | SITTING | 154 | mmHg | 154 | 154 | mmHg | External Cuff | CONSCIOUS |
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| 1999-06-19T08:45 | 1 | 1 | 8 hours postdose | 1 | PT8H | Day 1 Dose |
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| 2 | ABC | CV | ABC-001-001 | 2 | SYSBP | Systolic Blood Pressure | SITTING | 152 | mmHg | 152 | 152 | mmHg | External Cuff | CONSCIOUS |
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| 1999-06-19T09:00 | 1 | 1 | 8 hours postdose | 1 | PT8H | Day 1 Dose |
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| 3 | ABC | CV | ABC-001-001 | 3 | SYSBP | Systolic Blood Pressure | SITTING | 153 | mmHg | 153 | 153 | mmHg | External Cuff | CONSCIOUS | Y | Y | 1999-06-19 | 1 | 1 | 8 hours postdose | 1 | PT8H | Day 1 Dose |
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| 4 | ABC | CV | ABC-001-001 | 4 | DIABP | Diastolic Blood Pressure | SITTING | 44 | mmHg | 44 | 44 | mmHg | External Cuff | CONSCIOUS |
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| 1999-06-19T08:45 | 1 | 1 | 8 hours postdose | 1 | PT8H | Day 1 Dose |
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| 5 | ABC | CV | ABC-001-001 | 5 | DIABP | Diastolic Blood Pressure | SITTING | 48 | mmHg | 48 | 48 | mmHg | External Cuff | CONSCIOUS |
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| 1999-06-19T09:00 | 1 | 1 | 8 hours postdose | 1 | PT8H | Day 1 Dose |
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| 6 | ABC | CV | ABC-001-001 | 6 | DIABP | Diastolic Blood Pressure | SITTING | 46 | mmHg | 46 | 46 | mmHg | External Cuff | CONSCIOUS | Y | Y | 1999-06-19 | 1 | 1 | 8 hours postdose | 1 | PT8H | Day 1 Dose |
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| 7 | ABC | CV | ABC-001-001 | 7 | PULSEPR | Pulse Pressure | SITTING | 107 | mmHg | 72 | 72 | mmHg | External Cuff | CONSCIOUS | Y |
| 1999-06-19 | 1 | 1 | 8 hours postdose | 1 | PT8H | Day 1 Dose |
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