The ADaM ADVS dataset and associated metadata are designed to describe the main variables needed to evaulate vital signs. The dataset decribed below is based on the SDTM VS dataset shown here SDTM Example.Vital Signs.
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STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | ADT | ADTM | ADY | AVISIT | AVISTN | ATPT | ATPTN | APHASE | APERIOD | PARAM | PARAMCD | PARAMN | AVAL | BASE | CHG | PCHG | DTYPE | ABLFL | VSSEQ | VSTESTCD | VSTEST | VSPOS | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSSTAT | VSREASND | VSLOC | VSLAT | VSLOBXFL | VISITNUM | VISIT | VSDTC | VSDY | VSTPT | VSTPTNUM |
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ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 19JUN1999:08:45 | 1 | Baseline | 1 | Baseline 1 | 1 | SCREENING |
| Systolic Blood Pressure (mmHg) | SYSBP | 4 | 154 |
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| 1 | SYSBP | Systolic Blood Pressure | SITTING | 154 | mmHg | 154 | 154 | mmHg |
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| ARM | LEFT |
| 1 | Baseline | 1999-06-19T08:45 | 1 | BASELINE 1 | 1 | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 19JUN1999:09:00 | 1 | Baseline | 1 | Baseline 2 | 2 | SCREENING |
| Systolic Blood Pressure (mmHg) | SYSBP | 4 | 152 |
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| 2 | SYSBP | Systolic Blood Pressure | SITTING | 152 | mmHg | 152 | 152 | mmHg |
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| ARM | LEFT | Y | 1 | Baseline | 1999-06-19T09:00 | 1 | BASELINE 2 | 2 | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 |
| 1 | Baseline | 1 |
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| SCREENING |
| Systolic Blood Pressure (mmHg) | SYSBP | 4 | 153 | 153 | 0 |
| AVERAGE | Y |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 19JUN1999:08:45 | 1 | Baseline | 1 | Baseline 1 | 1 | SCREENING |
| Diastolic Blood Pressure (mmHg) | DIABP | 1 | 44 |
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| 3 | DIABP | Diastolic Blood Pressure | SITTING | 44 | mmHg | 44 | 44 | mmHg |
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| ARM | LEFT |
| 1 | Baseline | 1999-06-19T08:45 | 1 | BASELINE 1 | 1 | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 19JUN1999:09:00 | 1 | Baseline | 1 | Baseline 2 | 2 | SCREENING |
| Diastolic Blood Pressure (mmHg) | DIABP | 1 | 48 |
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| 4 | DIABP | Diastolic Blood Pressure | SITTING | 48 | mmHg | 48 | 48 | mmHg |
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| ARM | LEFT | Y | 1 | Baseline | 1999-06-19T09:00 | 1 | BASELINE 2 | 2 | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 |
| 1 | Baseline | 1 |
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| SCREENING |
| Diastolic Blood Pressure (mmHg) | DIABP | 1 | 46 | 46 | 0 |
| AVERAGE | Y |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 |
| 1 | Baseline | 1 |
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| SCREENING |
| Pulse Rate (beats/min) | PULSE | 3 | 72 | 72 | 0 |
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| Y | 5 | PULSE | Pulse Rate | SITTING | 72 | beats/min | 72 | 72 | beats/min |
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| ARM | LEFT | Y | 1 | Baseline | 1999-06-19 | 1 |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 19JUN1999:08:45 | 1 | Baseline | 1 | Baseline 1 | 1 | SCREENING |
| Temperature (C) | TEMP | 5 | 34.7 |
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| 6 | TEMP | Temperature |
| 34.7 | C | 34.7 | 34.7 | C |
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| SUBLINGUAL REGION |
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| 1 | Baseline | 1999-06-19T08:45 | 1 | BASELINE 1 | 1 | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 19JUN1999:09:00 | 1 | Baseline | 1 | Baseline 2 | 2 | SCREENING |
| Temperature (C) | TEMP | 5 | 36.2 |
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| 7 | TEMP | Temperature |
| 36.2 | C | 36.2 | 36.2 | C |
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| SUBLINGUAL REGION |
| Y | 1 | Baseline | 1999-06-19T09:00 | 1 | BASELINE 2 | 2 | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 |
| 1 | Baseline | 1 |
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| SCREENING |
| Temperature (C) | TEMP | 5 | 35.45 | 35.45 | 0 |
| AVERAGE | Y |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 |
| 1 | Baseline | 1 |
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| SCREENING |
| Weight (kg) | WEIGHT | 6 | 90.5 | 90.5 | 0 |
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| Y | 8 | WEIGHT | Weight | STANDING | 90.5 | kg | 90.5 | 90.5 | kg |
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| Y | 1 | Baseline | 1999-06-19 | 1 |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 |
| 1 | Baseline | 1 |
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| SCREENING |
| Height (cm) | HEIGHT | 2 | 157 | 157 | 0 |
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| Y | 9 | HEIGHT | Height | STANDING | 157 | cm | 157 | 157 | cm |
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| Y | 1 | Baseline | 1999-06-19 | 1 |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 |
| 33 | Visit 2 | 2 |
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| TREATMENT |
| Systolic Blood Pressure (mmHg) | SYSBP | 4 | 95 | 153 | -58 | -37.9085 |
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| 10 | SYSBP | Systolic Blood Pressure | SITTING | 95 | mmHg | 95 | 95 | mmHg |
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| ARM | LEFT |
| 2 | Visit 2 | 1999-07-21 | 33 |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 |
| 33 | Visit 2 | 2 |
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| TREATMENT |
| Diastolic Blood Pressure (mmHg) | DIABP | 1 | 44 | 46 | -2 | -4.3478 |
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| 11 | DIABP | Diastolic Blood Pressure | SITTING | 44 | mmHg | 44 | 44 | mmHg |
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| ARM | LEFT |
| 2 | Visit 2 | 1999-07-21 | 33 |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 |
| 33 | Visit 2 | 2 |
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| TREATMENT |
| Temperature (C) | TEMP | 5 | 36.2 | 35.45 | .75 | 2.1157
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| 12 | TEMP | Temperature |
| 97.16 | F | 36.2 | 36.2 | C |
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| SUBLINGUAL REGION |
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| 2 | Visit 2 | 1999-07-21 | 33 |
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| ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 |
| 33 | Visit 2 | 2 |
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| TREATMENT |
| Weight (kg) | WEIGHT | 6 |
| 90.5 |
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| 13 | WEIGHT | Weight |
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| NOT DONE | SUBJECT REFUSED |
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| 2 | Visit 2 |
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Definexmltable |
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Level | Dataset |
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Purpose | Analysis |
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Name | ADVS |
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Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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ADVS | VS Analysis Data | Basic Data Structure |
| Analysis | STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT, | ADVS.xpt | ADVS.SAS/SAP | |
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