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The ADaM dataset and associated metadata are designed to describe the main variables needed to evaulate vital signs. The dataset decribed below is called ADVS and is based on the SDTM VS dataset shown here SDTM Example.Vital Signs.
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The ADaM ADSL associated with this study are not shown. An example on the creation of an ADLS for another study is provided here ADaM Example.ADSL Analysis Data Subject Level New |
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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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ABC | ABC-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 | 1 | SYSBP | Systolic Blood Pressure | SITTING | 154 | mmHg | 154 | 154 | mmHg | ARM | LEFT | 1 | Baseline | 1999-06-19T08:45 | 1 | BASELINE 1 | 1 | |||||||||
ABC | ABC-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 | 2 | SYSBP | Systolic Blood Pressure | SITTING | 152 | mmHg | 152 | 152 | mmHg | ARM | LEFT | Y | 1 | Baseline | 1999-06-19T09:00 | 1 | BASELINE 2 | 2 | ||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 1 | Baseline | 1 | SCREENING | Systolic Blood Pressure (mmHg) | SYSBP | 4 | 153 | 153 | 0 | AVERAGE | Y | Baseline | ||||||||||||||||||||||||
ABC | ABC-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 | 3 | DIABP | Diastolic Blood Pressure | SITTING | 44 | mmHg | 44 | 44 | mmHg | ARM | LEFT | 1 | Baseline | 1999-06-19T08:45 | 1 | BASELINE 1 | 1 | |||||||||
ABC | ABC-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 | 4 | DIABP | Diastolic Blood Pressure | SITTING | 48 | mmHg | 48 | 48 | mmHg | ARM | LEFT | Y | 1 | Baseline | 1999-06-19T09:00 | 1 | BASELINE 2 | 2 | ||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 1 | Baseline | 1 | SCREENING | Diastolic Blood Pressure (mmHg) | DIABP | 1 | 46 | 46 | 0 | AVERAGE | Y | Baseline | ||||||||||||||||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 1 | Baseline | 1 | SCREENING | Pulse Rate (beats/min) | PULSE | 3 | 72 | 72 | 0 | Y | 5 | PULSE | Pulse Rate | SITTING | 72 | beats/min | 72 | 72 | beats/min | ARM | LEFT | Y | 1 | Baseline | 1999-06-19 | 1 | ||||||||||
ABC | ABC-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 | 6 | TEMP | Temperature | 34.7 | C | 34.7 | 34.7 | C | SUBLINGUAL REGION | 1 | Baseline | 1999-06-19T08:45 | 1 | BASELINE 1 | 1 | |||||||||||
ABC | ABC-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 | 7 | TEMP | Temperature | 36.2 | C | 36.2 | 36.2 | C | SUBLINGUAL REGION | Y | 1 | Baseline | 1999-06-19T09:00 | 1 | BASELINE 2 | 2 | ||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 1 | Baseline | 1 | SCREENING | Temperature (C) | TEMP | 5 | 35.45 | 35.45 | 0 | AVERAGE | Y | Baseline | ||||||||||||||||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 1 | Baseline | 1 | SCREENING | Weight (kg) | WEIGHT | 6 | 90.5 | 90.5 | 0 | Y | 8 | WEIGHT | Weight | STANDING | 90.5 | kg | 90.5 | 90.5 | kg | Y | 1 | Baseline | 1999-06-19 | 1 | ||||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | 1 | Baseline | 1 | SCREENING | Height (cm) | HEIGHT | 2 | 157 | 157 | 0 | Y | 9 | HEIGHT | Height | STANDING | 157 | cm | 157 | 157 | cm | Y | 1 | Baseline | 1999-06-19 | 1 | ||||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 | 33 | Visit 2 | 2 | TREATMENT | Systolic Blood Pressure (mmHg) | SYSBP | 4 | 95 | 153 | -58 | -37.9085 | 10 | SYSBP | Systolic Blood Pressure | SITTING | 95 | mmHg | 95 | 95 | mmHg | ARM | LEFT | 2 | Visit 2 | 1999-07-21 | 33 | |||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 | 33 | Visit 2 | 2 | TREATMENT | Diastolic Blood Pressure (mmHg) | DIABP | 1 | 44 | 46 | -2 | -4.3478 | 11 | DIABP | Diastolic Blood Pressure | SITTING | 44 | mmHg | 44 | 44 | mmHg | ARM | LEFT | 2 | Visit 2 | 1999-07-21 | 33 | |||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 | 33 | Visit 2 | 2 | TREATMENT | Temperature (C) | TEMP | 5 | 36.2 | 35.45 | .75 | 2.1157 | 12 | TEMP | Temperature | 97.16 | F | 36.2 | 36.2 | C | SUBLINGUAL REGION | 2 | Visit 2 | 1999-07-21 | 33 | |||||||||||||
ABC | ABC-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 | 33 | Visit 2 | 2 | TREATMENT | Weight (kg) | WEIGHT | 6 | 90.5 | 13 | WEIGHT | Weight | NOT DONE | SUBJECT REFUSED | 2 | Visit 2 |
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