The ADaM This is an example of the 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. This is just an example and does not mean to indicate that ADVS must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study.
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| STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | ADT | ADTM | ADY | AVISIT |
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AVISTNAPERIOD | PARAM | PARAMCD | PARAMN | AVAL | BASE | CHG | PCHG | DTYPE | ABLFL |
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VSSEQVSTESTCDVSTESTVSPOSVSORRESVSORRESUVSSTRESCVSSTRESN | VSSTRESU| VSTEST | 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 | | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | 01JAN2021 |
19JUN19991| -6 | Baseline | 1 | Baseline 1 | 1 | SCREENING | Systolic Blood Pressure (mmHg) | SYSBP | 4 | 154 |
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| Y | Y | Y | 2021-01-08 | 2021-01-28 | 1 | SYSBP | Systolic Blood Pressure |
SITTING | 154mmHg | 154 | 154 | mmHg | 19990619T081ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | 01JAN2021 |
19JUN19991| -6 | Baseline | 1 | Baseline 2 | 2 | SCREENING | Systolic Blood Pressure (mmHg) | SYSBP | 4 | 152 |
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| Y | Y | Y | 2021-01-08 | 2021-01-28 | 2 | SYSBP | Systolic Blood Pressure |
SITTING | 152 | mmHg | 152 | 152 | mmHg19990619T091ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 |
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1 | Baseline | 1 |
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| SCREENING | Systolic Blood Pressure (mmHg) | SYSBP | 4 | 153 | 153 | 0 |
| AVERAGE | Y | Y |
Baseline | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | Y | Y | 2021-01-08 | 2021-01-28 |
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| | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | 01JAN2021 |
19JUN19991| -6 | Baseline | 1 | Baseline 1 | 1 | SCREENING | Diastolic Blood Pressure (mmHg) | DIABP | 1 | 44 |
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| Y | Y | Y | 2021-01-08 | 2021-01-28 | 3 | DIABP | Diastolic Blood Pressure |
SITTING | 44 | mmHg | 44 | 44 | mmHg | 19990619T081ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | 01JAN2021 |
19JUN19991| -6 | Baseline | 1 | Baseline 2 | 2 | SCREENING | Diastolic Blood Pressure (mmHg) | DIABP | 1 | 48 |
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| Y | Y | Y | 2021-01-08 | 2021-01-28 | 4 | DIABP | Diastolic Blood Pressure |
SITTING | 48 | mmHg | 48 | 48 | mmHg | 19990619T091ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 |
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1 | Baseline | 1 |
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| SCREENING | Diastolic Blood Pressure (mmHg) | DIABP | 1 | 46 | 46 | 0 |
| AVERAGE | Y |
Baseline | | Y | Y | Y | 2021-01-08 | 2021-01-28 |
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| | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 |
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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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5PULSEPulse Rate | SITTING | 72 | beats/min | 72 | 72 | beats/min | | Y | 2021-01-08 | 2021-01-28 | 5 | PULSE | Pulse Rate |
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| ARM | LEFT | Y | 1 | Baseline |
199906191 | ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | 02T08:45 | -6 |
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| | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | 01JAN2021 |
19JUN19991| -6 | Baseline | 1 | Baseline 1 | 1 | SCREENING | Temperature (C) | TEMP | 5 | 34.7 |
6TEMPTemperature | 34.7 | C | 34.7 | 34.7 | | Y | 2021-01-08 | 2021-01-28 | 6 | TEMP | Temperature |
C |
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| SUBLINGUAL REGION |
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19990619T081ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | 01JAN2021 |
19JUN19991| -6 | Baseline | 1 | Baseline 2 | 2 | SCREENING | Temperature (C) | TEMP | 5 | 36.2 |
7TEMPTemperature | 36.2 | C | 36.2 | 36.2 | | Y | 2021-01-08 | 2021-01-28 | 7 | TEMP | Temperature |
C |
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| SUBLINGUAL REGION |
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19990619T091ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 | | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 |
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1 | Baseline | 1 |
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| SCREENING | Temperature (C) | TEMP | 5 | 35.45 | 35.45 | 0 |
| AVERAGE | Y |
Baseline | | Y | Y | Y | 2021-01-08 | 2021-01-28 |
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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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8WEIGHTWeight | STANDING | 90.5 | kg | 90.5 | 90.5 | | Y | 2021-01-08 | 2021-01-28 | 8 | WEIGHT | Weight |
kg199906191ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 19JUN1999 |
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| | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 |
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1 | Baseline | 1 |
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| SCREENING | Height (cm) | HEIGHT | 2 | 157 | 157 | 0 |
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9HEIGHTHeight | STANDING | 157 | cm | 157 | 157 | cm | | Y | 2021-01-08 | 2021-01-28 | 9 | HEIGHT | Height |
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| Y | 1 | Baseline |
199906191ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 |
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| | A123 | A2001 | Placebo | Placebo | Placebo | Placebo | 28JAN2021 |
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33TREATMENT
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| PRODUCT | Systolic Blood Pressure (mmHg) | SYSBP | 4 | 95 | 153 | -58 | -37.9085 |
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| Y | Y | Y | 2021-01-08 | 2021-01-28 | 10 | SYSBP | Systolic Blood Pressure |
SITTING | 95mmHg | 95 | 95 | mmHg | 19990733ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 | | A2001 | Placebo | Placebo | Placebo | Placebo | 28JAN2021 |
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33TREATMENT
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| PRODUCT | Diastolic Blood Pressure (mmHg) | DIABP | 1 | 44 | 46 | -2 | -4.3478 |
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| Y | Y | Y | 2021-01-08 | 2021-01-28 | 11 | DIABP | Diastolic Blood Pressure |
SITTING | 44 | mmHg | 4444 | mmHg | 19990733ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 | 33 | | A2001 | Placebo | Placebo | Placebo | Placebo | 28JAN2021 |
| 21 | Visit 2 | 2 |
TREATMENT
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| PRODUCT | Temperature (C) | TEMP | 5 | 36.2 | 35.45 | .75 | 2.1157 |
12TEMPTemperature | 97.16 | F | 36.2 | 36.2 | | Y | 2021-01-08 | 2021-01-28 | 12 | TEMP | Temperature |
C |
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19990733ABCVS | ABCVS-001-001 | Product A | Product A | Product A | Product A | 21JIL1999 | | A2001 | Placebo | Placebo | Placebo | Placebo | 28JAN2021 |
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33TREATMENT
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| PRODUCT | Weight (kg) | WEIGHT | 6 |
90.5 | 13 | WEIGHT | Weight | NOT DONE | SUBJECT REFUSED |
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| 2 | Visit 2 | 2021-01-28 | 21 |
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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| Vital Signs Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter per analysis visit per analysis timepoint | Analysis | STUDYID, USUBJID, |
| PARAM, PARAMCD, AVISIT, ATPT | ADVS.xpt | ADVS.SAS/SAP |
| Definexmltable |
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| Dataset | ADVS |
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| Level | Variable |
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| Purpose | Analysis |
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| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
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| Study Identifier | text |
| Req | VS.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Req | VS.USUBJID | | TRTP | Planned | | Product | Char |
| Cond | ADSL.TRT01P | | TRT01P | Planned |
| Product for Period 01 | Char |
| Cond | ADSL.TRT01P | | TRTA | Actual |
| Product | Char |
| Cond | ADSL.TRT01A | | TRT01A | Actual |
| Product for Period 01 | Char |
| Cond | ADSL.TRT01A | | ADT | Analysis Date | Num |
| Perm | VS.VSDTC captured as a date in numeric format. | | ADTM | Analysis Datetime | integer |
| Perm | VS.VSDTC captured as a datetime in numeric format. | | ADY | Analysis Relative Day | Num |
| Perm | VS.VSDY | | AVISIT | Analysis Visit | Char |
| Cond | VS.VISIT | | AVISITN | Analysis Visit (N) | Num |
| Perm | VS.VISITNUM | | ATPT | Analysis Timepoint | Char |
| Cond | VS.VSTPT | | ATPTN | Analysis Timepoint (N) | Num |
| Cond | VS.VSTPTNUM | | APHASE | Phase | Char |
| Perm | if ADT lt ADSL,TRTSDT then set to SCREENING, else if TRTSDT le ADT le TRTEDT then set to |
| PRODUCT, else if ADT gt TRTEDT then set to FOLLOW-UP |
| APERIOD | Period | NumCond | set to 1 if TRTSDT le ADT le TRTEDT and there is only one treatment period | | PARAM | Parameter | Char |
| Req | set to VS.VSTEST concatenated with VS.VSTRESU |
| PARAMCD | Parameter Code | text |
| Req | set to VS.VSTESTCD |
| PARAMN | Parameter (N) | Num |
| Perm | Numeric representation of PARAM. sort by VSTESTCD and increment by 1 for each unique value of VSTESTCD |
| AVAL | Analysis Value | Num |
| Cond | VS.VSSTRESN for records taken from VS, Average of values taken on same datedataset |
AVALC | Analysis Value (C) | Char | Cond | VS.VSSTRESC where VSvSTRESN is null |
| BASE | Baseline Value | Num |
| Cond | AVAL where ABLFL=Y |
| CHG | Change from Baseline | Num |
| Perm | AVAL-BASE |
| PCHG | Percent Change from Baseline | Num |
| Perm | ((AVAL-BASE)/BASE)*100 |
| DTYPE | Derivation Type | Char | AVERAGE | Cond | set to AVERAGE for rows added to capture average value for parameters with multiple assessments done at a VISIT |
| ABLFL | Baseline Record Flag | Char | Y | Cond | set to Y on the record that captures the baseline value |
| ANL01FL | Analysis Flag 01 | Char | Y | Cond | set to Y on record chosen to represent AVISIT for analysis |
COUNTRY | Country | Char | Perm | ADSL.COUNTRY | AGE | Age | Num | Perm | ADSL.AGE | SEX | Sex | Char | Perm | ADSL.SEX | RACE | Race | CharPerm | ADSL.RACE | ETHNIC | Ethnicity | Char | Perm | ADSL.ETHNIC | | SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
| RANDFL | Randomized Population Flag | Char | Y;N | Cond | ADSL.RANDFL |
| TRTSDT | Date of First Exposure to |
| Product | Num |
| Perm | ADSL.TRTSDT |
TRTSDTM | Datetime of First Exposure to Treatment | Num | PermADSL.TRTSDTM | | TRTEDT | Date of Last Exposure to |
| Product | Num |
| Perm | ADSL.TRTEDT |
TRTEDTM | Datetime of Last Exposure to Treatment | integer | Perm | ADSL.TRTEDTM | | VSSEQ | Sequence Number | Num |
| Perm | VS.VSSEQ |
| VISIT | Visit Name | Char |
| Perm | VS.VISIT |
| VISITNUM | Visit Number | Num |
| Perm | VS.VISITNUM |
| VSTPT | Planned Time |
| Point Name | Char |
| Perm | VS.VSTPT |
| VSTPTNUM | Planned Time |
c