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This is an example of an ADVS dataset and is based on input from the SDTM VS dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL).

Example

This is an example SDTM datasets used to create the ADVS dataset. Only variables needed for illustration are shown in the examples. 

vs.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSPOSVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSSTATVSREASNDVSLOCVSLATVSLOBXFLVISITNUMVISITVSDTCVSTPTVSTPTNUM
1A123VSA20011SYSBPSystolic Blood PressureSITTING154mmHg154154mmHg

ARMLEFT
1Baseline2021-01-02T08:45BASELINE 11
2A123VSA20012SYSBPSystolic Blood PressureSITTING152mmHg152152mmHg

ARMLEFTY1Baseline2021-01-02T09:00BASELINE 22
3A123VSA20013DIABPDiastolic Blood PressureSITTING44mmHg4444mmHg

ARMLEFT
1Baseline2021-01-02T08:45BASELINE 11
4A123VSA20014DIABPDiastolic Blood PressureSITTING48mmHg4848mmHg

ARMLEFTY1Baseline2021-01-02T09:00BASELINE 22
5A123VSA20015PULSEPulse RateSITTING72beats/min7272beats/min

ARMLEFTY1Baseline2021-01-02T08:45

6A123VSA20016TEMPTemperature
34.7C34.734.7C

SUBLINGUAL REGION

1Baseline2021-01-02T08:45BASELINE 11
7A123VSA20017TEMPTemperature
36.2C36.236.2C

SUBLINGUAL REGION
Y1Baseline2021-01-02T09:00BASELINE 22
8A123VSA20018WEIGHTWeight
90.5kg90.590.5kg



Y1Baseline2021-01-02

9A123VSA20019HEIGHTHeight
157cm157157cm



Y1Baseline2021-01-02

10A123VSA200110SYSBPSystolic Blood PressureSITTING95mmHg9595mmHg

ARMLEFT
2Visit 42021-01-28

11A123VSA200111DIABPDiastolic Blood PressureSITTING44mmHg4444mmHg

ARMLEFT
2Visit 42021-01-28

12A123VSA200112TEMPTemperature
97.16F36.236.2C

SUBLINGUAL REGION

2Visit 42021-01-28

13A123VSA200113WEIGHTWeight





NOT DONESUBJECT REFUSED


2Visit 42021-01-28

$warningHtml

This is an example of the ADVS dataset and associated metadata. 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.

$titleHtml

advs.xpt

STUDYIDUSUBJIDTRTPTRT01PTRTATRT01AADTADTMADYAVISITAVISITNATPTATPTNAPHASEPARAMPARAMCDPARAMNAVALBASECHGPCHGDTYPEABLFLANL01FLSAFFLRANDFLTRTSDTTRTEDTVSSEQVSTESTCDVSTESTVSSTATVSREASNDVSLOCVSLATVSLOBXFLVISITNUMVISITVSDTCVSDYVSTPTVSTPTNUM
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN202101JAN2021:08:45-6Baseline1Baseline 11SCREENINGSystolic Blood Pressure (mmHg)SYSBP4154




YYY2021-01-082021-01-281SYSBPSystolic Blood Pressure

ARMLEFT
1Baseline2021-01-02T08:45-6BASELINE 11
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN202101JAN2021:09:00-6Baseline1Baseline 22SCREENINGSystolic Blood Pressure (mmHg)SYSBP4152




YYY2021-01-082021-01-282SYSBPSystolic Blood Pressure

ARMLEFTY1Baseline2021-01-02-T09:00-6BASELINE 22
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021
-6Baseline1

SCREENINGSystolic Blood Pressure (mmHg)SYSBP41531530
AVERAGEYYYY2021-01-082021-01-28













A123A2001PlaceboPlaceboPlaceboPlacebo02JAN202101JAN2021:08:45-6Baseline1Baseline 11SCREENINGDiastolic Blood Pressure (mmHg)DIABP144




YYY2021-01-082021-01-283DIABPDiastolic Blood Pressure

ARMLEFT
1Baseline2021-01-02T08:45-6BASELINE 11
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN202101JAN2021:09:00-6Baseline1Baseline 22SCREENINGDiastolic Blood Pressure (mmHg)DIABP148




YYY2021-01-082021-01-284DIABPDiastolic Blood Pressure

ARMLEFTY1Baseline2021-01-02-T09:00-6BASELINE 22
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021
-6Baseline1

SCREENINGDiastolic Blood Pressure (mmHg)DIABP146460
AVERAGEYYYY2021-01-082021-01-28













A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021
-6Baseline1

SCREENINGPulse Rate (beats/min)PULSE372720

YYYY2021-01-082021-01-285PULSEPulse Rate

ARMLEFTY1Baseline2021-01-02T08:45-6

A123A2001PlaceboPlaceboPlaceboPlacebo02JAN202101JAN2021:08:45-6Baseline1Baseline 11SCREENINGTemperature (C)TEMP534.7




YYY2021-01-082021-01-286TEMPTemperature

SUBLINGUAL REGION

1Baseline2021-01-02T08:45-6BASELINE 11
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN202101JAN2021:09:00-6Baseline1Baseline 22SCREENINGTemperature (C)TEMP536.2




YYY2021-01-082021-01-287TEMPTemperature

SUBLINGUAL REGION
Y1Baseline2021-01-02-T09:00-6BASELINE 22
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021
-6Baseline1

SCREENINGTemperature (C)TEMP535.4535.450
AVERAGEYYYY2021-01-082021-01-28













A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021
-6Baseline1

SCREENINGWeight (kg)WEIGHT690.590.50

YYYY2021-01-082021-01-288WEIGHTWeight



Y1Baseline2021-01-02-6

A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021
-6Baseline1

SCREENINGHeight (cm)HEIGHT21571570

YYYY2021-01-082021-01-289HEIGHTHeight



Y1Baseline2021-01-02-6

A123A2001PlaceboPlaceboPlaceboPlacebo28JAN2021
21Visit 22

PRODUCTSystolic Blood Pressure (mmHg)SYSBP495153-58-37.9085

YYY2021-01-082021-01-2810SYSBPSystolic Blood Pressure

ARMLEFT
2Visit 22021-01-2821

A123A2001PlaceboPlaceboPlaceboPlacebo28JAN2021
21Visit 22

PRODUCTDiastolic Blood Pressure (mmHg)DIABP14446-2-4.3478

YYY2021-01-082021-01-2811DIABPDiastolic Blood Pressure

ARMLEFT
2Visit 22021-01-2821

A123A2001PlaceboPlaceboPlaceboPlacebo28JAN2021
21Visit 22

PRODUCTTemperature (C)TEMP536.235.45.75

2.1157



YYY2021-01-082021-01-2812TEMPTemperature

SUBLINGUAL REGION

2Visit 22021-01-2821

A123A2001PlaceboPlaceboPlaceboPlacebo28JAN2021
21Visit 22

PRODUCTWeight (kg)WEIGHT6





YY
2021-01-082021-01-2813WEIGHTWeightNOT DONESUBJECT REFUSED


2Visit 22021-01-2821

$warningHtml

ADVS Dataset Metadata

ADVS Variable Metadata



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