Example

This example shows vital signs collected for subject ABC-001-001.

Rows 1-2:Show 2 temperatures taken at study day 1 (VSDY="1"). Row 2 has a "Y" in the VSBLFL to indicate it was used as the baseline measurement.
Row 3:Shows a value collected in 1 unit but converted to selected standard unit, reflected in VSSTRESC, VSSTRESN, and VSSTRESU.
Row 4:Shows the proper use of the VSSTAT variable to indicate "NOT DONE" where a test was not done.

vs.xpt

vs.xpt

RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSSTATVSREASNDVSLOCVSBLFLVSDTCVSDYVSNOMDY
1ABCVSABC-001-0018TEMPTemperature34.7C34.734.7C

RECTAL
1999-06-19T08:4511
2ABCVSABC-001-0019TEMPTemperature36.2C36.236.2C

RECTALY1999-06-19T09:0011
3ABCVSABC-001-00114TEMPTemperature97.2F36.236.2C

RECTAL
1999-07-21T9:043333
4ABCVSABC-001-00115TEMPTemperature




NOT DONEEquipment failure

1999-07-314343
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This example shows a collection of vital signs for subject ABC-001-001, where the time was not collected. The dosing regimen is once-weekly administration, which is why the first dose of the study (VSTPTREF) is on study day 1 (VSDY) and the second dose is on study day 8.

Rows 1-8:VSELTM show planned elapsed times after the first dose and after the second dose for a series of vital signs measurements.
Rows 4, 8:The study plan stated that the last measurement should be performed 4 to 6 hours post dosing (shown in VSTPT). The applicant chose to show this as a planned elapsed time of 4 hours in VSELTM.

vs.xpt

vs.xpt

RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSBLFLVSDTCVSDYVSNOMDYVSTPTVSTPTNUMVSELTMVSTPTREF
1ABCVSABC-001-0011TEMPTemperature34.7C34.734.7CY2012-10-2511PREDOSE1PT0HDay 1 Dose
2ABCVSABC-001-0012TEMPTemperature36.2C36.236.2C
2012-10-251130 MIN2PT0.5HDay 1 Dose
3ABCVSABC-001-0013TEMPTemperature37.1C37.137.1C
2012-10-25111H3PT1HDay 1 Dose
4ABCVSABC-001-0014TEMPTemperature34.3C34.334.3C
2012-10-25114H-6H4PT4HDay 1 Dose
5ABCVSABC-001-0015TEMPTemperature35.2C35.235.2C
2012-11-0188PREDOSE1PT0HDay 2 Dose
6ABCVSABC-001-0016TEMPTemperature35.9C35.935.9C
2012-11-018830 MIN2PT0.5HDay 2 Dose
7ABCVSABC-001-0017TEMPTemperature36.5C36.536.5C
2012-11-01881H3PT1HDay 2 Dose
8ABCVSABC-001-0018TEMPTemperature34.9C34.934.9C
2012-11-01884H-6H4PT4HDay 2 Dose
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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