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
Row
STUDYID
DOMAIN
USUBJID
VSSEQ
VSTESTCD
VSTEST
VSORRES
VSORRESU
VSSTRESC
VSSTRESN
VSSTRESU
VSSTAT
VSREASND
VSLOC
VSBLFL
VSDTC
VSDY
VSNOMDY
1
ABC
VS
ABC-001-001
8
TEMP
Temperature
34.7
C
34.7
34.7
C
RECTAL
1999-06-19T08:45
1
1
2
ABC
VS
ABC-001-001
9
TEMP
Temperature
36.2
C
36.2
36.2
C
RECTAL
Y
1999-06-19T09:00
1
1
3
ABC
VS
ABC-001-001
14
TEMP
Temperature
97.2
F
36.2
36.2
C
RECTAL
1999-07-21T9:04
33
33
4
ABC
VS
ABC-001-001
15
TEMP
Temperature
NOT DONE
Equipment failure
1999-07-31
43
43
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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.