SEND Example.In vivo VS Example 2

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

Row	STUDYID	DOMAIN	USUBJID	VSSEQ	VSTESTCD	VSTEST	VSORRES	VSORRESU	VSSTRESC	VSSTRESN	VSSTRESU	VSBLFL	VSDTC	VSDY	VSNOMDY	VSTPT	VSTPTNUM	VSELTM	VSTPTREF
1	ABC	VS	ABC-001-001	1	TEMP	Temperature	34.7	C	34.7	34.7	C	Y	2012-10-25	1	1	PREDOSE	1	PT0H	Day 1 Dose
2	ABC	VS	ABC-001-001	2	TEMP	Temperature	36.2	C	36.2	36.2	C		2012-10-25	1	1	30 MIN	2	PT0.5H	Day 1 Dose
3	ABC	VS	ABC-001-001	3	TEMP	Temperature	37.1	C	37.1	37.1	C		2012-10-25	1	1	1H	3	PT1H	Day 1 Dose
4	ABC	VS	ABC-001-001	4	TEMP	Temperature	34.3	C	34.3	34.3	C		2012-10-25	1	1	4H-6H	4	PT4H	Day 1 Dose
5	ABC	VS	ABC-001-001	5	TEMP	Temperature	35.2	C	35.2	35.2	C		2012-11-01	8	8	PREDOSE	1	PT0H	Day 2 Dose
6	ABC	VS	ABC-001-001	6	TEMP	Temperature	35.9	C	35.9	35.9	C		2012-11-01	8	8	30 MIN	2	PT0.5H	Day 2 Dose
7	ABC	VS	ABC-001-001	7	TEMP	Temperature	36.5	C	36.5	36.5	C		2012-11-01	8	8	1H	3	PT1H	Day 2 Dose
8	ABC	VS	ABC-001-001	8	TEMP	Temperature	34.9	C	34.9	34.9	C		2012-11-01	8	8	4H-6H	4	PT4H	Day 2 Dose

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SEND Example.In vivo VS Example 2