| 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. |
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| Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSBLFL | VSDTC | VSDY | VSNOMDY | VSTPT | VSTPTNUM | VSELTM | VSTPTREF |
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| 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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