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This example shows heart rates for a single animal where the evaluation intervals changed across the study. |
The applicant chose to label its time points (CVTPT) based on the hours, minutes, and seconds of the planned time away from dose, based on the end of the evaluation interval.
Dataset wrap |
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Rowcaps |
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Row 1: | The pre-dose was monitored for a period of 1 hour, summarized into a 1-hour increment. | Rows 2-9: | From the dose to 2 hours post-dose, the data were summarized in 15-minute increments. | Rows 10-13: | From 2 hours post-dose up to 6 hours post-dose, the data were summarized into 1-hour increments. | Rows 14-16: | From 6 hours post-dose up to 12 hours post-dose, the data were summarized into 2-hour increments. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVPOS | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | CVCSTATE | CVBLFL | CVDTC | CVDY | CVNOMDY | CVTPT | CVTPTNUM | CVELTM | CVTPTREF | CVRFTDTC | CVSTINT | CVENINT |
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1 | ABC-123 | CV | 101 | 1 | HR | Heart Rate | UNCONSTRAINED | 162 | beats/min | 162 | 162 | beats/min | Intravascular | CONSCIOUS | Y | 2012-03-22 | 1 | 1 | 00:00:00 | 1 | PT0M | Day 1 Dose | 2012-03-22T09:52 | -PT1H | PT0M | 2 | ABC-123 | CV | 101 | 2 | HR | Heart Rate | UNCONSTRAINED | 158 | beats/min | 158 | 158 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 00:15:00 | 2 | PT15M | Day 1 Dose | 2012-03-22T09:52 | PT0M | PT15M | 3 | ABC-123 | CV | 101 | 3 | HR | Heart Rate | UNCONSTRAINED | 152 | beats/min | 152 | 152 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 00:30:00 | 3 | PT30M | Day 1 Dose | 2012-03-22T09:52 | PT15M | PT30M | 4 | ABC-123 | CV | 101 | 4 | HR | Heart Rate | UNCONSTRAINED | 141 | beats/min | 141 | 141 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 00:45:00 | 4 | PT45M | Day 1 Dose | 2012-03-22T09:52 | PT30M | PT45M | 5 | ABC-123 | CV | 101 | 5 | HR | Heart Rate | UNCONSTRAINED | 120 | beats/min | 120 | 120 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 01:00:00 | 5 | PT1H | Day 1 Dose | 2012-03-22T09:52 | PT45M | PT1H | 6 | ABC-123 | CV | 101 | 6 | HR | Heart Rate | UNCONSTRAINED | 113 | beats/min | 113 | 113 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 01:15:00 | 6 | PT1H15M | Day 1 Dose | 2012-03-22T09:52 | PT1H | PT1H15M | 7 | ABC-123 | CV | 101 | 7 | HR | Heart Rate | UNCONSTRAINED | 123 | beats/min | 123 | 123 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 01:30:00 | 7 | PT1H30M | Day 1 Dose | 2012-03-22T09:52 | PT1H15M | PT1H30M | 8 | ABC-123 | CV | 101 | 8 | HR | Heart Rate | UNCONSTRAINED | 143 | beats/min | 143 | 143 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 01:45:00 | 8 | PT1H45M | Day 1 Dose | 2012-03-22T09:52 | PT1H30M | PT1H45M | 9 | ABC-123 | CV | 101 | 9 | HR | Heart Rate | UNCONSTRAINED | 146 | beats/min | 146 | 146 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 02:00:00 | 9 | PT2H | Day 1 Dose | 2012-03-22T09:52 | PT1H45M | PT2H | 10 | ABC-123 | CV | 101 | 10 | HR | Heart Rate | UNCONSTRAINED | 166 | beats/min | 166 | 166 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 03:00:00 | 10 | PT3H | Day 1 Dose | 2012-03-22T09:52 | PT2H | PT3H | 11 | ABC-123 | CV | 101 | 11 | HR | Heart Rate | UNCONSTRAINED | 146 | beats/min | 146 | 146 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 04:00:00 | 11 | PT4H | Day 1 Dose | 2012-03-22T09:52 | PT3H | PT4H | 12 | ABC-123 | CV | 101 | 12 | HR | Heart Rate | UNCONSTRAINED | 149 | beats/min | 149 | 149 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 05:00:00 | 12 | PT5H | Day 1 Dose | 2012-03-22T09:52 | PT4H | PT5H | 13 | ABC-123 | CV | 101 | 13 | HR | Heart Rate | UNCONSTRAINED | 123 | beats/min | 123 | 123 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 06:00:00 | 13 | PT6H | Day 1 Dose | 2012-03-22T09:52 | PT5H | PT6H | 14 | ABC-123 | CV | 101 | 14 | HR | Heart Rate | UNCONSTRAINED | 105 | beats/min | 105 | 105 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 08:00:00 | 14 | PT8H | Day 1 Dose | 2012-03-22T09:52 | PT6H | PT8H | 15 | ABC-123 | CV | 101 | 15 | HR | Heart Rate | UNCONSTRAINED | 100 | beats/min | 100 | 100 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 10:00:00 | 15 | PT10H | Day 1 Dose | 2012-03-22T09:52 | PT8H | PT10H | 16 | ABC-123 | CV | 101 | 16 | HR | Heart Rate | UNCONSTRAINED | 113 | beats/min | 113 | 113 | beats/min | Intravascular | CONSCIOUS |
| 2012-03-22 | 1 | 1 | 12:00:00 | 16 | PT12H | Day 1 Dose | 2012-03-22T09:52 | PT10H | PT12H |
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