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.
cv.xpt
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.
cv.xpt
cv.xpt
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 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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