This example contains ECG measurements during a repeat dose study. Results are for a discrete observation period with a target time point (e.g., 1 hour post-dose). The duration of the ECG recording could be based on a defined period of time (e.g., a cardiologist examining a 2-hour recording and selecting a segment of waveforms for analysis) or number of complexes (e.g., after 200 good complexes are recorded). As a result, EGSTINT and EGENINT are not populated, because the specific assessment interval is not planned.
eg.xpt
Rows 1-18: ECGs are performed once, 14 days prior to the day 1 dose; and twice on day 23, once immediately prior to dose and once 2 hours post-dose. Measurements that were collected originally in seconds are converted to units of milliseconds for the study.
eg.xpt
eg.xpt
Row STUDYID DOMAIN USUBJID EGSEQ EGTESTCD EGTEST EGPOS EGORRES EGORRESU EGSTRESC EGSTRESN EGSTRESU EGLEAD EGMETHOD EGCSTATE EGBLFL EGDTC EGDY EGNOMDY EGTPT EGTPTNUM EGELTM EGTPTREF EGRFTDTC 1 TSA1397 EG 1 1 EGHRMN ECG Mean Heart Rate SLING 89 beats/min 89 89 beats/min LEAD II 6 LEAD STANDARD CONSCIOUS 2008-10-28T07:46 -14 -14 Pretest 1 -P14D Day 1 Dose 2008-11-11T08:54 2 TSA1397 EG 1 2 EGHRMN ECG Mean Heart Rate SLING 91 beats/min 91 91 beats/min LEAD II 6 LEAD STANDARD CONSCIOUS Y 2008-12-03T09:05 23 23 Predose 2 -PT5M Day 23 Dose 2008-12-03T09:10 3 TSA1397 EG 1 3 EGHRMN ECG Mean Heart Rate SLING 116 beats/min 116 116 beats/min LEAD II 6 LEAD STANDARD CONSCIOUS 2008-12-03T11:03 23 23 2 Hour Postdose 3 PT120M Day 23 Dose 2008-12-03T09:10 4 TSA1397 EG 1 4 QRSAG QRS Duration, Aggregate SLING 0.050 sec 50 50 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-10-28T07:46 -14 -14 Pretest 1 -P14D Day 1 Dose 2008-11-11T08:54 5 TSA1397 EG 1 5 QRSAG QRS Duration, Aggregate SLING 0.038 sec 38 38 msec LEAD II 6 LEAD STANDARD CONSCIOUS Y 2008-12-03T09:05 23 23 Predose 2 -PT5M Day 23 Dose 2008-12-03T09:10 6 TSA1397 EG 1 6 QRSAG QRS Duration, Aggregate SLING 0.039 sec 39 39 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-12-03T11:03 23 23 2 Hour Postdose 3 PT120M Day 23 Dose 2008-12-03T09:10 7 TSA1397 EG 1 7 PPAG PP Interval, Aggregate SLING 0.073 sec 73 73 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-10-28T07:46 -14 -14 Pretest 1 -P14D Day 1 Dose 2008-11-11T08:54 8 TSA1397 EG 1 8 PPAG PP Interval, Aggregate SLING 0.083 sec 83 83 msec LEAD II 6 LEAD STANDARD CONSCIOUS Y 2008-12-03T09:05 23 23 Predose 2 -PT5M Day 23 Dose 2008-12-03T09:10 9 TSA1397 EG 1 9 PPAG PP Interval, Aggregate SLING 0.076 sec 76 76 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-12-03T11:03 23 23 2 Hour Postdose 3 PT120M Day 23 Dose 2008-12-03T09:10 10 TSA1397 EG 1 10 QTAG QT Interval, Aggregate SLING 0.209 sec 209 209 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-10-28T07:46 -14 -14 Pretest 1 -P14D Day 1 Dose 2008-11-11T08:54 11 TSA1397 EG 1 11 QTAG QT Interval, Aggregate SLING 0.222 sec 222 222 msec LEAD II 6 LEAD STANDARD CONSCIOUS Y 2008-12-03T09:05 23 23 Predose 2 -PT5M Day 23 Dose 2008-12-03T09:10 12 TSA1397 EG 1 12 QTAG QT Interval, Aggregate SLING 0.192 sec 192 192 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-12-03T11:03 23 23 2 Hour Postdose 3 PT120M Day 23 Dose 2008-12-03T09:10 13 TSA1397 EG 1 13 QTCFAG QTcF Interval, Aggregate SLING 0.238 sec 238 238 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-10-28T07:46 -14 -14 Pretest 1 -P14D Day 1 Dose 2008-11-11T08:54 14 TSA1397 EG 1 14 QTAG QT Interval, Aggregate SLING 0.255 sec 255 255 msec LEAD II 6 LEAD STANDARD CONSCIOUS Y 2008-12-03T09:05 23 23 Predose 2 -PT5M Day 23 Dose 2008-12-03T09:10 15 TSA1397 EG 1 15 QTAG QT Interval, Aggregate SLING 0.240 sec 240 240 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-12-03T11:03 23 23 2 Hour Postdose 3 PT120M Day 23 Dose 2008-12-03T09:10 16 TSA1397 EG 1 16 QTCVAG QTcV Interval, Aggregate SLING 0.237 sec 237 237 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-10-28T07:46 -14 -14 Pretest 1 -P14D Day 1 Dose 2008-11-11T08:54 17 TSA1397 EG 1 17 QTCVAG QTcV Interval, Aggregate SLING 0.252 sec 252 252 msec LEAD II 6 LEAD STANDARD CONSCIOUS Y 2008-12-03T09:05 23 23 Predose 2 -PT5M Day 23 Dose 2008-12-03T09:10 18 TSA1397 EG 1 18 QTCVAG QTcV Interval, Aggregate SLING 0.234 sec 234 234 msec LEAD II 6 LEAD STANDARD CONSCIOUS 2008-12-03T11:03 23 23 2 Hour Postdose 3 PT120M Day 23 Dose 2008-12-03T09:10
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