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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.
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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.
Dataset2 |
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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 |
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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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