This example shows data for 2 subjects for a crossover trial study with 4 epochs.
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| Row 1: | The record for the SCREEN element for subject 789. Note that only the date of the start of the SCREEN element was collected, whereas for the end of the element (which corresponds to the start of IV dosingPRODUCT X ) both date and time were collected. | | Row 2: | The record for the IV FIRST PRODUCT EXPOSURE element for subject 789. The IV element started FIRST PRODUCT EXPOSURE element started with the start of IV of PRODUCT X dosing and ended with the start of oral PRODUCT Y dosing, and full date/times were collected for both. | | Row 3: | The record for the ORAL SECOND PRODUCT EXPOSURE element for subject 789. Only the date, and not the time, of the start of follow-up was collected. | | Row 4: | The FOLLOWUP element for subject 789 started and ended on the same day. Presumably, the element had a positive duration, but no times were collected. | | Rows 5-8: | Subject 790 was treated incorrectlyexposed to products in the wrong order. This subject entered the IV PRODUCT X element before the ORAL PRODUCT Y element, although the planned order of elements for this subject was ORAL, then IVPRODUCT Y, then PRODUCT X. The sponsor applicant has assigned EPOCH values for this subject according to the actual order of elements, rather than the planned order. Per Assumption 6, TAETORD is missing for the elements that were out of order. The correct order of elements is the subject's ARMCD, shown in the DM dataset.Rows 9-10: | Subject 791 was screened, randomized to the IV-ORAL arm, and received the IV treatment, but did not return to the unit for the treatment epoch or follow-up. |
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| Row | STUDYID | USUBJID | SESEQ | ETCD | SESTDTC | SEENDTC | SEUPDES | TAETORD | EPOCH |
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| 1 | SEABC | 789 | 1 | SCREEN | 2006-06-01 | 2006-06-03T10:32 |
| 1 | SCREENING | | 2 | SEABC | 789 | 2IV | PRODUCT X EXPOSURE | 2006-06-03T10:32 | 2006-06-10T09:47 |
| 2 | TREATMENT PRODUCT EXPOSURE 1 | | 3 | SEABC | 789 | 3ORAL | PRODUCT Y EXPOSURE | 2006-06-10T09:47 | 2006-06-17 |
| 3 | TREATMENT PRODUCT EXPOSURE 2 | | 4 | SEABC | 789 | 4 | FOLLOWUP | 2006-06-17 | 2006-06-17 |
| 4 | FOLLOW-UP | | 5 | SEABC | 790 | 1 | SCREEN | 2006-06-01 | 2006-06-03T10:14 |
| 1 | SCREENING | | 6 | SEABC | 790 | 2IV | PRODUCT X EXPOSURE | 2006-06-03T10:14 | 2006-06-10T10:32 |
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| TREATMENT PRODUCT EXPOSURE 1 | | 7 | SEABC | 790 | 3ORAL | PRODUCT Y EXPOSURE | 2006-06-10T10:32 | 2006-06-17 |
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| TREATMENT 2PRODUCT EXPOSURE 1 | | 8 | SEABC | 790 | 4 | FOLLOWUP | 2006-06-17 | 2006-06-17 |
| 4 | FOLLOW-UP | 9 | 791 | 1 | SCREEN | 2006-06-01 | 2006-06-03T10:17 | 1 | SCREENING | 10 | 791 | 2 | IV | 2006-06-03T10:17 | 2006-06-07 | 2 | TREATMENT 1 |
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| Row 1: | Subject 789 was assigned to the IVProd X-ORAL Prod Y arm and was treated exposed accordingly. | | Row 2: | Subject 790 was assigned to the ORALProd Y-IV Prod X arm, but their actual treatment was IV, then oral. | | Row 3: | Subject 791 was assigned to the IV-ORAL arm, received the first of the 2 planned treatment elements, and were following the assigned treatment when they withdrew early. The actual arm variables are populated with the values for the arm to which subject 791 was assigned. | | product exposure order was Product X then Product Y . |
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| Row | USUBJID | SUBJID | RFSTDTC | RFENDTC | SITEID | INVNAM | BIRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
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| 1 | SEABC | 789 | 001 | 2006-06-03 | 2006-06-17 | 01 | SMITH, J | 1948-12-13 | 57 | YEARS | M | WHITE | HISPANIC OR LATINO | IOXY | IVProd X-ORALProd Y | IOXY | IVProd X-ORALProd Y |
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| USA | | 2 | SEABC | 790 | 002 | 2006-06-03 | 2006-06-17 | 01 | SMITH, J | 1955-03-22 | 51 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | OIYX | ORALProd Y-IVProd X | IOXY | IV-ORAL | USA | 3 | 791 | 003 | 2006-06-03 | 2006-06-07 | 01 | SMITH, J | 1956-07-17 | 49 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | IO | IV-ORAL | IO | IV-ORALProd X-Prod Y |
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