This example shows data for 2 subjects for a crossover trial with 4 epochs.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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 PRODUCT X ) both date and time were collected. | | Row 2: | The record for the FIRST PRODUCT EXPOSURE element for subject 789. The FIRST PRODUCT EXPOSURE element started with the start of PRODUCT X dosing and ended with the start of PRODUCT Y dosing, and full date/times were collected for both. | | Row 3: | The record for the 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 exposed to products in the wrong order. This subject entered the PRODUCT X element before the PRODUCT Y element, although the planned order of elements for this subject was PRODUCT Y, then PRODUCT X. The 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. |
|
| Dataset2 |
|---|
| Row | STUDYID | USUBJID | SESEQ | ETCD | SESTDTC | SEENDTC | SEUPDES | TAETORD | EPOCH |
|---|
| 1 | SEABC | 789 | 1 | SCREEN | 2006-06-01 | 2006-06-03T10:32 |
| 1 | SCREENING | | 2 | SEABC | 789 | 2 | PRODUCT X EXPOSURE | 2006-06-03T10:32 | 2006-06-10T09:47 |
| 2 | PRODUCT EXPOSURE 1 | | 3 | SEABC | 789 | 3 | PRODUCT Y EXPOSURE | 2006-06-10T09:47 | 2006-06-17 |
| 3 | 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 | 2 | PRODUCT X EXPOSURE | 2006-06-03T10:14 | 2006-06-10T10:32 |
|
| PRODUCT EXPOSURE 1 | | 7 | SEABC | 790 | 3 | PRODUCT Y EXPOSURE | 2006-06-10T10:32 | 2006-06-17 |
|
| PRODUCT EXPOSURE 1 | | 8 | SEABC | 790 | 4 | FOLLOWUP | 2006-06-17 | 2006-06-17 |
| 4 | FOLLOW-UP |
|
|
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Row 1: | Subject 789 was assigned to the Prod X-Prod Y arm and was exposed accordingly. | | Row 2: | Subject 790 was assigned to the Prod Y-Prod X arm, but their actual product exposure order was Product X then Product Y . |
|
| Dataset2 |
|---|
| Row | STUDYID | USUBJID | SUBJID | RFSTDTC | RFENDTC | SITEID | INVNAM | BIRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
|---|
| 1 | SEABC | 789 | 001 | 2006-06-03 | 2006-06-17 | 01 | SMITH, J | 1948-12-13 | 57 | YEARS | M | WHITE | HISPANIC OR LATINO | XY | Prod X-Prod Y | XY | Prod X-Prod Y |
|
| 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 | YX | Prod Y-Prod X | XY | Prod X-Prod Y |
|
| USA |
|
|