This example shows data for 2 subjects for a crossover trial with 4 epochs.
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 dosing) both date and time were collected.
Row 2:
The record for the IV element for subject 789. The IV element started with the start of IV dosing and ended with the start of oral dosing, and full date/times were collected for both.
Row 3:
The record for the ORAL 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 incorrectly. This subject entered the IV element before the ORAL element, although the planned order of elements for this subject was ORAL, then IV. The sponsor 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
USUBJID
SESEQ
ETCD
SESTDTC
SEENDTC
SEUPDES
TAETORD
EPOCH
1
789
1
SCREEN
2006-06-01
2006-06-03T10:32
1
SCREENING
2
789
2
IV
2006-06-03T10:32
2006-06-10T09:47
2
TREATMENT 1
3
789
3
ORAL
2006-06-10T09:47
2006-06-17
3
TREATMENT 2
4
789
4
FOLLOWUP
2006-06-17
2006-06-17
4
FOLLOW-UP
5
790
1
SCREEN
2006-06-01
2006-06-03T10:14
1
SCREENING
6
790
2
IV
2006-06-03T10:14
2006-06-10T10:32
TREATMENT 1
7
790
3
ORAL
2006-06-10T10:32
2006-06-17
TREATMENT 2
8
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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Dataset Wrapper Debug Message
Please add a row column to your dataset.
Row 1:
Subject 789 was assigned to the IV-ORAL arm and was treated accordingly.
Row 2:
Subject 790 was assigned to the ORAL-IV 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.