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Name	se

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 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 incorrectly. 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 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.

Dataset2

Row	USUBJID	SESEQ	ETCD	SESTDTC	SEENDTC	TAETORD	EPOCH
1	789	1	SCREEN	2006-06-01	2006-06-03T10:32	1	SCREENING
2	789	2IV	PRODUCT X EXPOSURE	2006-06-03T10:32	2006-06-10T09:47	2	TREATMENT PRODUCT EXPOSURE 1
3	789	3ORAL	PRODUCT Y EXPOSURE	2006-06-10T09:47	2006-06-17	3	TREATMENT PRODUCT EXPOSURE 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	2IV	PRODUCT X EXPOSURE	2006-06-03T10:14	2006-06-10T10:32		TREATMENT PRODUCT EXPOSURE 1
7	790	3ORAL	PRODUCT Y EXPOSURE	2006-06-10T10:32	2006-06-17		TREATMENT 2PRODUCT EXPOSURE 1
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

Dataset wrap

Name	dm

Rowcaps

Row 1:	Subject 789 was assigned to the IVProd X-ORAL Prod Y arm and was treated accordingly.
Row 2:	Subject 790 was assigned to the ORAL-IV armProd Y- Prod X, 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 X then Product Y .

Dataset2

Row	USUBJID	SUBJID	RFSTDTC	RFENDTC	SITEID	INVNAM	BIRTHDTC	AGE	AGEU	SEX	RACE	ETHNIC	ARMCD	ARM	ACTARMCD	ACTARM	ARMNRS	ACTARMUD	COUNTRY
1	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	IV-ORAL			USA
2	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- IV	IO	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	Prod X	XYIO	IV-ORAL			USA

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