Target Lesion Assessment

Illustrates Domains

TU
TR

Illustrates Variables

TULOC
TULAT
TUMETHOD
TRLNKID
TRMETHOD
TRLOBXFL
TREVAL

Content

In this example, 2 target lesions were identified for the subject. The investigator evaluated the erythema, scaling, and elevation severity/intensity of each lesion using a 5-point scale. The sponsor planned to analyze the total severity score (sum of the erythema, scaling, and elevation scores), as well as the individual erythema, scaling, and elevation scores. The total score was derived by the sponsor and is not included in the SDTM dataset.

tu.xpt

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TULAT	TUMETHOD	TUEVAL	VISITNUM	TUDTC	TUDY
1	PS007	TU	001	1		LESIDENT	Lesion Identification	TARGET PLAQUE 1	TARGET PLAQUE 1	ARM	LEFT	PHYSICAL EXAMINATION	INVESTIGATOR	1	2015-06-15	-3
2	PS007	TU	001	2		LESIDENT	Lesion Identification	TARGET PLAQUE 2	TARGET PLAQUE 2	ARM	RIGHT	PHYSICAL EXAMINATION	INVESTIGATOR	1	2015-06-15	-3

The target lesions were identified by physical examination (TUMETHOD). The lesions were evaluated using a 5-point numerical rating scale, from 0 = "None", to 4 = "Very Severe." This was represented using TRMETHOD. However, if information on additional methods needs to be represented (e.g., photography with a third-party assessor), an additional method may be included. A sponsor may use "MULTIPLE" in TRMETHOD and represent the methods in the NSVs METHD1 and METHD2 (PHOTOGRAPHY, NUMERICAL RATING SCALE 5-POINT).

tr.xpt

Rows 1-6:	Show the erythema, scaling, and elevation severity/intensity scores for target lesion 1 at 2 visits.
Rows 7-12:	Show the erythema, scaling, and elevation severity/intensity scores for target lesion 2 at 2 visits.

tr.xpt

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRSTRESC	TRSTRESN	TRMETHOD	TRLOBXFL	TREVAL	VISITNUM	TRDTC
1	PS007	TR	001	1	TARGET PLAQUE 1	LESERYSV	Lesion Erythema Severity/Intensity	SEVERE	3	3	NUMERICAL RATING SCALE 5-POINT	Y	INVESTIGATOR	1	2015-06-15
2	PS007	TR	001	2	TARGET PLAQUE 1	LESSCLSV	Lesion Scaling Severity/Intensity	SEVERE	3	3	NUMERICAL RATING SCALE 5-POINT	Y	INVESTIGATOR	1	2015-06-15
3	PS007	TR	001	3	TARGET PLAQUE 1	LESELESV	Lesion Elevation Severity/Intensity	MODERATE	2	2	NUMERICAL RATING SCALE 5-POINT	Y	INVESTIGATOR	1	2015-06-15
4	PS007	TR	001	4	TARGET PLAQUE 1	LESERYSV	Lesion Erythema Severity/Intensity	SEVERE	3	3	NUMERICAL RATING SCALE 5-POINT		INVESTIGATOR	2	2015-07-15
5	PS007	TR	001	5	TARGET PLAQUE 1	LESSCLSV	Lesion Scaling Severity/Intensity	SEVERE	3	3	NUMERICAL RATING SCALE 5-POINT		INVESTIGATOR	2	2015-07-15
6	PS007	TR	001	6	TARGET PLAQUE 1	LESELESV	Lesion Elevation Severity/Intensity	MODERATE	2	2	NUMERICAL RATING SCALE 5-POINT		INVESTIGATOR	2	2015-07-15
7	PS007	TR	001	7	TARGET PLAQUE 2	LESERYSV	Lesion Erythema Severity/Intensity	SEVERE	3	3	NUMERICAL RATING SCALE 5-POINT	Y	INVESTIGATOR	1	2015-06-15
8	PS007	TR	001	8	TARGET PLAQUE 2	LESSCLSV	Lesion Scaling Severity/Intensity	MILD	1	1	NUMERICAL RATING SCALE 5-POINT	Y	INVESTIGATOR	1	2015-06-15
9	PS007	TR	001	9	TARGET PLAQUE 2	LESELESV	Lesion Elevation Severity/Intensity	MILD	1	1	NUMERICAL RATING SCALE 5-POINT	Y	INVESTIGATOR	1	2015-06-15
10	PS007	TR	001	10	TARGET PLAQUE 2	LESERYSV	Lesion Erythema Severity/Intensity	SEVERE	3	3	NUMERICAL RATING SCALE 5-POINT		INVESTIGATOR	2	2015-07-15
11	PS007	TR	001	11	TARGET PLAQUE 2	LESSCLSV	Lesion Scaling Severity/Intensity	MILD	1	1	NUMERICAL RATING SCALE 5-POINT		INVESTIGATOR	2	2015-07-15
12	PS007	TR	001	12	TARGET PLAQUE 2	LESELESV	Lesion Elevation Severity/Intensity	MILD	1	1	NUMERICAL RATING SCALE 5-POINT		INVESTIGATOR	2	2015-07-15