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Dataset wrap

Name	tu

Rowcaps

Rows 1-6:	Show a subject with 4 target lesions with (TULNKIDs "T01"-"T04") and 2 non-target lesions with (TULNKIDs "NT01" and "NT02") identified at screening. "T01" and "T02" target lesions are lymph nodes. "T01" is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). The TULOC contains the location from the anatomical location terminology. Note that some locations in controlled terminology contain laterality and/or directionality (as shown in row 7). The laterality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality.
Row 7:	Shows that, at week 36, an equivocal new lesion (TULNKID = "NEW01") was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location.
Row 8-9:	Show that, at week 44, new unequivocal new lesions (TULNKID = "NEW02" and TULNKID = "NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE").

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TUREFID	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TULAT	TUDIR	TUMETHOD	TUEVAL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	EX11111	TU	90001	1	IMG-00001	T01	TUMIDENT	Tumor Identification	TARGET	TARGET	SUPRACLAVICULAR LYMPH NODE	RIGHT		MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-01	-3
2	EX11111	TU	90001	2	IMG-00002	T02	TUMIDENT	Tumor Identification	TARGET	TARGET	THORACIC LYMPH NODE			CT SCAN	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-02	-2
3	EX11111	TU	90001	3	IMG-00001	T03	TUMIDENT	Tumor Identification	TARGET	TARGET	THYROID GLAND	LEFT		MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-01	-3
4	EX11111	TU	90001	4	IMG-00003	T04	TUMIDENT	Tumor Identification	TARGET	TARGET	SKIN OF THE TRUNK		UPPER	PHOTOGRAPHY	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-03	-1
5	EX11111	TU	90001	5	IMG-00002	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	MEDIASTINAL LYMPH NODE	RIGHT		CT SCAN	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-02	-2
6	EX11111	TU	90001	6	IMG-00001	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	CEREBELLUM	RIGHT		MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-01	1
7	EX11111	TU	90001	7	IMG-00020	NEW01	TUMIDENT	Tumor Identification	NEW	NEW	LUNG, LEFT LOWER LOBE			CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
8	EX11111	TU	90001	8	IMG-00019	NEW02	TUMIDENT	Tumor Identification	NEW	NEW	CEREBELLUM	LEFT		MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
9	EX11111	TU	90001	9	IMG-00022	NEW03	TUMIDENT	Tumor Identification	NEW	NEW	FEMORAL LYMPH NODE	LEFT		ULTRASOUND	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313

The following supptu.xpt table below shows the data on whether a tumor was previously irradiated (QNAM = "TUPRVIR") and whether that tumor was shown to be progressing since it was irradiated (QNAM = "TUPRVIRP").

Dataset wrap

Name	supptu

Rowcaps

Rows 1-3:	Show that the target lesions with TUSEQs equal to "1", "2", and "3" where were not previously irradiated.
Rows 4-5:	Show that that target lesion with TUSEQ = "4" was previously irradiated and shown to be progressing since it was irradiated.

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX11111	TU	90001	TUSEQ	1	TUPRVIR	Previously Irradiated Indicator	N	CRF
2	EX11111	TU	90001	TUSEQ	2	TUPRVIR	Previously Irradiated Indicator	N	CRF
3	EX11111	TU	90001	TUSEQ	3	TUPRVIR	Previously Irradiated Indicator	N	CRF
4	EX11111	TU	90001	TUSEQ	4	TUPRVIR	Previously Irradiated Indicator	Y	CRF
5	EX11111	TU	90001	TUSEQ	4	TUPRVIRP	Previously Irradiated Progression	Y	CRF

4.1.3 TR Domain Model

The The following tr.xpt table below table shows the terminology used to implement implement RECIST 1.1 in the TR domain1 in the TR domain. This example shows the data for one 1 subject collected at screening, week 6, week 12, and subsequent 8-week follow-up visits. The This example below shows measurements (i.e., longest perpendicular) of lymph nodes as well as measurements of other non-lymph node Target target tumors (i.e., longest diameter). In this example, when TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL", it indicates that the lymph node tumor is less than 10mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "PATHOLOGICAL". The image identifier is in TRREFID and matches a PRREFID in the PR Domaindomain.

Dataset wrap

Name	tr

Rowcaps

Rows 1-6:	Show the screening assessments of the target lesions. For lymph node target lesions "T01" and "T02", the TRTESTCD used for the assessments are "LPREP" and "LNSTATE". For non-lymph node target lesions , "T03" and "T04", the TRTESTCD used for the assessments is "LDIAM".
Rows 7-8:	Show the results for the non-targets. "NT01" is a lymph node where the TRTEST used for the assessments is "Lymph Node State" (TRTESTCD = "LNSTATE"). "NT02" is a non-lymph node where the TRTEST used for the assessments is "Tumor State" (TRTESTCD = "TUMSTATE").
Row 14:	Shows a case where case where the scan was not performed at week 6 (for TRTEST = "Longest Diameter", TRSTAT = "NOT DONE" with TRREASND = "SCAN NOT PERFORMED").
Row 15:	Shows a case where the non-target "NT01" was not evaluable (for TRTEST = "Lymph Node State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE").
Row 16:	Shows a case where the non-target "NT02" was not evaluable (for TRTEST = "Tumor State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE").
Row 30:	Shows a target lesion ("T04") which is too small to measure . The (TRORRES = "TOO SMALL TO MEASURE", and the ; TRSTRESC and TRSTRESN are standardized to "5" with TRSTRESU as "mm"). The standardized value of "5" ensures that the sum of diameters includes a value for that lesion because it has not disappeared. The method of standardization of the TRSTRESC and TRSTRESN values is sponsor specific.
Row 58:	Shows a new lesion ("NEW01") which has a measurement of 4 mm. Note that this value is less than 5 mm and has not been reported as "TOO SMALL TO MEASURE".

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRREFID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRSTAT	TRREASND	TRMETHOD	TREVAL	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	EX11111	TR	90001	1	TARGET	IMG-00001	A1	T01	LPERP	Longest Perpendicular	17	mm	17	17	mm			MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-01	-3
2	EX11111	TR	90001	2	TARGET	IMG-00001	A1	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-01	-3
3	EX11111	TR	90001	3	TARGET	IMG-00002	A1	T02	LPERP	Longest Perpendicular	16	mm	16	16	mm			CT SCAN	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-02	-2
4	EX11111	TR	90001	4	TARGET	IMG-00002	A1	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-02	-2
5	EX11111	TR	90001	5	TARGET	IMG-00001	A1	T03	LDIAM	Longest Diameter	15	mm	15	15	mm			MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-01	-3
6	EX11111	TR	90001	6	TARGET	IMG-00003	A1	T04	LDIAM	Longest Diameter	14	mm	14	14	mm			PHOTOGRAPHY	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-03	-1
7	EX11111	TR	90001	7	NON-TARGET	IMG-00002	A1	NT01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-02	-2
8	EX11111	TR	90001	8	NON-TARGET	IMG-00001	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-01	-3
9	EX11111	TR	90001	9	TARGET	IMG-00004	A2	T01	LPERP	Longest Perpendicular	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	43
10	EX11111	TR	90001	10	TARGET	IMG-00004	A2	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	43
11	EX11111	TR	90001	11	TARGET	IMG-00005	A2	T02	LPERP	Longest Perpendicular	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-16	44
12	EX11111	TR	90001	12	TARGET	IMG-00005	A2	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-16	44
13	EX11111	TR	90001	13	TARGET	IMG-00004	A2	T03	LDIAM	Longest Diameter	14	mm	14	14	mm			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	43
14	EX11111	TR	90001	14	TARGET		A2	T04	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED	PHOTOGRAPHY	INVESTIGATOR	TREATMENT	40	WEEK 6
15	EX11111	TR	90001	15	NON-TARGET	IMG-00005	A2	NT01	LNSTATE	Lymph Node State						NOT DONE	NOT EVALUABLE	CT SCAN	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-16	44
16	EX11111	TR	90001	16	NON-TARGET	IMG-00004	A2	NT02	TUMSTATE	Tumor State						NOT DONE	NOT EVALUABLE	MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	43
17	EX11111	TR	90001	17	TARGET	IMG-00007	A3	T01	LPERP	Longest Perpendicular	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
18	EX11111	TR	90001	18	TARGET	IMG-00007	A3	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
19	EX11111	TR	90001	19	TARGET	IMG-00008	A3	T02	LPERP	Longest Perpendicular	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-30	86
20	EX11111	TR	90001	20	TARGET	IMG-00008	A3	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-30	86
21	EX11111	TR	90001	21	TARGET	IMG-00007	A3	T03	LDIAM	Longest Diameter	15	mm	15	15	mm			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
22	EX11111	TR	90001	22	TARGET	IMG-00009	A3	T04	LDIAM	Longest Diameter	8	mm	8	8	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-01	87
23	EX11111	TR	90001	23	NON-TARGET	IMG-00008	A3	NT01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-30	86
24	EX11111	TR	90001	24	NON-TARGET	IMG-00007	A3	NT02	TUMSTATE	Tumor State						NOT DONE	NOT EVALUABLE	MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
25	EX11111	TR	90001	25	TARGET	IMG-00010	A4	T01	LPERP	Longest Perpendicular	9	mm	9	9	mm			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
26	EX11111	TR	90001	26	TARGET	IMG-00010	A4	T01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
27	EX11111	TR	90001	27	TARGET	IMG-00011	A4	T02	LPERP	Longest Perpendicular	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-28	145
28	EX11111	TR	90001	28	TARGET	IMG-00011	A4	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-28	145
29	EX11111	TR	90001	29	TARGET	IMG-00010	A4	T03	LDIAM	Longest Diameter	11	mm	11	11	mm			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
30	EX11111	TR	90001	30	TARGET	IMG-00012	A4	T04	LDIAM	Longest Diameter	TOO SMALL TO MEASURE	mm	5	5	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
31	EX11111	TR	90001	31	NON-TARGET	IMG-00011	A4	NT01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-28	145
32	EX11111	TR	90001	32	NON-TARGET	IMG-00010	A4	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
33	EX11111	TR	90001	33	TARGET	IMG-00013	A5	T01	LPERP	Longest Perpendicular	9	mm	9	9	mm			MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
34	EX11111	TR	90001	34	TARGET	IMG-00013	A5	T01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
35	EX11111	TR	90001	35	TARGET	IMG-00014	A5	T02	LPERP	Longest Perpendicular	8	mm	8	8	mm			CT SCAN	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-24	202
36	EX11111	TR	90001	36	TARGET	IMG-00014	A5	T02	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-24	202
37	EX11111	TR	90001	37	TARGET	IMG-00013	A5	T03	LDIAM	Longest Diameter	6	mm	6	6	mm			MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
38	EX11111	TR	90001	38	TARGET	IMG-00015	A5	T04	LDIAM	Longest Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-25	203
39	EX11111	TR	90001	39	NON-TARGET	IMG-00014	A5	NT01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-24	202
40	EX11111	TR	90001	40	NON-TARGET	IMG-00013	A5	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
41	EX11111	TR	90001	41	TARGET	IMG-00016	A6	T01	LPERP	Longest Perpendicular	8	mm	8	8	mm			MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
42	EX11111	TR	90001	42	TARGET	IMG-00016	A6	T01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
43	EX11111	TR	90001	43	TARGET	IMG-00017	A6	T02	LPERP	Longest Perpendicular	9	mm	9	9	mm			CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
44	EX11111	TR	90001	44	TARGET	IMG-00017	A6	T02	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
45	EX11111	TR	90001	45	TARGET	IMG-00016	A6	T03	LDIAM	Longest Diameter	0	mm	0	0	mm			MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
46	EX11111	TR	90001	46	TARGET	IMG-00018	A6	T04	LDIAM	Longest Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
47	EX11111	TR	90001	47	NON-TARGET	IMG-00017	A6	NT01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
48	EX11111	TR	90001	48	NON-TARGET	IMG-00016	A6	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
49	EX11111	TR	90001	49	NEW	IMG-00017	A6	NEW01	TUMSTATE	Tumor State	EQUIVOCAL		EQUIVOCAL					CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
50	EX11111	TR	90001	50	TARGET	IMG-00019	A7	T01	LPERP	Longest Perpendicular	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
51	EX11111	TR	90001	51	TARGET	IMG-00019	A7	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
52	EX11111	TR	90001	52	TARGET	IMG-00020	A7	T02	LPERP	Longest Perpendicular	9	mm	9	9	mm			CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
53	EX11111	TR	90001	53	TARGET	IMG-00020	A7	T02	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
54	EX11111	TR	90001	54	TARGET	IMG-00019	A7	T03	LDIAM	Longest Diameter	0	mm	0	0	mm			MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
55	EX11111	TR	90001	55	TARGET	IMG-00021	A7	T04	LDIAM	Longest Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-16	315
56	EX11111	TR	90001	56	NON-TARGET	IMG-00020	A7	NT01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
57	EX11111	TR	90001	57	NON-TARGET	IMG-00019	A7	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
58	EX11111	TR	90001	58	NEW	IMG-00020	A7	NEW01	LDIAM	Longest Diameter	4	mm	4	4	mm			CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
59	EX11111	TR	90001	59	NEW	IMG-00020	A7	NEW01	TUMSTATE	Tumor State	UNEQUIVOCAL		UNEQUIVOCAL					CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
60	EX11111	TR	90001	60	NEW	IMG-00019	A7	NEW02	LDIAM	Longest Diameter	7	mm	7	7	mm			MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
61	EX11111	TR	90001	61	NEW	IMG-00019	A7	NEW02	TUMSTATE	Tumor State	UNEQUIVOCAL		UNEQUIVOCAL					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
62	EX11111	TR	90001	62	NEW	IMG-00022	A7	NEW03	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					ULTRASOUND	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	315

The following supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.

Dataset wrap

Name	supprs

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX11111	TR	90001	TRSEQ	15	TRREASNE	Reason Tumor/Lesion Not Evaluable	Imaging quality issues	CRF
2	EX11111	TR	90001	TRSEQ	16	TRREASNE	Reason Tumor/Lesion Not Evaluable	Image obscured	CRF
3	EX11111	TR	90001	TRSEQ	24	TRREASNE	Reason Tumor/Lesion Not Evaluable	Imaging quality issues	CRF

4.1.4 PR Domain Model

The following pr.xpt table below shows table shows the terminology used to implement RECIST implement RECIST 1.1 in 1 in the PR domainPR domain. This example shows the data for one 1 subject collected at screening, week 6, week 12, and subsequent 8-week follow-up visits. The The example shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin of the trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN OF THE TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.

Dataset wrap

Name	pr

Rowcaps

Rows 1-3:	Show the scans performed at screening. The results of the scans are in TU and TR.
Rows 4-6:	Show that the MRI and CT scan were performed (PROCCUR = "Y") and that the medical photography was not performed (PROCCUR = "N") at week 6.
Rows 7-22:	Show the scans performed at weeks 12, 20, 28, 36, and 44. The results of the scans are in TU and TR. In row 22, a non-RECIST 1.1 method was used and this example shows a way to represent the additional scan in PR , (i.e., "ULTRASOUND").

Dataset2

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRREFID	PRLNKGRP	PRTRT	PRPRESP	PROCCUR	PRLOC	EPOCH	VISITNUM	VISIT	PRSTDTC	PRSTDY
1	EX11111	PR	90001	1	IMG-00001	A1	MRI	Y	Y	HEAD AND NECK	SCREEN	10	SCREENING	2010-01-01	-3
2	EX11111	PR	90001	2	IMG-00002	A1	CT SCAN	Y	Y	CHEST	SCREEN	10	SCREENING	2010-01-02	-2
3	EX11111	PR	90001	3	IMG-00003	A1	PHOTOGRAPHY	Y	Y	SKIN OF THE TRUNK	SCREEN	10	SCREENING	2010-01-03	-1
4	EX11111	PR	90001	4	IMG-00004	A2	MRI	Y	Y	HEAD AND NECK	TREATMENT	40	WEEK 6	2010-02-15	43
5	EX11111	PR	90001	5	IMG-00005	A2	CT SCAN	Y	Y	CHEST	TREATMENT	40	WEEK 6	2010-02-16	44
6	EX11111	PR	90001	6		A2	PHOTOGRAPHY	Y	N	SKIN OF THE TRUNK	TREATMENT	40	WEEK 6
7	EX11111	PR	90001	7	IMG-00007	A3	MRI	Y	Y	HEAD AND NECK	TREATMENT	60	WEEK 12	2010-03-29	85
8	EX11111	PR	90001	8	IMG-00008	A3	CT SCAN	Y	Y	CHEST	TREATMENT	60	WEEK 12	2010-03-30	86
9	EX11111	PR	90001	9	IMG-00009	A3	PHOTOGRAPHY	Y	Y	SKIN OF THE TRUNK	TREATMENT	60	WEEK 12	2010-04-01	87
10	EX11111	PR	90001	10	IMG-00010	A4	MRI	Y	Y	HEAD AND NECK	TREATMENT	80	WEEK 20	2010-05-27	144
11	EX11111	PR	90001	11	IMG-00011	A4	CT SCAN	Y	Y	CHEST	TREATMENT	80	WEEK 20	2010-05-28	145
12	EX11111	PR	90001	12	IMG-00012	A4	PHOTOGRAPHY	Y	Y	SKIN OF THE TRUNK	TREATMENT	80	WEEK 20	2010-05-30	147
13	EX11111	PR	90001	13	IMG-00013	A5	MRI	Y	Y	HEAD AND NECK	TREATMENT	100	WEEK 28	2010-07-23	201
14	EX11111	PR	90001	14	IMG-00014	A5	CT SCAN	Y	Y	CHEST	TREATMENT	100	WEEK 28	2010-07-24	202
15	EX11111	PR	90001	15	IMG-00015	A5	PHOTOGRAPHY	Y	Y	SKIN OF THE TRUNK	TREATMENT	100	WEEK 28	2010-07-25	203
16	EX11111	PR	90001	16	IMG-00016	A6	MRI	Y	Y	HEAD AND NECK	TREATMENT	120	WEEK 36	2010-09-17	257
17	EX11111	PR	90001	17	IMG-00017	A6	CT SCAN	Y	Y	CHEST	TREATMENT	120	WEEK 36	2010-09-17	257
18	EX11111	PR	90001	18	IMG-00018	A6	PHOTOGRAPHY	Y	Y	SKIN OF THE TRUNK	TREATMENT	120	WEEK 36	2010-09-17	257
19	EX11111	PR	90001	19	IMG-00019	A7	MRI	Y	Y	HEAD AND NECK	TREATMENT	140	WEEK 44	2010-11-14	313
20	EX11111	PR	90001	20	IMG-00020	A7	CT SCAN	Y	Y	CHEST	TREATMENT	140	WEEK 44	2010-11-15	314
21	EX11111	PR	90001	21	IMG-00021	A7	PHOTOGRAPHY	Y	Y	SKIN OF THE TRUNK	TREATMENT	140	WEEK 44	2010-11-16	315
22	EX11111	PR	90001	22	IMG-00022	A7	ULTRASOUND			PELVIS	TREATMENT	140	WEEK 44	2010-11-16	315

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4.1.3 TR Domain Model

4.1.4 PR Domain Model