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The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at week 8 and subsequent 8-week follow-up visits.

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Name	rs

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The Overall Response (RSTESTCD = "OVRLRESP") has RSORRES = "NE" because the scans of the target and non-target lesions were not done.

Dataset wrap

Name	rs

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSSTAT	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	EX33333	RS	90003	1		TRGRESP	Target Response	RECIST 1.1	SD	SD		INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
2	EX33333	RS	90003	2		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD		INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
3	EX33333	RS	90003	3	A2	OVRLRESP	Overall Response	RECIST 1.1	SD	SD		INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
4	EX33333	RS	90003	4		TRGRESP	Target Response	RECIST 1.1	PR	PR		INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
5	EX33333	RS	90003	5		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD		INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
6	EX33333	RS	90003	6	A3	OVRLRESP	Overall Response	RECIST 1.1	PR	PR		INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
7	EX33333	RS	90003	7		TRGRESP	Target Response	RECIST 1.1	PR	PR		INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-26	175
8	EX33333	RS	90003	8		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD		INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-26	175
9	EX33333	RS	90003	9	A4	OVRLRESP	Overall Response	RECIST 1.1	PR	PR		INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-26	175
10	EX33333	RS	90003	10		TRGRESP	Target Response	RECIST 1.1			NOT DONE	INVESTIGATOR	TREATMENT	9	WEEK 32
11	EX33333	RS	90003	11		NTRGRESP	Non-Target Response	RECIST 1.1			NOT DONE	INVESTIGATOR	TREATMENT	9	WEEK 32
12	EX33333	RS	90003	12	A5	OVRLRESP	Overall Response	RECIST 1.1	NE	NE		INVESTIGATOR	TREATMENT	9	WEEK 32

The supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable) (QNAM = "RSREASNE") in the case where it is collected.

Dataset wrap

Name	supprs

Rowcaps
Row 1: Show that the QVAL for Reason Response Not Evaluable (QNAM = "RSREASNE").

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX33333	RS	90005	RSSEQ	12	RSREASNE	Reason Response Not Evaluable	Scans of target and non-target tumors were not performed	CRF

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The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the identification of target and non-target tumors at screening. The tumor The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

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Name	tu

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TRLNKIDs in the TR Domain. This example shows a subject with 4 target lesions with TULNKID "T01"-"T04" and 3 non-target lesions with TULNKID "NT01"-"NT03" identified at screening. The subject did not have any new lesions.

Dataset wrap

Name	tu

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TULAT	TUMETHOD	TUEVAL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	EX33333	TU	90003	1	T01	TUMIDENT	Tumor Identification	TARGET	TARGET	LUNG, RIGHT MIDDLE LOBE		CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
2	EX33333	TU	90003	2	T02	TUMIDENT	Tumor Identification	TARGET	TARGET	LIVER		CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
3	EX33333	TU	90003	3	T03	TUMIDENT	Tumor Identification	TARGET	TARGET	LIVER		CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
4	EX33333	TU	90003	4	T04	TUMIDENT	Tumor Identification	TARGET	TARGET	KIDNEY, UPPER LOBE	RIGHT	CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
5	EX33333	TU	90003	5	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	LUNG		CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
6	EX33333	TU	90003	6	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	ABDOMINAL CAVITY		CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
7	EX33333	TU	90003	7	NT03	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	CLAVICLE	RIGHT	SCINTIGRAPHY	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1

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Dataset wrap

Name	tr

Rowcaps

Rows 1-32:	Show RECIST 1.1 assessments of target and non-target lesions at screening, week 8, week 16 and week 24.
Rows 33-39:	Show that the scans of target and non-target lesions were not done at week 32.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRSTAT	TRREASND	TRMETHOD	TREVAL	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	EX33333	TR	90003	1	TARGET	A1	T01	LDIAM	Longest Diameter	16	mm	16	16	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
2	EX33333	TR	90003	2	TARGET	A1	T02	LDIAM	Longest Diameter	28	mm	28	28	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
3	EX33333	TR	90003	3	TARGET	A1	T03	LDIAM	Longest Diameter	41	mm	41	41	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
4	EX33333	TR	90003	4	TARGET	A1	T04	LDIAM	Longest Diameter	82	mm	83	83	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
5	EX33333	TR	90003	5	TARGET	A1		SUMDIAM	Sum of Diameter	167	mm	168	168	mm				INVESTIGATOR	SCREEN	1	SCREENING
6	EX33333	TR	90003	6	NON-TARGET	A1	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
7	EX33333	TR	90003	7	NON-TARGET	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
8	EX33333	TR	90003	8	NON-TARGET	A1	NT03	TUMSTATE	Tumor State	PRESENT		PRESENT					SCINTIGRAPHY	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
9	EX33333	TR	90003	9	TARGET	A2	T01	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
10	EX33333	TR	90003	10	TARGET	A2	T02	LDIAM	Longest Diameter	20	mm	20	20	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
11	EX33333	TR	90003	11	TARGET	A2	T03	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
12	EX33333	TR	90003	12	TARGET	A2	T04	LDIAM	Longest Diameter	65	mm	65	65	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
13	EX33333	TR	90003	13	TARGET	A2		SUMDIAM	Sum of Diameter	125	mm	125	125	mm				INVESTIGATOR	TREATMENT	3	WEEK 8
14	EX33333	TR	90003	14	NON-TARGET	A2	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
15	EX33333	TR	90003	15	NON-TARGET	A2	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
16	EX33333	TR	90003	16	NON-TARGET	A2	NT03	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED	SCINTIGRAPHY	INVESTIGATOR	TREATMENT	3	WEEK 8
17	EX33333	TR	90003	17	TARGET	A3	T01	LDIAM	Longest Diameter	TOO SMALL TO MEASURE	mm	5	5	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
18	EX33333	TR	90003	18	TARGET	A3	T02	LDIAM	Longest Diameter	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
19	EX33333	TR	90003	19	TARGET	A3	T03	LDIAM	Longest Diameter	15	mm	15	15	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
20	EX33333	TR	90003	20	TARGET	A3	T04	LDIAM	Longest Diameter	40	mm	40	40	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
21	EX33333	TR	90003	21	TARGET	A3		SUMDIAM	Sum of Diameter	72	mm	72	72	mm				INVESTIGATOR	TREATMENT	5	WEEK 16
22	EX33333	TR	90003	22	NON-TARGET	A3	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
23	EX33333	TR	90003	23	NON-TARGET	A3	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
24	EX33333	TR	90003	24	NON-TARGET	A3	NT03	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED	SCINTIGRAPHY	INVESTIGATOR	TREATMENT	5	WEEK 16
25	EX33333	TR	90003	25	TARGET	A4	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
26	EX33333	TR	90003	26	TARGET	A4	T02	LDIAM	Longest Diameter	15	mm	15	15	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
27	EX33333	TR	90003	27	TARGET	A4	T03	LDIAM	Longest Diameter	5	mm	5	5	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
28	EX33333	TR	90003	28	TARGET	A4	T04	LDIAM	Longest Diameter	36	mm	36	36	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
29	EX33333	TR	90003	29	TARGET	A4		SUMDIAM	Sum of Diameter	56	mm	56	56	mm				INVESTIGATOR	TREATMENT	7	WEEK 24
30	EX33333	TR	90003	30	NON-TARGET	A4	NT01	TUMSTATE	Tumor State						NOT DONE	NOT EVALUABLE	CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
31	EX33333	TR	90003	31	NON-TARGET	A4	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
32	EX33333	TR	90003	32	NON-TARGET	A4	NT03	TUMSTATE	Tumor State	PRESENT		PRESENT					SCINTIGRAPHY	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-26	175
33	EX33333	TR	90003	33	TARGET	A5	T01	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED	CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32
34	EX33333	TR	90003	34	TARGET	A5	T02	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED	CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32
35	EX33333	TR	90003	35	TARGET	A5	T03	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED	CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32
36	EX33333	TR	90003	36	TARGET	A5	T04	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED	CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32
37	EX33333	TR	90003	37	NON-TARGET	A5	NT01	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED	CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32
38	EX33333	TR	90003	38	NON-TARGET	A5	NT02	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED	CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32
39	EX33333	TR	90003	39	NON-TARGET	A5	NT03	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED	SCINTIGRAPHY	INVESTIGATOR	TREATMENT	9	WEEK 32

The 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	supptr

Rowcaps
Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE").

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX33333	TR	90003	TRSEQ	30	TRREASNE	Reason Tumor/Lesion Not Evaluable	Image obscured	CRF

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This example also includes the situation where the Best Response assessment is provided by the data capture rather than derived.

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Name	rs

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This examples show data from an independent review where the RSNAM, RSEVAL and RSEVALID are used. The RSNAM contains the name of the vendor,

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the RSEVAL contains role of the

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person who provided the assessment, in this case, RSEVAL = "INDEPENDENT ASSESSOR" and the

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RSEVALID contains the specific type of medical reviewer who performed the independent assessment. In this case, two radiologists independently reviewed the scans. The RSEVALID indicates the assessments by 'RADIOLOGIST 1" and "RADIOLOGIST 2". The acceptance flag (RSACPTFL) indicates that the "RADIOLOGIST 2" records are the accepted records in rows 9-16. The Best Overall Response (RSTESTCD = "BESTRESP") is provided by the vendor in the data transfer in rows 4, 8, 12 and 16.

Dataset wrap

Name	rs

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSNAM	RSEVAL	RSEVALID	RSACPTFL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	EX44444	RS	90004	1		TRGRESP	Target Response	RECIST 1.1	SD	SD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
2	EX44444	RS	90004	2		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
3	EX44444	RS	90004	3	R1-A2	OVRLRESP	Overall Response	RECIST 1.1	SD	SD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
4	EX44444	RS	90004	4		BESTRESP	Best Overall Response	RECIST 1.1	SD	SD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
5	EX44444	RS	90004	5		TRGRESP	Target Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
6	EX44444	RS	90004	6		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
7	EX44444	RS	90004	7	R1-A3	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
8	EX44444	RS	90004	8		BESTRESP	Best Overall Response	RECIST 1.1	SD	SD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
9	EX44444	RS	90004	9		TRGRESP	Target Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8	2007-02-27	56
10	EX44444	RS	90004	10		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8	2007-02-27	56
11	EX44444	RS	90004	11	R2-A2	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8	2007-02-27	56
12	EX44444	RS	90004	12		BESTRESP	Best Overall Response	RECIST 1.1	SD	SD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8	2007-02-27	56
13	EX44444	RS	90004	13		TRGRESP	Target Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16	2007-04-24	112
14	EX44444	RS	90004	14		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16	2007-04-24	112
15	EX44444	RS	90004	15	R2-A3	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16	2007-04-24	112
16	EX44444	RS	90004	16		BESTRESP	Best Overall Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16	2007-04-24	112

...

Dataset wrap

Name	tu

Rowcaps

Rows 1-3:	Show the identification of two target lesions "R1-T01" and "R1-T02"and one non-target lesion "R1-NT01" by independent radiologist (TUEVALID = "RADIOLOGIST 1").
Rows 4-6:	Show the identification of two target lesions "R2-T01" and "R2-T02"and one non-target lesion "R2-NT01" by another independent radiologist (TUEVALID = "RADIOLOGIST 2").

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TUNAM	TULOC	TULAT	TUMETHOD	TUEVAL	TUEVALID	TUACPTFL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	EX44444	TU	90004	1	R1-T01	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	LIVER		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREENING	2007-01-02	1
2	EX44444	TU	90004	2	R1-T02	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	KIDNEY, UPPER LOBE	LEFT	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREENING	2007-01-02	1
3	EX44444	TU	90004	3	R1-NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	RADIOL INC.	ABDOMINAL CAVITY		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREENING	2007-01-02	1
4	EX44444	TU	90004	4	R2-T01	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	KIDNEY, UPPER LOBE	LEFT	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREENING	2007-01-02	1
5	EX44444	TU	90004	5	R2-T02	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	LIVER		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREENING	2007-01-02	1
6	EX44444	TU	90004	6	R2-NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	RADIOL INC.	ABDOMINAL CAVITY		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREENING	2007-01-02	1

...

Dataset wrap

Name	supptu

Rowcaps

Row 1:	Shows that the target lesion in the liver with TUSEQ = "1" is located in segment 5 of the liver as described by radiologist 1.
Row 2:	Shows that the non-target lesion in the abdominal cavity with TUSEQ = "3" is located in the back of the abdomen as described by radiologist 1.
Row 3:	Shows that the target lesion in the liver with TUSEQ = "5" is located in the lower part of segment 5 as described by radiologist 2.

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX44444	TU	90004	TUSEQ	1	TULOCDTL	Location Detail	Segment 5	CRF
2	EX44444	TU	90004	TUSEQ	3	TULOCDTL	Location Detail	Back of the abdomen	CRF
3	EX44444	TU	90004	TUSEQ	5	TULOCDTL	Location Detail	Lower part of Segment 5	CRF

...

Dataset wrap

Name	tr

Rowcaps

Rows 1-32:	Show that two radiologists independently reviewed the scans. TRLNKGRP has values "R1-A2" and "R1-A3" to indicate the assessments by "RADIOLOGIST 1" which are linked to the results determine by "RADIOLOGIST 1" in RS. Likewise, the values "R2-A2" and "R2-A3" to indicate the assessments by "RADIOLOGIST 2" which are linked to the results determine by "RADIOLOGIST 2" in RS.
Rows 17-32:	Show that the results provided by "RADIOLOGIST 2" are the accepted records (TRACPTFL). The accepted record flags are per the data transfer from the independent reviewer.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRNAM	TRMETHOD	TREVAL	TREVALID	TRACPTFL	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	EX44444	TR	90004	1	TARGET	R1-A1	R1-T01	LDIAM	Longest Diameter	15	mm	15	15	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREENING	2007-01-02	1
2	EX44444	TR	90004	2	TARGET	R1-A1	R1-T02	LDIAM	Longest Diameter	25	mm	25	25	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREENING	2007-01-02	1
3	EX44444	TR	90004	3	TARGET	R1-A1		SUMDIAM	Sum of Diameter	40	mm	40	40	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREENING	2007-01-02	1
4	EX44444	TR	90004	4	NON-TARGET	R1-A1	R1-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREENING	2007-01-02	1
5	EX44444	TR	90004	5	TARGET	R1-A2	R1-T01	LDIAM	Longest Diameter	10	mm	10	10	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
6	EX44444	TR	90004	6	TARGET	R1-A2	R1-T02	LDIAM	Longest Diameter	25	mm	25	25	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
7	EX44444	TR	90004	7	TARGET	R1-A2		SUMDIAM	Sum of Diameter	35	mm	35	35	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8
8	EX44444	TR	90004	8	TARGET	R1-A2		PCBSD	Percent Change From Baseline in Sum of Diameter	-13	%	-13	-13	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8
9	EX44444	TR	90004	9	TARGET	R1-A2		PCNSD	Percent Change From Nadir in Sum of Diameter	-13	%	-13	-13	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8
10	EX44444	TR	90004	10	NON-TARGET	R1-A2	R1-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
11	EX44444	TR	90004	11	TARGET	R1-A3	R1-T01	LDIAM	Longest Diameter	5	mm	5	5	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
12	EX44444	TR	90004	12	TARGET	R1-A3	R1-T02	LDIAM	Longest Diameter	10	mm	10	10	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
13	EX44444	TR	90004	13	TARGET	R1-A3		SUMDIAM	Sum of Diameter	15	mm	15	15	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16
14	EX44444	TR	90004	14	TARGET	R1-A3		PCBSD	Percent Change From Baseline in Sum of Diameter	-63	%	-63	-63	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16
15	EX44444	TR	90004	15	TARGET	R1-A3		PCNSD	Percent Change From Nadir in Sum of Diameter	-57	%	-57	-57	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16
16	EX44444	TR	90004	16	NON-TARGET	R1-A3	R1-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
17	EX44444	TR	90004	17	TARGET	R2-A1	R2-T01	LDIAM	Longest Diameter	25	mm	25	25	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREENING	2007-01-02	1
18	EX44444	TR	90004	18	TARGET	R2-A1	R2-T02	LDIAM	Longest Diameter	20	mm	20	20	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREENING	2007-01-02	1
19	EX44444	TR	90004	19	TARGET	R2-A1		SUMDIAM	Sum of Diameter	45	mm	45	45	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREENING
20	EX44444	TR	90004	20	NON-TARGET	R2-A1	R2-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREENING	2007-01-02	1
21	EX44444	TR	90004	21	TARGET	R2-A2	R2-T01	LDIAM	Longest Diameter	10	mm	10	10	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8	2007-02-27	56
22	EX44444	TR	90004	22	TARGET	R2-A2	R2-T02	LDIAM	Longest Diameter	8	mm	8	8	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8	2007-02-27	56
23	EX44444	TR	90004	23	TARGET	R2-A2		SUMDIAM	Sum of Diameter	18	mm	18	18	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8
24	EX44444	TR	90004	24	TARGET	R2-A2		PCBSD	Percent Change From Baseline in Sum of Diameter	-60	%	-60	-60	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8
25	EX44444	TR	90004	25	TARGET	R2-A2		PCNSD	Percent Change From Nadir in Sum of Diameter	-60	%	-60	-60	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8
26	EX44444	TR	90004	26	NON-TARGET	R2-A2	R2-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8	2007-02-27	56
27	EX44444	TR	90004	27	TARGET	R2-A3	R2-T01	LDIAM	Longest Diameter	15	mm	15	15	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16	2007-04-24	112
28	EX44444	TR	90004	28	TARGET	R2-A3	R2-T02	LDIAM	Longest Diameter	TOO SMALL TO MEASURE	mm	5	5	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16	2007-04-24	112
29	EX44444	TR	90004	29	TARGET	R2-A3		SUMDIAM	Sum of Diameter	20	mm	20	20	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16
30	EX44444	TR	90004	30	TARGET	R2-A3		PCBSD	Percent Change From Baseline in Sum of Longest Diameter	-56	%	-56	-56	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16
31	EX44444	TR	90004	31	TARGET	R2-A3		PCNSLD	Percent Change From Nadir in Sum of Longest Diameter	11	%	11	11	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16
32	EX44444	TR	90004	32	NON-TARGET	R2-A3	R2-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16	2007-04-24	112

4.5 Example 5: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the data for a subject that has only Target tumors at screening. This example includes an unscheduled assessment.

...

Dataset wrap

Name	rs

Rowcaps

Rows 1-2:	Rows 1-2: Show the Target Response (RSTESTCD = "TRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") of CR (Complete Response) at week 8. The subject only has one target lesion and no non-targets. The Non-target Response (RSTESTCD = "NTRGRESP") is not applicable and a record may be included to represent this, if desired.
Rows 3-4:	Show an unscheduled response assessment which was done to confirm the complete response ("CR"). The RSLNKGRP differentiates the assessment and the VISIT is "UNSCHEDULED WEEK 13".
Rows 5-6:	Show Target

Response

Response (RSTESTCD = "TRGRESP") of not evaluable ("NE") and Overall Response (RSTESTCD = "OVRLRESP") of not evaluable ("NE") due to an unreadable image.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	EX55555	RS	90005	1		TRGRESP	Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
2	EX55555	RS	90005	2	A2	OVRLRESP	Overall Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
3	EX55555	RS	90005	3		TRGRESP	Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13	2007-04-03	91
4	EX55555	RS	90005	4	A3	OVRLRESP	Overall Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13	2007-04-03	91
5	EX55555	RS	90005	5		TRGRESP	Target Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
6	EX55555	RS	90005	6	A5	OVRLRESP	Overall Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
7	EX55555	RS	90005	7		TRGRESP	Target Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
8	EX55555	RS	90005	8	A5	OVRLRESP	Overall Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168

The supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable) (QNAM = "RSREASNE") in the case where it is collected.

Dataset wrap

Name	supprs

Rowcaps
Row 1: Shows that the QVAL for RSSEQ = "6" for Reason Response Not Evaluable (QNAM = "RSREASNE").

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX55555	RS	90005	RSSEQ	6	RSREASNE	Reason Response Not Evaluable	Imaging Quality Issues	CRF

...

Dataset wrap

Name	tu

Rowcaps

Row 1:

Shows that the subject has at least one target tumor (TUTESTCD = "TIND"), i.e., the subject has measurable disease.

Prior

Prior to SDTMIG 3.4, this row would not be included.

However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU.
Row 2:	Shows that the subject does not have any non-target tumors (TUTESTCD = "NTIND"). Prior to SDTMIG 3.4, this row would not be included.

However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU.
Row 3:	Shows the single target lesion in the breast. The subject only has one target lesion and no non-targets.
Row 4:	Shows new bone lesion identified at week 24.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TULAT	TUMETHOD	TUEVAL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	EX55555	TU	90005	1		TIND	Target Indicator	Y	Y				INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
2	EX55555	TU	90005	2		NTIND	Non-Target Indicator	N	N				INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
3	EX55555	TU	90005	3	T01	TUMIDENT	Tumor Identification	TARGET	TARGET	BREAST	RIGHT	CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-01	1
4	EX55555	TU	90005	4	NEW01	TUMIDENT	Tumor Identification	NEW	NEW	BONE		CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168

...

Dataset wrap

Name	tr

Rowcaps

Rows 1-14:	Show the longest diameter and sum of longest diameter for the target lesion. The subject only has one target lesion and no non-targets.
Rows 3-6:	Show assessment where the target lesion is absent. The longest diameter is shown as "0". If a sponsor collects that the tumor is absent rather than entering the longest diameter as "0", then the sponsor may optionally derive the longest diameter as "0" and represent the tumor state as ABSENT, if desired.
Row 15:	Shows a new lesion state at week 24.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRSTAT	TRREASND	TRMETHOD	TREVAL	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	EX55555	TR	90005	1	TARGET	A1	T01	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
2	EX55555	TR	90005	2	TARGET	A1		SUMDIAM	Sum of Diameter	10	mm	10	10	mm				INVESTIGATOR	SCREEN	1	SCREENING
3	EX55555	TR	90005	3	TARGET	A2	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
4	EX55555	TR	90005	4	TARGET	A2	T01	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
5	EX55555	TR	90005	5	TARGET	A2		SUMDIAM	Sum of Diameter	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	3	WEEK 8
6	EX55555	TR	90005	6	TARGET	A3	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13	2007-04-03	91
7	EX55555	TR	90005	7	TARGET	A3	T01	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13	2007-04-03	91
8	EX55555	TR	90005	8	TARGET	A3		SUMDIAM	Sum of Diameter	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13
9	EX55555	TR	90005	9	TARGET	A4	T01	LDIAM	Longest Diameter						NOT DONE	NOT EVALUABLE	CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
10	EX55555	TR	90005	10	TARGET	A4	T01	TUMSTATE	Tumor State						NOT DONE	NOT EVALUABLE	CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
11	EX55555	TR	90005	11	TARGET	A4		SUMDIAM	Sum of Diameter						NOT DONE	MISSING DIAMETERS		INVESTIGATOR	TREATMENT	5	WEEK 16
12	EX55555	TR	90005	12	TARGET	A5	T01	LDIAM	Longest Diameter	5	mm	5	5	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
13	EX55555	TR	90005	13	TARGET	A5	T01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
14	EX55555	TR	90005	14	TARGET	A5		SUMDIAM	Sum of Diameter	5	mm	5	5	mm				INVESTIGATOR	TREATMENT	7	WEEK 24
15	EX55555	TR	90005	15	NEW	A5	NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168

The 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.

rowcaps

Dataset wrap

Name	supptr

Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE").

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX55555	TR	90005	TRSEQ	9	TRREASNE	Reason Tumor/Lesion Not Evaluable	Motion issue	CRF
2	EX55555	TR	90005	TRSEQ	10	TRREASNE	Reason Tumor/Lesion Not Evaluable	Motion issue	CRF

...

Dataset wrap

Name	rs

Rowcaps

Rows 1-6:

Show response assessments at cycle 2 and cycle 3 from the investigator following RECIST 1.1.


Rows 7-8:	Show response assessments at cycle 2 and cycle 3 from the independent radiologist using protocol specified response criteria based on volumetric measurements (RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA").

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSNAM	RSEVAL	RSEVALID	RSACPTFL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	EX66666	RS	90006	1		TRGRESP	Target Response	RECIST 1.1	SD	SD		INVESTIGATOR			TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
2	EX66666	RS	90006	2		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD		INVESTIGATOR			TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
3	EX66666	RS	90006	3	A2	OVRLRESP	Overall Response	RECIST 1.1	SD	SD		INVESTIGATOR			TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
4	EX66666	RS	90006	4		TRGRESP	Target Response	RECIST 1.1	SD	SD		INVESTIGATOR			TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
5	EX66666	RS	90006	5		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD		INVESTIGATOR			TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
6	EX66666	RS	90006	6	A3	OVRLRESP	Overall Response	RECIST 1.1	PD	PD		INVESTIGATOR			TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
7	EX66666	RS	90006	7	R1-A2	OVRLRESP	Overall Response	PROTOCOL DEFINED RESPONSE CRITERIA	SD	SD	ACME VENDOR	INDEPENDENT ASSESSOR	RADIOLOGIST	Y	TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
8	EX66666	RS	90006	8	R1-A3	OVRLRESP	Overall Response	PROTOCOL DEFINED RESPONSE CRITERIA	PD	PD	ACME VENDOR	INDEPENDENT ASSESSOR	RADIOLOGIST	Y	TREATMENT	4	Cycle 3 Day 1	2007-02-26	56

...

Dataset wrap

Name	tu

Rowcaps

Rows 1-5:	Show the identification of three target lesions "T01", "T02" and "T03", and 2 non-target lesions "NT01" and "NT02" by investigator.
Rows 6-7:	Show the identification of two target lesions "R-T01" and "R-T02" by the independent radiologist.
Row 8:	Shows the identification of a new tumor "NEW01" by investigator.
Row 9:	Shows the identification of a new tumor "R-NEW01" by independent radiologist.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TUNAM	TULOC	TULAT	TUDIR	TUMETHOD	TUEVAL	TUEVALID	TUACPTFL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	EX66666	TU	90006	1	T01	TUMIDENT	Tumor Identification	TARGET	TARGET		OCCIPITAL LOBE	LEFT	ANTERIOR	MRI	INVESTIGATOR			SCREEN	1	SCREENING	2007-01-01	1
2	EX66666	TU	90006	2	T02	TUMIDENT	Tumor Identification	TARGET	TARGET		OCCIPITAL LOBE	RIGHT		MRI	INVESTIGATOR			SCREEN	1	SCREENING	2007-01-01	1
3	EX66666	TU	90006	3	T03	TUMIDENT	Tumor Identification	TARGET	TARGET		TEMPORAL LOBE	LEFT		MRI	INVESTIGATOR			SCREEN	1	SCREENING	2007-01-01	1
4	EX66666	TU	90006	4	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET		FRONTAL LOBE	RIGHT		MRI	INVESTIGATOR			SCREEN	1	SCREENING	2007-01-01	1
5	EX66666	TU	90006	5	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET		CEREBELLUM	LEFT		MRI	INVESTIGATOR			SCREEN	1	SCREENING	2007-01-01	1
6	EX66666	TU	90006	6	R1-T01	TUMIDENT	Tumor Identification	TARGET	TARGET	ACME VENDOR	OCCIPITAL LOBE	RIGHT	ANTERIOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	Y	SCREEN	1	SCREENING	2007-01-01	1
7	EX66666	TU	90006	7	R1-T02	TUMIDENT	Tumor Identification	TARGET	TARGET	ACME VENDOR	TEMPORAL LOBE	LEFT		MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	Y	SCREEN	1	SCREENING	2007-01-01	1
8	EX66666	TU	90006	8	NEW01	TUMIDENT	Tumor Identification	NEW	NEW		FRONTAL LOBE	RIGHT		MRI	INVESTIGATOR			TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
9	EX66666	TU	90006	9	R1-NEW01	TUMIDENT	Tumor Identification	NEW	NEW	ACME VENDOR	FRONTAL LOBE	RIGHT		MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	Y	TREATMENT	4	Cycle 3 Day 1	2007-02-26	56

...

The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows investigator and independent radiologist's tumor results. The independent radiologist's tumor results are based on bi-dimensional and volumetric measurements. The example also includes the situation where new tumors are measured by the independent radiologist.

Dataset wrap

Name	tr

Rowcaps

Rows 1-6, 18-23

and

, 38-39:	Show Longest Diameter, Sum of Longest Diameter, and Tumor State for assessments at screening, cycle 2 and cycle 3 from the investigator.
Rows 7-17, 24-37

and

, 40-44:

Show the volumetric measurements at screening, cycle 2 and cycle 3 from the independent radiologist.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRNAM	TRMETHOD	TREVAL	TREVALID	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	EX66666	TR	90006	1	TARGET	A1	T01	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		SCREEN	1	SCREENING	2007-01-01	1
2	EX66666	TR	90006	2	TARGET	A1	T02	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		SCREEN	1	SCREENING	2007-01-01	1
3	EX66666	TR	90006	3	TARGET	A1	T03	LDIAM	Longest Diameter	5	mm	5	5	mm		MRI	INVESTIGATOR		SCREEN	1	SCREENING	2007-01-01	1
4	EX66666	TR	90006	4	TARGET	A1		SUMDIAM	Sum of Diameter	25	mm	25	25	mm			INVESTIGATOR		SCREEN	1	SCREENING
5	EX66666	TR	90006	5	NON-TARGET	A1	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		SCREEN	1	SCREENING	2007-01-01	1
6	EX66666	TR	90006	6	NON-TARGET	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		SCREEN	1	SCREENING	2007-01-01	1
7	EX66666	TR	90006	7	TARGET	R1-A1	R1-T01	LDIAM	Longest Diameter	10	mm	10	10	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING	2007-01-01	1
8	EX66666	TR	90006	8	TARGET	R1-A1	R1-T01	LPERP	Longest Perpendicular	5	mm	5	5	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING	2007-01-01	1
9	EX66666	TR	90006	9	TARGET	R1-A1	R1-T01	PPD	Product of Perpendicular Diameters	50	mm2	50	50	mm2	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING
10	EX66666	TR	90006	10	TARGET	R1-A1	R1-T01	VOLUME	Volume	250	uL	250	250	uL	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING	2007-01-01	1
11	EX66666	TR	90006	11	TARGET	R1-A1	R1-T02	LDIAM	Longest Diameter	7	mm	7	7	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING	2007-01-01	1
12	EX66666	TR	90006	12	TARGET	R1-A1	R1-T02	LPERP	Longest Perpendicular	10	mm	10	10	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING	2007-01-01	1
13	EX66666	TR	90006	13	TARGET	R1-A1	R1-T02	PPD	Product of Perpendicular Diameters	70	mm2	70	70	mm2	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING
14	EX66666	TR	90006	14	TARGET	R1-A1	R1-T02	VOLUME	Volume	350	uL	350	350	uL	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING	2007-01-01	1
15	EX66666	TR	90006	15	TARGET	R1-A1		SUMDIAM	Sum of Diameter	17	mm	17	17	mm	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING
16	EX66666	TR	90006	16	TARGET	R1-A1		SUMPPD	Sum of Products of Perpendicular Diameters	120	mm2	120	120	mm2	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING
17	EX66666	TR	90006	17	TARGET	R1-A1		SUMVOL	Sum of Volume	600	uL	600	600	uL	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREENING
18	EX66666	TR	90006	18	TARGET	A2	T01	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
19	EX66666	TR	90006	19	TARGET	A2	T02	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
20	EX66666	TR	90006	20	TARGET	A2	T03	LDIAM	Longest Diameter	5	mm	5	5	mm		MRI	INVESTIGATOR		TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
21	EX66666	TR	90006	21	TARGET	A2		SUMDIAM	Sum of Diameter	25	mm	25	25	mm			INVESTIGATOR		TREATMENT	3	Cycle 2 Day 1
22	EX66666	TR	90006	22	NON-TARGET	A2	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
23	EX66666	TR	90006	23	NON-TARGET	A2	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
24	EX66666	TR	90006	24	TARGET	R1-A2	R1-T01	LDIAM	Longest Diameter	12	mm	12	12	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
25	EX66666	TR	90006	25	TARGET	R1-A2	R1-T01	LPERP	Longest Perpendicular	7	mm	7	7	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
26	EX66666	TR	90006	26	TARGET	R1-A2	R1-T01	PPD	Product of Perpendicular Diameters	84	mm2	84	84	mm2	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
27	EX66666	TR	90006	27	TARGET	R1-A2	R1-T01	VOLUME	Volume	420	uL	420	420	uL	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
28	EX66666	TR	90006	28	TARGET	R1-A2	R1-T02	LDIAM	Longest Diameter	6	mm	6	6	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
29	EX66666	TR	90006	29	TARGET	R1-A2	R1-T02	LPERP	Longest Perpendicular	9	mm	9	9	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
30	EX66666	TR	90006	30	TARGET	R1-A2	R1-T02	PPD	Product of Perpendicular Diameters	54	mm2	54	54	mm2	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
31	EX66666	TR	90006	31	TARGET	R1-A2	R1-T02	VOLUME	Volume	315	uL	315	315	uL	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1	2007-01-28	28
32	EX66666	TR	90006	32	TARGET	R1-A2		SUMDIAM	Sum of Diameter	18	mm	18	18	mm	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
33	EX66666	TR	90006	33	TARGET	R1-A2		SUMPPD	Sum of Products of Perpendicular Diameters	138	mm2	138	138	mm2	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
34	EX66666	TR	90006	34	TARGET	R1-A2		SUMVOL	Sum of Volume	735	uL	735	735	uL	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
35	EX66666	TR	90006	35	TARGET	R1-A2		PCBSD	Percent Change From Baseline in Sum of Diameter	6	%	6	6	%	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
36	EX66666	TR	90006	36	TARGET	R1-A2		PCBSPPD	Percent Change Baseline in Sum of PPD	23	%	23	23	%	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
37	EX66666	TR	90006	37	TARGET	R1-A2		PCBSV	Percent Change From Baseline in Sum of Volume	23	%	23	23	%	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 2 Day 1
38	EX66666	TR	90006	38	NEW	A3	NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
39	EX66666	TR	90006	39	NEW	A3	NEW01	LDIAM	Longest Diameter	9	mm	9	9	mm		MRI	INVESTIGATOR		TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
40	EX66666	TR	90006	40	NEW	R1-A3	R1-NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT			ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
41	EX66666	TR	90006	41	NEW	R1-A3	R1-NEW01	LDIAM	Longest Diameter	9	mm	9	9	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
42	EX66666	TR	90006	42	NEW	R1-A3	R1-NEW01	LPERP	Longest Perpendicular	5	mm	5	5	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 3 Day 1	2007-02-26	56
43	EX66666	TR	90006	43	NEW	R1-A3	R1-NEW01	PPD	Product of Perpendicular Diameters	45	mm2	45	45	mm2	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 3 Day 1
44	EX66666	TR	90006	44	NEW	R1-A3	R1-NEW01	VOLUME	Volume	270	uL	270	270	uL	ACME VENDOR		INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 3 Day 1	2007-02-26	56

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4.5 Example 5: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the data for a subject that has only Target tumors at screening. This example includes an unscheduled assessment.