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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 the at the week 6, week 12 and subsequent 8-week follow-up visits. Note: Sponsor may include the New Lesion Indicator test (RSTESTCD = "NEWLIND") at every timepoint if the new lesion yes or no question is part of the data collection.

Dataset wrap

Name	rs

Rowcaps

Rows 1-3:	Show the Target Response (RSTESTCD = "TRGRESP") and Non-Target Response (RSTESTCD = "NTRGRESP") tests and corresponding Overall Response (RSTESTCD = "OVRLRESP") at the week 6 assessment. The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP is used to associate the Overall Response to underlying data in other domains (e.g., TR). Note that "NE" (Not evaluable) is a valid Overall Response value per the RECIST 1.1 criteria which means that RSORRES is "NE" rather than represented in RSSTAT.
Rows 4-12:	Show the week 12, week 20 and week 28 responses.
Rows 13-20:	At week 36, the New Lesion Progression test is used to represent an equivocal new lesion (RSTESTCD = "NEWLPROG" and RSORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (RSTESTCD = "NEWLPROG" and RSORRES = "UNEQUIVOCAL"). There are different methods of collecting data when there is an equivocal new lesion. Some sponsors update the Overall Response when equivocal evidence of a new lesion has been confirmed at a later assessment (i.e., documented as unequivocal). Other sponsors derive (in ADaM) the new progression date as the date when the new lesion was first identified.

Note: Sponsor may include the New Lesion Indicator test (RSTESTCD = "NEWLIND") at every timepoint if the new lesion yes or no question is part of the data collection

.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	EX11111	RS	90001	1		TRGRESP	Target Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	46
2	EX11111	RS	90001	2		NTRGRESP	Non-Target Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	46
3	EX11111	RS	90001	3	A2	OVRLRESP	Overall Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	46
4	EX11111	RS	90001	4		TRGRESP	Target Response	RECIST 1.1	SD	SD	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-39	88
5	EX11111	RS	90001	5		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	88
6	EX11111	RS	90001	6	A3	OVRLRESP	Overall Response	RECIST 1.1	SD	SD	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	88
7	EX11111	RS	90001	7		TRGRESP	Target Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
8	EX11111	RS	90001	8		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
9	EX11111	RS	90001	9	A4	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
10	EX11111	RS	90001	10		TRGRESP	Target Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-25	204
11	EX11111	RS	90001	11		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-25	204
12	EX11111	RS	90001	12	A5	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-25	204
13	EX11111	RS	90001	13		TRGRESP	Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
14	EX11111	RS	90001	14		NTRGRESP	Non-Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
15	EX11111	RS	90001	15		NEWLPROG	New Lesion Progression	RECIST 1.1	EQUIVOCAL	EQUIVOCAL	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
16	EX11111	RS	90001	16	A6	OVRLRESP	Overall Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
17	EX11111	RS	90001	17		TRGRESP	Target Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
18	EX11111	RS	90001	18		NTRGRESP	Non-Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
19	EX11111	RS	90001	19		NEWLPROG	New Lesion Progression	RECIST 1.1	UNEQUIVOCAL	UNEQUIVOCAL	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
20	EX11111	RS	90001	20	A7	OVRLRESP	Overall Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313

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Dataset wrap

Name	tr

Rowcaps

Row 11:	Shows the longest diameter of "T04" at the assessment before it splits.
Rows 18-19:	Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 16.
Rows 24-25:	Show that tumors "T02" and "T03" are no longer measured individually. The TRSTAT = "NOT DONE" and the TRREASND = "TUMOR MERGED". These rows are optional and can be included if part of the collection. In the case where a sponsor includes TUMSTATE for target lesions, TUMSTATE may be assigned to "TUMOR MERGED".
Row 26:	Shows the longest diameter of the newly merged "T02/T03" tumor at week 24.
Rows 27-28:	Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 24.
Row 33:	Shows the longest diameter of the newly merged "T02/T03" tumor at week 32. Sponsors can continue to include individual tumors as not done as in rows 24-25.
Rows 34-35:	Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 32.
Row 37:	Shows the Tumor State of the non-target "NT01" as enlargement from nadir (TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). This Tumor State indicates that the non-Target tumors in the "LUNG" have shown enlargement from their previous smallest state.
Rows 39-40:	Shows the Tumor State of the a new tumor "NEW01" and the longest diameter of the new tumor.

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	EX22222	TR	90002	1	TARGET	A1	T01	LDIAM	Longest Diameter	16	mm	16	16	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
2	EX22222	TR	90002	2	TARGET	A1	T02	LDIAM	Longest Diameter	28	mm	28	28	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
3	EX22222	TR	90002	3	TARGET	A1	T03	LDIAM	Longest Diameter	41	mm	41	41	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
4	EX22222	TR	90002	4	TARGET	A1	T04	LDIAM	Longest Diameter	83	mm	83	83	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
5	EX22222	TR	90002	5	TARGET	A1		SUMDIAM	Sum of Diameter	168	mm	168	168	mm				INVESTIGATOR	SCREEN	1	SCREENING
6	EX22222	TR	90002	6	NON-TARGET	A1	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
7	EX22222	TR	90002	7	NON-TARGET	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	SCREEN	1	SCREENING	2007-01-02	1
8	EX22222	TR	90002	8	TARGET	A2	T01	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
9	EX22222	TR	90002	9	TARGET	A2	T02	LDIAM	Longest Diameter	20	mm	20	20	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
10	EX22222	TR	90002	10	TARGET	A2	T03	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
11	EX22222	TR	90002	11	TARGET	A2	T04	LDIAM	Longest Diameter	65	mm	65	65	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
12	EX22222	TR	90002	12	TARGET	A2		SUMDIAM	Sum of Diameter	125	mm	125	125	mm				INVESTIGATOR	TREATMENT	3	WEEK 8
13	EX22222	TR	90002	13	NON-TARGET	A2	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
14	EX22222	TR	90002	14	NON-TARGET	A2	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
15	EX22222	TR	90002	15	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
16	EX22222	TR	90002	16	TARGET	A3	T02	LDIAM	Longest Diameter	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
17	EX22222	TR	90002	17	TARGET	A3	T03	LDIAM	Longest Diameter	15	mm	15	15	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
18	EX22222	TR	90002	18	TARGET	A3	T04.1	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
19	EX22222	TR	90002	19	TARGET	A3	T04.2	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
20	EX22222	TR	90002	20	TARGET	A3		SUMDIAM	Sum of Diameter	72	mm	72	72	mm				INVESTIGATOR	TREATMENT	5	WEEK 16
21	EX22222	TR	90002	21	NON-TARGET	A3	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
22	EX22222	TR	90002	22	NON-TARGET	A3	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
23	EX22222	TR	90002	23	TARGET	A4	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
24	EX22222	TR	90002	24	TARGET	A4	T02	LDIAM	Longest Diameter						NOT DONE	TUMOR MERGED	CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
25	EX22222	TR	90002	25	TARGET	A4	T03	LDIAM	Longest Diameter						NOT DONE	TUMOR MERGED	CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
26	EX22222	TR	90002	26	TARGET	A4	T02/T03	LDIAM	Longest Diameter	35	mm	35	35	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
27	EX22222	TR	90002	27	TARGET	A4	T04.1	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
28	EX22222	TR	90002	28	TARGET	A4	T04.2	LDIAM	Longest Diameter	19	mm	19	19	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
29	EX22222	TR	90002	29	TARGET	A4		SUMDIAM	Sum of Diameter	84	mm	84	84	mm				INVESTIGATOR	TREATMENT	7	WEEK 24
30	EX22222	TR	90002	30	NON-TARGET	A4	NT01	TUMSTATE	Tumor State						NOT DONE	NOT EVALUABLE	CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
31	EX22222	TR	90002	31	NON-TARGET	A4	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2007-06-19	168
32	EX22222	TR	90002	32	TARGET	A5	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224
33	EX22222	TR	90002	33	TARGET	A5	T02/T03	LDIAM	Longest Diameter	80	mm	80	80	mm			CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224
34	EX22222	TR	90002	34	TARGET	A5	T04.1	LDIAM	Longest Diameter	49	mm	49	49	mm			CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224
35	EX22222	TR	90002	35	TARGET	A5	T04.2	LDIAM	Longest Diameter	26	mm	26	26	mm			CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224
36	EX22222	TR	90002	36	TARGET	A5		SUMDIAM	Sum of Diameter	155	mm	155	155	mm			CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32
37	EX22222	TR	90002	37	NON-TARGET	A5	NT01	TUMSTATE	Tumor State	ENLARGEMENT FROM NADIR		ENLARGEMENT FROM NADIR					CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224
38	EX22222	TR	90002	38	NON-TARGET	A5	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224
39	EX22222	TR	90002	39	NEW	A5	NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224
40	EX22222	TR	90002	40	NEW	A5	NEW01	LDIAM	Longest Diameter	9	mm	9	9	mm			CT SCAN	INVESTIGATOR	TREATMENT	9	WEEK 32	2007-08-14	224

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