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Dataset wrap

Name	rs

Rowcaps

Rows 1-3:	Show the week 6 response assessment for a subject with non-target disease only. The Target Response (RSTESTCD = "TRGRESP") is not applicable for subjects with non-target disease only. This can be represented as RSSTAT = "NOT DONE" and RSREASND = "Subject does not have target lesions". The Non-Target Response (RSTESTCD = "NTRGRESP") is non complete response/non progressive disease (NON-CR/NON-PD). The Overall Response (RSTESTCD = "OVRLRESP") is non complete response/non progressive disease (NON-CR/NON-PD) which is a valid Overall Response in RECIST 1.1 for subjects with non-target disease only.
Rows 4-6:	Show the week 12 response assessment for a subject with non-target disease only. The Non-Target Response (RSTESTCD = "NTRGRESP") is NE (Not Evaluable) because not all non-target lesions were evaluated and none of the evaluated non-targets showed progression. The brain did not show progression and the assessments of the non-target lesions in the skeletal muscle tissue and pericardium were not done because the non-target lesions were obscured on the MRI and not assessable. Therefore, the Overall Response (RSTESTCD = "OVRLRESP") is "NE" (not evaluable). Note that "NE" is a valid Overall Response value per the RECIST 1.1 criteria which means it that RSORRES is "NE" rather than represented in RSSTAT.
Rows 7-9:	Show the week 20 assessment where the non-targets were enlarged from a previous smallest size. The Non-Target Response (RSTESTCD = "NTRGRESP") is "PD" (progressive disease) which results in an Overall Response (RSTESTCD = "OVRLRESP") of "PD".

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY	RSSTAT	RSREASND
1	EX77777	RS	90007	1		TRGRESP	Target Response	RECIST 1.1			INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46	NOT DONE	Subject does not have target lesions
2	EX77777	RS	90007	2		NTRGRESP	Non-Target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
3	EX77777	RS	90007	3	A2	OVRLRESP	Overall Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
4	EX77777	RS	90007	4		TRGRESP	Target Response	RECIST 1.1			INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88	NOT DONE	Subject does not have target lesions
5	EX77777	RS	90007	5		NTRGRESP	Non-Target Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
6	EX77777	RS	90007	6	A3	OVRLRESP	Overall Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
7	EX77777	RS	90007	7		TRGRESP	Target Response	RECIST 1.1			INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144	NOT DONE	Subject does not have target lesions
8	EX77777	RS	90007	8		NTRGRESP	Non-Target Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
9	EX77777	RS	90007	9	A4	OVRLRESP	Overall Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144

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

rowcaps

Dataset wrap

Name	supprs

Row 1: Shows that the QVAL for RSSEQ = "5" for Reason Response Not Evaluable (QNAM = "RSREASNE").

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX77777	RS	90005	RSSEQ	5	RSREASNE	Reason Response Not Evaluable	Imaging Quality Issues	CRF

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Dataset wrap

Name	tu

Rowcaps

Row 1:	Shows that the subject has no target tumors (TUTESTCD = "TIND"), i.e., the subject does not have measurable disease.
Row 2:	Shows that the subject has non-target tumors (TUTESTCD = "NTIND"). The subject has non-measurable only disease.
Rows 3-5:	Show the identification of 3 non-target lesions for a subject with non-target disease only. See below for details on on the tumor presentation type (QNAM = "TUPRTYP") supplemental qualifier.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TUREFID	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TUMETHOD	TUEVAL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	EX77777	TU	90007	1			TIND	Target Indicator	N	N			INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1
2	EX77777	TU	90007	2			NTIND	Non-Target Indicator	Y	Y			INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1
3	EX77777	TU	90007	3	IMG-00001	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	BRAIN	MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1
4	EX77777	TU	90007	4	IMG-00002	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	SKELETAL MUSCLE TISSUE	MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1
5	EX77777	TU	90007	5	IMG-00002	NT03	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	PERICARDIUM	MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1

...

Dataset wrap

Name	supptu

Rowcaps

Row 1:

Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e.,

for

for the non-target site in the brain (TULNKID = "NT01"), the QVAL is "LEPTOMENINGEAL DISEASE".
Rows 2-3:	Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified.
Rows 4-5:	Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the skeletal muscle tissue non-target lesion (TULNKID = "NT02") was identified.
Row 6:	Shows that the presentation of the disease in the pericardium is effusion, i.e., for the non-target site in the pericardium (TULNKID = "NT03"), the QVAL is "EFFUSION".

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX77777	TU	90007	TUSEQ	3	TUPRTYP	Tumor or Lesion Presentation Type	LEPTOMENINGEAL DISEASE	CRF
2	EX77777	TU	90007	TUSEQ	3	TUANTPLN	Anatomical Plane	SAGITTAL	CRF
3	EX77777	TU	90007	TUSEQ	3	TUSLNUM	Slice Number	55	CRF
4	EX77777	TU	90007	TUSEQ	4	TUANTPLN	Anatomical Plane	SAGITTAL	CRF
5	EX77777	TU	90007	TUSEQ	4	TUSLNUM	Slice Number	88-91	CRF
6	EX77777	TU	90007	TUSEQ	4	TUPRTYP	Tumor or Lesion Presentation Type	EFFUSION	CRF

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The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain domain. This example shows the data for one subject with assessments of non-target tumors only at screening, week 6, week 12 and subsequent 8-week follow-up visits.

Dataset wrap

Name	tr

Rowcaps

Rows 1-6:	Show the qualitative assessments of the tumor state of the 3 non-target lesions "NT01", "NT02", and "NT03" at screening and week 6.
Rows 7-9:	Show the week 12 assessments. Row 7 shows the assessment of "NT01" non-target lesion in the brain whereas rows 8 and 9 illustrate the assessments of the non-target lesions "NT02" and "NT03" in the skeletal muscle tissue and pericardium, respectively, were not done. This is because the non-target lesions were obscured on the MRI and not assessable (TRSTAT = "NOT DONE" and TRREASND = "NOT EVALUABLE: Lesion obscured").
Rows 10-11:	Show that at the week 20 assessment, the "NT01" and "NT02" were enlarged from a previous smallest size, i.e., TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR".

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRREFID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRSTRESC	TRSTAT	TRREASND	TRMETHOD	TREVAL	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	EX77777	TR	90007	1	NON-TARGET	IMG-00001	A1	NT01	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1
2	EX77777	TR	90007	2	NON-TARGET	IMG-00001	A1	NT02	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1
3	EX77777	TR	90007	3	NON-TARGET	IMG-00001	A1	NT03	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	SCREEN	10	SCREENING	2010-01-04	1
4	EX77777	TR	90007	4	NON-TARGET	IMG-00003	A2	NT01	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
5	EX77777	TR	90007	5	NON-TARGET	IMG-00003	A2	NT02	TUMSTATE	Tumor State	ABSENT	ABSENT			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
6	EX77777	TR	90007	6	NON-TARGET	IMG-00003	A2	NT03	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
7	EX77777	TR	90007	7	NON-TARGET	IMG-00005	A3	NT01	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
8	EX77777	TR	90007	8	NON-TARGET	IMG-00005	A3	NT02	TUMSTATE	Tumor State			NOT DONE	NOT EVALUABLE	MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
9	EX77777	TR	90007	9	NON-TARGET	IMG-00005	A3	NT03	TUMSTATE	Tumor State			NOT DONE	NOT EVALUABLE	MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
10	EX77777	TR	90007	10	NON-TARGET	IMG-00007	A4	NT01	TUMSTATE	Tumor State	ENLARGEMENT FROM NADIR	ENLARGEMENT FROM NADIR			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
11	EX77777	TR	90007	11	NON-TARGET	IMG-00007	A4	NT02	TUMSTATE	Tumor State	ENLARGEMENT FROM NADIR	ENLARGEMENT FROM NADIR			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
12	EX77777	TR	90007	12	NON-TARGET	IMG-00007	A4	NT03	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144

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.

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

Dataset wrap

Name	supptr

Rowcaps

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX77777	TR	90007	TRSEQ	8	TRREASNE	Reason Tumor/Lesion Not Evaluable	Scan blurry	CRF
2	EX77777	TR	90007	TRSEQ	9	TRREASNE	Reason Tumor/Lesion Not Evaluable	Scan blurry	CRF

...

Dataset wrap

Name	pr

Rowcaps

Rows 1-2:

Show the scans preformed at the screening disease assessment. The MRI is the primary method used to assess the lesions for RECIST 1.1 and the results are in TU and TR. Row 2 shows

the correlative

the correlative imaging of the brain (i.e., CT SCAN of the HEAD).
Rows 3-8:	Show the scans preformed at the disease assessments at weeks 6, 12 and 20.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRREFID	PRLNKGRP	PRTRT	PRPRESP	PROCCUR	PRLOC	EPOCH	VISITNUM	VISIT	PRSTDTC	PRSTDY
1	EX77777	PR	90007	1	IMG-00001	A1	MRI	Y	Y	MULTIPLE	SCREEN	10	SCREENING	2010-01-01	-3
2	EX77777	PR	90007	2	IMG-00002	A1	CT SCAN	Y	Y	HEAD	SCREEN	10	SCREENING	2010-01-01	-3
3	EX77777	PR	90007	3	IMG-00003	A2	MRI	Y	Y	MULTIPLE	TREATMENT	40	WEEK 6	2010-02-15	43
4	EX77777	PR	90007	4	IMG-00004	A2	CT SCAN	Y	Y	HEAD	TREATMENT	40	WEEK 6	2010-02-15	43
5	EX77777	PR	90007	5	IMG-00005	A3	MRI	Y	Y	MULTIPLE	TREATMENT	60	WEEK 12	2010-03-29	85
6	EX77777	PR	90007	6	IMG-00006	A3	CT SCAN	Y	Y	HEAD	TREATMENT	60	WEEK 12	2010-03-29	85
7	EX77777	PR	90007	7	IMG-00007	A4	MRI	Y	Y	MULTIPLE	TREATMENT	80	WEEK 20	2010-05-27	144
8	EX77777	PR	90007	8	IMG-00008	A4	CTSCAN	Y	Y	HEAD	TREATMENT	80	WEEK 20	2010-05-27	144

...

Dataset wrap

Name	supppr

Rowcaps

Rows 1-2:	Show the 2 locations of the MRI at screening for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST".
Row 3:	Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at screening for PRSEQ = "1".
Rows 4-5:	Show the 2 locations of the MRI at week 6 for PRSEQ = "3" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST".
Row 6:	Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 6 for PRSEQ = "3".
Rows 7-8:	Show the 2 locations of the MRI at week 12 for PRSEQ = "5" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST".
Row 9:	Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 12 for PRSEQ = "5".
Row 10:	Shows the overall image quality issue (QNAM = "PROIQ") of the MRI at week 12 for PRSEQ = "5".

Dataset2

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	EX77777	PR	90007	PRSEQ	1	PRLOC1	Anatomical Location 1	HEAD	CRF
2	EX77777	PR	90007	PRSEQ	1	PRLOC2	Anatomical Location 2	CHEST	CRF
3	EX77777	PR	90007	PRSEQ	1	PRSLTHK	Slice Thickness	5 mm	CRF
4	EX77777	PR	90007	PRSEQ	3	PRLOC1	Anatomical Location 1	HEAD	CRF
5	EX77777	PR	90007	PRSEQ	3	PRLOC2	Anatomical Location 2	CHEST	CRF
6	EX77777	PR	90007	PRSEQ	3	PRSLTHK	Slice Thickness	5 mm	CRF
7	EX77777	PR	90007	PRSEQ	5	PRLOC1	Anatomical Location 1	HEAD	CRF
8	EX77777	PR	90007	PRSEQ	5	PRLOC2	Anatomical Location 2	CHEST	CRF
9	EX77777	PR	90007	PRSEQ	5	PRSLTHK	Slice Thickness	5 mm	CRF
10	EX77777	PR	90007	PRSEQ	5	PROIQ	Overall Image Quality	Motion issues and lesions where obscured	CRF
11	EX77777	PR	90007	PRSEQ	7	PRLOC1	Anatomical Location 1	HEAD	CRF
12	EX77777	PR	90007	PRSEQ	7	PRLOC2	Anatomical Location 2	CHEST	CRF
13	EX77777	PR	90007	PRSEQ	7	PRSLTHK	Slice Thickness	5 mm	CRF

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