Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text and all examples; this text represents the changes made to the template that are specific to this disease response criteria.

Title	Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
CDISC Reference	Disease Response Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
Criteria Short Name	RECIST 1.1
Criteria Permission Status	Public Domain
Team	CDISC Oncology Therapeutic Area Subteam
Supplement Version	1.0
Status	DRAFT
Date	2019-06-21
Notes	This supplement is intended to be used with other CDISC User Guides for specific Therapeutic/Disease Areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

Revision History

Date	Version
2019-06-21	1.0 Draft

1 Introduction

This document describes the CDISC implementation of the Response Evaluation Criteria in Solid Tumors 1.1 Version (RECIST 1.1) disease response criteria.

I removed the statement, "CDISC does not modify QRS instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards." because we are not currently using a CRF; however, I recommend including the CDASH statement if/when CRFs are used for disease response criteria. I am recommending we use the following instead when we are not using a CRF:

CDISC is not including an annotated case report form (CRF) for this disease response supplement as the primary purpose of the supplement is to show examples of how to implement the disease response criteria in CDISC data standards domains.

The representation of data collected for this disease response criteria is based on the Study Data Tabulation Model Implementation Guide (SDTMIG), which can be found at the CDISC website at: (https://www.cdisc.org/standards/foundational/sdtmig).

These specific implementation details for this disease response criteria are meant to be used in conjunction with the SDTMIG. All CDISC Disease Response documentation packages can be found on the CDISC web site at: (https://www.cdisc.org/foundational/qrs).

The CDISC Intellectual Property Policy can be found on the CDISC web site at: (https://www.cdisc.org/about/bylaws).

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

2 Copyright Status

The RECIST Working Group owns the copyright for the RECIST 1.1 disease response criteria. CDISC has developed data standards for tumor identification and response and applied these to RECIST 1.1. Examples were developed to represent RECIST 1.1 and include in the CDISC library of QRS data standards supplements. There may be many versions of this criteria in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this criteria consists of: (1) controlled terminology and (2) standard database structure with examples.

Note: CDISC controlled terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website (https://www.cdisc.org/standards/semantics/terminology).

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the criteria beyond the normal license fees charged by the copyright holder.

CDISC acknowledges the RECIST Working Group and the European Journal of Cancer (EJC) for having the RECIST 1.1 available for free.

References for the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1):

E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij. New response evaluation criteria in solid tumours; Revised RECIST guideline (version 1.1). European Journal of Cancer 2009; 45:228-247.
http://recist.eortc.org/recist-1-1-2/, accessed 2019-06-21.

3 The Oncology Disease Response Domains Model for RECIST 1.1

3.1 Assumptions for the Oncology Disease Response Domains

All assumptions and business rules described in the SDTMIG are applicable to this supplement. Additional assumptions specific to the RECIST 1.1 are listed below.

RECIST 1.1 is a set of criteria used to evaluate the activity and efficacy of new cancer therapeutics in solid tumors.

The Oncology Codetable on the CDISC website at https://www.cdisc.org/standards/terminology contains the valid value list for the tests in the TU, TR, and RS domains.
1. RSORRES is populated with the original result and the standardized result represented in the standardized character result variable RSSTRESC.
2. TUORRES and TUSTRESC are populated with the original tumor identification result.
3. For the TR domain, TRORRES and TRSTRESC can contain numeric or character results and TRSTRESN is only populated for numeric results. There are situations when a character result in TRORRES is standardized to a numeric representation of the result in TRSTRESC and TRSTRESN.

We are unable to make examples consistently show blue in the Wiki. All examples are updated for each disease response supplement so we ask that you please review the examples below.

RS Example being developed.

3.2 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

3.2.1 RS Domain Model

The example 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 Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.

The table represents the items from the RECIST 1.1 criteria.

Rows 1-3: Show the Target Response and Non-target Response tests and corresponding Overall Response at the Week 6 assessment. The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP is used to associate underlying data in other domains to the Overall Response.

Rows 4-13: Show the Week 12, Week 20 and Week 28 responses.

Row 14-21: At Week 36, the NEWLPROG test is used to represent an EQUIVOCAL new lesion and to represent at Week 44 that there are UNEQUIVOCAL new lesions. There are different methods of collecting data when there is a EQUIVOCAL new lesion. Some sponsors update the Overall Response when EQUIVOCAL evidence of a new lesion has been later been confirmed (i.e., documented as UNEQUIVOCAL). Other sponsors during the analysis programmatically derive the new lesion progression date as the date when the new lesion was first identified.

Note: Sponsor may include the NEWLIND test at every timepoint if the new lesion yes or no question is part of the data collection.

rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	JKL12345	RS	40070	1		TRGRESP	Target Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
2	JKL12345	RS	40070	2		NTRGRESP	Non-target Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
3	JKL12345	RS	40070	3	A2	OVRLRESP	Overall Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
4	JKL12345	RS	40070	4		TRGRESP	Target Response	RECIST 1.1	SD	SD	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
5	JKL12345	RS	40070	5		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
6	JKL12345	RS	40070	6	A3	OVRLRESP	Overall Response	RECIST 1.1	SD	SD	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
7	JKL12345	RS	40070	7		TRGRESP	Target Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
8	JKL12345	RS	40070	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	JKL12345	RS	40070	9	A4	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
10	JKL12345	RS	40070	10		TRGRESP	Target Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-26	204
11	JKL12345	RS	40070	11		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-26	204
12	JKL12345	RS	40070	12	A5	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-26	204
13	JKL12345	RS	40070	13		TRGRESP	Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
14	JKL12345	RS	40070	14		NTRGRESP	Non-target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
15	JKL12345	RS	40070	15		NEWLPROG	New Lesion Progression	RECIST 1.1	EQUIVOCAL	EQUIVOCAL	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
16	JKL12345	RS	40070	16	A6	OVRLRESP	Overall Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
17	JKL12345	RS	40070	17		TRGRESP	Target Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
18	JKL12345	RS	40070	18		NTRGRESP	Non-target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
19	JKL12345	RS	40070	19		NEWLPROG	New Lesion Progression	RECIST 1.1	UNEQUIVOCAL	UNEQUIVOCAL	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
20	JKL12345	RS	40070	20	A7	OVRLRESP	Overall Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313

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3.2.2 TU Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject collected at screening, the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.

The tu.xpt table below shows lymph nodes as target tumors identified at screening. The image identifier is in TRREFID and matches a PRREFID in the PR Domain.

Rows 1-6: Show a subject with 4 target lesions with TULNKID T01-T04 and 2 non-target lesions with TULNKID NT01-NT02 identified at screening. T01 and T02 target lesions are lymph nodes. T01 is located in the TULOC=SUPRACLAVICULAR LYMPH NODE on the TULAT=RIGHT side. The TULOC contains the location from the anatomical location terminology. Note that some locations contain in the anatomical location controlled terminology contain laterality and/or directionality. The laterality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality.

Row 7: At week 36, an EQUIVOCAL new lesion (NEW01) was identified in the LUNG, LEFT LOWER LOBE. In this instance, LUNG, LEFT LOWER LOBE is a published controlled term

for anatomical location.

Row 8-9: At week 44, new UNEQUIVOCAL new lesions (NEW02 and NEW03) were identified in the CEREBELLUM and FEMORAL LYMPH NODE.

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TUREFID	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TULAT	TUDIR	TUMETHOD	TUEVAL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	JKL12345	TU	40070	1	IMG-00002	T01	TUMIDENT	Tumor Identification	TARGET	TARGET	SUPRACLAVICULAR LYMPH NODE	RIGHT		CT SCAN	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
2	JKL12345	TU	40070	2	IMG-00002	T02	TUMIDENT	Tumor Identification	TARGET	TARGET	CELIAC LYMPH NODE			CT SCAN	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-02	-2
3	JKL12345	TU	40070	3	IMG-00001	T03	TUMIDENT	Tumor Identification	TARGET	TARGET	THYROID GLAND	LEFT		MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
4	JKL12345	TU	40070	4	IMG-00003	T04	TUMIDENT	Tumor Identification	TARGET	TARGET	SKIN OF THE TRUNK		UPPER	PHOTOGRAPHY	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-03	-1
5	JKL12345	TU	40070	5	IMG-00001	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	MEDIASTINAL LYMPH NODE	RIGHT		MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-02	-2
6	JKL12345	TU	40070	6	IMG-00001	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	CEREBELLUM	RIGHT		MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1
7	JKL12345	TU	40070	7	IMG-00017	NEW01	TUMIDENT	Tumor Identification	NEW	NEW	LUNG, LEFT LOWER LOBE			CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
8	JKL12345	TU	40070	8	IMG-00019	NEW02	TUMIDENT	Tumor Identification	NEW	NEW	CEREBELLUM	LEFT		MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317
9	JKL12345	TU	40070	9	IMG-00019	NEW03	TUMIDENT	Tumor Identification	NEW	NEW	FEMORAL LYMPH NODE	LEFT		MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317

$warningHtml

The supptu.xpt table below shows the data on whether a tumor was previously irradiated (QNAM.PREVIR) and whether that tumor was shown to be progressing since it was irradiated (QNAM.PREVIRP).

Rows 1-3: Show that the 1st, 2nd and 3rd target lesions where not previously irradiated.

Rows 4-5: Show that that 4th target lesions as previously irradiated and shown to be progressing since it was irradiated.

$titleHtml

supptu.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
1	JKL12345	TU	40070	TUSEQ	1	PREVIR	Previously Irradiated Indicator	N	CRF
2	JKL12345	TU	40070	TUSEQ	2	PREVIR	Previously Irradiated Indicator	N	CRF
3	JKL12345	TU	40070	TUSEQ	3	PREVIR	Previously Irradiated Indicator	N	CRF
4	JKL12345	TU	40070	TUSEQ	4	PREVIR	Previously Irradiated Indicator	Y	CRF
5	JKL12345	TU	40070	TUSEQ	4	PREVIRP	Previously Irradiated Progression	Y	CRF

$warningHtml

3.2.3 TR Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.

The table below shows measurements (i.e., short axis) of lymph nodes as well as measurements of other non-lymph node target tumors (i.e., longest diameter). In this example, when TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL", it indicates that the lymph node lesion was not pathological, i.e. the diameter has reduced below 10mm. The assessment of a lymph node is represented with TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL" when that all target lymph node lesions have short axis less than 10mm or TRORRES = "PATHOLOGICAL" when at least one target lymph node lesion has short axis greater than or equal to 10mm.

Rows 1-10: Show the screening results for the target and non-target lesions. For lymph node target lesions T01 and T02 the TRTESTCD used are LPREP and LNSTATE. For non-lymph node target lesions T03 and T04 the TRTESTCD use is LDIAM.

Rows 7-8: Show the results for the target lesions as a group (TRGRPID=TARGET). The TRTESTCDs are SUMDIAM and SUMNLNLD.

Rows 9-10: Show the results for the non-targets. NT01 is a lymph node where the TRTESTCD is LNSTATE. NT02 is a non-lymph node where the TRTESTCD is TUMSTATE.

#### add NOT EVALUABLE , TOO SMALL TO MEASURE

Rows 11-16: Show the week 6 results for the target lesions.

Rows 17-21: Show the Week 6 results for the target lesions as a group (TRGRPID=TARGET). The TRTESTCDs are SUMDIAM, SUMNLNLD, ACNSD, PCBSD and PCNSD.

Rows -16: Show the week 6 that NT02 was not scanned and the results the NT01 non-target lesion using TRTESTCD as TUMSTATE.

Row 25: Shows target tumor T04 was photographed at Week 6 but the tumor was not assessable. When there is no result TRSTAT is assigned NOT DONE and TRREASND contains the reason, in this case NOT EVALUABLE.

Row : Shows that the Percent Change From Baseline in Sum of Diameter could not be calculated because T04 was not measured. TRSTAT is assigned NOT DONE and TRREASND contains the reason, in this case at least one target lesions was not measured.

tr.xpt

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	JKL12345	TR	40070	1	TARGET	IMG-00001	A1	T01	LPERP	Longest Perpendicular	17	mm	17	17	mm			MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
2	JKL12345	TR	40070	3	TARGET	IMG-00001	A1	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
3	JKL12345	TR	40070	4	TARGET	IMG-00002	A1	T02	LPERP	Longest Perpendicular	16	mm	16	16	mm			CT SCAN	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-02	-2
4	JKL12345	TR	40070	6	TARGET	IMG-00002	A1	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-02	-2
5	JKL12345	TR	40070	7	TARGET	IMG-00001	A1	T03	LDIAM	Longest Diameter								MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
6	JKL12345	TR	40070	9	TARGET	IMG-00003	A1	T04	LDIAM	Longest Diameter								PHOTOGRAPHY	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-03	-1
7	JKL12345	TR	40070	11	TARGET		A1		SUMDIAM	Sum of Diameter	62	mm	62	62	mm				INVESTIGATOR	SCREEN	10	SCREEN
8	JKL12345	TR	40070	12	TARGET		A1		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	29	mm	29	29	mm				INVESTIGATOR	SCREEN	10	SCREEN
9	JKL12345	TR	40070	14	NON-TARGET	IMG-00002	A1	NT01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-02	-2
10	JKL12345	TR	40070	15	NON-TARGET	IMG-00001	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1
11	JKL12345	TR	40070	16	TARGET	IMG-00004	A2	T01	LPERP	Longest Perpendicular	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	43
12	JKL12345	TR	40070	18	TARGET	IMG-00004	A2	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	40	WEEK 6
13	JKL12345	TR	40070	19	TARGET	IMG-00005	A2	T02	LPERP	Longest Perpendicular	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-16	44
14	JKL12345	TR	40070	21	TARGET	IMG-00005	A2	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	40	WEEK 6
15	JKL12345	TR	40070	22	TARGET	IMG-00004	A2	T03	LDIAM	Longest Diameter	14	mm	14	14	mm			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-15	43
16	JKL12345	TR	40070	25	TARGET	IMG-00006	A2	T04	LDIAM	Longest Diameter						NOT DONE	NOT EVALUABLE	PHOTOGRAPHY	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-17	45
17	JKL12345	TR	40070	27	TARGET		A2		SUMDIAM	Sum of Diameter	52	mm	52	52	mm				INVESTIGATOR	TREATMENT	40	WEEK 6
18	JKL12345	TR	40070	28	TARGET		A2		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	28	mm	28	28	mm				INVESTIGATOR	TREATMENT	40	WEEK 6
19	JKL12345	TR	40070	29	TARGET		A2		ACNSD	Absolute Change From Nadir in Sum of Diameter	-10	mm	-10	-10	mm				INVESTIGATOR	TREATMENT	40	WEEK 6
20	JKL12345	TR	40070	30	TARGET		A2		PCBSD	Percent Change From Baseline in Sum of Diameter	-16	%	-16	-16	%	NOT DONE	at least one target lesions was not measured		INVESTIGATOR	TREATMENT	40	WEEK 6
21	JKL12345	TR	40070	31	TARGET		A2		PCNSD	Percent Change From Nadir in Sum of Diameter	-16	%	-16	-16	%				INVESTIGATOR	TREATMENT	40	WEEK 6
22	JKL12345	TR	40070	32	NON-TARGET	IMG-00002	A2	NT01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-16	44
23	JKL12345	TR	40070	33	NON-TARGET		A2	NT02	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
24	JKL12345	TR	40070	34	TARGET	IMG-00007	A3	T01	DIAMETER	Diameter	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
25	JKL12345	TR	40070	36	TARGET	IMG-00007	A3	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
26	JKL12345	TR	40070	37	TARGET	IMG-00008	A3	T02	DIAMETER	Diameter	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-30	86
27	JKL12345	TR	40070	40	TARGET	IMG-00008	A3	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-30	86
28	JKL12345	TR	40070	41	TARGET	IMG-00007	A3	T03	DIAMETER	Diameter	15	mm	15	15	mm			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
29	JKL12345	TR	40070	43	TARGET	IMG-00009	A3	T04	DIAMETER	Diameter	8	mm	8	8	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-01	87
30	JKL12345	TR	40070	45	TARGET		A3		SUMDIAM	Sum of Diameter	47	mm	47	47	mm				INVESTIGATOR	TREATMENT	60	WEEK 12
31	JKL12345	TR	40070	46	TARGET		A3		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	23	mm	23	23	mm				INVESTIGATOR	TREATMENT	60	WEEK 12
32	JKL12345	TR	40070	45	TARGET		A3		ACNSD	Absolute Change From Nadir in Sum of Diameter	-5	mm	-5	-5	mm				INVESTIGATOR	TREATMENT	60	WEEK 12
33	JKL12345	TR	40070	46	TARGET		A3		PCBSD	Percent Change From Baseline in Sum of Diameter	-24	%	-24	-24	%				INVESTIGATOR	TREATMENT	60	WEEK 12
34	JKL12345	TR	40070	47	TARGET		A3		PCNSD	Percent Change From Nadir in Sum of Diameter	-9	%	-9	-9	%				INVESTIGATOR	TREATMENT	60	WEEK 12
35	JKL12345	TR	40070	49	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
36	JKL12345	TR	40070	50	NON-TARGET		A3	NT02	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
37	JKL12345	TR	40070	51	TARGET	IMG-00010	A4	T01	DIAMETER	Diameter	9	mm	9	9	mm			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
38	JKL12345	TR	40070	53	TARGET	IMG-00010	A4	T01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
39	JKL12345	TR	40070	55	TARGET	IMG-00011	A4	T02	DIAMETER	Diameter	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-28	145
40	JKL12345	TR	40070	57	TARGET	IMG-00011	A4	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-28	145
41	JKL12345	TR	40070	58	TARGET	IMG-00010	A4	T03	DIAMETER	Diameter	11	mm	11	11	mm			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
42	JKL12345	TR	40070	60	TARGET	IMG-00012	A4	T04	DIAMETER	Diameter	TOO SMALL TO MEASURE	mm	5	5	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
43	JKL12345	TR	40070	61	TARGET		A4		SUMDIAM	Sum of Diameter	37	mm	37	37	mm				INVESTIGATOR	TREATMENT	80	WEEK 20
44	JKL12345	TR	40070	62	TARGET		A4		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	16	mm	16	16	mm				INVESTIGATOR	TREATMENT	80	WEEK 20
45	JKL12345	TR	40070	63	TARGET		A4		ACNSD	Absolute Change From Nadir in Sum of Diameter	-10	mm	-10	-10	mm				INVESTIGATOR	TREATMENT	80	WEEK 20
46	JKL12345	TR	40070	64	TARGET		A4		PCBSD	Percent Change From Baseline in Sum of Diameter	-40	%	-40	-40	%				INVESTIGATOR	TREATMENT	80	WEEK 20
47	JKL12345	TR	40070	64	TARGET		A4		PCNSD	Percent Change From Nadir in Sum of Diameter	-21	%	-21	-21	%				INVESTIGATOR	TREATMENT	80	WEEK 20
48	JKL12345	TR	40070	66	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
49	JKL12345	TR	40070	67	NON-TARGET	IMG-00010	A4	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
50	JKL12345	TR	40070	68	TARGET	IMG-00013	A5	T01	DIAMETER	Diameter	9	mm	9	9	mm			MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
51	JKL12345	TR	40070	71	TARGET	IMG-00013	A5	T01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
52	JKL12345	TR	40070	72	TARGET	IMG-00014	A5	T02	DIAMETER	Diameter	8	mm	8	8	mm			CT SCAN	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-24	202
53	JKL12345	TR	40070	74	TARGET	IMG-00014	A5	T02	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-24	202
54	JKL12345	TR	40070	75	TARGET	IMG-00013	A5	T03	DIAMETER	Diameter	6	mm	6	6	mm			MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
55	JKL12345	TR	40070	77	TARGET	IMG-00015	A5	T04	DIAMETER	Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-25	203
56	JKL12345	TR	40070	79	TARGET		A5		SUMDIAM	Sum of Diameter	23	mm	23	23	mm				INVESTIGATOR	TREATMENT	100	WEEK 28
57	JKL12345	TR	40070	80	TARGET		A5		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	6	mm	6	6	mm				INVESTIGATOR	TREATMENT	100	WEEK 28
58	JKL12345	TR	40070	81	TARGET		A5		ACNSD	Absolute Change From Nadir in Sum of Diameter	-14	mm	-14	-14	mm				INVESTIGATOR	TREATMENT	100	WEEK 28
59	JKL12345	TR	40070	82	TARGET		A5		PCBSD	Percent Change From Baseline in Sum of Diameter	-62	%	-62	-62	%				INVESTIGATOR	TREATMENT	100	WEEK 28
60	JKL12345	TR	40070	82	TARGET		A5		PCNSD	Percent Change From Nadir in Sum of Diameter	-37	%	-37	-37	%				INVESTIGATOR	TREATMENT	100	WEEK 28
61	JKL12345	TR	40070	84	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
62	JKL12345	TR	40070	85	NON-TARGET		A5	NT02	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-26	204
63	JKL12345	TR	40070	87	TARGET	IMG-00016	A6	T01	DIAMETER	Diameter	8	mm	8	8	mm			MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
64	JKL12345	TR	40070	89	TARGET	IMG-00016	A6	T01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
65	JKL12345	TR	40070	90	TARGET	IMG-00017	A6	T02	DIAMETER	Diameter	9	mm	9	9	mm			CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
66	JKL12345	TR	40070	92	TARGET	IMG-00017	A6	T02	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
67	JKL12345	TR	40070	93	TARGET	IMG-00016	A6	T03	DIAMETER	Diameter	0	mm	0	0	mm			MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
68	JKL12345	TR	40070	95	TARGET	IMG-00018	A6	T04	DIAMETER	Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
69	JKL12345	TR	40070	97	TARGET		A6		SUMDIAM	Sum of Diameter	17	mm	17	17	mm				INVESTIGATOR	TREATMENT	120	WEEK 36
70	JKL12345	TR	40070	98	TARGET		A6		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	120	WEEK 36
71	JKL12345	TR	40070	99	TARGET		A6		ACNSD	Absolute Change From Nadir in Sum of Diameter	-6	mm	-6	-6	mm				INVESTIGATOR	TREATMENT	120	WEEK 36
72	JKL12345	TR	40070	100	TARGET		A6		PCBSD	Percent Change From Baseline in Sum of Diameter	-72	%	-72	-72	%				INVESTIGATOR	TREATMENT	120	WEEK 36
73	JKL12345	TR	40070	100	TARGET		A6		PCNSD	Percent Change From Nadir in Sum of Diameter	-26	%	-26	-26	%				INVESTIGATOR	TREATMENT	120	WEEK 36
74	JKL12345	TR	40070	102	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
75	JKL12345	TR	40070	103	NON-TARGET	IMG-00016	A6	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-19	259
76	JKL12345	TR	40070	105	NEW	IMG-00017	A6	NEW01	DIAMETER	Diameter						NOT DONE	UNKNOWN	CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
77	JKL12345	TR	40070	106	NEW	IMG-00017	A6	NEW01	TUMSTATE	Tumor State	EQUIVOCAL		EQUIVOCAL					CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
78	JKL12345	TR	40070	107	TARGET	IMG-00019	A7	T01	DIAMETER	Diameter	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
79	JKL12345	TR	40070	109	TARGET	IMG-00019	A7	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
80	JKL12345	TR	40070	110	TARGET	IMG-00020	A7	T02	DIAMETER	Diameter	9	mm	9	9	mm			CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
81	JKL12345	TR	40070	112	TARGET	IMG-00020	A7	T02	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
82	JKL12345	TR	40070	113	TARGET	IMG-00019	A7	T03	DIAMETER	Diameter	0	mm	0	0	mm			MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
83	JKL12345	TR	40070	115	TARGET	IMG-00021	A7	T04	DIAMETER	Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-16	315
84	JKL12345	TR	40070	117	TARGET		A7		SUMDIAM	Sum of Diameter	21	mm	21	21	mm				INVESTIGATOR	TREATMENT	140	WEEK 44
85	JKL12345	TR	40070	118	TARGET		A7		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	140	WEEK 44
86	JKL12345	TR	40070	119	TARGET		A7		ACNSD	Absolute Change From Nadir in Sum of Diameter	4	mm	4	4	mm				INVESTIGATOR	TREATMENT	140	WEEK 44
87	JKL12345	TR	40070	120	TARGET		A7		PCBSD	Percent Change From Baseline in Sum of Diameter	-66	%	-66	-66	%				INVESTIGATOR	TREATMENT	140	WEEK 44
88	JKL12345	TR	40070	120	TARGET		A7		PCNSD	Percent Change From Nadir in Sum of Diameter	23	%	23	23	%				INVESTIGATOR	TREATMENT	140	WEEK 44
89	JKL12345	TR	40070	122	NON-TARGET	IMG-00020	A7	NT01	LNSTATE	Lymph Node State	NON-PATHOLOGICAL		NON-PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
90	JKL12345	TR	40070	123	NON-TARGET	IMG-00019	A7	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317
91	JKL12345	TR	40070	124	NEW	IMG-00020	A7	NEW01	DIAMETER	Diameter	8	mm	8	8	mm			CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
92	JKL12345	TR	40070	125	NEW	IMG-00020	A7	NEW01	TUMSTATE	Tumor State	UNEQUIVOCAL		UNEQUIVOCAL					CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
93	JKL12345	TR	40070	126	NEW	IMG-00019	A7	NEW02	DIAMETER	Diameter						NOT DONE	UNKNOWN	MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317
94	JKL12345	TR	40070	127	NEW	IMG-00019	A7	NEW02	TUMSTATE	Tumor State	UNEQUIVOCAL		UNEQUIVOCAL					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317
95	JKL12345	TR	40070	128	NEW	IMG-00019	A7	NEW03	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317

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3.2.4 PR Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.

The table below 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 and trunk (PRTRT = "PHOTOGRAPHY" and PROLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.

The above paragraph was originally as follows in the spreadsheet. Please confirm I have not changed the meaning or intent:

Example shows an MRI of the 'HEAD AND NECK', CT SCAN of the 'CHEST' and medical PHOTOGRAPHY of the 'SKIN OF THE TRUNK' at each disease assessment timepoint. The image identifier is in PRREFID.

Rows 1-3: Show the scan preformed at the screening assessment. The results of the scans are record in TU and TR. scan

pr.xpt

ROW	STUDYID	DOMAIN	USUBJID	PRSEQ	PRREFID	PRLNKGRP	PRTRT	PRPRESP	PROCCUR	PRLOC	EPOCH	VISITNUM	VISIT	PRSTDTC	PRSTDY
1	JKL12345	PR	40070	1	IMG-00001	A1	MRI	Y	Y	HEAD AND NECK	SCREEN	10	SCREEN	2010-01-01	-3
2	JKL12345	PR	40070	2	IMG-00002	A1	CT SCAN	Y	Y	CHEST	SCREEN	10	SCREEN	2010-01-02	-2
3	JKL12345	PR	40070	3	IMG-00003	A1	PHOTOGRAPHY			SKIN OF THE TRUNK	SCREEN	10	SCREEN	2010-01-03	-1
4	JKL12345	PR	40070	4	IMG-00004	A2	MRI	Y	Y	HEAD AND NECK	TREATMENT	40	WEEK 6	2010-02-15	43
5	JKL12345	PR	40070	5	IMG-00005	A2	CT SCAN	Y	Y	CHEST	TREATMENT	40	WEEK 6	2010-02-16	44
6	JKL12345	PR	40070	6	IMG-00006	A2	PHOTOGRAPHY			SKIN OF THE TRUNK	TREATMENT	40	WEEK 6	2010-02-17	45
7	JKL12345	PR	40070	7	IMG-00007	A3	MRI	Y	Y	HEAD AND NECK	TREATMENT	60	WEEK 12	2010-03-29	85
8	JKL12345	PR	40070	8	IMG-00008	A3	CT SCAN	Y	Y	CHEST	TREATMENT	60	WEEK 12	2010-03-30	86
9	JKL12345	PR	40070	9	IMG-00009	A3	PHOTOGRAPHY			SKIN OF THE TRUNK	TREATMENT	60	WEEK 12	2010-04-01	87
10	JKL12345	PR	40070	10	IMG-00010	A4	MRI	Y	Y	HEAD AND NECK	TREATMENT	80	WEEK 20	2010-05-27	144
11	JKL12345	PR	40070	11	IMG-00011	A4	CT SCAN	Y	Y	CHEST	TREATMENT	80	WEEK 20	2010-05-28	145
12	JKL12345	PR	40070	12	IMG-00012	A4	PHOTOGRAPHY			SKIN OF THE TRUNK	TREATMENT	80	WEEK 20	2010-05-30	147
13	JKL12345	PR	40070	13	IMG-00013	A5	MRI	Y	Y	HEAD AND NECK	TREATMENT	100	WEEK 28	2010-07-23	201
14	JKL12345	PR	40070	14	IMG-00014	A5	CT SCAN	Y	Y	CHEST	TREATMENT	100	WEEK 28	2010-07-24	202
15	JKL12345	PR	40070	15	IMG-00015	A5	PHOTOGRAPHY			SKIN OF THE TRUNK	TREATMENT	100	WEEK 28	2010-07-25	203
16	JKL12345	PR	40070	16	IMG-00016	A6	MRI	Y	Y	HEAD AND NECK	TREATMENT	120	WEEK 36	2010-09-17	257
17	JKL12345	PR	40070	17	IMG-00017	A6	CT SCAN	Y	Y	CHEST	TREATMENT	120	WEEK 36	2010-09-19	259
18	JKL12345	PR	40070	18	IMG-00018	A6	PHOTOGRAPHY			SKIN OF THE TRUNK	TREATMENT	120	WEEK 36	2010-09-17	257
19	JKL12345	PR	40070	19	IMG-00019	A7	MRI	Y	Y	HEAD AND NECK	TREATMENT	140	WEEK 44	2010-11-15	314
20	JKL12345	PR	40070	20	IMG-00020	A7	CT SCAN	Y	Y	CHEST	TREATMENT	140	WEEK 44	2010-11-14	313
21	JKL12345	PR	40070	21	IMG-00021	A7	PHOTOGRAPHY			SKIN OF THE TRUNK	TREATMENT	140	WEEK 44	2010-11-16	315

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3.2.5 TD Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TD domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.

The table below shows three distinct disease-assessment schedule patterns. A single anchor date variable (TDANCVAR) provides the anchor date for each pattern. The offset variable (TDSTOFF) used in conjunction with the anchor date variable provides the start point of each pattern of assessments.

Row 1: The 1st schedule starts at reference start date and repeats every 8 weeks for 6 repeats (i.e., Week 8, 16, 24, 32, 40, and 48).

Rows 2: The 2nd schedule starts from Week 48 and repeats every 12 weeks for 4 repeats ( i.e., Week 60, 72, 84, 96).

Row 3: The 3rd schedule starts from Week 96 and repeats every 24 weeks (i.e. Week 120, 144, etc.).

td.xpt

Row	STUDYID	DOMAIN	TDORDER	TDANCVAR	TDSTOFF	TDTGTPAI	TDMINPAI	TDMAXPAI	TDNUMRPT
1	ABC123	TD	1	ANCH1DT	P0D	P8W	P53D	P9W	6
2	ABC123	TD	2	ANCH1DT	P60W	P12W	P11W	P13W	4
3	ABC123	TD	3	ANCH1DT	P120W	P24W	P23W	P25W	12

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3.2.6 Relrec

This example shows how the RELREC dataset is used for RECIST 1.1 to represent related information between two domains which have a one-to-many relationship. This example represents dataset to dataset relationships where records in one domain are being related to records in another domain using the IDVAR as the join key. Both USUBJID and IDVARVAL are null when representing dataset to dataset relationships. Specifically, this example shows the relationship between TU and TR using --LNKID and the relationship between TR and RS using --LNKGRP.

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relrec.xpt

Row	STUDYID	RDOMAIN	IDVAR	RELTYPE	RELID
1	ABC12345	TU	TULNKID	One	A
2	ABC12345	TR	TRLNKID	Many	A
3	ABC12345	TR	TRLNKGRP	Many	B
4	ABC12345	RS	RSLNKGRP	One	B
5	ABC12345	PR	PRREFID	One	C
6	ABC12345	TU	TUREFID	Many	C
7	ABC123	PR	PRLNKGRP	MANY	D
8	ABC123	RS	RSLNKGRP	ONE	D

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5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for the TU domain special purpose dataset.

QNAM	RDOMAIN	QLABEL	QVAL
PREVIR	TU	Previously Irradiated Indicator	Yes/No
PREVIRP	TU	Previously Irradiated Progression	Yes/No

3.2 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

3.2.1 RS Domain Model

The example 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 Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.

The table represents the items from the RECIST 1.1 criteria.

rs.xpt

xx.xpt

STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSNAM	RSEVAL	RSEVALID	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
CDE12345	RS	4000400%	100%		TRGRESP	Target Response	RECIST 1.1	SD	SD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	300%	WEEK 8	3914000%	5600%
CDE12345	RS	40004	2		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	WEEK 8	2007-02-27	56
CDE12345	RS	40004	3	R-A2	OVRLRESP	Overall Response	RECIST 1.1	SD	SD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	WEEK 8	2007-02-27	56
CDE12345	RS	40004	4		TRGRESP	Target Response	RECIST 1.1	PR	PR	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	5	WEEK 16	2007-04-24	112
CDE12345	RS	40004	5		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	5	WEEK 16	2007-04-24	112
CDE12345	RS	40004	6	R-A3	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	5	WEEK 16	2007-04-24	112
CDE12345	RS	40004	7		TRGRESP	Target Response	RECIST 1.1	PR	PR	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	7	WEEK 24	2009-06-19	168
CDE12345	RS	40004	8		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	7	WEEK 24	2009-06-19	168
CDE12345	RS	40004	9	R-A4	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	7	WEEK 24	2009-06-19	168
CDE12345	RS	40004	10		TRGRESP	Target Response	RECIST 1.1	PD	PD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	9	WEEK 32	2009-08-14	224
CDE12345	RS	40004	11		NTRGRESP	Non-target Response	RECIST 1.1	PD	PD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	9	WEEK 32	2009-08-14	224
CDE12345	RS	40004	12		SYMPTDTR	Symptomatic Deterioration	PROTOCOL DEFINED RESPONSE CRITERIA	Increased shortness of breath	PD		INVESTIGATOR		TREATMENT	9	WEEK 32	2009-08-12	222
CDE12345	RS	40004	13	R-A5	OVRLRESP	Overall Response	RECIST 1.1	PD	PD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	9	WEEK 32	2009-08-14	224

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End of Document

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1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The Oncology Disease Response Domains Model for RECIST 1.1

3.1 Assumptions for the Oncology Disease Response Domains

3.2 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.

3.2.1 RS Domain Model

3.2.2 TU Domain Model

3.2.4 PR Domain Model

3.2.5 TD Domain Model

3.2.6 Relrec

5 Supplemental Qualifier Name Codes

3.2 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.

3.2.1 RS Domain Model

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Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The Oncology Disease Response Domains Model for RECIST 1.1

3.1 Assumptions for the Oncology Disease Response Domains

3.2 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.

3.2.1 RS Domain Model

3.2.2 TU Domain Model

3.2.4 PR Domain Model

3.2.5 TD Domain Model

3.2.6 Relrec

5 Supplemental Qualifier Name Codes

3.2 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.

3.2.1 RS Domain Model