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.

3.2 General Points on Representation of Data within the Oncology Disease Response Domains

In the case where no evidence of disease was found at baseline, this can be represented by a RS record with RSTEST=Overall Response and RSORRES=NED and RSSTRESC=NED.

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.

4 Examples for the Oncology Disease Response Domains Model for RECIST 1.1

4.1 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.

4.1.1 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.

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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4.1.2 TU Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example 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: Shows 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: Show 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

4.1.3 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 1-6: Show the screening identification of 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.

Row 16: Shows a case where TRSTAT is NOT DONE with the reason for the result being not done as TRTEST of Longest Diameter with TRREASND as NOT EVALUABLE.

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. Within Row 20, the PCBSD 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.

Rows 22-23: 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 36: Shows a case where TRSTAT as NOT DONE with different possible reasons for the result being not done. In row 36, the TRTEST is Tumor State and the TRREASND is SCAN NOT PERFORMED

Row 93: Shows a case where TRSTAT as NOT DONE with different possible reasons for the result being not done. x. In row 93, the TRTEST is Longest Diameter with TRREASND as NOT ASSESSABLE: Image obscured

Row 42: Shows a target lesion T04 which is too small to measure. The TRORRES is TOO SMALL TO MEASURE, and the TRSTRESC and TRSTRESN are standardized to 5 with TRSTRESU as mm.

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	2	TARGET	IMG-00001	A1	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
3	JKL12345	TR	40070	3	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	4	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	5	TARGET	IMG-00001	A1	T03	LDIAM	Longest Diameter								MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
6	JKL12345	TR	40070	6	TARGET	IMG-00003	A1	T04	LDIAM	Longest Diameter								PHOTOGRAPHY	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-03	-1
7	JKL12345	TR	40070	7	TARGET		A1		SUMDIAM	Sum of Diameter	62	mm	62	62	mm				INVESTIGATOR	SCREEN	10	SCREEN
8	JKL12345	TR	40070	8	TARGET		A1		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	29	mm	29	29	mm				INVESTIGATOR	SCREEN	10	SCREEN
9	JKL12345	TR	40070	9	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	10	NON-TARGET	IMG-00001	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1
11	JKL12345	TR	40070	11	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	12	TARGET	IMG-00004	A2	T01	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					MRI	INVESTIGATOR	TREATMENT	40	WEEK 6
13	JKL12345	TR	40070	13	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	14	TARGET	IMG-00005	A2	T02	LNSTATE	Lymph Node State	PATHOLOGICAL		PATHOLOGICAL					CT SCAN	INVESTIGATOR	TREATMENT	40	WEEK 6
15	JKL12345	TR	40070	15	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	16	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	17	TARGET		A2		SUMDIAM	Sum of Diameter	52	mm	52	52	mm				INVESTIGATOR	TREATMENT	40	WEEK 6
18	JKL12345	TR	40070	18	TARGET		A2		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	28	mm	28	28	mm				INVESTIGATOR	TREATMENT	40	WEEK 6
19	JKL12345	TR	40070	19	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	20	TARGET		A2		PCBSD	Percent Change From Baseline in Sum of Diameter						NOT DONE	at least one target lesions was not measured		INVESTIGATOR	TREATMENT	40	WEEK 6
21	JKL12345	TR	40070	21	TARGET		A2		PCNSD	Percent Change From Nadir in Sum of Diameter	-16	%	-16	-16	%				INVESTIGATOR	TREATMENT	40	WEEK 6
22	JKL12345	TR	40070	22	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	23	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	24	TARGET	IMG-00007	A3	T01	LDIAM	Longest Diameter	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
25	JKL12345	TR	40070	25	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	26	TARGET	IMG-00008	A3	T02	LDIAM	Longest Diameter	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-30	86
27	JKL12345	TR	40070	27	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	28	TARGET	IMG-00007	A3	T03	LDIAM	Longest Diameter	15	mm	15	15	mm			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-03-29	85
29	JKL12345	TR	40070	29	TARGET	IMG-00009	A3	T04	LDIAM	Longest Diameter	8	mm	8	8	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-01	87
30	JKL12345	TR	40070	30	TARGET		A3		SUMDIAM	Sum of Diameter	47	mm	47	47	mm				INVESTIGATOR	TREATMENT	60	WEEK 12
31	JKL12345	TR	40070	31	TARGET		A3		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	23	mm	23	23	mm				INVESTIGATOR	TREATMENT	60	WEEK 12
32	JKL12345	TR	40070	32	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	33	TARGET		A3		PCBSD	Percent Change From Baseline in Sum of Diameter	-24	%	-24	-24	%				INVESTIGATOR	TREATMENT	60	WEEK 12
34	JKL12345	TR	40070	34	TARGET		A3		PCNSD	Percent Change From Nadir in Sum of Diameter	-9	%	-9	-9	%				INVESTIGATOR	TREATMENT	60	WEEK 12
35	JKL12345	TR	40070	35	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	36	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	37	TARGET	IMG-00010	A4	T01	LDIAM	Longest Diameter	9	mm	9	9	mm			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
38	JKL12345	TR	40070	38	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	39	TARGET	IMG-00011	A4	T02	LDIAM	Longest Diameter	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-28	145
40	JKL12345	TR	40070	40	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	41	TARGET	IMG-00010	A4	T03	LDIAM	Longest Diameter	11	mm	11	11	mm			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
42	JKL12345	TR	40070	42	TARGET	IMG-00012	A4	T04	LDIAM	Longest Diameter	TOO SMALL TO MEASURE	mm	5	5	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-30	147
43	JKL12345	TR	40070	43	TARGET		A4		SUMDIAM	Sum of Diameter	37	mm	37	37	mm				INVESTIGATOR	TREATMENT	80	WEEK 20
44	JKL12345	TR	40070	44	TARGET		A4		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	16	mm	16	16	mm				INVESTIGATOR	TREATMENT	80	WEEK 20
45	JKL12345	TR	40070	45	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	46	TARGET		A4		PCBSD	Percent Change From Baseline in Sum of Diameter	-40	%	-40	-40	%				INVESTIGATOR	TREATMENT	80	WEEK 20
47	JKL12345	TR	40070	47	TARGET		A4		PCNSD	Percent Change From Nadir in Sum of Diameter	-21	%	-21	-21	%				INVESTIGATOR	TREATMENT	80	WEEK 20
48	JKL12345	TR	40070	48	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	49	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	50	TARGET	IMG-00013	A5	T01	LDIAM	Longest Diameter	9	mm	9	9	mm			MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
51	JKL12345	TR	40070	51	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	52	TARGET	IMG-00014	A5	T02	LDIAM	Longest Diameter	8	mm	8	8	mm			CT SCAN	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-24	202
53	JKL12345	TR	40070	53	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	54	TARGET	IMG-00013	A5	T03	LDIAM	Longest Diameter	6	mm	6	6	mm			MRI	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-23	201
55	JKL12345	TR	40070	55	TARGET	IMG-00015	A5	T04	LDIAM	Longest Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	100	WEEK 28	2010-07-25	203
56	JKL12345	TR	40070	56	TARGET		A5		SUMDIAM	Sum of Diameter	23	mm	23	23	mm				INVESTIGATOR	TREATMENT	100	WEEK 28
57	JKL12345	TR	40070	57	TARGET		A5		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	6	mm	6	6	mm				INVESTIGATOR	TREATMENT	100	WEEK 28
58	JKL12345	TR	40070	58	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	59	TARGET		A5		PCBSD	Percent Change From Baseline in Sum of Diameter	-62	%	-62	-62	%				INVESTIGATOR	TREATMENT	100	WEEK 28
60	JKL12345	TR	40070	60	TARGET		A5		PCNSD	Percent Change From Nadir in Sum of Diameter	-37	%	-37	-37	%				INVESTIGATOR	TREATMENT	100	WEEK 28
61	JKL12345	TR	40070	61	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	62	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	63	TARGET	IMG-00016	A6	T01	LDIAM	Longest Diameter	8	mm	8	8	mm			MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
64	JKL12345	TR	40070	64	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	65	TARGET	IMG-00017	A6	T02	LDIAM	Longest Diameter	9	mm	9	9	mm			CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
66	JKL12345	TR	40070	66	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	67	TARGET	IMG-00016	A6	T03	LDIAM	Longest Diameter	0	mm	0	0	mm			MRI	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
68	JKL12345	TR	40070	68	TARGET	IMG-00018	A6	T04	LDIAM	Longest Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
69	JKL12345	TR	40070	69	TARGET		A6		SUMDIAM	Sum of Diameter	17	mm	17	17	mm				INVESTIGATOR	TREATMENT	120	WEEK 36
70	JKL12345	TR	40070	70	TARGET		A6		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	120	WEEK 36
71	JKL12345	TR	40070	71	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	72	TARGET		A6		PCBSD	Percent Change From Baseline in Sum of Diameter	-72	%	-72	-72	%				INVESTIGATOR	TREATMENT	120	WEEK 36
73	JKL12345	TR	40070	73	TARGET		A6		PCNSD	Percent Change From Nadir in Sum of Diameter	-26	%	-26	-26	%				INVESTIGATOR	TREATMENT	120	WEEK 36
74	JKL12345	TR	40070	74	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	75	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	76	NEW	IMG-00017	A6	NEW01	LDIAM	Longest Diameter						NOT DONE	NOT EVALUABLE	CT SCAN	INVESTIGATOR	TREATMENT	120	WEEK 36	2010-09-17	257
77	JKL12345	TR	40070	77	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	78	TARGET	IMG-00019	A7	T01	LDIAM	Longest Diameter	12	mm	12	12	mm			MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
79	JKL12345	TR	40070	79	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	80	TARGET	IMG-00020	A7	T02	LDIAM	Longest Diameter	9	mm	9	9	mm			CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
81	JKL12345	TR	40070	81	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	82	TARGET	IMG-00019	A7	T03	LDIAM	Longest Diameter	0	mm	0	0	mm			MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-15	314
83	JKL12345	TR	40070	83	TARGET	IMG-00021	A7	T04	LDIAM	Longest Diameter	0	mm	0	0	mm			PHOTOGRAPHY	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-16	315
84	JKL12345	TR	40070	84	TARGET		A7		SUMDIAM	Sum of Diameter	21	mm	21	21	mm				INVESTIGATOR	TREATMENT	140	WEEK 44
85	JKL12345	TR	40070	85	TARGET		A7		SUMNLNLD	Sum Diameters of Non Lymph Node Tumors	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	140	WEEK 44
86	JKL12345	TR	40070	86	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	87	TARGET		A7		PCBSD	Percent Change From Baseline in Sum of Diameter	-66	%	-66	-66	%				INVESTIGATOR	TREATMENT	140	WEEK 44
88	JKL12345	TR	40070	88	TARGET		A7		PCNSD	Percent Change From Nadir in Sum of Diameter	23	%	23	23	%				INVESTIGATOR	TREATMENT	140	WEEK 44
89	JKL12345	TR	40070	89	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	90	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	91	NEW	IMG-00020	A7	NEW01	LDIAM	Longest Diameter	8	mm	8	8	mm			CT SCAN	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-14	313
92	JKL12345	TR	40070	92	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	93	NEW	IMG-00019	A7	NEW02	LDIAM	Longest Diameter						NOT DONE	NOT ASSESSABLE: Image obscured	MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317
94	JKL12345	TR	40070	94	NEW	IMG-00019	A7	NEW02	TUMSTATE	Tumor State	UNEQUIVOCAL		UNEQUIVOCAL					MRI	INVESTIGATOR	TREATMENT	140	WEEK 44	2010-11-18	317
95	JKL12345	TR	40070	95	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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4.1.4 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 scans preformed at the screening disease assessment. The results of the scans are record in TU and TR.

Rows 4-21: Show the scans preformed at the disease assessments at Weeks 6, 12, 20, 28, 36 and 44. The results of the scans are record in TU and TR.

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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4.1.5 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).

Row 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

$warningHtml

4.2 Example 2: RECIST 1.1 example to show independent assessor response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example shows the preferred representation of split (fragmented) and merged (coalesced) tumors.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

4.2.1 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.

Rows 1-11: For data from an independent assessor the RSNAM, RSEVAL and RSEVALID are used. The RSNAM contains the name of the vendor, the RSEVAL contains role of the person who provided the assessment, in this case, INDEPENDENT ASSESSOR, and the RSEVALID contains the specific type of medical reviewer who performed the independent assessment, in this case, RADIOLOGIST 1.

Row 12: Shows a protocol defined response which is outside of RECIST 1.1. In this case, it is symptomatic deterioration. The RSORRES contains the actual symptomatic deterioration results which is standardized to PD in RSSTRESC.

rs.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSNAM	RSEVAL	RSEVALID	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	CDE12345	RS	40004	1		TRGRESP	Target Response	RECIST 1.1	SD	SD	ACE IMAGING	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	300%	WEEK 8	3914000%	5600%
2	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
3	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
4	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
5	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
6	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
7	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
8	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
9	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
10	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
11	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
12	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
13	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

$warningHtml

4.2.2 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 example shows the preferred representation of split (fragmented) and merged (coalesced) tumors.

The tu.xpt table below shows lymph nodes as target tumors identified at screening.

Rows 7-8: Show the identification of a split tumor when it was first identified as split. In this example, TULNKID=T04 split into two tumors TULNKID=T04.1 and TULNKID=T04.2.

Row 9: Shows the identification of a merged tumor when it was first identified as merged. In this example, TULNKID=T02 and TULNKID=T03 merged into tumor TULNKID=T02/T03.

tu.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TUSEQ	TUGRPID	TUREFID	TUSPID	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TUNAM	TULOC	TUMETHOD	TUEVAL	TUEVALID	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	CDE12345	TU	40004	1		IMG-00001	TRG-SCR-01	T01	TUMIDENT	Tumor Identification	TARGET	TARGET	ACE IMAGING	LUNG, RIGHT MIDDLE LOBE	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
2	CDE12345	TU	40004	2		IMG-00001	TRG-SCR-02	T02	TUMIDENT	Tumor Identification	TARGET	TARGET	ACE IMAGING	LUNG, LEFT LOWER LOBE	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
3	CDE12345	TU	40004	3		IMG-00001	TRG-SCR-03	T03	TUMIDENT	Tumor Identification	TARGET	TARGET	ACE IMAGING	LUNG, LEFT LOWER LOBE	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
4	CDE12345	TU	40004	4		IMG-00001	TRG-SCR-04	T04	TUMIDENT	Tumor Identification	TARGET	TARGET	ACE IMAGING	KIDNEY, UPPER LOBE	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
5	CDE12345	TU	40004	5		IMG-00001	NTG-SCR-01	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	ACE IMAGING	LUNG	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
6	CDE12345	TU	40004	6		IMG-00001	NTG-SCR-02	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	ACE IMAGING	LIVER	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
7	CDE12345	TU	40004	7	T04	IMG-00002	TRG-W16-07	T04.1	TUSPLIT	Tumor Split	TARGET	TARGET	ACE IMAGING	KIDNEY, UPPER LOBE	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	5	WEEK 16	2007-04-24	112
8	CDE12345	TU	40004	8	T04	IMG-00002	TRG-W16-08	T04.2	TUSPLIT	Tumor Split	TARGET	TARGET	ACE IMAGING	KIDNEY, UPPER LOBE	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	5	WEEK 16	2007-04-24	112
9	CDE12345	TU	40004	9		IMG-00003	TRG-W28-07	T02/T03	TUMERGE	Tumor Merged	TARGET	TARGET	ACE IMAGING	LUNG, LEFT LOWER LOBE	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	7	WEEK 24	2009-06-19	168
10	CDE12345	TU	40004	10		IMG-00004	NWT-W32-01	NEW01	TUMIDENT	Tumor Identification	NEW	NEW	ACE IMAGING	LIVER	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	9	WEEK 32	2009-08-14	224

Dataset Debug Message

There are 20 leading, trailing, or non-breaking spaces in the dataset.

4.2.3 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 example shows the preferred representation of split (fragmented) and merged (coalesced) tumors.

Row 11: Shows the longest diameter of T04 at the assessment before it splits.

Rows 19-20: Show the longest diameters of the split lesions T04.1 and T04.2 at Week 16.

Rows 25-26: Show that tumors T02 and T03 are no longer measured individually. The TRSTAT=NOT DONE and the TRREASND=TUMOR MERGED.

Row 27: Shows the longest diameter of the newly merged T02/T03 tumor at Week 24.

Rows 29-30: Show the longest diameters of the split lesions T04.1 and T04.2 at Week 24.

Row 37: Shows the longest diameter of the newly merged T02/T03 tumor at Week 32.

Rows 38-39: Show the longest diameters of the split lesions T04.1 and T04.2 at Week 32.

Row 42: Shows the Tumor State of the non-target NT01 as ENLARGEMENT FROM NADIR. This Tumor State indicates that the non-target tumors in the LUNG have shown enlargement from their previous smallest state.

Rows 44-45: Shows the Tumor State of the a new tumor NEW01 and the longest diameter of the new tumor.

tr.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRSTAT	TRREASND	TRMETHOD	TREVAL	TREVALID	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	CDE12345	TR	40004	1	TARGET	R-A1	T01	LDIAM	Longest Diameter	16	mm	16	16	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-02	1
2	CDE12345	TR	40004	2	TARGET	R-A1	T02	LDIAM	Longest Diameter	28	mm	28	28	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-02	1
3	CDE12345	TR	40004	3	TARGET	R-A1	T03	LDIAM	Longest Diameter	41	mm	41	41	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-02	1
4	CDE12345	TR	40004	4	TARGET	R-A1	T04	LDIAM	Longest Diameter	83	mm	83	83	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-02	1
5	CDE12345	TR	40004	5	TARGET	R-A1		SUMLDIAM	Sum of Longest Diameter	168	mm	168	168	mm				INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN
6	CDE12345	TR	40004	6	NON-TARGET	R-A1	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-02	1
7	CDE12345	TR	40004	7	NON-TARGET	R-A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-02	1
8	CDE12345	TR	40004	8	TARGET	R-A2	T01	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	WEEK 8	2007-02-27	56
9	CDE12345	TR	40004	9	TARGET	R-A2	T02	LDIAM	Longest Diameter	20	mm	20	20	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	WEEK 8	2007-02-27	56
10	CDE12345	TR	40004	10	TARGET	R-A2	T03	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	WEEK 8	2007-02-27	56
11	CDE12345	TR	40004	11	TARGET	R-A2	T04	LDIAM	Longest Diameter	65	mm	65	65	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	WEEK 8	2007-02-27	56
12	CDE12345	TR	40004	12	TARGET	R-A2		SUMLDIAM	Sum of Longest Diameter	125	mm	125	125	mm				INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	WEEK 8
13	CDE12345	TR	40004	13	NON-TARGET	R-A2	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	WEEK 8	2007-02-27	56
14	CDE12345	TR	40004	14	NON-TARGET	R-A2	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	WEEK 8	2007-02-27	56
15	CDE12345	TR	40004	15	TARGET	R-A3	T01	LDIAM	Longest Diameter	TOO SMALL TO MEASURE	mm	5	5	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16	2007-04-24	112
16	CDE12345	TR	40004	16	TARGET	R-A3	T02	LDIAM	Longest Diameter	12	mm	12	12	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16	2007-04-24	112
17	CDE12345	TR	40004	17	TARGET	R-A3	T03	LDIAM	Longest Diameter	15	mm	15	15	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16	2007-04-24	112
18	CDE12345	TR	40004	18	TARGET	R-A3	T04.1	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16	2007-04-24	112
19	CDE12345	TR	40004	19	TARGET	R-A3	T04.2	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16	2007-04-24	112
20	CDE12345	TR	40004	20	TARGET	R-A3		SUMLDIAM	Sum of Longest Diameter	72	mm	72	72	mm				INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16
21	CDE12345	TR	40004	21	NON-TARGET	R-A3	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16	2007-04-24	112
22	CDE12345	TR	40004	22	NON-TARGET	R-A3	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	5	WEEK 16	2007-04-24	112
23	CDE12345	TR	40004	23	TARGET	R-A4	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
24	CDE12345	TR	40004	24	TARGET	R-A4	T02	LDIAM	Longest Diameter						NOT DONE	TUMOR MERGED	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
25	CDE12345	TR	40004	25	TARGET	R-A4	T03	LDIAM	Longest Diameter						NOT DONE	TUMOR MERGED	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
26	CDE12345	TR	40004	26	TARGET	R-A4	T02/T03	LDIAM	Longest Diameter	35	mm	35	35	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
27	CDE12345	TR	40004	27	TARGET	R-A4	T04.1	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
28	CDE12345	TR	40004	28	TARGET	R-A4	T04.2	LDIAM	Longest Diameter	19	mm	19	19	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
29	CDE12345	TR	40004	29	TARGET	R-A4		SUMLDIAM	Sum of Longest Diameter	84	mm	84	84	mm				INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24
30	CDE12345	TR	40004	30	NON-TARGET	R-A4	NT01	TUMSTATE	Tumor State						NOT DONE	NOT ASSESSABLE: Image obscured	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
31	CDE12345	TR	40004	31	NON-TARGET	R-A4	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	7	WEEK 24	2007-06-19	168
32	CDE12345	TR	40004	32	TARGET	R-A5	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
33	CDE12345	TR	40004	33	TARGET	R-A5	T02/T03	LDIAM	Longest Diameter	80	mm	80	80	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
34	CDE12345	TR	40004	34	TARGET	R-A5	T04.1	LDIAM	Longest Diameter	49	mm	49	49	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
35	CDE12345	TR	40004	35	TARGET	R-A5	T04.2	LDIAM	Longest Diameter	26	mm	26	26	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
36	CDE12345	TR	40004	36	TARGET	R-A5		SUMLDIAM	Sum of Longest Diameter	155	mm	155	155	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
37	CDE12345	TR	40004	37	NON-TARGET	R-A5	NT01	TUMSTATE	Tumor State	ENLARGEMENT FROM NADIR		ENLARGEMENT FROM NADIR					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
38	CDE12345	TR	40004	38	NON-TARGET	R-A5	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
39	CDE12345	TR	40004	39	NEW	R-A5	NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224
40	CDE12345	TR	40004	40	NEW	R-A5	NEW01	LDIAM	Longest Diameter	9	mm	9	9	mm			CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	9	WEEK 32	2007-08-14	224

Dataset Debug Message

There are 12 leading, trailing, or non-breaking spaces in the dataset.

4.3 Example 3: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example also shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

4.3.1 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.

Row 12: Shows RSCAT=RECIST 1.1. The RSTEST=Overall Response with RSORRES=NE because the scans of the target and non-target lesions were not done.

Row 13: Shows RSCAT=PROTOCOL DEFINED RESPONSE CRITERIA. The RSTEST=Symptomatic Deterioration with RSORRES=Increased weakness and weight loss. The RSSTRESC=PD which is a standardized representation of the Symptomatic Deterioration response.

Row 14: Shows RSCAT= PROTOCOL DEFINED RESPONSE CRITERIA. The RSTEST=Overall Response with RSORRES=PD.

rs.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY	RSSTAT
1	CDE12345	RS	40003	1		TRGRESP	Target Response	RECIST 1.1	SD	SD	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
2	CDE12345	RS	40003	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	CDE12345	RS	40003	3	A2	OVRLRESP	Overall Response	RECIST 1.1	SD	SD	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
4	CDE12345	RS	40003	4		TRGRESP	Target Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
5	CDE12345	RS	40003	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	CDE12345	RS	40003	6	A3	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
7	CDE12345	RS	40003	7		TRGRESP	Target Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
8	CDE12345	RS	40003	8		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
9	CDE12345	RS	40003	9	A4	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
10	CDE12345	RS	40003	10		TRGRESP	Target Response	RECIST 1.1			INVESTIGATOR	TREATMENT	9	WEEK 32			NOT DONE
11	CDE12345	RS	40003	11		NTRGRESP	Non-target Response	RECIST 1.1			INVESTIGATOR	TREATMENT	9	WEEK 32			NOT DONE
12	CDE12345	RS	40003	12		OVRLRESP	Overall Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	9	WEEK 32
13	CDE12345	RS	40003	13		SYMPTDTR	Symptomatic Deterioration	PROTOCOL DEFINED RESPONSE CRITERIA	Increased weakness and weight loss	PD	INVESTIGATOR	TREATMENT	9	WEEK 32	2009-08-12	226
14	CDE12345	RS	40003	14	A5	OVRLRESP	Overall Response	PROTOCOL DEFINED RESPONSE CRITERIA	PD	PD	INVESTIGATOR	TREATMENT	9	WEEK 32	2009-08-12	226

$warningHtml

4.3.2 TU Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator.

The tu.xpt table below shows lymph nodes as target tumors identified at screening.

Rows 1-7: Show the identification of target and non-target tumors at screening.

tu.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TULAT	TUMETHOD	TUEVAL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	CDE12345	TU	40003	1	T01	TUMIDENT	Tumor Identification	TARGET	TARGET	LUNG, RIGHT MIDDLE LOBE		CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1
2	CDE12345	TU	40003	2	T02	TUMIDENT	Tumor Identification	TARGET	TARGET	LIVER		CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1
3	CDE12345	TU	40003	3	T03	TUMIDENT	Tumor Identification	TARGET	TARGET	LIVER		CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1
4	CDE12345	TU	40003	4	T04	TUMIDENT	Tumor Identification	TARGET	TARGET	KIDNEY, UPPER LOBE	RIGHT	CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1
5	CDE12345	TU	40003	5	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	LUNG		CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1
6	CDE12345	TU	40003	6	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	ABDOMINAL CAVITY		CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1
7	CDE12345	TU	40003	7	NT03	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	CLAVICLE	RIGHT	SCINTIGRAPHY	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1

Dataset Debug Message

There are 14 leading, trailing, or non-breaking spaces in the dataset.

4.3.3 TR Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example also shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator.

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.

tr.xpt

xx.xpt

TRSEQ	STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRSTAT	TRREASND	TRMETHOD	TREVAL	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
1	CDE12345	TR	40003	1	TARGET	A1	T01	LDIAM	Longest Diameter	16	mm	16	16	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-02	1
2	CDE12345	TR	40003	2	TARGET	A1	T02	LDIAM	Longest Diameter	28	mm	28	28	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-02	1
3	CDE12345	TR	40003	3	TARGET	A1	T03	LDIAM	Longest Diameter	41	mm	41	41	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-02	1
4	CDE12345	TR	40003	4	TARGET	A1	T04	LDIAM	Longest Diameter	82	mm	83	83	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-02	1
5	CDE12345	TR	40003	5	TARGET	A1		SUMLDIAM	Sum of Longest Diameter	167	mm	168	168	mm				INVESTIGATOR	SCREEN	1	SCREEN
6	CDE12345	TR	40003	6	NON-TARGET	A1	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-02	1
7	CDE12345	TR	40003	7	NON-TARGET	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-02	1
8	CDE12345	TR	40003	8	NON-TARGET	A1	NT03	TUMSTATE	Tumor State	PRESENT		PRESENT					SCINTIGRAPHY	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-01	1
9	CDE12345	TR	40003	9	TARGET	A2	T01	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
10	CDE12345	TR	40003	10	TARGET	A2	T02	LDIAM	Longest Diameter	20	mm	20	20	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
11	CDE12345	TR	40003	11	TARGET	A2	T03	LDIAM	Longest Diameter	30	mm	30	30	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
12	CDE12345	TR	40003	12	TARGET	A2	T04	LDIAM	Longest Diameter	65	mm	65	65	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
13	CDE12345	TR	40003	13	TARGET	A2		SUMLDIAM	Sum of Longest Diameter	125	mm	125	125	mm				INVESTIGATOR	TREATMENT	3	WEEK 8
14	CDE12345	TR	40003	14	NON-TARGET	A2	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
15	CDE12345	TR	40003	15	NON-TARGET	A2	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
16	CDE12345	TR	40003	16	NON-TARGET	A2	NT03	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	3	WEEK 8
17	CDE12345	TR	40003	17	TARGET	A3	T01	LDIAM	Longest Diameter	TOO SMALL TO MEASURE	mm	5	5	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	39196	112
18	CDE12345	TR	40003	18	TARGET	A3	T02	LDIAM	Longest Diameter	12	mm	12	12	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
19	CDE12345	TR	40003	19	TARGET	A3	T03	LDIAM	Longest Diameter	15	mm	15	15	mm			CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
20	CDE12345	TR	40003	20	TARGET	A3	T04	LDIAM	Longest Diameter	40	mm	40	40	mm
21	CDE12345	TR	40003	21	TARGET	A3		SUMLDIAM	Sum of Longest Diameter	72	mm	72	72	mm				INVESTIGATOR	TREATMENT	5	WEEK 16
22	CDE12345	TR	40003	22	NON-TARGET	A3	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
23	CDE12345	TR	40003	23	NON-TARGET	A3	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
24	CDE12345	TR	40003	24	NON-TARGET	A3	NT03	TUMSTATE	Tumor State						NOT DONE	DISEASE ASSESSMENT NOT PERFORMED	SCINTIGRAPHY	INVESTIGATOR	TREATMENT	5	WEEK 16
25	CDE12345	TR	40003	25	TARGET	A4	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
26	CDE12345	TR	40003	26	TARGET	A4	T02	LDIAM	Longest Diameter	15	mm	15	15	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
27	CDE12345	TR	40003	27	TARGET	A4	T03	LDIAM	Longest Diameter	5	mm	5	5	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
28	CDE12345	TR	40003	28	TARGET	A4	T04	LDIAM	Longest Diameter	36	mm	36	36	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
29	CDE12345	TR	40003	29	TARGET	A4		SUMLDIAM	Sum of Longest Diameter	56	mm	56	56	mm				INVESTIGATOR	TREATMENT	7	WEEK 24
30	CDE12345	TR	40003	30	NON-TARGET	A4	NT01	TUMSTATE	Tumor State						NOT DONE	NOT EVALUABLE	CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
31	CDE12345	TR	40003	31	NON-TARGET	A4	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
32	CDE12345	TR	40003	32	NON-TARGET	A4	NT03	TUMSTATE	Tumor State	PRESENT		PRESENT					SCINTIGRAPHY	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-26	175
33	CDE12345	TR	40003	33	TARGET	A5	T01	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	9	WEEK 32
34	CDE12345	TR	40003	34	TARGET	A5	T02	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	9	WEEK 32
35	CDE12345	TR	40003	35	TARGET	A5	T03	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	9	WEEK 32
36	CDE12345	TR	40003	36	TARGET	A5	T04	LDIAM	Longest Diameter						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	9	WEEK 32
37	CDE12345	TR	40003	37	NON-TARGET	A5	NT01	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	9	WEEK 32
38	CDE12345	TR	40003	38	NON-TARGET	A5	NT02	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	9	WEEK 32
39	CDE12345	TR	40003	39	NON-TARGET	A5	NT03	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	9	WEEK 32

Dataset Debug Messages

There are 16 leading, trailing, or non-breaking spaces in the dataset.
There is a duplicate variable (TRSEQ) in the dataset.

4.4 Example 4: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR) data. Example to show the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

4.4.1 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. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1.

The table represents the items from the RECIST 1.1 criteria.

Rows 1-16: Show that 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.

rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSNAM	RSEVAL	RSEVALID	RSACPTFL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	FGH12345	RS	40050	1		TRGRESP	Target Response	RECIST 1.1	SD	SD	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8	2007-02-27	56
2	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	5		TRGRESP	Target Response	RECIST 1.1	PR	PR	RADIOL INC.	INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16	2007-04-24	112
6	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	11	R2-A2	OVRLRESP	Overall 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
12	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	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	FGH12345	RS	40050	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

$warningHtml

4.4.2 TU Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1. The acceptance flag indicates records which are chosen by an adjudicator. Not all sponsors have both sets of independent reviews exported, i.e., only the accepted records are transferred.

The tu.xpt table below shows lymph nodes as target tumors identified at screening.

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 (TUACPTFL). The accepted record flags are per the data transfer from the independent reviewer.

tu.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TUNAM	TULOC	TULAT	TUMETHOD	TUEVAL	TUEVALID	TUACPTFL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	FGH12345	TU	40050	1	R1-T01	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	LIVER		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREEN	2007-01-02	1
2	FGH12345	TU	40050	2	R1-T02	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	KIDNEY, UPPER LOBE	LEFT	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREEN	2007-01-02	1
3	FGH12345	TU	40050	3	R1-NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	RADIOL INC.	ABDOMINAL CAVITY		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREEN	2007-01-02	1
4	FGH12345	TU	40050	4	R2-T01	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	KIDNEY, UPPER LOBE	LEFT	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREEN	2007-01-02	1
5	FGH12345	TU	40050	5	R2-T02	TUMIDENT	Tumor Identification	TARGET	TARGET	RADIOL INC.	LIVER		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREEN	2007-01-02	1
6	FGH12345	TU	40050	6	R2-NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	RADIOL INC.	ABDOMINAL CAVITY		CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREEN	2007-01-02	1

Dataset Debug Message

There are 12 leading, trailing, or non-breaking spaces in the dataset.

4.4.3 TR Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to show the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1.

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.

tr.xpt

xx.xpt

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	FGH12345	TR	40050	1	TARGET	R1-A1	R1-T01	LDIAM	Longest Diameter	15	mm	15	15	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREEN	2007-01-02	1
2	FGH12345	TR	40050	2	TARGET	R1-A1	R1-T02	LDIAM	Longest Diameter	25	mm	25	25	mm	RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREEN	2007-01-02	1
3	FGH12345	TR	40050	3	TARGET	R1-A1		SUMLDIAM	Sum of Longest Diameter	40	mm	40	40	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREEN	2007-01-02	1
4	FGH12345	TR	40050	4	NON-TARGET	R1-A1	R1-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 1		SCREEN	1	SCREEN	2007-01-02	1
5	FGH12345	TR	40050	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	FGH12345	TR	40050	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	FGH12345	TR	40050	7	TARGET	R1-A2		SUMLDIAM	Sum of Longest Diameter	35	mm	35	35	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8
8	FGH12345	TR	40050	8	TARGET	R1-A2		PCBSLD	Percent Change From Baseline in Sum of Longest Diameter	-13	%	-13	-13	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8
9	FGH12345	TR	40050	9	TARGET	R1-A2		PCNSLD	Percent Change From Nadir in Sum of Longest Diameter	-13	%	-13	-13	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	3	WEEK 8
10	FGH12345	TR	40050	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	FGH12345	TR	40050	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	FGH12345	TR	40050	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	FGH12345	TR	40050	13	TARGET	R1-A3		SUMLDIAM	Sum of Longest Diameter	15	mm	15	15	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16
14	FGH12345	TR	40050	14	TARGET	R1-A3		PCBSLD	Percent Change From Baseline in Sum of Longest Diameter	-63	%	-63	-63	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16
15	FGH12345	TR	40050	15	TARGET	R1-A3		PCNSLD	Percent Change From Nadir in Sum of Longest Diameter	-57	%	-57	-57	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 1		TREATMENT	5	WEEK 16
16	FGH12345	TR	40050	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	FGH12345	TR	40050	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	SCREEN	2007-01-02	1
18	FGH12345	TR	40050	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	SCREEN	2007-01-02	1
19	FGH12345	TR	40050	19	TARGET	R2-A1		SUMLDIAM	Sum of Longest Diameter	45	mm	45	45	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREEN
20	FGH12345	TR	40050	20	NON-TARGET	R2-A1	R2-NT01	TUMSTATE	Tumor State	PRESENT		PRESENT			RADIOL INC.	CT SCAN	INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	SCREEN	1	SCREEN	2007-01-02	1
21	FGH12345	TR	40050	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	FGH12345	TR	40050	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	FGH12345	TR	40050	23	TARGET	R2-A2		SUMLDIAM	Sum of Longest Diameter	18	mm	18	18	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8
24	FGH12345	TR	40050	24	TARGET	R2-A2		PCBSLD	Percent Change From Baseline in Sum of Longest Diameter	-60	%	-60	-60	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8
25	FGH12345	TR	40050	25	TARGET	R2-A2		PCNSLD	Percent Change From Nadir in Sum of Longest Diameter	-60	%	-60	-60	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	3	WEEK 8
26	FGH12345	TR	40050	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	FGH12345	TR	40050	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	FGH12345	TR	40050	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	FGH12345	TR	40050	29	TARGET	R2-A3		SUMLDIAM	Sum of Longest Diameter	20	mm	20	20	mm	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16
30	FGH12345	TR	40050	30	TARGET	R2-A3		PCBSLD	Percent Change From Baseline in Sum of Longest Diameter	-56	%	-56	-56	%	RADIOL INC.		INDEPENDENT ASSESSOR	RADIOLOGIST 2	Y	TREATMENT	5	WEEK 16
31	FGH12345	TR	40050	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	FGH12345	TR	40050	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

Dataset Debug Message

There are seven leading, trailing, or non-breaking spaces in the dataset.

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.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

4.5.1 RS Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to show investigator tumor identification, tumor results and response data using RECIST 1.1 for a subject that have only target tumors at screening. This includes an unscheduled assessment.

Rows 1-2: Show the target response and overall response of CR at Week 8. The subject only has one target lesion and no non-targets.

Rows 3-4: Show an unscheduled response assessment which was done to confirm the CR. The RSLNKGRP differentiates the assessment and the VISIT is 'UNSCHEDULED WEEK 13'.

rs.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	IJK12345	RS	40060	1		TRGRESP	Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
2	IJK12345	RS	40060	2	A2	OVRLRESP	Overall Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
3	IJK12345	RS	40060	3		TRGRESP	Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13	2007-04-03	91
4	IJK12345	RS	40060	4	A3	OVRLRESP	Overall Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13	2007-04-03	91
5	IJK12345	RS	40060	5		TRGRESP	Target Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
6	IJK12345	RS	40060	6	A5	OVRLRESP	Overall Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168

$warningHtml

4.5.2 TU Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TU domain

The tu.xpt table below shows a subject that has only target tumors at screening. This example includes an unscheduled assessment.

Row 1: Shows the single target lesion in the breast. The subject only has one target lesion and no non-targets.

Row 2: Shows new bone lesion identified at Week 24.

tu.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TUSEQ	TUCAT	TUSCAT	TUGRPID	TULNKGRP	TUREFID	TUSPID	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TUNAM	TULOC	TULAT	TUDIR	TUMETHOD	TUEVAL	TUEVALID	TUACPTFL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	IJK12345	TU	40060	1							T01	TUMIDENT	Tumor Identification	TARGET	TARGET		BREAST	RIGHT		CT SCAN	INVESTIGATOR			SCREEN	1	SCREEN	2007-01-01	1
2	IJK12345	TU	40060	2							NEW01	TUMIDENT	Tumor Identification	NEW	NEW		BONE			CT SCAN	INVESTIGATOR			TREATMENT	7	WEEK 24	2009-06-19	168

Dataset Debug Message

There are two leading, trailing, or non-breaking spaces in the dataset.

4.5.3 TR Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to show investigator tumor identification, tumor results and response data using RECIST 1.1 for a subject that have only target tumors at screening. This includes an unscheduled assessment.

Rows 1-11: 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 12: Shows a new lesion state at Week 24.

tr.xpt

xx.xpt

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	IJK12345	TR	40060	1	TARGET	A1	T01	LDIAM	Longest Diameter	10	mm	10	10	mm			CT SCAN	INVESTIGATOR	SCREEN	1	SCREEN	2007-01-02	1
2	IJK12345	TR	40060	2	TARGET	A1		SUMLDIAM	Sum of Longest Diameter	10	mm	10	10	mm				INVESTIGATOR	SCREEN	1	SCREEN
3	IJK12345	TR	40060	3	TARGET	A2	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
4	IJK12345	TR	40060	4	TARGET	A2	T01	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	3	WEEK 8	2007-02-27	56
5	IJK12345	TR	40060	5	TARGET	A2		SUMLDIAM	Sum of Longest Diameter	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	3	WEEK 8
6	IJK12345	TR	40060	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	IJK12345	TR	40060	7	TARGET	A3	T01	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13	2007-04-03	91
8	IJK12345	TR	40060	8	TARGET	A3		SUMLDIAM	Sum of Longest Diameter	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	4.1	UNCHEDULED WEEK 13
9	IJK12345	TR	40060	9	TARGET	A4	T01	LDIAM	Longest Diameter						NOT DONE	NOT ASSESSABLE: Image obscured	CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
10	IJK12345	TR	40060	10	TARGET	A4	T01	TUMSTATE	Tumor State						NOT DONE	NOT ASSESSABLE: Poor Contrast	CT SCAN	INVESTIGATOR	TREATMENT	5	WEEK 16	2007-04-24	112
11	IJK12345	TR	40060	11	TARGET	A4		SUMLDIAM	Sum of Longest Diameter						NOT DONE	NOT ASSESSABLE: Motion issue		INVESTIGATOR	TREATMENT	5	WEEK 16
12	IJK12345	TR	40060	12	TARGET	A5	T01	LDIAM	Longest Diameter	5	mm	5	5	mm			CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
13	IJK12345	TR	40060	13	TARGET	A5	T01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168
14	IJK12345	TR	40060	14	TARGET	A5		SUMLDIAM	Sum of Longest Diameter	5	mm	5	5	mm				INVESTIGATOR	TREATMENT	7	WEEK 24
15	IJK12345	TR	40060	15	NEW	A5	NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	7	WEEK 24	2009-06-19	168

Dataset Debug Message

There are six leading, trailing, or non-breaking spaces in the dataset.

4.6 Example 6: 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 independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

4.6.1 RS Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to show investigator tumor identification, tumor results, and response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements.

Rows 1-6: Show response assessments at the end of Cycle 1 and Cycle 2 from the investigator following RECIST 1.1.

Rows 7-8: Show response assessments at the end of Cycle 1 and Cycle 2 from the independent radiologist using PROTOCOL DEFINED RESPONSE CRITERIA based on volumetric measurements.

rs.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSNAM	RSEVAL	RSEVALID	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	RST63421	RS	70001	1		TRGRESP	Target Response	RECIST 1.1	SD	SD		INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
2	RST63421	RS	70001	2		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD		INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
3	RST63421	RS	70001	3	A2	OVRLRESP	Overall Response	RECIST 1.1	SD	SD		INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
4	RST63421	RS	70001	4		TRGRESP	Target Response	RECIST 1.1	SD	SD		INVESTIGATOR		TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
5	RST63421	RS	70001	5		NTRGRESP	Non-target Response	RECIST 1.1	NON-CR/NON-PD	NON-CR/NON-PD		INVESTIGATOR		TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
6	RST63421	RS	70001	6	A3	OVRLRESP	Overall Response	RECIST 1.1	PD	PD		INVESTIGATOR		TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
7	RST63421	RS	70001	7	R1-A2	OVRLRESP	Overall Response	PROTOCOL DEFINED RESPONSE CRITERIA	SD	SD	ACME VENDOR	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
8	RST63421	RS	70001	8	R1-A3	OVRLRESP	Overall Response	PROTOCOL DEFINED RESPONSE CRITERIA	PD	PD	ACME VENDOR	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	4	Cycle 1 Week 8	2007-02-26	56

$warningHtml

4.6.2 TU Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TU domain.

The tu.xpt table below shows investigator tumor identification, tumor results, and response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements.

Rows 1-5: Show the identification of three target lesions and 2 non-target lesions by investigator.

Rows 6-7: Show the identification of two target lesions by the independent radiologist.

Row 8: Shows the identification of a new tumor by investigator.

Row 9: Shows the identification of a new tumor by independent radiologist.

tu.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TUNAM	TULOC	TULAT	TUDIR	TUMETHOD	TUEVAL	TUEVALID	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	RST63421	TU	70001	1	T01	TUMIDENT	Tumor Identification	TARGET	TARGET		OCCIPITAL LOBE	LEFT	ANTERIOR	MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
2	RST63421	TU	70001	2	T02	TUMIDENT	Tumor Identification	TARGET	TARGET		OCCIPITAL LOBE	RIGHT		MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
3	RST63421	TU	70001	3	T03	TUMIDENT	Tumor Identification	TARGET	TARGET		TEMPORAL LOBE	LEFT		MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
4	RST63421	TU	70001	4	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET		FRONTAL LOBE	RIGHT		MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
5	RST63421	TU	70001	5	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET		CEREBELLUM	LEFT		MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
6	RST63421	TU	70001	6	R-T01	TUMIDENT	Tumor Identification	TARGET	TARGET	ACME VENDOR	OCCIPITAL LOBE	RIGHT	ANTERIOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-01	1
7	RST63421	TU	70001	7	R-T02	TUMIDENT	Tumor Identification	TARGET	TARGET	ACME VENDOR	TEMPORAL LOBE	LEFT		MRI	INDEPENDENT ASSESSOR	RADIOLOGIST	SCREEN	1	SCREEN	2007-01-01	1
8	RST63421	TU	70001	8	NEW01	TUMIDENT	Tumor Identification	NEW	NEW		FRONTAL LOBE	RIGHT		MRI	INVESTIGATOR		TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
9	RST63421	TU	70001	9	R-NEW01	TUMIDENT	Tumor Identification	NEW	NEW	ACME VENDOR	FRONTAL LOBE	RIGHT		MRI	INDEPENDENT ASSESSOR	RADIOLOGIST	TREATMENT	4	Cycle 1 Week 8	2007-02-26	56

Dataset Debug Message

There are 20 leading, trailing, or non-breaking spaces in the dataset.

4.6.3 TR Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to shows investigator tumor identification, tumor results, and response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements.

Rows 1-6: Show response assessments at the end of Cycle 1 and Cycle 2 from the investigator following RECIST 1.1.

Rows 7-8: Show response assessments at the end of Cycle 1 and Cycle 2 from the independent radiologist using PROTOCOL DEFINED RESPONSE CRITERIA based on volumetric measurements.

$titleHtml

xx.xpt

STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	TRNAM	TRMETHOD	TREVAL	TREVALID	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
RST63421	TR	70001	1	TARGET	A1	T01	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	2	TARGET	A1	T02	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	3	TARGET	A1	T03	LDIAM	Longest Diameter	5	mm	5	5	mm		MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	4	TARGET	A1		SUMLDIAM	Sum of Longest Diameter	25	mm	25	25	mm			INVESTIGATOR		SCREEN	1	SCREEN
RST63421	TR	70001	5	NON-TARGET	A1	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	6	NON-TARGET	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	7	TARGET	R1-A1	R1-T01	LDIAM	Longest Diameter	10	mm	10	10	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	8	TARGET	R1-A1	R1-T01	LPERP	Longest Perpendicular	5	mm	5	5	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	9	TARGET	R1-A1	R1-T01	PPD	Product of Perpendicular Diameters	50	mm2	50	50	mm2	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	10	TARGET	R1-A1	R1-T01	VOLUME	Volume	250	mm3	250	250	mm3	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	11	TARGET	R1-A1	R1-T02	LDIAM	Longest Diameter	7	mm	7	7	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	12	TARGET	R1-A1	R1-T02	LPERP	Longest Perpendicular	10	mm	10	10	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	13	TARGET	R1-A1	R1-T02	PPD	Product of Perpendicular Diameters	70	mm2	70	70	mm2	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	14	TARGET	R1-A1	R1-T02	VOLUME	Volume	350	mm3	350	350	mm3	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN	2007-01-01	1
RST63421	TR	70001	15	TARGET	R1-A1		SUMLDIAM	Sum of Longest Diameter	17	mm	17	17	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN
RST63421	TR	70001	16	TARGET	R1-A1		SUMPPD	Sum of Products of Perpendicular Diameters	120	mm2	120	120	mm2	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN
RST63421	TR	70001	17	TARGET	R1-A1		SUMVOL	Sum of Volume	600	mm3	600	600	mm3	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	SCREEN	1	SCREEN
RST63421	TR	70001	18	TARGET	A2	T01	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	19	TARGET	A2	T02	LDIAM	Longest Diameter	10	mm	10	10	mm		MRI	INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	20	TARGET	A2	T03	LDIAM	Longest Diameter	5	mm	5	5	mm		MRI	INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	21	TARGET	A2		SUMLDIAM	Sum of Longest Diameter	25	mm	25	25	mm			INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4
RST63421	TR	70001	22	NON-TARGET	A2	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001		NON-TARGET	A2	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	30	TARGET	R1-A2	R1-T01	LDIAM	Longest Diameter	12	mm	10	10	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	31	TARGET	R1-A2	R1-T01	LPERP	Longest Perpendicular	7	mm	5	5	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	32	TARGET	R1-A2	R1-T01	PPD	Product of Perpendicular Diameters	84	mm2	50	50	mm2	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	33	TARGET	R1-A2	R1-T01	VOLUME	Volume	420	mm3	250	250	mm3	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	34	TARGET	R1-A2	R1-T02	LDIAM	Longest Diameter	6	mm	7	7	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	35	TARGET	R1-A2	R1-T02	LPERP	Longest Perpendicular	9	mm	10	10	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	36	TARGET	R1-A2	R1-T02	PPD	Product of Perpendicular Diameters	54	mm2	70	70	mm2	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	37	TARGET	R1-A2	R1-T02	VOLUME	Volume	315	mm3	350	350	mm3	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4	2007-01-28	28
RST63421	TR	70001	38	TARGET	R1-A2		SUMLDIAM	Sum of Longest Diameter	18	mm	17	17	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4
RST63421	TR	70001	39	TARGET	R1-A2		SUMPPD	Sum of Products of Perpendicular Diameters	138	mm2	120	120	mm2	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4
RST63421	TR	70001	40	TARGET	R1-A2		SUMVOL	Sum of Volume	735	mm3	600	600	mm3	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4
RST63421	TR	70001	41	TARGET	R1-A2		PCBSLD	Percent Change From Baseline in Sum of Longest Diameter	6	%	6	6	%	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4
RST63421	TR	70001	42	TARGET	R1-A2		PCBSPPD	Percent Change Baseline in Sum of PPD	23	%	23	23	%	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4
RST63421	TR	70001	43	TARGET	R1-A2		PCBSV	Percent Change From Baseline in Sum of Volume	23	%	23	23	%	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	3	Cycle 1 Week 4
RST63421	TR	70001	44	NEW	A3	NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT				MRI	INVESTIGATOR		TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
RST63421	TR	70001	45	NEW	A3	NEW01	LDIAM	Longest Diameter	9	mm	9	9	mm		MRI	INVESTIGATOR		TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
RST63421	TR	70001	46	NEW	R1-A3	R1-NEW01	TUMSTATE	Tumor State	PRESENT		PRESENT			ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
RST63421	TR	70001	47	NEW	R1-A3	R1-NEW01	LDIAM	Longest Diameter	9	mm	9	9	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
RST63421	TR	70001	48	NEW	R1-A3	R1-NEW01	LPERP	Longest Perpendicular	5	mm	5	5	mm	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
RST63421	TR	70001	49	NEW	R1-A3	R1-NEW01	PPD	Product of Perpendicular Diameters	45	mm2	45	45	mm2	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 1 Week 8	2007-02-26	56
RST63421	TR	70001	50	NEW	R1-A3	R1-NEW01	VOLUME	Volume	270	mm3	270	270	mm3	ACME VENDOR	MRI	INDEPENDENT ASSESSOR	RADIOLOGIST 1	TREATMENT	4	Cycle 1 Week 8	2007-02-26	56

$warningHtml

4.7 Example 7: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows data for a subject with non-target disease only.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

4.7.1 RS Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to show investigator tumor identification, tumor results and response data using RECIST 1.1 for a subject with non-target disease only.

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-CR/NON-PD. The Overall Response (RSTESTCD=OVRLRESP) is NON-CR/NON-PD which is a valid Overall Response in RECIST 1.1 for subjects with non-target disease only.

Rows 4-5: Show the Week 12 response assessment for a subject with non-target disease only. The Non-target Response (RSTESTCD=NTRGRESP) is NE 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 obsured 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 6-7: Show the Week 20 assessment where the non-targets were enlarged from a previous smallest size. The Non-target Response (RSTESTCD=NTRGRESP) is PD and the Overall Response (RSTESTCD=OVRLRESP) is PD as well because it is based on non-target disease only.

rs.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY	RSSTAT	RSREASND
1	MNO3333	RS	67676	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	MNO3333	RS	567676	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	MNO3333	RS	67676	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	MNO3333	RS	67676	4		NTRGRESP	Non-target Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
5	MNO3333	RS	67676	5	A3	OVRLRESP	Overall Response	RECIST 1.1	NE	NE	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
6	MNO3333	RS	67676	6		NTRGRESP	Non-target Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
7	MNO3333	RS	67676	7	A4	OVRLRESP	Overall Response	RECIST 1.1	PD	PD	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144

Dataset Debug Message

There are seven leading, trailing, or non-breaking spaces in the dataset.

4.7.2 TU Domain Model

The example below shows the terminology used to implement RECIST 1.1 in the TU domain.

The tu.xpt table below shows a subject that has only target tumors at screening.

Rows 1-3: Show the identification of 3 non-target lesions for a subject with non-target disease only.

The supplemental qualifier QNAM.PRTYP (Disease presentation type) is used describe the disease presentation of a non-target tumor when needed. For NT01, the non-target site in the BRAIN, the QVAL is LEPTOMENINGEAL DISEASE and for NT03, the non-target site in the PERICARDIUM, the QVAL is EFFUSION.

The QNAM.TULOCTXT indicates the presentation of the disease in the brain is leptomeningeal carcinomatosis and the presentation of the disease in the pericardium is effusion.

tu.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TULOC	TUMETHOD	TUEVAL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY	QNAM.PRTYP (Disease presentation type)
1	MNO3333	TU	67676	1	NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	BRAIN	MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1	LEPTOMENINGEAL DISEASE
2	MNO3333	TU	67676	2	NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	SKELETAL MUSCLE TISSUE	MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1
3	MNO3333	TU	67676	3	NT03	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET	PERICARDIUM	MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1	EFFUSION

Dataset Debug Message

There are six leading, trailing, or non-breaking spaces in the dataset.

4.7.3 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.

Rows 1-6: Show the qualitative assessments of the tumor state of the 3 non-target lesions at screening and Week 6.

Rows 7-9: Show the Week 12 assessment of the NT01 non-target lesion in the BRAIN, but assessments of the non-target lesions NT02 and NT03, in the SKELETAL MUSCLE TISSUE and PERICARDIUM, respectively, were NOT DONE because the non-target lesions were obsured on the MRI and not assessable. This is represented with TRSTAT=NOT DONE and TRREASND=NOT ASSESSABLE: 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.

$titleHtml

xx.xpt

STUDYID	DOMAIN	USUBJID	TRSEQ	TRGRPID	TRLNKGRP	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRSTRESC	TRSTAT	TRREASND	TRMETHOD	TREVAL	EPOCH	VISITNUM	VISIT	TRDTC	TRDY
MNO3333	TR	67676	1	NON-TARGET	A1	NT01	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1
MNO3333	TR	67676	2	NON-TARGET	A1	NT02	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1
MNO3333	TR	67676	3	NON-TARGET	A1	NT03	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-04	1
MNO3333	TR	67676	4	NON-TARGET	A2	NT01	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
MNO3333	TR	67676	5	NON-TARGET	A2	NT02	TUMSTATE	Tumor State	ABSENT	ABSENT			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
MNO3333	TR	67676	6	NON-TARGET	A2	NT03	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	40	WEEK 6	2010-02-18	46
MNO3333	TR	67676	7	NON-TARGET	A3	NT01	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
MNO3333	TR	67676	8	NON-TARGET	A3	NT02	TUMSTATE	Tumor State			NOT DONE	NOT ASSESSABLE: Lesion obscured	MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
MNO3333	TR	67676	9	NON-TARGET	A3	NT03	TUMSTATE	Tumor State			NOT DONE	NOT ASSESSABLE: Lesion obscured	MRI	INVESTIGATOR	TREATMENT	60	WEEK 12	2010-04-02	88
MNO3333	TR	67676	10	NON-TARGET	A4	NT01	TUMSTATE	Tumor State	ENLARGEMENT FROM NADIR	ENLARGEMENT FROM NADIR			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
MNO3333	TR	67676	11	NON-TARGET	A4	NT02	TUMSTATE	Tumor State	ENLARGEMENT FROM NADIR	ENLARGEMENT FROM NADIR			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144
MNO3333	TR	67676	12	NON-TARGET	A4	NT03	TUMSTATE	Tumor State	PRESENT	PRESENT			MRI	INVESTIGATOR	TREATMENT	80	WEEK 20	2010-05-27	144

$warningHtml

4.8 Example 8: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows data from a breast cancer study in a metastatic setting.

The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.

4.8.1 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.

Example shows a subject who did not have target lesions at baseline (target response is not applicable) with a non-target response of 'NON-CR/NON-PD' and overall response 'NOT ALL EVALUATED'.

Row 2-3: Show a situation where the protocol does not require SCINTIGRAPHY of the 'BONE at every disease assessments. RECIST 1.1. allows overall response teven if not all non-targets were scanned per protocol.

This example also shows a situation where a new lesion is 'EQUIVOCAL' at Week 36 and then later determined to be 'UNEQUIVOCAL' at Week 44. This example also shows a 'NE' overall response due to an unreadable image with RSREASNE='Poor Scan Quality/Imaging Quality Issues'.

rs.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	RSSEQ	RSLNKGRP	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSEVAL	EPOCH	VISITNUM	VISIT	RSDTC	RSDY
1	VWX7777	RS	90000	1		TRGRESP	Target Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	20	WEEK 12	2010-03-29	85
2	VWX7777	RS	90000	2		NTRGRESP	Non-target Response	RECIST 1.1	NOT ALL EVALUATED	NOT ALL EVALUATED	INVESTIGATOR	TREATMENT	20	WEEK 12	2010-03-29	85
3	VWX7777	RS	90000	3	A2	OVRLRESP	Overall Response	RECIST 1.1	PR	PR	INVESTIGATOR	TREATMENT	20	WEEK 12	2010-03-29	85
4	VWX7777	RS	90000	4		TRGRESP	Target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	30	WEEK 24	2010-06-23	171
5	VWX7777	RS	90000	5		NTRGRESP	Non-target Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	30	WEEK 24	2010-06-23	171
6	VWX7777	RS	90000	6	A3	OVRLRESP	Overall Response	RECIST 1.1	CR	CR	INVESTIGATOR	TREATMENT	30	WEEK 24	2010-06-23	171

Dataset Debug Message

There are six leading, trailing, or non-breaking spaces in the dataset.

4.8.2 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.

This example shows a case where the subject has 1 target and 2 non-target lesions. The target lesion is in the liver, one non-target is in the bone and the other non-target is in the pleural cavity.

Rows 1-4: Show the measurements of the T01 target tumor in the LIVER and the assessments of the 2 non-target lesions in the BONE and PLEURAL CAVITY at screening. Rows 5-11: Show the measurement of the T01 target tumor and the tumor state of the NT02 non-target in the PLEURAL CAVITY at Week 12. In the protocol, SCINTIGRAPHY is onyl to be performed every 6 months or in order to verify CR. Therefore, the SCINTIGRAPHY of NT01 non-target in the BONE was not performed at Week 12. This is representated as TRSTAT=NOT DONE and TRREASND=SCAN NOT PERFORMED. At Week 24, the T01 target lesion was absent (i.e., DIAMETER=0) and the non-targets NT01 and NT02 in the BONE and PLEURAL CAVITY, respectively, were TRTESTCD=TUMSTATE with TRORRES=ABSENT.

The QNAM.TULOCTXT indicates the presentation of the disease in the pleural cavity is a pleural effusion.

tu.xpt

xx.xpt

ROW	STUDYID	DOMAIN	USUBJID	TUSEQ	TUCAT	TUSCAT	TUGRPID	TULNKGRP	TUREFID	TUSPID	TULNKID	TUTESTCD	TUTEST	TUORRES	TUSTRESC	TUNAM	TULOC	TULAT	TUDIR	TUMETHOD	TUEVAL	TUEVALID	TUACPTFL	EPOCH	VISITNUM	VISIT	TUDTC	TUDY
1	VWX7777	TU	90000	1					IMG-00002		NT01	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET		BONE			SCINTIGRAPHY	INVESTIGATOR			SCREEN	10	SCREEN	2010-01-01	-3
2	VWX7777	TU	90000	2					IMG-00001		NT02	TUMIDENT	Tumor Identification	NON-TARGET	NON-TARGET		PLEURAL CAVITY			CT SCAN	INVESTIGATOR			SCREEN	10	SCREEN	2010-01-02	-2

Dataset Debug Message

There are four leading, trailing, or non-breaking spaces in the dataset.

4.8.3 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 examples shows that the SCINTIGRAPHY of the 'BONE' was not done at Week 12. The T The The image identifier is in TRREFID. The example also shows that the tumor state for the non-target in the pleural cavity is an assessment of the pleural effusion. SCINTIGRAPHY of the BONE was not required at every disease assessment per protocol.

Rows 1-4: Show the measurements of the T01 target tumor in the LIVER and the assessments of the 2 non-target lesions in the BONE and PLEURAL CAVITY at screening.

Rows 5-11: Show the measurement of the T01 target tumor and the tumor state of the NT02 non-target in the PLEURAL CAVITY at Week 12. In the protocol, SCINTIGRAPHY is only to be performed every 6 months or in order to verify CR. Therefore, the SCINTIGRAPHY of NT01 non-target in the BONE was not performed at Week 12. This is representated as TRSTAT=NOT DONE and TRREASND=SCAN NOT PERFORMED.

Rows 12- At Week 24, the T01 target lesion was absent (i.e., DIAMETER=0) and the non-targets NT01 and NT02 in the BONE and PLEURAL CAVITY, respectively, were TRTESTCD=TUMSTATE with TRORRES=ABSENT.

$titleHtml

xx.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	VWX7777	TR	90000	1	TARGET	IMG-00001	A1	T01	LDIAM	Longest Diameter	17	mm	17	17	mm			CT SCAN	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-02	-2
	VWX7777	TR	90000	3	TARGET		A1		SUMDIAM	Sum of Diameter	17	mm	17	17	mm				INVESTIGATOR	SCREEN	10	SCREEN
	VWX7777	TR	90000	4	NON-TARGET	IMG-00002	A1	NT01	TUMSTATE	Tumor State	PRESENT		PRESENT					SCINTIGRAPHY	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-01	-3
	VWX7777	TR	90000	5	NON-TARGET	IMG-00001	A1	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	SCREEN	10	SCREEN	2010-01-02	-2
	VWX7777	TR	90000	6	TARGET	IMG-00003	A2	T01	LDIAM	Longest Diameter	7	mm	7	7	mm			CT SCAN	INVESTIGATOR	TREATMENT	20	WEEK 12	2010-03-29	85
	VWX7777	TR	90000	8	TARGET		A2		SUMDIAM	Sum of Diameter	7	mm	7	7	mm				INVESTIGATOR	TREATMENT	20	WEEK 12
	VWX7777	TR	90000	9	TARGET		A2		ACNSD	Absolute Change From Nadir in Sum of Diameter	-10	mm	-10	-10	mm				INVESTIGATOR	TREATMENT	20	WEEK 12
	VWX7777	TR	90000	10	TARGET		A2		PCBSD	Percent Change From Baseline in Sum of Diameter	-59	%	-59	-59	%				INVESTIGATOR	TREATMENT	20	WEEK 12
	VWX7777	TR	90000	11	TARGET		A2		PCNSD	Percent Change From Nadir in Sum of Diameter	-59	%	-59	-59	%				INVESTIGATOR	TREATMENT	20	WEEK 12
	VWX7777	TR	90000	12	NON-TARGET		A2	NT01	TUMSTATE	Tumor State						NOT DONE	SCAN NOT PERFORMED		INVESTIGATOR	TREATMENT	20	WEEK 12
	VWX7777	TR	90000	13	NON-TARGET	IMG-00003	A2	NT02	TUMSTATE	Tumor State	PRESENT		PRESENT					CT SCAN	INVESTIGATOR	TREATMENT	20	WEEK 12	2010-03-29	85
	VWX7777	TR	90000	14	TARGET	IMG-00005	A3	T01	LDIAM	Longest Diameter	0	mm	0	0	mm			CT SCAN	INVESTIGATOR	TREATMENT	30	WEEK 24	2010-06-23	171
	VWX7777	TR	90000	16	TARGET		A3		SUMDIAM	Sum of Diameter	0	mm	0	0	mm				INVESTIGATOR	TREATMENT	30	WEEK 24
	VWX7777	TR	90000	17	TARGET		A3		ACNSD	Absolute Change From Nadir in Sum of Diameter	-17	mm	-17	-17	mm				INVESTIGATOR	TREATMENT	30	WEEK 24
	VWX7777	TR	90000	18	TARGET		A3		PCBSD	Percent Change From Baseline in Sum of Diameter	-100	%	-100	-100	%				INVESTIGATOR	TREATMENT	30	WEEK 24
	VWX7777	TR	90000	19	TARGET		A3		PCNSD	Percent Change From Nadir in Sum of Diameter	-100	%	-100	-100	%				INVESTIGATOR	TREATMENT	30	WEEK 24
	VWX7777	TR	90000	20	NON-TARGET	IMG-00006	A3	NT01	TUMSTATE	Tumor State	ABSENT		ABSENT					SCINTIGRAPHY	INVESTIGATOR	TREATMENT	30	WEEK 24	2010-06-24	172
	VWX7777	TR	90000	21	NON-TARGET	IMG-00005	A3	NT02	TUMSTATE	Tumor State	ABSENT		ABSENT					CT SCAN	INVESTIGATOR	TREATMENT	30	WEEK 24	2010-06-23	171

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4.9 Example 9: Add example - where enlargement from nadir does not mean RS non-target response=PD

4.9.1 RS Domain Model

Th

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4.9.2 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.

$warningHtml

4.9.3 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.

$warningHtml

5 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.

$titleHtml

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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6 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

To set up your dataset wrapper, row caption, dataset combination when in edit mode:

Type "{dataset" (no quotes)
Choose "Dataset Wrapper" and hit return.
Then place your cursor in the grey box, type "{row" (no quotes) and choose "Row Captions" and hit return.
Finally place the cursor below that box and do the same with "{dataset" and clicking "Dataset".

Now you can select your table from Excel, copy, and then paste (control v) into the dataset box. To be sure there are no extraneous formats, if you click the grey bar at the top of the dataset macro, it will select all of the data in the table. You can now go to the top of the edit window, click on the down arrow by the A and click "Clear formatting" to clean up the table.

Feel free to delete this info box whenever you'd like

End of Document

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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 General Points on Representation of Data within the Oncology Disease Response Domains

4 Examples for the Oncology Disease Response Domains Model for RECIST 1.1

4.1 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.

4.1.1 RS Domain Model

4.1.2 TU Domain Model

4.1.3 TR Domain Model

4.1.4 PR Domain Model

4.1.5 TD Domain Model

4.2 Example 2: RECIST 1.1 example to show independent assessor response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example shows the preferred representation of split (fragmented) and merged (coalesced) tumors.

4.2.1 RS Domain Model

4.2.2 TU Domain Model

4.2.3 TR Domain Model

4.3.1 RS Domain Model

4.3.2 TU Domain Model

4.3.3 TR Domain Model

4.4.1 RS Domain Model

4.4.2 TU Domain Model

4.4.3 TR Domain Model

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.

4.5.1 RS Domain Model

4.5.2 TU Domain Model

4.5.3 TR Domain Model

4.6 Example 6: 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 independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.

4.6.1 RS Domain Model

4.6.2 TU Domain Model

4.6.3 TR Domain Model

4.7 Example 7: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows data for a subject with non-target disease only.

4.7.1 RS Domain Model

4.7.2 TU Domain Model

4.7.3 TR Domain Model

4.8 Example 8: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows data from a breast cancer study in a metastatic setting.

4.8.1 RS Domain Model

4.8.2 TU Domain Model

4.8.3 TR Domain Model

4.9 Example 9: Add example - where enlargement from nadir does not mean RS non-target response=PD

4.9.1 RS Domain Model

4.9.2 TU Domain Model

4.9.3 TR Domain Model

5 RELREC

6 Supplemental Qualifier Name Codes