Title

Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

CDISC ReferenceDisease Response Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
Criteria Short Name

RECIST 1.1

Criteria Permission StatusExempt from Copyright
TeamCDISC Oncology Subteam
Supplement Version1.0
StatusDRAFT
Date2022-09-13
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

DateVersion
2022-09-131.0 Draft

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

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

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 the disease response criteria is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for the disease response criteria are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/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. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument. 

2 Copyright Status

The RECIST Working Group and European Journal of Cancer (EJC) own the copyright for the RECIST 1.1 guidelines and have made the RECIST 1.1 guidelines available for non-commercial purposes exempt from copyright restrictions. All other rights are reserved. CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed data standards for tumor identification, tumor results and disease response, and applied these to RECIST 1.1.

The CDISC documentation of the criteria consists of: (1) controlled terminology and (2) standard data structures 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 at: https://www.cdisc.org/standards/terminology/controlled-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.

References for the 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.
  • https://recist.eortc.org/recist-1-1-2/

3 The Oncology Disease Response and Supporting Domains Model for RECIST 1.1

RECIST 1.1 is a set of criteria used to evaluate the activity and efficacy of anti-neoplastic agents in solid tumors. The "Oncology Disease Response and Supporting Domains Model for RECIST 1.1" encompasses the subset of SDTMIG domains used for the representation of RECIST 1.1 disease response and supporting tumor/lesion data in oncology studies. The SDTMIG domains used include:

  • Disease Response and Clin Classification (RS) is a findings domain used to represent disease response findings and QRS clinical classifications instruments. The disease responses based on RECIST 1.1 are represented in RS.¬†
  • Tumor/Lesion Identification¬†(TU) is a findings domain. The supporting tumor identification of RECIST 1.1 target, non-target and new tumors are represented in the TU domain.¬†
  • Tumor/Lesion Results (TR) is a findings domain.¬†The supporting tumor measurements and assessments of the RECIST 1.1 target, non-target and new tumors are represented in the TR domain.

Note that the Procedures (PR) domain is not required for RECIST 1.1 but it may be used to represent scan data including medical photography data.

These domains are related using RSLNKGRP, TULNKID, TUREFID, TRLNKID, TRLNKGRP, TRREFID and PRREFID. See Section 5 for more information on the relationships and an example RELREC dataset.

3.1 Assumptions for the Oncology Disease Response and Supporting Domains Model

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.

  1. The Oncology Codetable on the CDISC website at https://www.cdisc.org/standards/terminology/controlled-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 RSSTRESC is populated with the standardized character result according to the associated controlled terminology. For example RSORRES = "CR" and RSSTRESC = "CR" where "CR" is a valid value in the associated controlled terminology.

    2. TUORRES is populated with the original result and TUSTRESC is populated with the standardized character result according to the associated controlled terminology. For example TUORRES = "TARGET" and TUSTRESC = "TARGET" where "TARGET" is a valid value in the associated controlled terminology.
    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 for RECIST 1.1

In RECIST 1.1, a subject's tumors are identified as target tumors, non-target tumors and new tumors. At a specific disease assessment timepoint, the overall response in RECIST 1.1 is based on measurements of target tumors (target response), qualitative assessments of non-target tumors (non-target response) and the appearance of new tumors. Subjects with at least one target tumor can have overall response of CR (Complete Response), PR (Partial Response), SD (Stable Disease), PD (Progressive Disease) and NE (Not Evaluable). Subjects with only non-measurable disease (i.e., no target tumors) can have overall response of CR (Complete Response), NON-CR/NON-PD, PD (Progressive Disease) and NE (Not Evaluable).

Target tumors are measured in the longest diameter except when the location is a lymph node, then they are measured in the longest perpendicular. The examples in this disease response supplement use TRTESTCD = "LDIAM" (Longest Diameter) for measurements of non-lymph node target tumors and TRTESTCD = "LPERP" (Longest Perpendicular) for measurements of lymph node target tumors. The SDTMIG examples have previously used TRTESTCD = "DIAMETER" (Diameter) for measurements of both lymph nodes and non-lymph nodes. Either representation is acceptable for RECIST 1.1. The latter approach requires looking at the anatomical location in conjunction with the TRTESTCD to know whether the diameter was measured in the longest diameter or the longest perpendicular. The "LDIAM" and "LPERP" tests provide more specificity in the TRTESTCD itself and does not required looking to the anatomical location. In addition, "LDIAM" and "LPERP" are tests used in other disease response criteria so the use of these two tests provides standardization that work across criteria for the same measurement. Some sponsors prefer the approach used within this disease response supplement due to these reasons. 

Target tumors may split (fragment) and/or merge (coalesce) during a study. See example 4.2 for a detailed example on the recording of the measurements of split and merged tumors.

In RECIST1.1, the following calculations are used in determination of the target response: sum of the diameters of target tumors (target sum), percentage change from baseline in the target sum, and percentage change from nadir in the target sum (smallest target sum at any assessment). These are referred to as summary values in the examples below. These summary values are not typically collected/calculated in investigator CRFs but they are usually provided by independent assessors.  When derived in EDC,  Summary values not in the collected data may be derived in the analysis datasets (i.e., ADaM).

RECIST 1.1 recommends a standardized value of 5 mm is used in the calculation of sum of diameters when a target tumor is too small to measure. Note that this imputation should only be done when the lesion diameter is too small to measure.  When a numerical value is given for the lesion diameter, then that value will be used even if the diameter is less than 5 mm. The original or collected value "TOO SMALL TO MEASURE" should be represented in the TRORRES variable and the standardized value should be represented in the TRSTRESC and TRSTRESN variables. For absent non-lymph node target tumors, 0 mm is used in the calculation of the target sum. The longest perpendicular measurements of lymph node target tumors which are pathological (>= 10 mm) or non-pathological (< 10 mm) are included in the target sum. 

The examples in this disease response supplement use RSTESTCD = "NEWLPROG" (New Lesion Progression) to indicate whether a new lesion is equivocal or unequivocal. There are different methods of collecting data when there is an equivocal new lesion. Some sponsors update the Overall Response when unequivocal evidence of a new lesion has been later confirmed (i.e., documented as unequivocal). Other sponsors programmatically derive the new lesion progression date as the date when the new lesion was first identified during the analysis. RSTESTCD = "NEWLSIND" can have RSORRES = "Y" or RSORRES = "N" values only. This test can be used if the sponsor collects yes and no responses to indicate new lesion(s) were identified at the disease assessment timepoint.

"NE" (Not Evaluable) is a standard result in the Oncology Response Assessment Result codelist (ONCRSR) which is applicable to RECIST 1.1. Therefore, in RS, "NE" (Not Evaluable) is a valid RSORRES/RSSTRESC for RSTEST = "Overall Response". For RS, a suppqual for "Reason Response Not Evaluable" (REASNE) has been used in some examples. However, in TR, the current modeling for NE (not evaluable) results follows the approach where TRSTAT is populated with "NOT DONE".  TRSTAT = "NOT DONE" means that the result was missing and the reason that the result was missing is mapped to TRREASND. The TRREASND values cover reasons such as scan was not performed or the various reason that the tumor was not evaluable. This modelling does not always explicitly or consistently identify the tumors which are not evaluable but some of the examples include "NOT EVALUABLE" in the TRREASND.

In the case where there is an independent review and the investigator identified tumors at baseline but the independent assessor found no evidence of disease (NED) at baseline, this can be represented by a RS record with RSTEST = "Overall Response" and RSORRES = "NED" and RSSTRESC = "NED".

The SDTMIG states "When a clinical classification result is based on multiple procedures/scans/images/physical exams performed on different dates, RSDTC may be derived." Some sponsors assign or derive the date of overall response (RSDTC) associated with the disease assessment timepoint and some sponsors collect the date of overall response (RSDTC) associated with the disease assessment timepoint and provide instructions to the site/vendor on their convention on how to populate it when there is more than one evaluation date. In the RS examples, when there are multiple dates of evaluation performed as part of the disease assessment timepoint, the RSDTC is populated using the following commonly used convention (either entered by the investigator, assigned by the sponsor, or assigned by an independent assessor): For responses of CR (Complete Response) and PR (Partial Response), the latest date associated with the evaluation is used; for responses of PD (Progressive Disease) and SD (Stable Disease), the earliest date associated with an evaluation is used. This convention is based on the following concepts: when evaluating measures of disease burden over time such as duration of response or progression free survival, it is generally considered conservative to assign a negative outcome, such as disease progression, to the date the assessment is initiated but not to assign a date to a positive response until the assessment is completed. A SD (Stable Disease) implies no change in disease status for at least a minimum time. While the absence of progression can only be certain with a complete evaluation, the status of the first evaluations cannot be carried forward to the last evaluation date in the assessment; therefore, using the earliest date gives the most conservative approach when determining if a subject met the criteria for stable disease. For NE (Not evaluable), a date associated with the assessment is required but it generally does not impact the analysis so either the earliest or latest date can be used.

In TR, the TRDTC is populated with the date of tumor/lesion assessment/measurement, i.e., the date of the scan, image, or physical exam. In the examples, the summary results (e.g., Sum of Diameter) do not have TRMETHOD and TRDTC associated with them.  However, if an appropriate TRDTC is available, it can be populated. In TR, scans which are not performed do not have a TRDTC populated.

Symptomatic deterioration may be collected in studies using RECIST 1.1 but it is not part of an objective RECIST 1.1 response.  See example 4.3 for a detailed example for representing these data.

Note that examples in this disease response supplement are based on assumptions about the data collection forms. For example, the collection of split and merged tumors may be collected in different ways depending on the form design and system limitations. The preferred SDTM data representation is shown in the examples.

Note that examples in this disease response supplement assume that no protocol modifications were made to RECIST 1.1.

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 example shows the case where lymph nodes are selected as target lesions. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.

4.1.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 6, week 12 and subsequent 8-week follow-up visits.

Rows 1-3: Show the Target Response (RSTESTCD = "TRGRESP") and Non-Target Response (RSTESTCD = "NTRGRESP") tests and corresponding Overall Response (RSTESTCD = "OVRLRESP") at the week 6 assessment. The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP is used to associate the Overall Response to underlying data in other domains (e.g., TR). Note that "NE" (Not evaluable) is a valid Overall Response value per the RECIST 1.1 criteria which means that RSORRES is "NE" rather than represented in RSSTAT.

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

Rows 13-20: At week 36, the New Lesion Progression test is used to represent an equivocal new lesion (RSTESTCD = "NEWLPROG" and RSORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (RSTESTCD = "NEWLPROG" and RSORRES = "UNEQUIVOCAL"). There are different methods of collecting data when there is an equivocal new lesion. Some sponsors update the Overall Response when equivocal evidence of a new lesion has been confirmed at a later assessment (i.e., documented as unequivocal). Other sponsors derive (in ADaM) the new progression date as the date when the new lesion was first identified. 

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

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSEVALEPOCHVISITNUMVISITRSDTCRSDY
1EX11111RS900011
TRGRESPTarget ResponseRECIST 1.1NENEINVESTIGATORTREATMENT40WEEK 62010-02-1546
2EX11111RS900012
NTRGRESPNon-Target ResponseRECIST 1.1NENEINVESTIGATORTREATMENT40WEEK 62010-02-1546
3EX11111RS900013A2OVRLRESPOverall ResponseRECIST 1.1NENEINVESTIGATORTREATMENT40WEEK 62010-02-1546
4EX11111RS900014
TRGRESPTarget ResponseRECIST 1.1SDSDINVESTIGATORTREATMENT60WEEK 122010-03-3988
5EX11111RS900015
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDINVESTIGATORTREATMENT60WEEK 122010-03-2988
6EX11111RS900016A3OVRLRESPOverall ResponseRECIST 1.1SDSDINVESTIGATORTREATMENT60WEEK 122010-03-2988
7EX11111RS900017
TRGRESPTarget ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT80WEEK 202010-05-30147
8EX11111RS900018
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDINVESTIGATORTREATMENT80WEEK 202010-05-30147
9EX11111RS900019A4OVRLRESPOverall ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT80WEEK 202010-05-30147
10EX11111RS9000110
TRGRESPTarget ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT100WEEK 282010-07-25204
11EX11111RS9000111
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDINVESTIGATORTREATMENT100WEEK 282010-07-25204
12EX11111RS9000112A5OVRLRESPOverall ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT100WEEK 282010-07-25204
13EX11111RS9000113
TRGRESPTarget ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT120WEEK 362010-09-17257
14EX11111RS9000114
NTRGRESPNon-Target ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT120WEEK 362010-09-17257
15EX11111RS9000115
NEWLPROGNew Lesion ProgressionRECIST 1.1EQUIVOCALEQUIVOCALINVESTIGATORTREATMENT120WEEK 362010-09-17257
16EX11111RS9000116A6OVRLRESPOverall ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT120WEEK 362010-09-17257
17EX11111RS9000117
TRGRESPTarget ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT140WEEK 442010-11-14313
18EX11111RS9000118
NTRGRESPNon-Target ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT140WEEK 442010-11-14313
19EX11111RS9000119
NEWLPROGNew Lesion ProgressionRECIST 1.1UNEQUIVOCALUNEQUIVOCALINVESTIGATORTREATMENT140WEEK 442010-11-14313
20EX11111RS9000120A7OVRLRESPOverall ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT140WEEK 442010-11-14313
The supprs.xpt table below shows the data on the reason that the response was not evaluable (QNAM = "REASNE") in the case where the reason is collected.

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

supprs.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX11111RS90001RSSEQ3REASNEReason Response Not EvaluableImaging quality issues and not all scan performedCRF

4.1.2 TU Domain Model

The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors.  In RECIST 1.1, target lymph node tumors are measured in the longest perpendicular (TRTESTCD = "LPERP") in the TR domain. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

Rows 1-6: Show a subject with 4 target lesions with TULNKIDs "T01"-"T04" and 2 non-target lesions with TULNKIDs "NT01" and "NT02" identified at screening. "T01" and "T02" target lesions are lymph nodes. "T01" is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). The TULOC contains the location from the anatomical location terminology. Note that some locations in controlled terminology contain laterality and/or directionality (as shown in row 7). 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 (TULNKID = "NEW01") was identified in the left lower lobe of the lung (TULOC = "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 (TULNKID = "NEW02" and TULNKID = "NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE").

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTUREFIDTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTULOCTULATTUDIRTUMETHODTUEVALEPOCHVISITNUMVISITTUDTCTUDY

1

EX11111TU900011IMG-00001T01TUMIDENTTumor IdentificationTARGETTARGETSUPRACLAVICULAR LYMPH NODERIGHT
MRIINVESTIGATORSCREEN10SCREENING2010-01-01-3
2EX11111TU900012IMG-00002T02TUMIDENTTumor IdentificationTARGETTARGETTHORACIC LYMPH NODE

CT SCANINVESTIGATORSCREEN10SCREENING2010-01-02-2
3EX11111TU900013IMG-00001T03TUMIDENTTumor IdentificationTARGETTARGETTHYROID GLANDLEFT
MRIINVESTIGATORSCREEN10SCREENING2010-01-01-3
4EX11111TU900014IMG-00003T04TUMIDENTTumor IdentificationTARGETTARGETSKIN OF THE TRUNK
UPPERPHOTOGRAPHYINVESTIGATORSCREEN10SCREENING2010-01-03-1
5EX11111TU900015IMG-00002NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETMEDIASTINAL LYMPH NODERIGHT
CT SCANINVESTIGATORSCREEN10SCREENING2010-01-02-2
6EX11111TU900016IMG-00001NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGETCEREBELLUMRIGHT
MRIINVESTIGATORSCREEN10SCREENING2010-01-011
7EX11111TU900017IMG-00020NEW01TUMIDENTTumor IdentificationNEWNEWLUNG, LEFT LOWER LOBE

CT SCANINVESTIGATORTREATMENT120WEEK 362010-09-17257
8EX11111TU900018IMG-00019NEW02TUMIDENTTumor IdentificationNEWNEWCEREBELLUMLEFT
MRIINVESTIGATORTREATMENT140WEEK 442010-11-14313
9EX11111TU900019IMG-00022NEW03TUMIDENTTumor IdentificationNEWNEWFEMORAL LYMPH NODELEFT
ULTRASOUNDINVESTIGATORTREATMENT140WEEK 442010-11-14313
The supptu.xpt table below shows the data on whether a tumor was previously irradiated (QNAM = "PRVIR") and whether that tumor was shown to be progressing since it was irradiated (QNAM = "PRVIRP"). 

Rows 1-3: Show that the target lesions with TUSEQs equal to "1", "2" and "3" where not previously irradiated.

Rows 4-5: Show that that target lesion with TUSEQ = "4" was previously irradiated and shown to be progressing since it was irradiated.

supptu.xpt

Row STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
 1EX11111TU90001TUSEQ1PRVIRPreviously Irradiated IndicatorNCRF
 2EX11111TU90001TUSEQ2PRVIRPreviously Irradiated IndicatorNCRF
 3EX11111TU90001TUSEQ3PRVIRPreviously Irradiated IndicatorNCRF
 4EX11111TU90001TUSEQ4PRVIRPreviously Irradiated IndicatorYCRF
 5EX11111TU90001TUSEQ4PRVIRPPreviously Irradiated ProgressionYCRF

4.1.3 TR Domain Model

The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at screening, week 6, week 12 and subsequent 8-week follow-up visits. The example below shows measurements (i.e., longest perpendicular) 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 tumor is less than 10mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "PATHOLOGICAL". The image identifier is in TRREFID and matches a PRREFID in the PR Domain.

Rows 1-6: Show the screening assessments of the target lesions. For lymph node target lesions "T01" and "T02" the TRTESTCD used for the assessments are "LPREP" and "LNSTATE".  For non-lymph node target lesions,"T03" and "T04", the TRTESTCD used for the assessments is "LDIAM".

Rows 7-8: Show the results for the non-targets. "NT01" is a lymph node where the TRTEST used for the assessments is "Lymph Node State" (TRTESTCD = "LNSTATE"). "NT02" is a non-lymph node where the TRTEST used for the assessments is "Tumor State" (TRTESTCD = "TUMSTATE").

Row 14: Shows a case where the scan was not performed at week 6 (for TRTEST = "Longest Diameter", TRSTAT = "NOT DONE" with TRREASND = "SCAN NOT PERFORMED").

Row 15: Shows a case where the non-target "NT01" was not evaluable (for TRTEST = "Lymph Node State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE"). 

Row 16: Shows a case where the non-target "NT02" was not evaluable (for TRTEST = "Tumor State", TRSTAT = "NOT DONE" with TRREASND = "NOT ASSESSABLE: Image obscured").

Row 30: Shows a target lesion "T04" which is too small to measure. The TRORRES = "TOO SMALL TO MEASURE", and the TRSTRESC and TRSTRESN are standardized to "5" with TRSTRESU as "mm".  The standardized value of "5" ensures that the sum of diameters includes a value for that lesion because it has not disappeared. The method of standardization of the TRSTRESC and TRSTRESN values is sponsor specific.  

Row 58: Shows a new lesion "NEW01" which has a measurement of 4 mm.  Note that this value is less than 5 mm and has not been reported as "TOO SMALL TO MEASURE".



tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRREFIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRMETHODTREVALEPOCHVISITNUMVISITTRDTCTRDY
1EX11111TR900011TARGETIMG-00001A1

T01


LPERPLongest Perpendicular17mm1717mm

MRIINVESTIGATORSCREEN10SCREENING2010-01-01-3
2EX11111TR900012TARGETIMG-00001A1T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIINVESTIGATORSCREEN10SCREENING2010-01-01-3
3EX11111TR900013TARGETIMG-00002A1T02LPERPLongest Perpendicular16mm1616mm

CT SCANINVESTIGATORSCREEN10SCREENING2010-01-02-2
4EX11111TR900014TARGETIMG-00002A1T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANINVESTIGATORSCREEN10SCREENING2010-01-02-2
5EX11111TR900015TARGETIMG-00001A1T03LDIAMLongest Diameter15mm1515mm

MRIINVESTIGATORSCREEN10SCREENING2010-01-01-3
6EX11111TR900016TARGETIMG-00003A1T04LDIAMLongest Diameter14mm1414mm

PHOTOGRAPHYINVESTIGATORSCREEN10SCREENING2010-01-03-1
7EX11111TR900017NON-TARGETIMG-00002A1NT01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANINVESTIGATORSCREEN10SCREENING2010-01-02-2
8EX11111TR900018NON-TARGETIMG-00001A1NT02TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORSCREEN10SCREENING2010-01-01-3
9EX11111TR900019TARGETIMG-00004A2T01LPERPLongest Perpendicular12mm1212mm

MRIINVESTIGATORTREATMENT40WEEK 62010-02-1543
10EX11111TR9000110TARGETIMG-00004A2T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIINVESTIGATORTREATMENT40WEEK 62010-02-1543
11EX11111TR9000111TARGETIMG-00005A2T02LPERPLongest Perpendicular12mm1212mm

CT SCANINVESTIGATORTREATMENT40WEEK 62010-02-1644
12EX11111TR9000112TARGETIMG-00005A2T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT40WEEK 62010-02-1644
13EX11111TR9000113TARGETIMG-00004A2T03LDIAMLongest Diameter14mm1414mm

MRIINVESTIGATORTREATMENT40WEEK 62010-02-1543
14EX11111TR9000114TARGET
A2T04LDIAMLongest Diameter




NOT DONESCAN NOT PERFORMEDPHOTOGRAPHYINVESTIGATORTREATMENT40WEEK 6

15EX11111TR9000115NON-TARGETIMG-00005A2NT01LNSTATELymph Node State




NOT DONENOT EVALUABLECT SCANINVESTIGATORTREATMENT40WEEK 62010-02-1644
16EX11111TR9000116NON-TARGETIMG-00004A2NT02TUMSTATETumor State




NOT DONENOT ASSESSABLE: Image obscuredMRIINVESTIGATORTREATMENT40WEEK 62010-02-1543
17EX11111TR9000117TARGETIMG-00007A3T01LPERPLongest Perpendicular12mm1212mm

MRIINVESTIGATORTREATMENT60WEEK 122010-03-2985
18EX11111TR9000118TARGETIMG-00007A3T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIINVESTIGATORTREATMENT60WEEK 122010-03-2985
19EX11111TR9000119TARGETIMG-00008A3T02LPERPLongest Perpendicular12mm1212mm

CT SCANINVESTIGATORTREATMENT60WEEK 122010-03-3086
20EX11111TR9000120TARGETIMG-00008A3T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT60WEEK 122010-03-3086
21EX11111TR9000121TARGETIMG-00007A3T03LDIAMLongest Diameter15mm1515mm

MRIINVESTIGATORTREATMENT60WEEK 122010-03-2985
22EX11111TR9000122TARGETIMG-00009A3T04

LDIAM

Longest Diameter8mm88mm

PHOTOGRAPHYINVESTIGATORTREATMENT60WEEK 122010-04-0187
23EX11111TR9000123NON-TARGETIMG-00008A3NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT60WEEK 122010-03-3086
24EX11111TR9000124NON-TARGETIMG-00007A3NT02TUMSTATETumor State




NOT DONENOT ASSESSABLE: Image obscuredMRIINVESTIGATORTREATMENT60WEEK 122010-03-2985
25EX11111TR9000125TARGETIMG-00010A4T01LPERPLongest Perpendicular9mm99mm

MRIINVESTIGATORTREATMENT80WEEK 202010-05-27144
26EX11111TR9000126TARGETIMG-00010A4T01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



MRIINVESTIGATORTREATMENT80WEEK 202010-05-27144
27EX11111TR9000127TARGETIMG-00011A4T02LPERPLongest Perpendicular12mm1212mm

CT SCANINVESTIGATORTREATMENT80WEEK 202010-05-28145
28EX11111TR9000128TARGETIMG-00011A4T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT80WEEK 202010-05-28145
29EX11111TR9000129TARGETIMG-00010A4T03LDIAMLongest Diameter11mm1111mm

MRIINVESTIGATORTREATMENT80WEEK 202010-05-27144
30EX11111TR9000130TARGETIMG-00012A4T04LDIAMLongest DiameterTOO SMALL TO MEASUREmm55mm

PHOTOGRAPHYINVESTIGATORTREATMENT80WEEK 202010-05-30147
31EX11111TR9000131NON-TARGETIMG-00011A4NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT80WEEK 202010-05-28145
32EX11111TR9000132NON-TARGETIMG-00010A4NT02TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORTREATMENT80WEEK 202010-05-27144
33EX11111TR9000133TARGETIMG-00013A5T01LPERPLongest Perpendicular9mm99mm

MRIINVESTIGATORTREATMENT100WEEK 282010-07-23201
34EX11111TR9000134TARGETIMG-00013A5T01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



MRIINVESTIGATORTREATMENT100WEEK 282010-07-23201
35EX11111TR9000135TARGETIMG-00014A5T02LPERPLongest Perpendicular8mm88mm

CT SCANINVESTIGATORTREATMENT100WEEK 282010-07-24202
36EX11111TR9000136TARGETIMG-00014A5T02LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT100WEEK 282010-07-24202
37EX11111TR9000137TARGETIMG-00013A5T03LDIAMLongest Diameter6mm66mm

MRIINVESTIGATORTREATMENT100WEEK 282010-07-23201
38EX11111TR9000138TARGETIMG-00015A5T04LDIAMLongest Diameter0mm00mm

PHOTOGRAPHYINVESTIGATORTREATMENT100WEEK 282010-07-25203
39EX11111TR9000139NON-TARGETIMG-00014A5NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT100WEEK 282010-07-24202
40EX11111TR9000140NON-TARGETIMG-00013A5NT02TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORTREATMENT100WEEK 282010-07-23201
41EX11111TR9000141TARGETIMG-00016A6T01LPERPLongest Perpendicular8mm88mm

MRIINVESTIGATORTREATMENT120WEEK 362010-09-17257
42EX11111TR9000142TARGETIMG-00016A6T01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



MRIINVESTIGATORTREATMENT120WEEK 362010-09-17257
43EX11111TR9000143TARGETIMG-00017A6T02LPERPLongest Perpendicular9mm99mm

CT SCANINVESTIGATORTREATMENT120WEEK 362010-09-17257
44EX11111TR9000144TARGETIMG-00017A6T02LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT120WEEK 362010-09-17257
45EX11111TR9000145TARGETIMG-00016A6T03LDIAMLongest Diameter0mm00mm

MRIINVESTIGATORTREATMENT120WEEK 362010-09-17257
46EX11111TR9000146TARGETIMG-00018A6T04LDIAMLongest Diameter0mm00mm

PHOTOGRAPHYINVESTIGATORTREATMENT120WEEK 362010-09-17257
47EX11111TR9000147NON-TARGETIMG-00017A6NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT120WEEK 362010-09-17257
48EX11111TR9000148NON-TARGETIMG-00016A6NT02TUMSTATETumor StateABSENT
ABSENT



MRIINVESTIGATORTREATMENT120WEEK 362010-09-17257
49EX11111TR9000149NEWIMG-00017A6NEW01TUMSTATETumor StateEQUIVOCAL
EQUIVOCAL



CT SCANINVESTIGATORTREATMENT120WEEK 362010-09-17257
50EX11111TR9000150TARGETIMG-00019A7T01LPERPLongest Perpendicular12mm1212mm

MRIINVESTIGATORTREATMENT140WEEK 442010-11-15314
51EX11111TR9000151TARGETIMG-00019A7T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIINVESTIGATORTREATMENT140WEEK 442010-11-15314
52EX11111TR9000152TARGETIMG-00020A7T02LPERPLongest Perpendicular9mm99mm

CT SCANINVESTIGATORTREATMENT140WEEK 442010-11-14313
53EX11111TR9000153TARGETIMG-00020A7T02LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT140WEEK 442010-11-14313
54EX11111TR9000154TARGETIMG-00019A7T03LDIAMLongest Diameter0mm00mm

MRIINVESTIGATORTREATMENT140WEEK 442010-11-15314
55EX11111TR9000155TARGETIMG-00021A7T04LDIAMLongest Diameter0mm00mm

PHOTOGRAPHYINVESTIGATORTREATMENT140WEEK 442010-11-16315
56EX11111TR9000156NON-TARGETIMG-00020A7NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANINVESTIGATORTREATMENT140WEEK 442010-11-15314
57EX11111TR9000157NON-TARGETIMG-00019A7NT02TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORTREATMENT140WEEK 442010-11-14313
58EX11111TR9000158NEWIMG-00020A7NEW01LDIAMLongest Diameter4mm44mm

CT SCANINVESTIGATORTREATMENT140WEEK 442010-11-15314
59EX11111TR9000159NEWIMG-00020A7NEW01TUMSTATETumor StateUNEQUIVOCAL
UNEQUIVOCAL



CT SCANINVESTIGATORTREATMENT140WEEK 442010-11-15314
60EX11111TR9000160NEWIMG-00019A7NEW02LDIAMLongest Diameter7mm77mm

MRIINVESTIGATORTREATMENT140WEEK 442010-11-14313
61EX11111TR9000161NEWIMG-00019A7NEW02TUMSTATETumor StateUNEQUIVOCAL
UNEQUIVOCAL



MRIINVESTIGATORTREATMENT140WEEK 442010-11-14313
62EX11111TR9000162NEWIMG-00022A7NEW03LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



ULTRASOUNDINVESTIGATORTREATMENT140WEEK 442010-11-15315

Dataset Debug Message

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4.1.4 PR Domain Model

The pr.xpt table below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at screening, week 6, week 12 and subsequent 8-week follow-up visits. The example 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 of the trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN OF THE TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.

Rows 1-3: Show the scans performed at screening. The results of the scans are in TU and TR.

Rows 4-6: Show that the MRI and CT scan were performed (PROCCUR = "Y") and that the medical photography was not performed (PROCCUR = "N") at week 6.

Rows 7-22: Show the scans performed at weeks 12, 20, 28, 36 and 44. The results of the scans are in TU and TR. In row 22, a non-RECIST 1.1 method was used and this example shows a way to represent the additional scan in PR, i.e., "ULTRASOUND".

pr.xpt

RowSTUDYIDDOMAINUSUBJIDPRSEQPRREFIDPRLNKGRPPRTRTPRPRESPPROCCURPRLOCEPOCHVISITNUMVISITPRSTDTCPRSTDY
1EX11111PR900011IMG-00001A1MRIYYHEAD AND NECKSCREEN10SCREENING2010-01-01-3
2EX11111PR900012IMG-00002A1CT SCANYYCHESTSCREEN10SCREENING2010-01-02-2
3EX11111PR900013IMG-00003A1PHOTOGRAPHYYYSKIN OF THE TRUNKSCREEN10SCREENING2010-01-03-1
4EX11111PR900014IMG-00004A2MRIYYHEAD AND NECKTREATMENT40WEEK 62010-02-1543
5EX11111PR900015IMG-00005A2CT SCANYYCHESTTREATMENT40WEEK 62010-02-1644
6EX11111PR900016
A2PHOTOGRAPHYYNSKIN OF THE TRUNKTREATMENT40WEEK 6

7EX11111PR900017IMG-00007A3MRIYYHEAD AND NECKTREATMENT60WEEK 122010-03-2985
8EX11111PR900018IMG-00008A3CT SCANYYCHESTTREATMENT60WEEK 122010-03-3086
9EX11111PR900019IMG-00009A3PHOTOGRAPHYYYSKIN OF THE TRUNKTREATMENT60WEEK 122010-04-0187
10EX11111PR9000110IMG-00010A4MRIYYHEAD AND NECKTREATMENT80WEEK 202010-05-27144
11EX11111PR9000111IMG-00011A4CT SCANYYCHESTTREATMENT80WEEK 202010-05-28145
12EX11111PR9000112IMG-00012A4PHOTOGRAPHYYYSKIN OF THE TRUNKTREATMENT80WEEK 202010-05-30147
13EX11111PR9000113IMG-00013A5MRIYYHEAD AND NECKTREATMENT100WEEK 282010-07-23201
14EX11111PR9000114IMG-00014A5CT SCANYYCHESTTREATMENT100WEEK 282010-07-24202
15EX11111PR9000115IMG-00015A5PHOTOGRAPHYYYSKIN OF THE TRUNKTREATMENT100WEEK 282010-07-25203
16EX11111PR9000116IMG-00016A6MRIYYHEAD AND NECKTREATMENT120WEEK 362010-09-17257
17EX11111PR9000117IMG-00017A6CT SCANYYCHESTTREATMENT120WEEK 362010-09-17257
18EX11111PR9000118IMG-00018A6PHOTOGRAPHYYYSKIN OF THE TRUNKTREATMENT120WEEK 362010-09-17257
19EX11111PR9000119IMG-00019A7MRIYYHEAD AND NECKTREATMENT140WEEK 442010-11-14313
20EX11111PR9000120IMG-00020A7CT SCANYYCHESTTREATMENT140WEEK 442010-11-15314
21EX11111PR9000121IMG-00021A7PHOTOGRAPHYYYSKIN OF THE TRUNKTREATMENT140WEEK 442010-11-16315
22EX11111PR9000122IMG-00022A7ULTRASOUND

PELVISTREATMENT140WEEK 442010-11-16315

4.2 Example 2: 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 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 rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows response data for one subject collected at the week 8 and subsequent 8-week follow-up visits. 

Rows 1-12:  Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 8, 16, 24 and 32.  RSLNKGRP is used to link the Overall Response to the underlying assessments in the TR domain which support the Overall Response at the assessment.

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSEVALEPOCHVISITNUMVISITRSDTCRSDY
1EX22222RS900021
TRGRESPTarget ResponseRECIST 1.1SDSDINVESTIGATORTREATMENT3WEEK 82007-02-2756
2EX22222RS900022
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDINVESTIGATORTREATMENT3WEEK 82007-02-2756
3EX22222RS900023A2OVRLRESPOverall ResponseRECIST 1.1SDSDINVESTIGATORTREATMENT3WEEK 82007-02-2756
4EX22222RS900024
TRGRESPTarget ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT5WEEK 162007-04-24112
5EX22222RS900025
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDINVESTIGATORTREATMENT5WEEK 162007-04-24112
6EX22222RS900026A3OVRLRESPOverall ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT5WEEK 162007-04-24112
7EX22222RS900027
TRGRESPTarget ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT7WEEK 242009-06-19168
8EX22222RS900028
NTRGRESPNon-Target ResponseRECIST 1.1NENEINVESTIGATORTREATMENT7WEEK 242009-06-19168
9EX22222RS900029A4OVRLRESPOverall ResponseRECIST 1.1PRPRINVESTIGATORTREATMENT7WEEK 242009-06-19168
10EX22222RS9000210
TRGRESPTarget ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT9WEEK 322009-08-14224
11EX22222RS9000211
NTRGRESPNon-Target ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT9WEEK 322009-08-14224
12EX22222RS9000212A5OVRLRESPOverall ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT9WEEK 322009-08-14224


4.2.2 TU Domain Model

The tu.xpt table 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 and subsequent visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This example also shows TUREFID used to represent the image identifier and TUSPID used to represent a sponsors internal tracking identifier.  

Rows 7-8: Show the identification of a split tumor when it was first identified as split (fragmented). In this example, TULNKID = "T04" splits into two tumors TULNKID = "T04.1" and TULNKID = "T04.2" with TUGRPID = "T04". TUGRPID = "T04" provides traceability and links the split tumor to its parent records.

Row 9: Shows the identification of a merged tumor when it was first identified as merged (coalesced). In this example, TULNKID = "T02" and TULNKID = "T03" merged into tumor TULNKID = "T02/T03". The TULNKID is a combination of the child tumors before more and therefore provides the transability back to the child tumors.

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTUGRPIDTUREFIDTUSPIDTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTULOCTUMETHODTUEVALEPOCHVISITNUMVISITTUDTCTUDY
1EX22222TU900021
IMG-00001TRG-SCR-01T01TUMIDENTTumor IdentificationTARGETTARGETLUNG, RIGHT MIDDLE LOBECT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
2EX22222TU900022
IMG-00001TRG-SCR-02T02TUMIDENTTumor IdentificationTARGETTARGETLUNG, LEFT LOWER LOBECT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
3EX22222TU900023
IMG-00001TRG-SCR-03T03TUMIDENTTumor IdentificationTARGETTARGETLUNG, LEFT LOWER LOBECT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
4EX22222TU900024
IMG-00001TRG-SCR-04T04TUMIDENTTumor IdentificationTARGETTARGETKIDNEY, UPPER LOBECT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
5EX22222TU900025
IMG-00001NTG-SCR-01NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETLUNGCT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
6EX22222TU900026
IMG-00001NTG-SCR-02NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGETLIVERCT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
7EX22222TU900027T04IMG-00002TRG-W16-07T04.1TUSPLITTumor SplitTARGETTARGETKIDNEY, UPPER LOBECT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
8EX22222TU900028T04IMG-00002TRG-W16-08T04.2TUSPLITTumor SplitTARGETTARGETKIDNEY, UPPER LOBECT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
9EX22222TU900029
IMG-00003TRG-W28-07T02/T03TUMERGETumor MergedTARGETTARGETLUNG, LEFT LOWER LOBECT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
10EX22222TU9000210
IMG-00004NWT-W32-01NEW01TUMIDENTTumor IdentificationNEWNEWLIVERCT SCANINVESTIGATORTREATMENT9WEEK 322009-08-14224

4.2.3 TR Domain Model

The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at screening, week 6 and subsequent 8-week follow-up visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This preferred approach provides transparent with traceability with parent lesions. This example shows how to represent data on a single row when a target tumor becomes too small to measure. In terms of RECIST 1.1, the original results would be "TOO SMALL TO MEASURE" and the standard results (TRSTRESN and TRSTRESC) would be "5". In addition, the example represents a situation where a result was not provided because the image was obscured and the tumor was not assessable.

This example shows a situation where the Investigator provided the summary values for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCD = "DIAM" is used for the assessments. Note that the sponsor should not derived these values if they were not part of the data capture.

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

Rows 18-19: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 16.

Rows 24-25: Show that tumors "T02" and "T03" are no longer measured individually. The TRSTAT = "NOT DONE" and the TRREASND = "TUMOR MERGED". These rows are optional and can be included if part of the collection. In the case where a sponsor includes TUMSTATE for target lesions, TUMSTATE may be assigned to "TUMOR MERGED".

Row 26: Shows the longest diameter of the newly merged "T02/T03" tumor at week 24.

Rows 27-28: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 24.

Row 33: Shows the longest diameter of the newly merged "T02/T03" tumor at week 32. Sponsors can continue to include individual tumors as not done as in rows 24-25.

Rows 34-35: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 32.

Row 37: Shows the Tumor State of the non-target "NT01" as enlargement from nadir (TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). This Tumor State indicates that the non-Target tumors in the "LUNG" have shown enlargement from their previous smallest state.

Rows 39-40: Shows the Tumor State of the a new tumor "NEW01" and the longest diameter of the new tumor.

tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRMETHODTREVALEPOCHVISITNUMVISITTRDTCTRDY
1EX22222TR900021TARGETA1T01LDIAMLongest Diameter16mm1616mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
2EX22222TR900022TARGETA1T02LDIAMLongest Diameter28mm2828mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
3EX22222TR900023TARGETA1T03LDIAMLongest Diameter41mm4141mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
4EX22222TR900024TARGETA1T04LDIAMLongest Diameter83mm8383mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
5EX22222TR900025TARGETA1
SUMDIAMSum of  Diameter168mm168168mm


INVESTIGATORSCREEN1SCREENING

6EX22222TR900026NON-TARGETA1NT01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
7EX22222TR900027NON-TARGETA1NT02TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
8EX22222TR900028TARGETA2T01LDIAMLongest Diameter10mm1010mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
9EX22222TR900029TARGETA2T02LDIAMLongest Diameter20mm2020mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
10EX22222TR9000210TARGETA2T03LDIAMLongest Diameter30mm3030mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
11EX22222TR9000211TARGETA2T04LDIAMLongest Diameter65mm6565mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
12EX22222TR9000212TARGETA2
SUMDIAMSum of  Diameter125mm125125mm


INVESTIGATORTREATMENT3WEEK 8

13EX22222TR9000213NON-TARGETA2NT01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
14EX22222TR9000214NON-TARGETA2NT02TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
15EX22222TR9000215TARGETA3T01LDIAMLongest DiameterTOO SMALL TO MEASUREmm55mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
16EX22222TR9000216TARGETA3T02LDIAMLongest Diameter12mm1212mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
17EX22222TR9000217TARGETA3T03LDIAMLongest Diameter15mm1515mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
18EX22222TR9000218TARGETA3T04.1LDIAMLongest Diameter30mm3030mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
19EX22222TR9000219TARGETA3T04.2LDIAMLongest Diameter10mm1010mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
20EX22222TR9000220TARGETA3
SUMDIAMSum of  Diameter72mm7272mm


INVESTIGATORTREATMENT5WEEK 16

21EX22222TR9000221NON-TARGETA3NT01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
22EX22222TR9000222NON-TARGETA3NT02TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
23EX22222TR9000223TARGETA4T01LDIAMLongest Diameter0mm00mm

CT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
24EX22222TR9000224TARGETA4T02LDIAMLongest Diameter




NOT DONETUMOR MERGEDCT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
25EX22222TR9000225TARGETA4T03LDIAMLongest Diameter




NOT DONETUMOR MERGEDCT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
26EX22222TR9000226TARGETA4T02/T03LDIAMLongest Diameter35mm3535mm

CT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
27EX22222TR9000227TARGETA4T04.1LDIAMLongest Diameter30mm3030mm

CT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
28EX22222TR9000228TARGETA4T04.2LDIAMLongest Diameter19mm1919mm

CT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
29EX22222TR9000229TARGETA4
SUMDIAMSum of  Diameter84mm8484mm


INVESTIGATORTREATMENT7WEEK 24

30EX22222TR9000230NON-TARGETA4NT01TUMSTATETumor State




NOT DONENOT EVALUABLE: Image obscuredCT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
31EX22222TR9000231NON-TARGETA4NT02TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT7WEEK 242007-06-19168
32EX22222TR9000232TARGETA5T01LDIAMLongest Diameter0mm00mm

CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224
33EX22222TR9000233TARGETA5T02/T03LDIAMLongest Diameter80mm8080mm

CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224
34EX22222TR9000234TARGETA5T04.1LDIAMLongest Diameter49mm4949mm

CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224
35EX22222TR9000235TARGETA5T04.2LDIAMLongest Diameter26mm2626mm

CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224
36EX22222TR9000236TARGETA5
SUMDIAMSum of  Diameter155mm155155mm

CT SCANINVESTIGATORTREATMENT9WEEK 32

37EX22222TR9000237NON-TARGETA5NT01TUMSTATETumor StateENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR



CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224
38EX22222TR9000238NON-TARGETA5NT02TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224
39EX22222TR9000239NEWA5NEW01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224
40EX22222TR9000240NEWA5NEW01LDIAMLongest Diameter9mm99mm

CT SCANINVESTIGATORTREATMENT9WEEK 322007-08-14224

Dataset Debug Message

There are five 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.  

4.3.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at week 8 and subsequent 8-week follow-up visits. The investigator also indicated that there was symptomatic deterioration indicating progression based on a clinical assessment that is not part of the response criteria (RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA"). The actual symptomatic deterioration is represented in the RSORRES value and the standardize representation (RSSTRESC) is "PD" (progressive disease). The Symptomatic Deterioration test (RSTESTCD = "SYMPTDTR") should only be used when this information is collected as part of the response forms.  Normally, it is expected that the subject continues having disease assessments until objective evidence of progression is documented. 

Row 12: Shows RSCAT = "RECIST 1.1". The Overall Response (RSTESTCD = "OVRLRESP") has RSORRES = "NE" because the scans of the target and non-target lesions were not done. 

Row 13: Shows a protocol defined response which is outside of RECIST 1.1. In this case, it is symptomatic deterioration. This is represented with RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA" and Symptomatic Deterioration (RSTESTCD = "SYMPTDTR") with RSORRES = "Increased weakness and weight loss". The RSORRES contains the actual symptomatic deterioration results. The RSSTRESC = "PD" is a standardized representation of the symptomatic deterioration response.    

Row 14: Shows RSCAT= "PROTOCOL DEFINED RESPONSE CRITERIA and the Overall Response (RSTESTCD = "OVRLRESP") with RSORRES = "PD".

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTATRSEVALEPOCHVISITNUMVISITRSDTCRSDY
1EX33333RS900031
TRGRESPTarget ResponseRECIST 1.1SDSD
INVESTIGATORTREATMENT3WEEK 82007-02-2756
2EX33333RS900032
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PD
INVESTIGATORTREATMENT3WEEK 82007-02-2756
3EX33333RS900033A2OVRLRESPOverall ResponseRECIST 1.1SDSD
INVESTIGATORTREATMENT3WEEK 82007-02-2756
4EX33333RS900034
TRGRESPTarget ResponseRECIST 1.1PRPR
INVESTIGATORTREATMENT5WEEK 162007-04-24112
5EX33333RS900035
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PD
INVESTIGATORTREATMENT5WEEK 162007-04-24112
6EX33333RS900036A3OVRLRESPOverall ResponseRECIST 1.1PRPR
INVESTIGATORTREATMENT5WEEK 162007-04-24112
7EX33333RS900037
TRGRESPTarget ResponseRECIST 1.1PRPR
INVESTIGATORTREATMENT7WEEK 242009-06-26175
8EX33333RS900038
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PD
INVESTIGATORTREATMENT7WEEK 242009-06-26175
9EX33333RS900039A4OVRLRESPOverall ResponseRECIST 1.1PRPR
INVESTIGATORTREATMENT7WEEK 242009-06-26175
10EX33333RS9000310
TRGRESPTarget ResponseRECIST 1.1

NOT DONEINVESTIGATORTREATMENT9WEEK 32

11EX33333RS9000311
NTRGRESPNon-Target ResponseRECIST 1.1

NOT DONEINVESTIGATORTREATMENT9WEEK 32

12EX33333RS9000312A5OVRLRESPOverall ResponseRECIST 1.1NENE
INVESTIGATORTREATMENT9WEEK 32

13EX33333RS9000313
SYMPTDTRSymptomatic DeteriorationPROTOCOL DEFINED RESPONSE CRITERIAIncreased weakness and weight lossPD
INVESTIGATORTREATMENT9WEEK 322009-08-12226
14EX33333RS9000314A5OVRLRESPOverall ResponsePROTOCOL DEFINED RESPONSE CRITERIAPDPD
INVESTIGATORTREATMENT9WEEK 322009-08-12226
The supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable) (QNAM = "REASNE") in the case where it is collected.

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

supprs.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX33333RS90005RSSEQ12REASNEReason Response Not EvaluableScans of target and non-target tumors were not performedCRF

4.3.2 TU Domain Model

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

Rows 1-7: Show a subject with 4 target lesions with TULNKID "T01"-"T04" and 3 non-target lesions with TULNKID "NT01"-"NT03" identified at screening. The subject did not have any new lesions. 

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTUNAMTULOCTULATTUMETHODTUEVALTUACPTFLEPOCHVISITNUMVISITTUDTCTUDY
1EX33333TU900031T01TUMIDENTTumor IdentificationTARGETTARGET
LUNG, RIGHT MIDDLE LOBE
CT SCANINVESTIGATOR
SCREEN1SCREENING2007-01-011
2EX33333TU900032T02TUMIDENTTumor IdentificationTARGETTARGET
LIVER
CT SCANINVESTIGATOR
SCREEN1SCREENING2007-01-011
3EX33333TU900033T03TUMIDENTTumor IdentificationTARGETTARGET
LIVER
CT SCANINVESTIGATOR
SCREEN1SCREENING2007-01-011
4EX33333TU900034T04TUMIDENTTumor IdentificationTARGETTARGET
KIDNEY, UPPER LOBERIGHTCT SCANINVESTIGATOR
SCREEN1SCREENING2007-01-011
5EX33333TU900035NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGET
LUNG
CT SCANINVESTIGATOR
SCREEN1SCREENING2007-01-011
6EX33333TU900036NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGET
ABDOMINAL CAVITY
CT SCANINVESTIGATOR
SCREEN1SCREENING2007-01-011
7EX33333TU900037NT03TUMIDENTTumor IdentificationNON-TARGETNON-TARGET
CLAVICLERIGHTSCINTIGRAPHYINVESTIGATOR
SCREEN1SCREENING2007-01-011

4.3.3 TR Domain Model

The tr.xpt table 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. In addition, the example represents a situation where a result was not provided because the scan was not performed.

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

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRMETHODTREVALEPOCHVISITNUMVISITTRDTCTRDY
1EX33333TR900031TARGETA1T01LDIAMLongest Diameter16mm1616mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
2EX33333TR900032TARGETA1T02LDIAMLongest Diameter28mm2828mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
3EX33333TR900033TARGETA1T03LDIAMLongest Diameter41mm4141mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
4EX33333TR900034TARGETA1T04LDIAMLongest Diameter82mm8383mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
5EX33333TR900035TARGETA1
SUMDIAMSum of  Diameter167mm168168mm


INVESTIGATORSCREEN1SCREENING

6EX33333TR900036NON-TARGETA1NT01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
7EX33333TR900037NON-TARGETA1NT02TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
8EX33333TR900038NON-TARGETA1NT03TUMSTATETumor StatePRESENT
PRESENT



SCINTIGRAPHYINVESTIGATORSCREEN1SCREENING2007-01-011
9EX33333TR900039TARGETA2T01LDIAMLongest Diameter10mm1010mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
10EX33333TR9000310TARGETA2T02LDIAMLongest Diameter20mm2020mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
11EX33333TR9000311TARGETA2T03LDIAMLongest Diameter30mm3030mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
12EX33333TR9000312TARGETA2T04LDIAMLongest Diameter65mm6565mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
13EX33333TR9000313TARGETA2
SUMDIAMSum of  Diameter125mm125125mm


INVESTIGATORTREATMENT3WEEK 8

14EX33333TR9000314NON-TARGETA2NT01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
15EX33333TR9000315NON-TARGETA2NT02TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
16EX33333TR9000316NON-TARGETA2NT03TUMSTATETumor State




NOT DONESCAN NOT PERFORMEDSCINTIGRAPHYINVESTIGATORTREATMENT3WEEK 8

17EX33333TR9000317TARGETA3T01LDIAMLongest DiameterTOO SMALL TO MEASUREmm55mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
18EX33333TR9000318TARGETA3T02LDIAMLongest Diameter12mm1212mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
19EX33333TR9000319TARGETA3T03LDIAMLongest Diameter15mm1515mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
20EX33333TR9000320TARGETA3T04LDIAMLongest Diameter40mm4040mm

CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
21EX33333TR9000321TARGETA3
SUMDIAMSum of  Diameter72mm7272mm


INVESTIGATORTREATMENT5WEEK 16

22EX33333TR9000322NON-TARGETA3NT01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
23EX33333TR9000323NON-TARGETA3NT02TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
24EX33333TR9000324NON-TARGETA3NT03TUMSTATETumor State




NOT DONESCAN NOT PERFORMEDSCINTIGRAPHYINVESTIGATORTREATMENT5WEEK 16

25EX33333TR9000325TARGETA4T01LDIAMLongest Diameter0mm00mm

CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
26EX33333TR9000326TARGETA4T02LDIAMLongest Diameter15mm1515mm

CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
27EX33333TR9000327TARGETA4T03LDIAMLongest Diameter5mm55mm

CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
28EX33333TR9000328TARGETA4T04LDIAMLongest Diameter36mm3636mm

CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
29EX33333TR9000329TARGETA4
SUMDIAMSum of  Diameter56mm5656mm


INVESTIGATORTREATMENT7WEEK 24

30EX33333TR9000330NON-TARGETA4NT01TUMSTATETumor State




NOT DONENOT EVALUABLECT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
31EX33333TR9000331NON-TARGETA4NT02TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
32EX33333TR9000332NON-TARGETA4NT03TUMSTATETumor StatePRESENT
PRESENT



SCINTIGRAPHYINVESTIGATORTREATMENT7WEEK 242009-06-26175
33EX33333TR9000333TARGETA5T01LDIAMLongest Diameter




NOT DONESCAN NOT PERFORMEDCT SCANINVESTIGATORTREATMENT9WEEK 32

34EX33333TR9000334TARGETA5T02LDIAMLongest Diameter




NOT DONESCAN NOT PERFORMEDCT SCANINVESTIGATORTREATMENT9WEEK 32

35EX33333TR9000335TARGETA5T03LDIAMLongest Diameter




NOT DONESCAN NOT PERFORMEDCT SCANINVESTIGATORTREATMENT9WEEK 32

36EX33333TR9000336TARGETA5T04LDIAMLongest Diameter




NOT DONESCAN NOT PERFORMEDCT SCANINVESTIGATORTREATMENT9WEEK 32

37EX33333TR9000337NON-TARGETA5NT01TUMSTATETumor State




NOT DONESCAN NOT PERFORMEDCT SCANINVESTIGATORTREATMENT9WEEK 32

38EX33333TR9000338NON-TARGETA5NT02TUMSTATETumor State




NOT DONESCAN NOT PERFORMEDCT SCANINVESTIGATORTREATMENT9WEEK 32

39EX33333TR9000339NON-TARGETA5NT03TUMSTATETumor State




NOT DONESCAN NOT PERFORMEDSCINTIGRAPHYINVESTIGATORTREATMENT9WEEK 32

Dataset Debug Message

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

4.4 Example 4: 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 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.

4.4.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at week 8 and week 16. 

This example shows the use of the acceptance flag (RSACPTFL) to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint, i.e., RSACPTFL indicates the "selected" response when more than read is performed. In some instances, a vendor may only supply a single response record for the "selected" response either because there was adjudication or the vendor would select the appropriate response. This alternative approach would result in only the "selected" response records in the RS domain. It is not expected that the RSACPTFL flag would be populated by the sponsor. That type of record selection or censoring would be part of the analysis dataset.

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

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

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSNAMRSEVALRSEVALIDRSACPTFLEPOCHVISITNUMVISITRSDTCRSDY
1EX44444RS900041
TRGRESPTarget ResponseRECIST 1.1SDSDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
2EX44444RS900042
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
3EX44444RS900043R1-A2OVRLRESPOverall ResponseRECIST 1.1SDSDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
4EX44444RS900044
BESTRESPBest Overall ResponseRECIST 1.1SDSDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
5EX44444RS900045
TRGRESPTarget ResponseRECIST 1.1PRPRRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
6EX44444RS900046
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
7EX44444RS900047R1-A3OVRLRESPOverall ResponseRECIST 1.1PRPRRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
8EX44444RS900048
BESTRESPBest Overall ResponseRECIST 1.1SDSDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
9EX44444RS900049
TRGRESPTarget ResponseRECIST 1.1PRPRRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
10EX44444RS9000410
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
11EX44444RS9000411R2-A2OVRLRESPOverall ResponseRECIST 1.1PRPRRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
12EX44444RS9000412
BESTRESPBest Overall ResponseRECIST 1.1SDSDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
13EX44444RS9000413
TRGRESPTarget ResponseRECIST 1.1PRPRRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112
14EX44444RS9000414
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112
15EX44444RS9000415R2-A3OVRLRESPOverall ResponseRECIST 1.1PRPRRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112
16EX44444RS9000416
BESTRESPBest Overall ResponseRECIST 1.1PRPRRADIOL INC.INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112

4.4.2 TU Domain Model

The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows the use of the acceptance flag (TUACPTFL) 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. It is not expected that the TUACPTFL flag would be populated by the sponsor. That type of record selection or censoring would be part of the analysis dataset. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. 

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

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

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTUNAMTULOCTULATTUMETHODTUEVALTUEVALIDTUACPTFLEPOCHVISITNUMVISITTUDTCTUDY
1EX44444TU900041R1-T01TUMIDENTTumor IdentificationTARGETTARGETRADIOL INC.LIVER
CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
2EX44444TU900042R1-T02TUMIDENTTumor IdentificationTARGETTARGETRADIOL INC.KIDNEY, UPPER LOBELEFTCT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
3EX44444TU900043R1-NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETRADIOL INC.ABDOMINAL CAVITY
CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
4EX44444TU900044R2-T01TUMIDENTTumor IdentificationTARGETTARGETRADIOL INC.KIDNEY, UPPER LOBELEFTCT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
5EX44444TU900045R2-T02TUMIDENTTumor IdentificationTARGETTARGETRADIOL INC.LIVER
CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
6EX44444TU900046R2-NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETRADIOL INC.ABDOMINAL CAVITY
CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
The supptu.xpt table below shows the textual data on the location detail (QNAM = "LOCDTL"). 

Row 1: Shows that the target lesion in the liver with TUSEQ = "1" is located in segment 5 of the liver as described by radiologist 1.

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

Row 3: Shows that the target lesion in the liver with TUSEQ = "5" is located in the lower part of segment 5 as described by radiologist 2.

supptu.xpt

Row STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
 1EX44444TU90004TUSEQ1LOCDTLLocation DetailSegment 5CRF
 2EX44444TU90004TUSEQ3LOCDTLLocation DetailBack of the abdomenCRF
 3EX44444TU90004TUSEQ5LOCDTLLocation DetailLower part of Segment 5CRF

4.4.3 TR Domain Model

The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. 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. It is not expected that the TUACPTFL flag would be populated by the sponsor. That type of record selection or censoring would be part of the analysis dataset.

This example shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "ACNSD", "PCBSD" and "PCNSD". Note that the sponsor should not derive these values if they were not part of the data capture or not provided in the transfer from the vendor.

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

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRNAMTRMETHODTREVALTREVALIDTRACPTFLEPOCHVISITNUMVISITTRDTCTRDY
1EX44444TR900041TARGETR1-A1R1-T01LDIAMLongest Diameter15mm1515mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
2EX44444TR900042TARGETR1-A1R1-T02LDIAMLongest Diameter25mm2525mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
3EX44444TR900043TARGETR1-A1
SUMDIAMSum of  Diameter40mm4040mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
4EX44444TR900044NON-TARGETR1-A1R1-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
5EX44444TR900045TARGETR1-A2R1-T01LDIAMLongest Diameter10mm1010mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
6EX44444TR900046TARGETR1-A2R1-T02LDIAMLongest Diameter25mm2525mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
7EX44444TR900047TARGETR1-A2
SUMDIAMSum of  Diameter35mm3535mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 8

8EX44444TR900048TARGETR1-A2
PCBSDPercent Change From Baseline in Sum of  Diameter-13%-13-13%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 8

9EX44444TR900049TARGETR1-A2
PCNSDPercent Change From Nadir in Sum of  Diameter-13%-13-13%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 8

10EX44444TR9000410NON-TARGETR1-A2R1-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
11EX44444TR9000411TARGETR1-A3R1-T01LDIAMLongest Diameter5mm55mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
12EX44444TR9000412TARGETR1-A3R1-T02LDIAMLongest Diameter10mm1010mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
13EX44444TR9000413TARGETR1-A3
SUMDIAMSum of  Diameter15mm1515mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 16

14EX44444TR9000414TARGETR1-A3
PCBSDPercent Change From Baseline in Sum of  Diameter-63%-63-63%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 16

15EX44444TR9000415TARGETR1-A3
PCNSDPercent Change From Nadir in Sum of  Diameter-57%-57-57%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 16

16EX44444TR9000416NON-TARGETR1-A3R1-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
17EX44444TR9000417TARGETR2-A1R2-T01LDIAMLongest Diameter25mm2525mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
18EX44444TR9000418TARGETR2-A1R2-T02LDIAMLongest Diameter20mm2020mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
19EX44444TR9000419TARGETR2-A1
SUMDIAMSum of  Diameter45mm4545mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING

20EX44444TR9000420NON-TARGETR2-A1R2-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
21EX44444TR9000421TARGETR2-A2R2-T01LDIAMLongest Diameter10mm1010mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
22EX44444TR9000422TARGETR2-A2R2-T02LDIAMLongest Diameter8mm88mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
23EX44444TR9000423TARGETR2-A2
SUMDIAMSum of  Diameter18mm1818mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 8

24EX44444TR9000424TARGETR2-A2
PCBSDPercent Change From Baseline in Sum of  Diameter-60%-60-60%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 8

25EX44444TR9000425TARGETR2-A2
PCNSDPercent Change From Nadir in Sum of Diameter-60%-60-60%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 8

26EX44444TR9000426NON-TARGETR2-A2R2-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
27EX44444TR9000427TARGETR2-A3R2-T01LDIAMLongest Diameter15mm1515mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112
28EX44444TR9000428TARGETR2-A3R2-T02LDIAMLongest DiameterTOO SMALL TO MEASUREmm55mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112
29EX44444TR9000429TARGETR2-A3
SUMDIAMSum of  Diameter20mm2020mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 16

30EX44444TR9000430TARGETR2-A3
PCBSDPercent Change From Baseline in Sum of Longest Diameter-56%-56-56%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 16

31EX44444TR9000431TARGETR2-A3
PCNSLDPercent Change From Nadir in Sum of Longest Diameter11%1111%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 16

32EX44444TR9000432NON-TARGETR2-A3R2-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112

Dataset Debug Message

There are 11 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.

4.5.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator response data for a subject that has only target tumors at screening. This includes an unscheduled assessment.  

Rows 1-2: Show the Target Response (RSTESTCD = "TRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") of CR (Complete Response) at week 8. The subject only has one target lesion and no non-targets. The Non-target Response (RSTESTCD = "NTRGRESP") is not applicable and a record may be included to represent this, if desired.

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

Rows 5-6: Show Target Response (RSTESTCD = "TRGRESP") of not evaluable ("NE") and Overall Response (RSTESTCD = "OVRLRESP") of not evaluable ("NE") due to an unreadable image.

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSEVALEPOCHVISITNUMVISITRSDTCRSDY
1EX55555RS900051
TRGRESPTarget ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT3WEEK 82007-02-2756
2EX55555RS900052A2OVRLRESPOverall ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT3WEEK 82007-02-2756
3EX55555RS900053
TRGRESPTarget ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT4.1UNCHEDULED WEEK 132007-04-0391
4EX55555RS900054A3OVRLRESPOverall ResponseRECIST 1.1CRCRINVESTIGATORTREATMENT4.1UNCHEDULED WEEK 132007-04-0391
5EX55555RS900055
TRGRESPTarget ResponseRECIST 1.1NENEINVESTIGATORTREATMENT5WEEK 162007-04-24112
6EX55555RS900056A5OVRLRESPOverall ResponseRECIST 1.1NENEINVESTIGATORTREATMENT5WEEK 162007-04-24112
7EX55555RS900057
TRGRESPTarget ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT7WEEK 242009-06-19168
8EX55555RS900058A5OVRLRESPOverall ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT7WEEK 242009-06-19168

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

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

supprs.xpt

Row STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
 1EX55555RS90005RSSEQ6REASNEReason Response Not EvaluableImaging Quality IssuesCRF

4.5.2 TU Domain Model

The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject that has only Target tumors at screening. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.  

Row 1: Shows that the subject has at least one target tumor (TUTESTCD = "TIND"), i.e., the subject has measurable disease.   Prior to SDTMIG 3.4, this row would not be included.  However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU.

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

Row 3: Shows the single target lesion in the breast. The subject only has one target lesion and no non-targets.

Row 4: Shows new bone lesion identified at week 24.

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTULOCTULATTUMETHODTUEVALEPOCHVISITNUMVISITTUDTCTUDY
1EX55555TU900051
TINDTarget IndicatorYY


INVESTIGATORSCREEN1SCREENING2007-01-011
2EX55555TU900052
NTINDNon-Target IndicatorNN


INVESTIGATORSCREEN1SCREENING2007-01-011
3EX55555TU900053T01TUMIDENTTumor IdentificationTARGETTARGETBREASTRIGHTCT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
4EX55555TU900054NEW01TUMIDENTTumor IdentificationNEWNEWBONE
CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168

4.5.3 TR Domain Model

The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows investigator tumor results for a subject that has only target tumors at screening. This includes an unscheduled assessment and an unreadable image.

Rows 1-14: Show the longest diameter and sum of longest diameter for the target lesion. The subject only has one target lesion and no non-targets.

Rows 3-6: Show assessment where the target lesion is absent. The longest diameter is shown as "0". If a sponsor collects that the tumor is absent rather than entering the longest diameter as "0", then the sponsor may optionally derive the longest diameter as "0" and represent the tumor state as ABSENT, if desired. 

Row 15: Shows a new lesion state at week 24.

tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRMETHODTREVALEPOCHVISITNUMVISITTRDTCTRDY
1EX55555TR900051TARGETA1T01LDIAMLongest Diameter10mm1010mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
2EX55555TR900052TARGETA1
SUMDIAMSum of  Diameter10mm1010mm


INVESTIGATORSCREEN1SCREENING

3EX55555TR900053TARGETA2T01LDIAMLongest Diameter0mm00mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
4EX55555TR900054TARGETA2T01TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
5EX55555TR900055TARGETA2
SUMDIAMSum of  Diameter0mm00mm


INVESTIGATORTREATMENT3WEEK 8

6EX55555TR900056TARGETA3T01LDIAMLongest Diameter0mm00mm

CT SCANINVESTIGATORTREATMENT4.1UNCHEDULED WEEK 132007-04-0391
7EX55555TR900057TARGETA3T01TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT4.1UNCHEDULED WEEK 132007-04-0391
8EX55555TR900058TARGETA3
SUMDIAMSum of  Diameter0mm00mm


INVESTIGATORTREATMENT4.1UNCHEDULED WEEK 13

9EX55555TR900059TARGETA4T01LDIAMLongest Diameter




NOT DONENOT EVALUABLE: Motion issueCT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
10EX55555TR9000510TARGETA4T01TUMSTATETumor State




NOT DONENOT EVALUABLE: Motion issueCT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
11EX55555TR9000511TARGETA4
SUMDIAMSum of  Diameter




NOT DONE

INVESTIGATORTREATMENT5WEEK 16

12EX55555TR9000512TARGETA5T01LDIAMLongest Diameter5mm55mm

CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
13EX55555TR9000513TARGETA5T01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
14EX55555TR9000514TARGETA5
SUMDIAMSum of  Diameter5mm55mm


INVESTIGATORTREATMENT7WEEK 24

15EX55555TR9000515NEWA5NEW01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168

Dataset Debug Message

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

4.6 Example 6: RECIST 1.1 example to show investigator and independent assessor response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the investigator tumor identification, tumor results, and response data using RECIST 1.1 along with the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements. 

4.6.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator and independent radiologist's response data. 

Rows 1-6: Show response assessments at cycle 2 and cycle 3 from the investigator following RECIST 1.1. 

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

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSNAMRSEVALRSEVALIDRSACPTFLEPOCHVISITNUMVISITRSDTCRSDY
1EX66666RS900061
TRGRESPTarget ResponseRECIST 1.1SDSD
INVESTIGATOR

TREATMENT3Cycle 2 Day 12007-01-2828
2EX66666RS900062
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PD
INVESTIGATOR

TREATMENT3Cycle 2 Day 12007-01-2828
3EX66666RS900063A2OVRLRESPOverall ResponseRECIST 1.1SDSD
INVESTIGATOR

TREATMENT3Cycle 2 Day 12007-01-2828
4EX66666RS900064
TRGRESPTarget ResponseRECIST 1.1SDSD
INVESTIGATOR

TREATMENT4Cycle 3 Day 12007-02-2656
5EX66666RS900065
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PD
INVESTIGATOR

TREATMENT4Cycle 3 Day 12007-02-2656
6EX66666RS900066A3OVRLRESPOverall ResponseRECIST 1.1PDPD
INVESTIGATOR

TREATMENT4Cycle 3 Day 12007-02-2656
7EX66666RS900067R1-A2OVRLRESPOverall ResponsePROTOCOL DEFINED RESPONSE CRITERIASDSDACME VENDORINDEPENDENT ASSESSORRADIOLOGISTYTREATMENT3Cycle 2 Day 12007-01-2828
8EX66666RS900068R1-A3OVRLRESPOverall ResponsePROTOCOL DEFINED RESPONSE CRITERIAPDPDACME VENDORINDEPENDENT ASSESSORRADIOLOGISTYTREATMENT4Cycle 3 Day 12007-02-2656

4.6.2 TU Domain Model

The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows investigator and independent radiologist's tumor identification. The example shows the identification of a new tumor where the investigator identified the new tumor only and the independent assessor identified and measured it. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. 

Rows 1-5: Show the identification of three target lesions "T01", "T02" and "T03", and 2 non-target lesions "NT01" and "NT02" by investigator.

Rows 6-7: Show the identification of two target lesions "R-T01" and "R-T02" by the independent radiologist.

Row 8: Shows the identification of a new tumor "NEW01" by investigator.

Row 9: Shows the identification of a new tumor "R-NEW01" by independent radiologist.

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTUNAMTULOCTULATTUDIRTUMETHODTUEVALTUEVALIDTUACPTFLEPOCHVISITNUMVISITTUDTCTUDY
1EX66666TU900061T01TUMIDENTTumor IdentificationTARGETTARGET
OCCIPITAL LOBELEFTANTERIORMRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
2EX66666TU900062T02TUMIDENTTumor IdentificationTARGETTARGET
OCCIPITAL LOBERIGHT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
3EX66666TU900063T03TUMIDENTTumor IdentificationTARGETTARGET
TEMPORAL LOBELEFT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
4EX66666TU900064NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGET
FRONTAL LOBERIGHT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
5EX66666TU900065NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGET
CEREBELLUMLEFT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
6EX66666TU900066R1-T01TUMIDENTTumor IdentificationTARGETTARGETACME VENDOROCCIPITAL LOBERIGHTANTERIORMRIINDEPENDENT ASSESSORRADIOLOGIST 1YSCREEN1SCREENING2007-01-011
7EX66666TU900067R1-T02TUMIDENTTumor IdentificationTARGETTARGETACME VENDORTEMPORAL LOBELEFT
MRIINDEPENDENT ASSESSORRADIOLOGIST 1YSCREEN1SCREENING2007-01-011
8EX66666TU900068NEW01TUMIDENTTumor IdentificationNEWNEW
FRONTAL LOBERIGHT
MRIINVESTIGATOR

TREATMENT4Cycle 3 Day 12007-02-2656
9EX66666TU900069R1-NEW01TUMIDENTTumor IdentificationNEWNEWACME VENDORFRONTAL LOBERIGHT
MRIINDEPENDENT ASSESSORRADIOLOGIST 1YTREATMENT4Cycle 3 Day 12007-02-2656

4.6.3 TR Domain Model

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

Rows 1-6, 18-23 and 38-39: Show Longest Diameter, Sum of Longest Diameter, and Tumor State for assessments at screening, cycle 2 and cycle 3 from the investigator. 

Rows 7-17, 24-37 and 40-44: Show the volumetric measurements at screening, cycle 2 and cycle 3 from the independent radiologist.

tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRNAMTRMETHODTREVALTREVALIDEPOCHVISITNUMVISITTRDTCTRDY
1EX66666TR900061TARGETA1T01LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
2EX66666TR900062TARGETA1T02LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
3EX66666TR900063TARGETA1T03LDIAMLongest Diameter5mm55mm
MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
4EX66666TR900064TARGETA1
SUMDIAMSum of  Diameter25mm2525mm

INVESTIGATOR
SCREEN1SCREENING

5EX66666TR900065NON-TARGETA1NT01TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
6EX66666TR900066NON-TARGETA1NT02TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
7EX66666TR900067TARGETR1-A1R1-T01LDIAMLongest Diameter10mm1010mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
8EX66666TR900068TARGETR1-A1R1-T01LPERPLongest Perpendicular5mm55mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
9EX66666TR900069TARGETR1-A1R1-T01PPDProduct of Perpendicular Diameters50mm25050mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

10EX66666TR9000610TARGETR1-A1R1-T01VOLUMEVolume250uL250250uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
11EX66666TR9000611TARGETR1-A1R1-T02LDIAMLongest Diameter7mm77mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
12EX66666TR9000612TARGETR1-A1R1-T02LPERPLongest Perpendicular10mm1010mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
13EX66666TR9000613TARGETR1-A1R1-T02PPDProduct of Perpendicular Diameters70mm27070mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

14EX66666TR9000614TARGETR1-A1R1-T02VOLUMEVolume350uL350350uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
15EX66666TR9000615TARGETR1-A1
SUMDIAMSum of  Diameter17mm1717mmACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

16EX66666TR9000616TARGETR1-A1
SUMPPDSum of Products of Perpendicular Diameters120mm2120120mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

17EX66666TR9000617TARGETR1-A1
SUMVOLSum of Volume600uL600600uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

18EX66666TR9000618TARGETA2T01LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
19EX66666TR9000619TARGETA2T02LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
20EX66666TR9000620TARGETA2T03LDIAMLongest Diameter5mm55mm
MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
21EX66666TR9000621TARGETA2
SUMDIAMSum of  Diameter25mm2525mm

INVESTIGATOR
TREATMENT3Cycle 2 Day 1

22EX66666TR9000622NON-TARGETA2NT01TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
23EX66666TR9000623NON-TARGETA2NT02TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
24EX66666TR9000624TARGETR1-A2R1-T01LDIAMLongest Diameter12mm1212mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
25EX66666TR9000625TARGETR1-A2R1-T01LPERPLongest Perpendicular7mm77mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
26EX66666TR9000626TARGETR1-A2R1-T01PPDProduct of Perpendicular Diameters84mm28484mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

27EX66666TR9000627TARGETR1-A2R1-T01VOLUMEVolume420uL420420uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
28EX66666TR9000628TARGETR1-A2R1-T02LDIAMLongest Diameter6mm66mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
29EX66666TR9000629TARGETR1-A2R1-T02LPERPLongest Perpendicular9mm99mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
30EX66666TR9000630TARGETR1-A2R1-T02PPDProduct of Perpendicular Diameters54mm25454mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

31EX66666TR9000631TARGETR1-A2R1-T02VOLUMEVolume315uL315315uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
32EX66666TR9000632TARGETR1-A2
SUMDIAMSum of  Diameter18mm1818mmACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

33EX66666TR9000633TARGETR1-A2
SUMPPDSum of Products of Perpendicular Diameters138mm2138138mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

34EX66666TR9000634TARGETR1-A2
SUMVOLSum of Volume735uL735735uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

35EX66666TR9000635TARGETR1-A2
PCBSDPercent Change From Baseline in Sum of  Diameter6%66%ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

36EX66666TR9000636TARGETR1-A2
PCBSPPDPercent Change Baseline in Sum of PPD23%2323%ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

37EX66666TR9000637TARGETR1-A2
PCBSVPercent Change From Baseline in Sum of Volume23%2323%ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

38EX66666TR9000638NEWA3NEW01TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
TREATMENT4Cycle 3 Day 12007-02-2656
39EX66666TR9000639NEWA3NEW01LDIAMLongest Diameter9mm99mm
MRIINVESTIGATOR
TREATMENT4Cycle 3 Day 12007-02-2656
40EX66666TR9000640NEWR1-A3R1-NEW01TUMSTATETumor StatePRESENT
PRESENT

ACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656
41EX66666TR9000641NEWR1-A3R1-NEW01LDIAMLongest Diameter9mm99mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656
42EX66666TR9000642NEWR1-A3R1-NEW01LPERPLongest Perpendicular5mm55mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656
43EX66666TR9000643NEWR1-A3R1-NEW01PPDProduct of Perpendicular Diameters45mm24545mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 1

44EX66666TR9000644NEWR1-A3R1-NEW01VOLUMEVolume270uL270270uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656

Dataset Debug Message

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

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. The procedure (PR) data shows the scans performed for the disease assessment. 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. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.

4.7.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows non-target and overall responses for a subject who did not have target lesions at baseline (target response is not applicable). This example also shows a "NE" overall response due to an unreadable image.  

Rows 1-3: Show the week 6 response assessment for a subject with non-target disease only. The Target Response (RSTESTCD = "TRGRESP") is not applicable for subjects with non-target disease only. This can be represented as RSSTAT = "NOT DONE" and RSREASND = "Subject does not have target lesions". The Non-Target Response (RSTESTCD = "NTRGRESP") is non complete response/non progressive disease (NON-CR/NON-PD). The Overall Response (RSTESTCD = "OVRLRESP") is non complete response/non progressive disease (NON-CR/NON-PD) which is a valid Overall Response in RECIST 1.1 for subjects with non-target disease only.

Rows 4-6: Show the week 12 response assessment for a subject with non-target disease only. The Non-Target Response (RSTESTCD = "NTRGRESP") is NE (Not Evaluable) because not all non-target lesions were evaluated and none of the evaluated non-targets showed progression. The brain did not show progression and the assessments of the non-target lesions in the skeletal muscle tissue and pericardium were not done because the non-target lesions were obscured on the MRI and not assessable. Therefore, the Overall Response (RSTESTCD = "OVRLRESP") is "NE" (not evaluable). Note that "NE" is a valid Overall Response value per the RECIST 1.1 criteria which means it that RSORRES is "NE" rather than represented in RSSTAT.

Rows 7-9: Show the week 20 assessment where the non-targets were enlarged from a previous smallest size. The Non-Target Response (RSTESTCD = "NTRGRESP") is "PD" (progressive disease) which results in an Overall Response (RSTESTCD = "OVRLRESP") of "PD".

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSEVALEPOCHVISITNUMVISITRSDTCRSDYRSSTATRSREASND
1EX77777RS900071
TRGRESPTarget ResponseRECIST 1.1

INVESTIGATORTREATMENT40WEEK 62010-02-1846NOT DONESubject does not have target lesions
2EX77777RS900072
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDINVESTIGATORTREATMENT40WEEK 62010-02-1846

3EX77777RS900073A2OVRLRESPOverall ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDINVESTIGATORTREATMENT40WEEK 62010-02-1846

4EX77777RS900074
TRGRESPTarget ResponseRECIST 1.1

INVESTIGATORTREATMENT60WEEK 122010-04-0288NOT DONESubject does not have target lesions
5EX77777RS900075
NTRGRESPNon-Target ResponseRECIST 1.1NENEINVESTIGATORTREATMENT60WEEK 122010-04-0288

6EX77777RS900076A3OVRLRESPOverall ResponseRECIST 1.1NENEINVESTIGATORTREATMENT60WEEK 122010-04-0288

7EX77777RS900077
TRGRESPTarget ResponseRECIST 1.1

INVESTIGATORTREATMENT80WEEK 202010-05-27144NOT DONESubject does not have target lesions
8EX77777RS900078
NTRGRESPNon-Target ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT80WEEK 202010-05-27144

9EX77777RS900079A4OVRLRESPOverall ResponseRECIST 1.1PDPDINVESTIGATORTREATMENT80WEEK 202010-05-27144


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

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

supprs.xpt

Row STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
 1EX77777RS90005RSSEQ5REASNEReason Response Not EvaluableImaging Quality IssuesCRF

4.7.2 TU Domain Model

The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject that has only non-target tumors at screening.

Row 1: Shows that the subject has no target tumors (TUTESTCD = "TIND"), i.e., the subject does not have measurable disease.

Row 2: Shows that the subject has non-target tumors (TUTESTCD = "NTIND"). The subject has non-measurable only disease.

Rows 3-5: Show the identification of 3 non-target lesions for a subject with non-target disease only. See below for details on on the tumor presentation type (QNAM = "PRTYP") supplemental qualifier.

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTUREFIDTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTULOCTUMETHODTUEVALEPOCHVISITNUMVISITTUDTCTUDY
1EX77777TU900071

TINDTarget IndicatorNN

INVESTIGATORSCREEN10SCREENING2010-01-041
2EX77777TU900072

NTINDNon-Target IndicatorYY

INVESTIGATORSCREEN10SCREENING2010-01-041
3EX77777TU900073IMG-00001NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETBRAINMRIINVESTIGATORSCREEN10SCREENING2010-01-041
4EX77777TU900074IMG-00002NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGETSKELETAL MUSCLE TISSUEMRIINVESTIGATORSCREEN10SCREENING2010-01-041
5EX77777TU900075IMG-00002NT03TUMIDENTTumor IdentificationNON-TARGETNON-TARGETPERICARDIUMMRIINVESTIGATORSCREEN10SCREENING2010-01-041

The supptu.xpt table below shows the data to describe the disease presentation of a non-target tumor, when needed. The tumor presentation type (QNAM = "PRTYP") supplemental qualifier is used and controlled terminology is available (DSPRTYP). In addition, this example shows the plane of measurement and the slice number where the lesions was identified, when needed.

Row 1: Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e., for the non-target site in the brain (TULNKID = "NT01"), the QVAL is "LEPTOMENINGEAL DISEASE".

Rows 2-3: Show the anatomical plane (QNAM = "ANTPLN") and the slice number (QNAM = "SLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified.

Rows 4-5: Show the anatomical plane (QNAM = "ANTPLN") and the slice number (QNAM = "SLNUM") where the skeletal muscle tissue non-target lesion (TULNKID = "NT02") was identified.

Row 6: Shows that the presentation of the disease in the pericardium is effusion, i.e., for the non-target site in the pericardium (TULNKID = "NT03"), the QVAL is "EFFUSION".

supptu.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX77777TU90007TUSEQ3PRTYPTumor or Lesion Presentation TypeLEPTOMENINGEAL DISEASECRF
2EX77777TU90007TUSEQ3ANTPLNAnatomical PlaneSAGITTALCRF
3EX77777TU90007TUSEQ3SLNUMSlice Number55CRF
4EX77777TU90007TUSEQ4ANTPLNAnatomical PlaneSAGITTALCRF
5EX77777TU90007TUSEQ4SLNUMSlice Number88-91CRF
6EX77777TU90007TUSEQ4PRTYPTumor or Lesion Presentation TypeEFFUSIONCRF

4.7.3 TR Domain Model

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

Rows 1-6: Show the qualitative assessments of the tumor state of the 3 non-target lesions "NT01", "NT02", and "NT03" at screening and week 6.

Rows 7-9: Show the week 12 assessments. Row 7 shows the assessment of "NT01" non-target lesion in the brain whereas rows 8 and 9 illustrate the assessments of the non-target lesions "NT02" and "NT03" in the skeletal muscle tissue and pericardium, respectively, were not done.  This is because the non-target lesions were obscured on the MRI and not assessable (TRSTAT = "NOT DONE" and TRREASND = "NOT EVALUABLE: Lesion obscured").

Rows 10-11: Show that at the week 20 assessment, the "NT01" and "NT02" were enlarged from a previous smallest size, i.e., TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR".

tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRREFIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRMETHODTREVALEPOCHVISITNUMVISITTRDTCTRDY
1EX77777TR900071NON-TARGETIMG-00001A1NT01TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORSCREEN10SCREENING2010-01-041
2EX77777TR900072NON-TARGETIMG-00001A1NT02TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORSCREEN10SCREENING2010-01-041
3EX77777TR900073NON-TARGETIMG-00001A1NT03TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORSCREEN10SCREENING2010-01-041
4EX77777TR900074NON-TARGETIMG-00003A2NT01TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORTREATMENT40WEEK 62010-02-1846
5EX77777TR900075NON-TARGETIMG-00003A2NT02TUMSTATETumor StateABSENT
ABSENT



MRIINVESTIGATORTREATMENT40WEEK 62010-02-1846
6EX77777TR900076NON-TARGETIMG-00003A2NT03TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORTREATMENT40WEEK 62010-02-1846
7EX77777TR900077NON-TARGETIMG-00005A3NT01TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORTREATMENT60WEEK 122010-04-0288
8EX77777TR900078NON-TARGETIMG-00005A3NT02TUMSTATETumor State




NOT DONENOT EVALUABLE: Lesion obscuredMRIINVESTIGATORTREATMENT60WEEK 122010-04-0288
9EX77777TR900079NON-TARGETIMG-00005A3NT03TUMSTATETumor State




NOT DONENOT EVALUABLE: Lesion obscuredMRIINVESTIGATORTREATMENT60WEEK 122010-04-0288
10EX77777TR9000710NON-TARGETIMG-00007A4NT01TUMSTATETumor StateENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR



MRIINVESTIGATORTREATMENT80WEEK 202010-05-27144
11EX77777TR9000711NON-TARGETIMG-00007A4NT02TUMSTATETumor StateENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR



MRIINVESTIGATORTREATMENT80WEEK 202010-05-27144
12EX77777TR9000712NON-TARGETIMG-00007A4NT03TUMSTATETumor StatePRESENT
PRESENT



MRIINVESTIGATORTREATMENT80WEEK 202010-05-27144

4.7.4 PR Domain Model

The pr.xpt table 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 screening, week 6, week 12 and subsequent 8-week follow-up visits. The example shows an MRI of the head and chest (PRTRT = "MRI" and PRLOC = "MULTIPLE") at each disease assessment timepoint. Pre protocol, non-target lesions in the "BRAIN" are assessed using "MRI" as the primary method of assessment for RECIST 1.1. Correlative imaging is used in addition to the primary method for the RECIST 1.1 evaluation in order to assess the brain lesion(s). The primary method of assessment (i.e., MRI) in represented in TU and TR domains along with assessment results. Correlative imaging (e.g., CT SCAN of the HEAD) is represented only in the PR domain. The image identifier is in PRREFID.

Rows 1-2: Show the scans preformed at the screening disease assessment. The MRI is the primary method used to assess the lesions for RECIST 1.1 and the results are in TU and TR. Row 2 shows the correlative imaging of the brain (i.e., CT SCAN of the HEAD). 

Rows 3-8: Show the scans preformed at the disease assessments at weeks 6, 12 and 20.

pr.xpt

RowSTUDYIDDOMAINUSUBJIDPRSEQPRREFIDPRLNKGRPPRTRTPRPRESPPROCCURPRLOCEPOCHVISITNUMVISITPRSTDTCPRSTDY
1EX77777PR900071IMG-00001A1MRIYYMULTIPLESCREEN10SCREENING2010-01-01-3
2EX77777PR900072IMG-00002A1CT SCANYYHEADSCREEN10SCREENING2010-01-01-3
3EX77777PR900073IMG-00003A2MRIYYMULTIPLETREATMENT40WEEK 62010-02-1543
4EX77777PR900074IMG-00004A2CT SCANYYHEADTREATMENT40WEEK 62010-02-1543
5EX77777PR900075IMG-00005A3MRIYYMULTIPLETREATMENT60WEEK 122010-03-2985
6EX77777PR900076IMG-00006A3CT SCANYYHEADTREATMENT60WEEK 122010-03-2985
7EX77777PR900077IMG-00007A4MRIYYMULTIPLETREATMENT80WEEK 202010-05-27144
8EX77777PR900078IMG-00008A4CTSCANYYHEADTREATMENT80WEEK 202010-05-27144

The supppr.xpt table below shows the data to represent the multiple locations covered by the MRI. The Anatomical Location 1 and Anatomical Location 2 (QNAM = "LOC1" and QNAM = "LOC2") supplemental qualifiers are used and controlled terminology is available (LOC).

Rows 1-2: Show the 2 locations of the MRI at screening for PRSEQ = "1" where QNAM = "LOC1" with QVAL = "HEAD" and QNAM = "LOC2" with QVAL = "CHEST".

Row 3: Shows the slice thickness (QNAM = "SLTHK") of the MRI at screening for PRSEQ = "1".

Rows 4-5: Show the 2 locations of the MRI at week 6 for PRSEQ = "3" where QNAM = "LOC1" with QVAL = "HEAD" and QNAM = "LOC2" with QVAL = "CHEST".

Row 6: Shows the slice thickness (QNAM = "SLTHK") of the MRI at week 6 for PRSEQ = "3".

Rows 7-8: Show the 2 locations of the MRI at week 12 for PRSEQ = "5" where QNAM = "LOC1" with QVAL = "HEAD" and QNAM = "LOC2" with QVAL = "CHEST".

Row 9: Shows the slice thickness (QNAM = "SLTHK") of the MRI at week 12 for PRSEQ = "5". 

Row 10: Shows the overall image quality issue (QNAM = "OIQ") of the MRI at week 12 for PRSEQ = "5". 

supppr.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX77777PR90007PRSEQ1LOC1Anatomical Location 1HEADCRF
2EX77777PR90007PRSEQ1LOC2Anatomical Location 2CHESTCRF
3EX77777PR90007PRSEQ1SLTHKSlice Thickness5 mmCRF
4EX77777PR90007PRSEQ3LOC1Anatomical Location 1HEADCRF
5EX77777PR90007PRSEQ3LOC2Anatomical Location 2CHESTCRF
6EX77777PR90007PRSEQ3SLTHKSlice Thickness5 mmCRF
7EX77777PR90007PRSEQ5LOC1Anatomical Location 1HEADCRF
8EX77777PR90007PRSEQ5LOC2Anatomical Location 2CHESTCRF
9EX77777PR90007PRSEQ5SLTHKSlice Thickness5 mmCRF
10EX77777PR90007PRSEQ5OIQOverall Image QualityMotion issues and lesions where obscuredCRF
11EX77777PR90007PRSEQ7LOC1Anatomical Location 1HEADCRF
12EX77777PR90007PRSEQ7LOC2Anatomical Location 2CHESTCRF
13EX77777PR90007PRSEQ7SLTHKSlice Thickness5 mmCRF

4.8 Example 8: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. 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 rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 12 and week 24.

Rows 1-3: Show the response assessments at week 12. The target lesion showed 59% decrease from screening so the Target Response (RSTESTCD = "TRGRESP") is a partial response (RSSTRESC = "PR"). In the protocol, scintigraphy is only to be performed every 6 months or in order to verify CR (Complete Response). Therefore, the Non-target Response (RSTESTCD = "NTRGRESP") is not evaluable (RSSTRESC = "NE") because scintigraphy of the bone was not performed at week 12, i.e., not all non-target lesions were evaluated. The Overall Response (RSTESTCD = "OVRLRESP") is a partial response (RSSTRESC = "PR") based on the target lesions and protocol requirements.

Rows 4-6: Show the response assessments at week 24 where the target lesion and the non-target lesions were absent. The Target Response (RSTESTCD = "TRGRESP"), Non-target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") are CR (Complete Response). 

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSNAMRSEVALRSEVALIDEPOCHVISITNUMVISITRSDTCRSDY
1EX88888RS900081
TRGRESPTarget ResponseRECIST 1.1PRPRVENDOR1INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
2EX88888RS900082
NTRGRESPNon-Target ResponseRECIST 1.1NENEVENDOR1INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
3EX88888RS900083R-A2OVRLRESPOverall ResponseRECIST 1.1PRPRVENDOR1INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
4EX88888RS900084
TRGRESPTarget ResponseRECIST 1.1CRCRVENDOR1INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-24172
5EX88888RS900085
NTRGRESPNon-Target ResponseRECIST 1.1CRCRVENDOR1INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-24172
6EX88888RS900086R-A3OVRLRESPOverall ResponseRECIST 1.1CRCRVENDOR1INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-24172

4.8.2 TU Domain Model

The tu.xpt table 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. 

Rows 1-3: Show the identification of a "R-T01" target tumor in the "LIVER" and the assessment of the 2 non-target tumors "R-NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" at screening.

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTUREFIDTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTUNAMTULOCTUMETHODTUEVALTUEVALIDEPOCHVISITNUMVISITTUDTCTUDY
1EX88888TU900081IMG-00001R-T01TUMIDENTTumor IdentificationTARGETTARGETVENDOR1LIVERCT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
2EX88888TU900082IMG-00002R-NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETVENDOR1BONESCINTIGRAPHYINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
3EX88888TU900083IMG-00001R-NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGETVENDOR1PLEURAL CAVITYCT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2

The supptu.xpt table below shows the data to describe the disease presentation of a non-target tumor, when needed. The tumor presentation type (QNAM = "PRTYP") supplemental qualifier is used and controlled terminology is available (DSPRTYP).

Row 1: Shows that the presentation of the disease in the pleural cavity is effusion, i.e., for the non-target site in the pleural cavity (TULOC = "PLEURAL CAVITY" and TULNKID = "NT02"), the QVAL is "EFFUSION".

supptu.xpt

Row STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
 1EX88888TU900080TUSEQ3PRTYPTumor or Lesion Presentation TypeEFFUSIONCRF

4.8.3 TR Domain Model

The tr.xpt table 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 screening, week 12 and week 24 visits. 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. The image identifier is in TRREFID. 

This example shows that situation where the Independent Assessor provided the summary values for target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "ACNSD", "PCBSD" and "PCNSD". Note that the sponsor should not derived these values if they were not part of the data capture or not provided in the transfer from the vendor.

Rows 1-4: Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-target lesions "R-NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" at screening.  

Rows 5-11: Show the measurement of the "R-T01" target tumor and the tumor state of the "R-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 a CR (Complete Response). Therefore, the "SCINTIGRAPHY" of "R-NT01" non-target in the "BONE" was not performed at week 12 (TRSTAT = "NOT DONE" and TRREASND = "SCAN NOT PERFORMED").

Rows 12-18: Show at week 24, the "R-T01" target lesion was absent (i.e., DIAMETER = "0") and the non-targets R-"NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" were absent (TRTESTCD = "TUMSTATE" with TRORRES = "ABSENT"). The "SCINTIGRAPHY" was performed in order to verify the Overall Response of CR (Complete Response).

tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRREFIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRNAMTRMETHODTREVALTREVALIDEPOCHVISITNUMVISITTRDTCTRDY
1EX88888TR900081TARGETIMG-00001R-A1R-T01LDIAMLongest Diameter17mm1717mm

VENDOR1CT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
2EX88888TR900082TARGET

R-A1


SUMDIAMSum of Diameter17mm1717mm

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
3EX88888TR900083NON-TARGETIMG-00002R-A1R-NT01TUMSTATETumor StatePRESENT
PRESENT



VENDOR1SCINTIGRAPHYINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
4EX88888TR900084NON-TARGETIMG-00001

R-A1

R-NT02TUMSTATETumor StatePRESENT
PRESENT



VENDOR1CT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
5EX88888TR900085TARGETIMG-00004R-A2R-T01LDIAMLongest Diameter7mm77mm

VENDOR1CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
6EX88888TR900086TARGET
R-A2
SUMDIAMSum of Diameter7mm77mm

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

7EX88888TR900087TARGET
R-A2
ACNSDAbsolute Change From Nadir in Sum of Diameter-10mm-10-10mm

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

8EX88888TR900088TARGET
R-A2
PCBSDPercent Change From Baseline in Sum of Diameter-59%-59-59%

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

9EX88888TR900089TARGET
R-A2
PCNSDPercent Change From Nadir in Sum of Diameter-59%-59-59%

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

10EX88888TR9000810NON-TARGET
R-A2R-NT01TUMSTATETumor State




NOT DONESCAN NOT PERFORMEDVENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

11EX88888TR9000811NON-TARGETIMG-00004R-A2R-NT02TUMSTATETumor StatePRESENT
PRESENT



VENDOR1CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
12EX88888TR9000812TARGETIMG-00005R-A3R-T01LDIAMLongest Diameter0mm00mm

VENDOR1CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171
13EX88888TR9000813TARGET
R-A3
SUMDIAMSum of Diameter0mm00mm

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

14EX88888TR9000814TARGET
R-A3
ACNSDAbsolute Change From Nadir in Sum of Diameter-17mm-17-17mm

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

15EX88888TR9000815TARGET
R-A3
PCBSDPercent Change From Baseline in Sum of Diameter-100%-100-100%

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

16EX88888TR9000816TARGET
R-A3
PCNSDPercent Change From Nadir in Sum of Diameter-100%-100-100%

VENDOR1
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

17EX88888TR9000817NON-TARGETIMG-00006R-A3R-NT01TUMSTATETumor StateABSENT
ABSENT



VENDOR1SCINTIGRAPHYINDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-24172
18EX88888TR9000818NON-TARGETIMG-00005R-A3R-NT02TUMSTATETumor StateABSENT
ABSENT



VENDOR1CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171

4.8.4 PR Domain Model

The pr.xpt table 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 screening, week 12 and week 24 visits. Per protocol, non-target lesions in the "BONE" are assessed using "SCINTIGRAPHY" as the primary method of assessment for RECIST 1.1. Correlative imaging is used in addition to the primary method for the RECIST 1.1 evaluation in order to more closely assess the bone lesion(s). The primary method of assessment (i.e., scintigraphy) is represented in TU and TR domains along with assessment results. Correlative imaging (e.g., MRI of the FEMUR) is represented only in the PR domain. Scintigraphy and the correlative imaging are not required at every disease assessment per protocol. However, often times the correlative imaging is performed at every disease assessment timepoint because the same scans cover lesions that are assessed at every disease assessment timepoint. The image identifier is in PRREFID.

Rows 1-3: Show the scans performed at screening. The CT SCAN and SCINTIGRAPHY are the primary methods used to assess the target and non-target lesion for RECIST 1.1 and the results are in TU and TR. Row 3 shows the correlative imaging (i.e., MRI) of the bone lesion in the FEMUR. 

Rows 4-6: Show that the CT scan was performed (PROCCUR = "Y") and that the scintigraphy and MRI were not performed (PROCCUR = "N") at week 12.

Rows 7-9: Show the scans performed at week 24.

pr.xpt

RowSTUDYIDDOMAINUSUBJIDPRSEQPRREFIDPRLNKGRPPRTRTPRLOCPRPRESPPROCCUREPOCHVISITNUMVISITPRSTDTCPRSTDY
1EX88888PR900081IMG-00001A1CT SCANMULTIPLEY

Y

SCREEN10SCREENING2010-01-01-3
2EX88888PR900082IMG-00002A1SCINTIGRAPHYBONEYYSCREEN10SCREENING2010-01-02-2
3EX88888PR900083IMG-00003A1MRIFEMURYYSCREEN10SCREENING2010-01-03-1
4EX88888PR900084IMG-00004A2CT SCANMULTIPLEYYTREATMENT20WEEK 122010-03-2985
5EX88888PR900085
A2SCINTIGRAPHYBONEYNTREATMENT20WEEK 12

6EX88888PR900086
A2MRIFEMURYNTREATMENT20WEEK 12

7EX88888PR900087IMG-00005A3CT SCANMULTIPLEYYTREATMENT30WEEK 242010-06-24172
8EX88888PR900088IMG-00006A3SCINTIGRAPHYBONEYYTREATMENT30WEEK 242010-06-23171
9EX88888PR900089IMG-00007A3MRIFEMURYYTREATMENT30WEEK 242010-06-25173

The supppr.xpt table below shows the data to represent the multiple locations covered by the CT SCAN. The Anatomical Location 1 and Anatomical Location 2 (QNAM = "LOC1" and QNAM = "LOC2") supplemental qualifiers are used and controlled terminology is available (LOC).

Rows 1-2: Show the 2 locations of the CT SCAN for PRSEQ = "1" where QNAM = "LOC1" with QVAL = "CHEST" and QNAM = "LOC2" with QVAL = "ABDOMEN".

Rows 3-6: Show the 2 locations of the CT SCAN for PRSEQ 4 and 7.

supppr.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX88888PR90008PRSEQ1LOC1Anatomical Location 1CHESTeDC
2EX88888PR90008PRSEQ1LOC2Anatomical Location 2ABDOMENeDC
3EX88888PR90008PRSEQ4LOC1Anatomical Location 1CHESTeDC
4EX88888PR90008PRSEQ4LOC2Anatomical Location 2ABDOMENeDC
5EX88888PR90008PRSEQ7LOC1Anatomical Location 1CHESTeDC
6EX88888PR90008PRSEQ7LOC2Anatomical Location 2ABDOMENeDC

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4.9 Example 9: RECIST 1.1 example to show an assessment where independent radiologist found no evidence of disease at baseline. 

4.9.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at screening.  In this example, there are no data in TU or TR because no tumors were identified.

Row 1: Shows a case where the independent radiologist found no evidence of disease (RSSTRESC = "NED") at baseline. This a rare case where a response assessment would be recorded based on the screening assessment.

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSNAMRSEVALRSEVALIDEPOCHVISITNUMVISITRSDTCRSDY
1EX99999RS900091A1OVRLRESPOverall ResponseRECIST 1.1NEDNEDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-03-291

4.10 Example 10: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. This example shows the situation where enlargement from nadir of a single Non-target does not necessarily mean that the Non-Target Response is PD.

4.10.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 12 and a subsequent 12-week follow-up visit. 

Rows 1-3: Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 12. The Target Response of PR (Partial Response) is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. The Non-Target Response of SD (Stable Disease) is based on the judgement of the non-target lesions/tumors taken collectively. In this case at week 12, one of the non-targets is absent and one of the non-targets has enlarged from nadir. The Overall Response is PR (Partial Response).

Rows 4-6: Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 24. The Target Response of CR (Complete Response) is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. The Non-Target Response of SD (Stable Disease) is based on the judgement of the non-target lesions/tumors taken collectively. In this case at week 24, one of the non-targets is absent and one of the non-targets is still present. The Overall Response is PR (Partial Response).

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSNAMRSEVALRSEVALIDEPOCHVISITNUMVISITRSDTCRSDY
1EX01010RS900101
TRGRESPTarget ResponseRECIST 1.1PRPRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
2EX01010RS900102
NTRGRESPNon-Target ResponseRECIST 1.1SDSDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
3EX01010RS900103R-A2OVRLRESPOverall ResponseRECIST 1.1PRPRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
4EX01010RS900104
TRGRESPTarget ResponseRECIST 1.1CRCRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171
5EX01010RS900105
NRGRESPNon-Target ResponseRECIST 1.1SDSDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171
6EX01010RS900106R-A3OVRLRESPOverall ResponseRECIST 1.1PRPRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171

4.10.2 TU Domain Model

The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject with target and non-target tumors identified at screening. 

Rows 1-3: Show a subject with 1 target lesion with TULNKID "R-T01" and 2 non-target lesions/sites with TULNKID "R-NT01" and "R-NT02" identified at screening. "T01" is located in the "LIVER", "R-NT01" is also located in the liver and "R-NT02" is located in the "CHEST WALL".

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTUNAMTULOCTUMETHODTUEVALTUEVALIDEPOCHVISITNUMVISITTUDTCTUDY
1EX01010TU900101R-T01TUMIDENTTumor IdentificationTARGETTARGETRADIOL. INC.LIVERCT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
2EX01010TU900102R-NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETRADIOL. INC.LIVERCT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
3EX01010TU900103R-NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGETRADIOL. INC.CHEST WALLCT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2

4.10.3 TR Domain Model

The tr.xpt table 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 screening, week 12 and subsequent 12-week follow-up visits.

This example shows the situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "ACNSD", "PCBSD" and "PCNSD". Note that the sponsor should not derive these values if they were not part of the data capture or not provided in the transfer from the vendor.

Rows 1-4: Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-Target lesions/sites "R-NT01" and "R-NT02" in the "LIVER" and "CHEST WALL" at screening.

Rows 5-11: Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 12. "R-T01" show a decrease from 17mm at baseline to 7mm which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. "R-NT01" has a TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "ENLARGEMENT FROM NADIR". 

Rows 12-18: Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 24. "R-T01" is absent (LDIAM = "0") which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. "R-NT01" remained TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "PRESENT".

tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRNAMTRMETHODTREVALTREVALIDEPOCHVISITNUMVISITTRDTCTRDY
1EX01010TR900101TARGETR-A1R-T01LDIAMLongest Diameter17mm1717mmRADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
2EX01010TR900102TARGETR-A1
SUMDIAMSum of Diameter17mm1717mmRADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING

3EX01010TR900103NON-TARGETR-A1R-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
4EX01010TR900104NON-TARGETR-A1R-NT02TUMSTATETumor StatePRESENT
PRESENT

RADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
5EX01010TR900105TARGETR-R-A2R-T01LDIAMLongest Diameter7mm77mmRADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
6EX01010TR900106TARGETR-A2
SUMDIAMSum of Diameter7mm77mmRADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

7EX01010TR900107TARGETR-A2
ACNSDAbsolute Change From Nadir in Sum of Diameter-10mm-10-10mmRADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

8EX01010TR900108TARGETR-A2
PCBSDPercent Change From Baseline in Sum of Diameter-59%-59-59%RADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

9EX01010TR900109TARGETR-A2
PCNSDPercent Change From Nadir in Sum of Diameter-59%-59-59%RADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 12

10EX01010TR9001010NON-TARGETR-A2R-NT01TUMSTATETumor StateABSENT
ABSENT

RADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
11EX01010TR9001011NON-TARGETR-A2R-NT02TUMSTATETumor StateENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR

RADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT20WEEK 122010-03-2985
12EX01010TR9001012TARGETR-A3R-T01LDIAMLongest Diameter0mm00mmRADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171
13EX01010TR9001013TARGETR-A3
SUMDIAMSum of Diameter0mm00mmRADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

14EX01010TR9001014TARGETR-A3
ACNSDAbsolute Change From Nadir in Sum of Diameter-17mm-17-17mmRADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

15EX01010TR9001015TARGETR-A3
PCBSDPercent Change From Baseline in Sum of Diameter-100%-100-100%RADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

16EX01010TR9001016TARGETR-A3
PCNSDPercent Change From Nadir in Sum of Diameter-100%-100-100%RADIOL. INC.
INDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 24

17EX01010TR9001017NON-TARGETR-A3R-NT01TUMSTATETumor StateABSENT
ABSENT

RADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171
18EX01010TR9001018NON-TARGETR-A3R-NT02TUMSTATETumor StatePRESENT
PRESENT

RADIOL. INC.CT SCANINDEPENDENT ASSESSORRADIOLOGISTTREATMENT30WEEK 242010-06-23171



4.11 Example 11: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data based on an independent assessment.

The example shows the case where lymph nodes are selected as target lesions. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.

4.11.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 6, week 12 and subsequent 8-week follow-up visits.

Rows 1-3: Show the Target Response (RSTESTCD = "TRGRESP") and Non-Target Response (RSTESTCD = "NTRGRESP") tests and corresponding Overall Response (RSTESTCD = "OVRLRESP") at the week 6 assessment.  The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP is used to associate underlying data in other domains to the Overall Response. 

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

Row 13-20: At week 36, the New Lesion Progression (RSTESTCD = "NEWLPROG") test is used to represent an equivocal new lesion (RSORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (RSORRES = "UNEQUIVOCAL"). 

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSLNKGRPRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSNAMRSEVALRSEVALIDEPOCHVISITNUMVISITRSDTCRSDY
1EX11111RS900111
TRGRESPTarget ResponseRECIST 1.1NENERADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1644
2EX11111RS900112
NTRGRESPNon-Target ResponseRECIST 1.1NENERADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1644
3EX11111RS900113R-A2OVRLRESPOverall ResponseRECIST 1.1NENERADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1644
4EX11111RS900114
TRGRESPTarget ResponseRECIST 1.1SDSDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-2985
5EX11111RS900115
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-2985
6EX11111RS900116R-A3OVRLRESPOverall ResponseRECIST 1.1SDSDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-2985
7EX11111RS900117
TRGRESPTarget ResponseRECIST 1.1PRPRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-30147
8EX11111RS900118
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-30147
9EX11111RS900119R-A4OVRLRESPOverall ResponseRECIST 1.1PRPRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-30147
10EX11111RS9001110
TRGRESPTarget ResponseRECIST 1.1PRPRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-25203
11EX11111RS9001111
NTRGRESPNon-Target ResponseRECIST 1.1NON-CR/NON-PDNON-CR/NON-PDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-25203
12EX11111RS9001112R-A5OVRLRESPOverall ResponseRECIST 1.1PRPRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-25203
13EX11111RS9001113
TRGRESPTarget ResponseRECIST 1.1CRCRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
14EX11111RS9001114
NTRGRESPNon-Target ResponseRECIST 1.1CRCRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
15EX11111RS9001115
NEWLPROGNew Lesion ProgressionRECIST 1.1EQUIVOCALEQUIVOCALRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
16EX11111RS9001116R-A6OVRLRESPOverall ResponseRECIST 1.1CRCRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
17EX11111RS9001117
TRGRESPTarget ResponseRECIST 1.1PDPDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
18EX11111RS9001118
NTRGRESPNon-Target ResponseRECIST 1.1CRCRRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
19EX11111RS9001119
NEWLPROGNew Lesion ProgressionRECIST 1.1UNEQUIVOCALUNEQUIVOCALRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
20EX11111RS9001120R-A7OVRLRESPOverall ResponseRECIST 1.1PDPDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313

4.11.2 TU Domain Model

The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors.  In RECIST 1.1, target lymph node tumors are measured in the longest perpendicular (TRTESTCD = "LPERP"). The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

Rows 1-6: Show a subject with 4 target lesions with TULNKID "R-T01"-"R-T04" and 2 non-target lesions with TULNKID "R-NT01" and "R-NT02" identified at screening. "R-T01" and "R-T02" target lesions are lymph nodes. "R-T01" is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). 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 (TULNKID = "R-NEW01") was identified in the left lower lobe of the lung (TULOC = "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 (TULNKID = "R-NEW02" and "R-NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE").

tu.xpt

RowSTUDYIDDOMAINUSUBJIDTUSEQTUREFIDTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTULOCTULATTUDIRTUMETHODTUNUMTUEVALTUEVALIDEPOCHVISITNUMVISITTUDTCTUDY

1

EX11111TU900111IMG-00001R-T01TUMIDENTTumor IdentificationTARGETTARGETSUPRACLAVICULAR LYMPH NODERIGHT
MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
2EX11111TU900112IMG-00002R-T02TUMIDENTTumor IdentificationTARGETTARGETTHORACIC LYMPH NODE

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
3EX11111TU900113IMG-00001R-T03TUMIDENTTumor IdentificationTARGETTARGETTHYROID GLANDLEFT
MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
4EX11111TU900114IMG-00003R-T04TUMIDENTTumor IdentificationTARGETTARGETSKIN OF THE TRUNK
UPPERPHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-03-1
5EX11111TU900115IMG-00002R-NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGETMEDIASTINAL LYMPH NODERIGHT
CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
6EX11111TU900116IMG-00001R-NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGETCEREBELLUMRIGHT
MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-011
7EX11111TU900117IMG-00020R-NEW01TUMIDENTTumor IdentificationNEWNEWLUNG, LEFT LOWER LOBE

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
8EX11111TU900118IMG-00019R-NEW02TUMIDENTTumor IdentificationNEWNEWCEREBELLUMLEFT
MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-18317
9EX11111TU900119IMG-00022R-NEW03TUMIDENTTumor IdentificationNEWNEWFEMORAL LYMPH NODELEFT
ULTRASOUNDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-18317

4.11.3 TR Domain Model

The tr.xpt table below shows the terminology used to implement RECIST 1.1in the TR domain. The example shows the data for one subject collected at the screening, week 6, week 12 and subsequent 8-week follow-up visits.

The example below shows measurements (i.e., longest perpendicular) 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 tumor is less than 10mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "PATHOLOGICAL".

This examples shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". 

The image identifier is in TRREFID and matches a PRREFID in the PR Domain.

Rows 1-6: Show the screening identification of the target and non-target lesions.  For lymph node target lesions "R-T01" and "RT02" the TRTESTCD used for the assessments are "LPREP" and "LNSTATE".  For non-lymph node target lesions "R-T03" and "R-T04" the TRTESTCD used for the assessments is "LDIAM".

Rows 7-8: Show the results for the Target lesions as a group (TRGRPID = "TARGET").  The TRTESTCDs are Sum of Diameter (TRTESTCD = "SUMDIAM") and Sum Diameters of Non Lymph Node Tumors (TRTESTCD = "SUMNLNLD").

Rows 9-10: Show the results for the non-targets.  "R-NT01" is a lymph node where the TRTEST used for the assessments is "Lymph Node State" (TRTESTCD = "LNSTATE").  "R-NT02" is a non-lymph node where the TRTESTCD used for the assessments is Tumor State (TRTESTCD = "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 "SCAN NOT PERFORMED". 

Rows 17-21: Show the week 6 results for the Target lesions as a group (TRGRPID = "TARGET").  The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". Within Row 20, the PCBSD could not be calculated because "R-T04" was not measured.  TRSTAT is assigned "NOT DONE" and TRREASND contains the reason, in this case at least one target lesion was not measured.

Rows 22-23: Show the week 6 that "R-NT02" was not not evaluable and the results the "R-NT01" non-target lesion using TRTESTCD as TUMSTATE. 

Rows 30-34: Show the week 12 results for the Target lesions as a group (TRGRPID = "TARGET").  The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD".

Row 70: Shows the Sum Diameters of Non Lymph node Tumors (TRTESTCD = "SUMNLNLD") is "0".  This means that the non-lymph node target tumors are all absent.  

tr.xpt

RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRREFIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRMETHODTRNAMTREVALTREVALIDEPOCHVISITNUMVISITTRDTCTRDY
1EX11111TR900111TARGETIMG-00001R-A1R-T01LPERPLongest Perpendicular17mm1717mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
2EX11111TR900112TARGETIMG-00001R-A1R-T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
3EX11111TR900113TARGETIMG-00002R-A1R-T02LPERPLongest Perpendicular16mm1616mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
4EX11111TR900114TARGETIMG-00002R-A1R-T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
5EX11111TR900115TARGETIMG-00001R-A1R-T03LDIAMLongest Diameter15mm1515mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
6EX11111TR900116TARGETIMG-00003R-A1R-T04LDIAMLongest Diameter14mm1414mm

PHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-03-1
7EX11111TR900117TARGET
R-A1
SUMDIAMSum of Diameter62mm6262mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING

8EX11111TR900118TARGET
R-A1
SUMNLNLDSum Diameters of Non Lymph Node Tumors29mm2929mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING

9EX11111TR900119NON-TARGETIMG-00002R-A1R-NT01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
10EX11111TR9001110NON-TARGETIMG-00001R-A1R-NT02TUMSTATETumor StatePRESENT
PRESENT



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
11EX11111TR9001111TARGETIMG-00004R-A2R-T01LPERPLongest Perpendicular12mm1212mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1543
12EX11111TR9001112TARGETIMG-00004R-A2R-T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1543
13EX11111TR9001113TARGETIMG-00005R-A2R-T02LPERPLongest Perpendicular12mm1212mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1644
14EX11111TR9001114TARGETIMG-00005R-A2R-T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1644
15EX11111TR9001115TARGETIMG-00004R-A2R-T03LDIAMLongest Diameter14mm1414mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1543
16EX11111TR9001116TARGET
R-A2R-T04LDIAMLongest Diameter




NOT DONESCAN NOT PERFORMEDPHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 6

17EX11111TR9001117TARGET
R-A2
SUMDIAMSum of Diameter52mm5252mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 6

18EX11111TR9001118TARGET
R-A2
SUMNLNLDSum Diameters of Non Lymph Node Tumors28mm2828mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 6

19EX11111TR9001119TARGET
R-R-A2
ACNSDAbsolute Change From Nadir in Sum of Diameter-10mm-10-10mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 6

20EX11111TR9001120TARGET
R-A2
PCBSDPercent Change From Baseline in Sum of Diameter




NOT DONEAt least one target lesions was not measured
RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 6

21EX11111TR9001121TARGET
R-A2
PCNSDPercent Change From Nadir in Sum of Diameter-16%-16-16%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 6

22EX11111TR9001122NON-TARGETIMG-00005R-A2R-NT01LNSTATELymph Node State




NOT DONENOT EVALUABLECT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1644
23EX11111TR9001123NON-TARGETIMG-00004R-A2R-NT02TUMSTATETumor State




NOT DONENOT ASSESSABLE: Image obscuredMRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1543
24EX11111TR9001124TARGETIMG-00007R-A3R-T01LPERPLongest Perpendicular12mm1212mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-2985
25EX11111TR9001125TARGETIMG-00007R-A3R-T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-2985
26EX11111TR9001126TARGETIMG-00008R-A3R-T02LPERPLongest Perpendicular12mm1212mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-3086
27EX11111TR9001127TARGETIMG-00008R-A3R-T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-3086
28EX11111TR9001128TARGETIMG-00007R-A3R-T03LDIAMLongest Diameter15mm1515mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-2985
29EX11111TR9001129TARGETIMG-00009R-A3R-T04

LDIAM

Longest Diameter8mm88mm

PHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-04-0187
30EX11111TR9001130TARGET
R-A3
SUMDIAMSum of Diameter47mm4747mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 12

31EX11111TR9001131TARGET
R-A3
SUMNLNLDSum Diameters of Non Lymph Node Tumors23mm2323mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 12

32EX11111TR9001132TARGET
R-R-A3
ACNSDAbsolute Change From Nadir in Sum of Diameter-5mm-5-5mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 12

33EX11111TR9001133TARGET
R-A3
PCBSDPercent Change From Baseline in Sum of Diameter-24%-24-24%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 12

34EX11111TR9001134TARGET
R-A3
PCNSDPercent Change From Nadir in Sum of Diameter-9%-9-9%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 12

35EX11111TR9001135NON-TARGETIMG-00008R-A3R-NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-3086
36EX11111TR9001136NON-TARGETIMG-00007R-A3R-NT02TUMSTATETumor StatePRESENT
PRESENT



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-3086
37EX11111TR9001137TARGETIMG-00010R-A4R-T01LPERPLongest Perpendicular9mm99mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-27144
38EX11111TR9001138TARGETIMG-00010R-A4R-T01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-27144
39EX11111TR9001139TARGETIMG-00011R-A4R-T02LPERPLongest Perpendicular12mm1212mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-28145
40EX11111TR9001140TARGETIMG-00011R-A4R-T02LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-28145
41EX11111TR9001141TARGETIMG-00010R-A4R-T03LDIAMLongest Diameter11mm1111mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-27144
42EX11111TR9001142TARGETIMG-00012R-A4R-T04LDIAMLongest Diameter5mm55mm

PHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-30147
43EX11111TR9001143TARGET
R-A4
SUMDIAMSum of Diameter37mm3737mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-30147
44EX11111TR9001144TARGET
R-A4
SUMNLNLDSum Diameters of Non Lymph Node Tumors16mm1616mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 20

45EX11111TR9001145TARGET
R-A4
ACNSDAbsolute Change From Nadir in Sum of Diameter-10mm-10-10mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 20

46EX11111TR9001146TARGET
R-A4
PCBSDPercent Change From Baseline in Sum of Diameter-40%-40-40%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 20

47EX11111TR9001147TARGET
R-A4
PCNSDPercent Change From Nadir in Sum of Diameter-21%-21-21%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 20

48EX11111TR9001148NON-TARGETIMG-00011R-A4R-NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-28145
49EX11111TR9001149NON-TARGETIMG-00010R-A4R-NT02TUMSTATETumor StatePRESENT
PRESENT



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-27144
50EX11111TR9001150TARGETIMG-00013R-A5R-T01LPERPLongest Perpendicular9mm99mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-23201
51EX11111TR9001151TARGETIMG-00013R-A5R-T01LPERPLongest PerpendicularNON-PATHOLOGICAL
NON-PATHOLOGICAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-23201
52EX11111TR9001152TARGETIMG-00014R-A5R-T02LDIAMLongest Diameter8mm88mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-24202
53EX11111TR9001153TARGETIMG-00014R-A5R-T02LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-24202
54EX11111TR9001154TARGETIMG-00013R-A5R-T03LDIAMLongest Diameter6mm66mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-23201
55EX11111TR9001155TARGETIMG-00015R-A5R-T04LDIAMLongest Diameter0mm00mm

PHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-25203
56EX11111TR9001156TARGET
R-A5
SUMDIAMSum of Diameter23mm2323mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 28

57EX11111TR9001157TARGET
R-A5
SUMNLNLDSum Diameters of Non Lymph Node Tumors6mm66mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 28

58EX11111TR9001158TARGET
R-A5
ACNSDAbsolute Change From Nadir in Sum of Diameter-14mm-14-14mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 28

59EX11111TR9001159TARGET
R-A5
PCBSDPercent Change From Baseline in Sum of Diameter-62%-62-62%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 28

60EX11111TR9001160TARGET
R-A5
PCNSDPercent Change From Nadir in Sum of Diameter-37%-37-37%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 28

61EX11111TR9001161NON-TARGETIMG-00014R-A5R-NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-24202
62EX11111TR9001162NON-TARGETIMG-00013R-A5R-NT02TUMSTATETumor StatePRESENT
PRESENT



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-23201
63EX11111TR9001163TARGETIMG-00016R-A6R-T01LPERPLongest Perpendicular8mm88mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
64EX11111TR9001164TARGETIMG-00016R-A6R-T01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
65EX11111TR9001165TARGETIMG-00017R-A6R-T02LPERPLongest Perpendicular9mm99mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
66EX11111TR9001166TARGETIMG-00017R-A6R-T02LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
67EX11111TR9001167TARGETIMG-00016R-A6R-T03LDIAMLongest Diameter0mm00mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
68EX11111TR9001168TARGETIMG-00018R-A6R-T04LDIAMLongest Diameter0mm00mm

PHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
69EX11111TR9001169TARGET
R-A6
SUMDIAMSum of Diameter17mm1717mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 36

70EX11111TR9001170TARGET
R-A6
SUMNLNLDSum Diameters of Non Lymph Node Tumors0mm00mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 36

71EX11111TR9001171TARGET
R-A6
ACNSDAbsolute Change From Nadir in Sum of Diameter-6mm-6-6mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 36

72EX11111TR9001172TARGET
R-A6
PCBSDPercent Change From Baseline in Sum of Diameter-72%-72-72%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 36

73EX11111TR9001173TARGET
R-A6
PCNSDPercent Change From Nadir in Sum of Diameter-26%-26-26%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 36

74EX11111TR9001174NON-TARGETIMG-00017R-A6R-NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
75EX11111TR9001175NON-TARGETIMG-00016R-A6R-NT02TUMSTATETumor StateABSENT
ABSENT



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
76EX11111TR9001176NEWIMG-00017R-A6R-NEW01TUMSTATETumor StateEQUIVOCAL
EQUIVOCAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
77EX11111TR9001177TARGETIMG-00019R-A7R-T01LPERPLongest Perpendicular12mm1212mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-15314
78EX11111TR9001178TARGETIMG-00019R-A7R-T01LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-15314
79EX11111TR9001179TARGETIMG-00020R-A7R-T02LPERPLongest Perpendicular9mm99mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
80EX11111TR9001180TARGETIMG-00020R-A7R-T02LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
81EX11111TR9001181TARGETIMG-00019R-A7R-T03LDIAMLongest Diameter0mm00mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-15314
82EX11111TR9001182TARGETIMG-00021R-A7R-T04LDIAMLongest Diameter0mm00mm

PHOTOGRAPHYRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-16315
83EX11111TR9001183TARGET
R-A7
SUMDIAMSum of Diameter21mm2121mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 44

84EX11111TR9001184TARGET
R-A7
SUMNLNLDSum Diameters of Non Lymph Node Tumors0mm00mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 44

85EX11111TR9001185TARGET
R-A7
ACNSDAbsolute Change From Nadir in Sum of Diameter4mm44mm


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 44

86EX11111TR9001186TARGET
R-A7
PCBSDPercent Change From Baseline in Sum of Diameter-66%-66-66%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 44

87EX11111TR9001187TARGET
R-A7
PCNSDPercent Change From Nadir in Sum of Diameter23%2323%


RADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 44

88EX11111TR9001188NON-TARGETIMG-00020R-A7R-NT01LNSTATELymph Node StateNON-PATHOLOGICAL
NON-PATHOLOGICAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-15314
89EX11111TR9001189NON-TARGETIMG-00019R-A7R-NT02TUMSTATETumor StatePRESENT
PRESENT



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
90EX11111TR9001190NEWIMG-00020R-A7R-NEW01LDIAMLongest Diameter8mm88mm

CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-15314
91EX11111TR9001191NEWIMG-00020R-A7R-NEW01TUMSTATETumor StateUNEQUIVOCAL
UNEQUIVOCAL



CT SCANRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-15314
92EX11111TR9001192NEWIMG-00019R-A7R-NEW02LDIAMLongest Diameter6mm66mm

MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
93EX11111TR9001193NEWIMG-00019R-A7R-NEW02TUMSTATETumor StateUNEQUIVOCAL
UNEQUIVOCAL



MRIRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
94EX11111TR9001194NEWIMG-00022R-A7R-NEW03LNSTATELymph Node StatePATHOLOGICAL
PATHOLOGICAL



ULTRASOUNDRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-16315

4.11.4 PR Domain Model

The pr.xpt table 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, week 12, and subsequent 8-week follow-up visits. The example 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 PRLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.

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

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

pr.xpt

RowSTUDYIDDOMAINUSUBJIDPRSEQPRREFIDPRLNKGRPPRTRTPRLOCPRNAMPREVALPREVALIDEPOCHVISITNUMVISITPRSTDTCPRSTDY
1EX11111PR900111IMG-00001R-A1MRIHEAD AND NECKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-01-3
2EX11111PR900112IMG-00002R-A1CT SCANCHESTRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-02-2
3EX11111PR900113IMG-00003R-A1PHOTOGRAPHYSKIN OF THE TRUNKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTSCREEN10SCREENING2010-01-03-1
4EX11111PR900114IMG-00004R-A2MRIHEAD AND NECKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1543
5EX11111PR900115IMG-00005R-A2CT SCANCHESTRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT40WEEK 62010-02-1644
6EX11111PR900116IMG-00007R-A3MRIHEAD AND NECKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-2985
7EX11111PR900117IMG-00008R-A3CT SCANCHESTRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-03-3086
8EX11111PR900118IMG-00009R-A3PHOTOGRAPHYSKIN OF THE TRUNKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT60WEEK 122010-04-0187
9EX11111PR900119IMG-00010R-A4MRIHEAD AND NECKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-27144
10EX11111PR9001110IMG-00011R-A4CT SCANCHESTRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-28145
11EX11111PR9001111IMG-00012R-A4PHOTOGRAPHYSKIN OF THE TRUNKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT80WEEK 202010-05-30147
12EX11111PR9001112IMG-00013R-A5MRIHEAD AND NECKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-23201
13EX11111PR9001113IMG-00014R-A5CT SCANCHESTRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-24202
14EX11111PR9001114IMG-00015R-A5PHOTOGRAPHYSKIN OF THE TRUNKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT100WEEK 282010-07-25203
15EX11111PR9001115IMG-00016R-A6MRIHEAD AND NECKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
16EX11111PR9001116IMG-00017R-A6CT SCANCHESTRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
17EX11111PR9001117IMG-00018R-A6PHOTOGRAPHYSKIN OF THE TRUNKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT120WEEK 362010-09-17257
18EX11111PR9001118IMG-00019R-A7MRIHEAD AND NECKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-14313
19EX11111PR9001119IMG-00020R-A7CT SCANCHESTRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-15314
20EX11111PR9001120IMG-00021R-A7PHOTOGRAPHYSKIN OF THE TRUNKRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-16315
21EX11111PR9001121IMG-00022R-A7ULTRASOUNDPELVISRADIOL. INC.INDEPENDENT ASSESSORRADIOLOGISTTREATMENT140WEEK 442010-11-16315

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. 

Rows 1-2: Show the one-to-many relationship between TU and TR using --LNKID. --LNKID is the tumor identifier.  The matching RELID value indicates that the two rows form the relationship.

Rows 3-4: Show the many-to-one relationship between TR and RS using --LNKGRP. --LNKGRP is the identifier used to group and link all of the measurement/assessment records used in the assessment of the overall response record in the RS domain. The matching RELID value indicates that the two rows form the relationship.

Rows 5-6: Show the one-to-many relationship between TU and PR using --REFID. --REFID contains the image identifier. The matching RELID value indicates that the two rows form the relationship.

relrec.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1ABC12345TU
TULNKID
OneTUTR1
2ABC12345TR
TRLNKID
ManyTUTR1
3ABC12345TR
TRLNKGRP
ManyTRRS1
4ABC12345RS
RSLNKGRP
OneTRRS1
5ABC12345PR
PRREFID
OnePRTU1
6ABC12345TU
TUREFID
ManyPRTU1

6 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for SUPPRS, SUPPTU and SUPPPR datasets.

QNAMRDOMAINQLABELTYPECODELISTROLE
REASNERSReason Response Not EvaluabletextFree text from CRF

Non-Standard Record Qualifier

PRVIR

TUPreviously Irradiated IndicatortextNY

Non-Standard Record Qualifier

PRVIRPTUPreviously Irradiated ProgressiontextNY

Non-Standard Record Qualifier

PRTYPTUTumor or Lesion Presentation TypetextDSPRTYP

Non-Standard Record Qualifier

LOCDTLTULocation DetailtextFree text from CRF

Non-Standard Record Qualifier

SLNUMTUSlice NumbertextFree text from CRF

Non-Standard Record Qualifier

ANTPLNTUAnatomical PlanetextFree text from CRF

Non-Standard Record Qualifier

LOC1PRAnatomical Location 1textLOC

Non-Standard Record Qualifier

LOC2PRAnatomical Location 2textLOC

Non-Standard Record Qualifier

SLTHKPRSlice ThicknesstextFree text from CRF

Non-Standard Record Qualifier

OIQPROverall Image QualitytextFree text from CRF

Non-Standard Record Qualifier

End of Document

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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.

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