Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
CDISC Reference
Disease Response Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
Criteria Short Name
RECIST 1.1
Criteria Permission Status
Exempt from Copyright
Team
CDISC Oncology Subteam
Supplement Version
1.0
Status
FINAL
Date
2023-10-31
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.
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.
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 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.
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 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.
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 antineoplastic 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. These SDTMIG domains include:
Disease Response and Clin Classification (RS), 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), 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), 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 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, RELREC, for more information on the relationships and an example RELREC dataset.
CDISC biomedical concepts are available for RECIST 1.1 following the 2-layered approach:
Conceptual/abstract layer that provides standards-agnostic, unambiguous semantic definition largely based on NCIt concepts
Implementation layer based on valid CDISC dataset specializations that provide value-level metadata definitions that facilitate metadata-driven automation
SDTM dataset specializations have been defined for the TU, TR, and RS datasets. They are retrievable via the CDISC Library API as JSON output. See the CDISC Biomedical Concepts page for more information https://www.cdisc.org/cdisc-biomedical-concepts.
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 RECIST 1.1 are listed below.
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.
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.
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 1 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 nonmeasurable 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, when they are measured in the longest perpendicular. The examples in this 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. 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 do not require looking to the anatomical location. In addition, the LDIAM and LPERP tests are used in other disease response criteria; the use of these 2 tests provides standardization 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 Section 4.2, Example 2: Split and Merged Tumors, for the preferred representation of measurements of split and merged tumors. Regardless of the representation of split and merged lesions, it is essential that the summation of the diameters is accurate.
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 rather are usually provided by independent assessors. When not derived in EDC, summary values not in the collected data may be derived in the analysis datasets (i.e., ADaM).
RECIST 1.1 recommends using a standardized value of 5 mm 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 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 supplemental qualifier for "Reason Response Not Evaluable" (RSREASNE) 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 reason that the tumor was not evaluable. This modeling does not always explicitly or consistently identify the tumors which are not evaluable but some of the examples include "NOT EVALUABLE" in 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 an RS record with RSTEST = "Overall Response", RSORRES = "NED", and RSSTRESC = "NED".
Per the SDTMIG, "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 how to populate it when there is more than 1 evaluation date. In the RS examples, when there are multiple dates of evaluation performed as part of the disease assessment timepoint, 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), 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 (e.g., duration of response, progression-free survival), it is generally considered conservative to assign a negative outcome (e.g., disease progression) to the date the assessment is initiated but not to assign a date to a positive response until the assessment is completed. For SD (Stable Disease), different conventions have been used in industry and the rationale varies. For the examples in this supplement, the convention used for SD is to assign the earliest date to RSDTC. However, picking the latest date is acceptable and a common approach. 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, 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 TRDTC populated.
Note that:
Examples in this 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.
Examples in this 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: Investigator Assessment of Subject with Lymph Nodes as Target Lesions
This RECIST 1.1 example shows investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data. In this example, lymph nodes are selected as target lesions. The tumor identifier is in TULNKID and matches TRLNKID 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 following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for 1 subject collected at the week 6, week 12, and subsequent 8-week follow-up visits. Note: Sponsors 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.
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. RSLNKGRP is populated on the Overall Response record only and 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.
The following supprs.xpt table shows the data on the reason that the response was not evaluable (QNAM = "RSREASNE") in the case where the reason is collected.
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 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.
The following supptu.xpt table shows the data on whether a tumor was previously irradiated (QNAM = "TUPRVIR") and whether that tumor was shown to be progressing since it was irradiated (QNAM = "TUPRVIRP").
Rows 1-3:
Show that the target lesions with TUSEQ = "1", "2", and "3" were 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.
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX11111
TU
90001
TUSEQ
1
TUPRVIR
Previously Irradiated Indicator
N
CRF
2
EX11111
TU
90001
TUSEQ
2
TUPRVIR
Previously Irradiated Indicator
N
CRF
3
EX11111
TU
90001
TUSEQ
3
TUPRVIR
Previously Irradiated Indicator
N
CRF
4
EX11111
TU
90001
TUSEQ
4
TUPRVIR
Previously Irradiated Indicator
Y
CRF
5
EX11111
TU
90001
TUSEQ
4
TUPRVIRP
Previously Irradiated Progression
Y
CRF
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4.1.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at screening, week 6, week 12, and subsequent 8-week follow-up visits. This example 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.
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
The following table shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for 1 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 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").
This example illustrates 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 TRLNKID in the TR domain.
4.2.1 RS Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows response data for 1 subject collected at the week 8 and subsequent 8-week follow-up visits: target response (RSTESTCD = "TRGRESP"), non-target response (RSTESTCD = "NTRGRESP"), and overall response (RSTESTCD = "OVRLRESP"). RSLNKGRP is used to link the overall response to the underlying assessments in the TR domain which support the overall response at the assessment.
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 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 sponsor's internal tracking identifier.
Rows 7-8:
Show the identification of a split tumor when it was first identified as split (fragmented). In this example, tumor T04 splits into 2 tumors (T04.1, T04.2); TUGRPID = "T04" provides traceability and links the split tumor to its parent record.
Row 9:
Shows the identification of a merged tumor when it was first identified as merged (coalesced). In this example, tumors T02 and T03 merged into tumor T02/T03; TULNKID = "T02/T03" is a combination of the child tumors and provides the traceability back to the child tumors.
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 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 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 = "SUMDIAM" is used for the assessments. Note that sponsors 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 (TRSTAT = "NOT DONE" and 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:
Show the tumor state of the new tumor NEW01 and its longest diameter.
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
4.3 Example 3: Scans Either Not Done or Not Evaluable
This example shows investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data.
4.3.1 RS Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for 1 subject collected at week 8 and subsequent 8-week follow-up visits. The overall response (RSTESTCD = "OVRLRESP") has RSORRES = "NE" because the scans of the target and non-target lesions were not done.
The following table 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 TRLNKID in the TR domain. This example shows a subject with 4 target lesions (TULNKID = "T01"-"T04") and 3 non-target lesions (TULNKID = "NT01"-"NT03") identified at screening. The subject did not have any new lesions.
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This 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.
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
4.4 Example 4: Accepted Record Flag for Multiple Independent Assessors
This example shows 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 following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for 1 subject collected at week 8 and week 16.
The acceptance flag (RSACPTFL) is used to identify records when multiple assessments are performed by independent assessors (i.e., radiologist 1, radiologist 2) for the same timepoint. RSACPTFL indicates the "selected" response when more than 1 reading 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 selected 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.
This example uses RSNAM (name of the vendor), RSEVAL (role of the person providing the assessment; i.e., "INDEPENDENT ASSESSOR"), and RSEVALID (specific type of medical reviewer who performed the independent assessment). In this case, 2 radiologists independently reviewed the scans (RSEVALID = "RADIOLOGIST 1", "RADIOLOGIST 2"). The acceptance flag (RSACPTFL) indicates that the "RADIOLOGIST 2" records are the accepted records (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.
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the use of the acceptance flag (TUACPTFL) to identify records when multiple assessments are performed by independent assessors (i.e., radiologist 1, radiologist 2) for the same timepoint. The acceptance flag indicates records which are chosen by an adjudicator. Not all sponsors have both sets of independent reviews exported (i.e., only accepted records are transferred). It is not expected that TUACPTFL would be populated by the sponsor; this type of record selection or censoring would be part of the analysis dataset. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain.
Rows 1-3:
Show the identification of 2 target lesions (R1-T01, R1-T02) and 1 non-target lesion (R1-NT01) by radiologist 1 (TUEVALID).
Rows 4-6:
Show the identification of 2 target lesions (R1-T01, R1-T02) and 1 non-target lesion (R2-NT01) by radiologist 2 (TUEVALID).
The following supptu.xpt table shows the textual data on the location detail (QNAM = "TULOCDTL").
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.
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX44444
TU
90004
TUSEQ
1
TULOCDTL
Location Detail
Segment 5
CRF
2
EX44444
TU
90004
TUSEQ
3
TULOCDTL
Location Detail
Back of the abdomen
CRF
3
EX44444
TU
90004
TUSEQ
5
TULOCDTL
Location Detail
Lower part of Segment 5
CRF
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4.4.3 TR Domain Model
The following table 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 (i.e., radiologist 1, radiologist 2) for the same timepoint. It is not expected that TUACPTFL would be populated by the sponsor; this 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 sponsors 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 2 radiologists independently reviewed the scans. TRLNKGRP = "R1-A2", "R1-A3" indicate assessments by radiologist 1, which are linked to the results determined by that radiologist in RS. Likewise, the values "R2-A2" and "R2-A3" indicate assessments by radiologist 2, which are linked to the results determined by that radiologist 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
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
EX44444
TR
90004
1
TARGET
R1-A1
R1-T01
LDIAM
Longest Diameter
15
mm
15
15
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREENING
2007-01-02
1
2
EX44444
TR
90004
2
TARGET
R1-A1
R1-T02
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREENING
2007-01-02
1
3
EX44444
TR
90004
3
TARGET
R1-A1
SUMDIAM
Sum of Diameter
40
mm
40
40
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREENING
2007-01-02
1
4
EX44444
TR
90004
4
NON-TARGET
R1-A1
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREENING
2007-01-02
1
5
EX44444
TR
90004
5
TARGET
R1-A2
R1-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
6
EX44444
TR
90004
6
TARGET
R1-A2
R1-T02
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
7
EX44444
TR
90004
7
TARGET
R1-A2
SUMDIAM
Sum of Diameter
35
mm
35
35
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
8
EX44444
TR
90004
8
TARGET
R1-A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-13
%
-13
-13
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
9
EX44444
TR
90004
9
TARGET
R1-A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-13
%
-13
-13
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
10
EX44444
TR
90004
10
NON-TARGET
R1-A2
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
11
EX44444
TR
90004
11
TARGET
R1-A3
R1-T01
LDIAM
Longest Diameter
5
mm
5
5
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
12
EX44444
TR
90004
12
TARGET
R1-A3
R1-T02
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
13
EX44444
TR
90004
13
TARGET
R1-A3
SUMDIAM
Sum of Diameter
15
mm
15
15
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
14
EX44444
TR
90004
14
TARGET
R1-A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-63
%
-63
-63
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
15
EX44444
TR
90004
15
TARGET
R1-A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-57
%
-57
-57
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
16
EX44444
TR
90004
16
NON-TARGET
R1-A3
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
17
EX44444
TR
90004
17
TARGET
R2-A1
R2-T01
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREENING
2007-01-02
1
18
EX44444
TR
90004
18
TARGET
R2-A1
R2-T02
LDIAM
Longest Diameter
20
mm
20
20
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREENING
2007-01-02
1
19
EX44444
TR
90004
19
TARGET
R2-A1
SUMDIAM
Sum of Diameter
45
mm
45
45
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREENING
20
EX44444
TR
90004
20
NON-TARGET
R2-A1
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREENING
2007-01-02
1
21
EX44444
TR
90004
21
TARGET
R2-A2
R2-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
22
EX44444
TR
90004
22
TARGET
R2-A2
R2-T02
LDIAM
Longest Diameter
8
mm
8
8
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
23
EX44444
TR
90004
23
TARGET
R2-A2
SUMDIAM
Sum of Diameter
18
mm
18
18
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
24
EX44444
TR
90004
24
TARGET
R2-A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-60
%
-60
-60
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
25
EX44444
TR
90004
25
TARGET
R2-A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-60
%
-60
-60
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
26
EX44444
TR
90004
26
NON-TARGET
R2-A2
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
27
EX44444
TR
90004
27
TARGET
R2-A3
R2-T01
LDIAM
Longest Diameter
15
mm
15
15
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
28
EX44444
TR
90004
28
TARGET
R2-A3
R2-T02
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
29
EX44444
TR
90004
29
TARGET
R2-A3
SUMDIAM
Sum of Diameter
20
mm
20
20
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
30
EX44444
TR
90004
30
TARGET
R2-A3
PCBSD
Percent Change From Baseline in Sum of Longest Diameter
-56
%
-56
-56
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
31
EX44444
TR
90004
31
TARGET
R2-A3
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
4.5 Example 5: Subject with One Target Tumor at Screening and an Unscheduled Assessment
This example shows investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the data for a subject who has 1 target tumor and no non-targets at screening (i.e., a subject with target tumors only). This example includes an unscheduled assessment.
4.5.1 RS Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator response data for a subject who 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 has 1 target lesion and no non-targets. The non-target response (RSTESTCD = "NTRGRESP") is not applicable; a record may be included to represent this, if desired.
Rows 3-4:
Show an unscheduled response assessment at week 13, which was done to confirm the complete response ("CR"). The RSLNKGRP differentiates the assessment and VISIT = "UNSCHEDULED WEEK 13".
Rows 5-6:
Show that target response (RSTESTCD = "TRGRESP") and overall response (RSTESTCD = "OVRLRESP") were not evaluable (RSSTRESC = "NE") due to an unreadable image.
The following supprs.xpt table shows the data on the reason that the response was not evaluable (QNAM = "RSREASNE") in the case where it is collected.
$titleHtml
supprs.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX55555
RS
90005
RSSEQ
6
RSREASNE
Reason Response Not Evaluable
Imaging Quality Issues
CRF
$warningHtml
4.5.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject who has only target tumors at screening. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain.
Row 1:
Shows that the subject has at least 1 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 has 1 target lesion and no non-targets.
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows investigator tumor results for a subject who has only target tumors at screening. This example 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 has 1 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.
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
4.6 Example 6: Investigator-assessed RECIST 1.1 Measurements Along with Independent Assessor Volumetric Measurements
This example shows 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 measurements along with the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.
4.6.1 RS Domain Model
The following table 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").
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows investigator and independent radiologist's tumor identification, and includes the identification of a new tumor; the investigator only identified the new tumor, and the independent assessor identified and measured it. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain.
Rows 1-5:
Show the identification of 3 target lesions (T01, T02, T03), and 2 non-target lesions (NT01, NT02) by the investigator.
Rows 6-7:
Show the identification of 2 target lesions (R-T01, R-T02) by the independent radiologist.
Row 8:
Shows the identification of a new tumor by the investigator (NEW01).
Row 9:
Shows the identification of a new tumor by the independent radiologist (R-NEW01).
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows both investigator and independent radiologist tumor results. The independent radiologist's tumor results are based on bidimensional and volumetric measurements. This example also includes the situation where new tumors are measured by the independent radiologist.
Rows 1-6, 18-23, 38-39:
Show longest diameter, sum of longest diameter, and tumor state for investigator assessments at screening, cycle 2, and cycle 3.
Rows 7-17, 24-37, 40-44:
Show the volumetric measurements at screening, cycle 2, and cycle 3 from the independent radiologist.
4.7 Example 7: Subject with Non-target Disease Only
This example shows 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 (i.e., subject does not have target tumors). The tumor identifier is in TULNKID and matches TRLNKID 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 following table 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 does not have target lesions at baseline (target response is not applicable). This example also shows an "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. 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 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". Note that "NE" is a valid Overall Response value per the RECIST 1.1 criteria; 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 progressive disease, which results in an Overall Response (RSTESTCD = "OVRLRESP") of "PD".
The following supprs.xpt table shows the data on the reason that the response was not evaluable (QNAM = "RSREASNE") in the case where the reason is collected.
$titleHtml
supprs.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX77777
RS
90005
RSSEQ
5
RSREASNE
Reason Response Not Evaluable
Imaging Quality Issues
CRF
$warningHtml
4.7.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject who has only non-target tumors at screening.
Row 1:
Shows that the subject has no target tumors (TUTESTCD = "TIND").
Row 2:
Shows that the subject has non-target tumors (TUTESTCD = "NTIND").
Rows 3-5:
Show the identification of 3 non-target lesions for a subject with non-target disease only. See below for details on on the tumor presentation type (QNAM = "TUPRTYP") supplemental qualifier.
The following supptu.xpt table shows the data describing the disease presentation of non-target tumors. The tumor presentation type (QNAM = "TUPRTYP") 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.
Row 1:
Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis; for the non-target site in the brain (TULNKID = "NT01"), QVAL = "LEPTOMENINGEAL DISEASE".
Rows 2-3:
Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified.
Rows 4-5:
Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the skeletal muscle tissue non-target lesion (TULNKID = "NT02") was identified.
Row 6:
Shows that the presentation of the disease in the pericardium is effusion; for the non-target site in the pericardium (TULNKID = "NT03"), QVAL = "EFFUSION".
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 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, NT03) at screening and week 6.
Rows 7-9:
Show the week 12 assessments. Row 7 shows the assessment of non-target lesion NT01 in the brain; rows 8 and 9 indicate that assessments of 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").
Rows 10-11:
Show that at the week 20 assessment, NT01 and NT02 were enlarged from a previous smallest size (i.e., TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR").
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
The following table shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for 1 subject collected at 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. Per protocol, non-target lesions in the brain were assessed using MRI as the primary method of assessment. Correlative imaging is used in addition to the primary method for the RECIST 1.1 evaluation in order to assess brain lesions. The primary method of assessment (i.e., MRI) in represented in the TU and TR domains, along with assessment results. Correlative imaging (e.g., CT scan) is represented only in the PR domain. The image identifier is in PRREFID.
Rows 1-2:
Show the scans performed 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 performed at the disease assessments at weeks 6, 12, and 20.
The following supppr.xpt table shows the data to represent the multiple locations covered by the MRI. The anatomical location supplemental qualifiers (QNAM = "PRLOC1", "PRLOC2") 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 = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST".
Row 3:
Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at screening for PRSEQ = "1".
Rows 4-5:
Show the 2 locations of the MRI at week 6 for PRSEQ = "3" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST".
Row 6:
Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 6 for PRSEQ = "3".
Rows 7-8:
Show the 2 locations of the MRI at week 12 for PRSEQ = "5" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST".
Row 9:
Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 12 for PRSEQ = "5".
Row 10:
Shows the overall image quality issue (QNAM = "PROIQ") of the MRI at week 12 for PRSEQ = "5".
4.8 Example 8: Bone Scans Not Required at Each Disease Assessment
This example shows 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 TRLNKID in the TR domain.
4.8.1 RS Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for 1 subject collected at weeks 12 and 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 complete response. Therefore, the non-target response (RSTESTCD = "NTRGRESP") is not evaluable (RSSTRESC = "NE") because scintigraphy of the bone was not performed at this visit (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).
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 subject collected at screening, including the identification of a target tumor (R-T01) in the liver and the assessment of 2 non-target tumors (R-NT01, R-NT02) in the bone and pleural cavity, respectively, at screening.
The following supptu.xpt table shows the data describing the disease presentation of a non-target tumor. The tumor presentation type supplemental qualifier (QNAM = "TUPRTYP") is used and controlled terminology is available (DSPRTYP). The presentation of the disease in the pleural cavity is effusion; for the non-target site in the pleural cavity (TULOC = "PLEURAL CAVITY" and TULNKID = "NT02"), QVAL = "EFFUSION".
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX88888
TU
900080
TUSEQ
3
TUPRTYP
Tumor or Lesion Presentation Type
EFFUSION
CRF
$warningHtml
4.8.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at screening, week 12, and week 24. This 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 a 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 sponsors 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 target tumor (R-T01) in the liver and the assessments of the 2 non-target lesions (R-NT01, R-NT02) in the bone and pleural cavity at screening.
Rows 5-11:
Show the measurement of the target tumor (R-T01) and the tumor state of 1 non-target tumor (R-NT02) in the pleural cavity at week 12. Per protocol, scintigraphy was only to be performed every 6 months or in order to verify a complete response; therefore, scintigraphy of non-target R-NT01 in the bone was not performed at week 12 (TRSTAT = "NOT DONE" and TRREASND = "SCAN NOT PERFORMED").
Rows 12-18:
Show that, at week 24, the target lesion (R-T01) was absent (i.e., DIAMETER = "0"); non-targets R-NT01 and R-NT02 also were absent (TRTESTCD = "TUMSTATE" with TRORRES = "ABSENT"). Scintigraphy was performed in order to verify the overall response of CR (Complete Response).
The following table shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for 1 subject collected at screening, week 12, and week 24. Per protocol, non-target lesions in the bone were assessed using scintigraphy as the primary method of assessment. Correlative imaging was used in addition to the primary method for the RECIST 1.1 evaluation in order to more closely assess 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 correlative imaging were not required at every disease assessment per protocol. However, often 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 ; 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.
The following supppr.xpt table shows the data to represent the multiple locations covered by the CT SCAN. The anatomical location supplemental qualifiers (QNAM = "PRLOC1" and QNAM = "PRLOC2") are used and controlled terminology is available (LOC).
Rows 1-2:
Show the 2 locations of the CT scan for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "CHEST" and QNAM = "PRLOC2" with QVAL = "ABDOMEN".
Rows 3-6:
Show the 2 locations of the CT scan for PRSEQ 4 and 7.
This example shows an assessment where the independent radiologist found no evidence of disease at baseline.
4.9.1 RS Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data collected for 1 subject at screening; the independent radiologist found no evidence of disease at baseline (RSSTRESC = "NED"). This a rare case where a response assessment would be recorded based on the screening assessment. RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA" was used to indicate that this result is not based on RECIST 1.1. In this example, there are no data in TU or TR, because no tumors were identified.
4.10 Example 10: Enlargement from Nadir of a Single Non-target
This example shows response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. In this situation, enlargement from nadir of a single non-target lesion/tumor does not necessarily mean that the non-target response is progressive disease.
4.10.1 RS Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for 1 subject collected at 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 assessment of the non-target lesions/tumors taken collectively. In this case, 1 of the non-targets is absent and 1 of the non-targets has enlarged from nadir. The overall response is PR (Partial Response).
Rows 4-6:
Show the target response, non-target response, and overall response at week 24. The target response of CR (Complete Response) is based on the PCBSD of -100%. The non-target response of SD (Stable Disease) is based on assessment of the non-target lesions/tumors taken collectively. In this case, 1 of the non-targets is absent and 1 of the non-targets is still present. The overall response is PR (Partial Response).
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 subject with target and non-target tumors identified at screening. The subject has 1 target lesion (TULNKID = "R-T01") and 2 non-target lesions/sites (R-NT01, R-NT02) identified at screening. T01 and R-NT01 are located in the liver, and R-NT02 is located in the chest wall.
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at the screening, week 12, and subsequent 12-week follow-up visits.
In this example, 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 sponsors 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 target tumor and the tumor states of the non-targets at week 12. R-T01 shows a decrease from 17mm at baseline to 7mm, which is a 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 the non-targets at week 24. R-T01 is absent (LDIAM = "0"), which is a PCBSD of -100%. R-NT01 remains TUMSTATE = "ABSENT" and R-NT02 has a TUMSTATE = "PRESENT".
tr.xpt
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRNAM
TRMETHOD
TREVAL
TREVALID
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
EX01010
TR
90010
1
TARGET
R-A1
R-T01
LDIAM
Longest Diameter
17
mm
17
17
mm
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
2
EX01010
TR
90010
2
TARGET
R-A1
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
3
EX01010
TR
90010
3
NON-TARGET
R-A1
R-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
4
EX01010
TR
90010
4
NON-TARGET
R-A1
R-NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
5
EX01010
TR
90010
5
TARGET
R-R-A2
R-T01
LDIAM
Longest Diameter
7
mm
7
7
mm
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
6
EX01010
TR
90010
6
TARGET
R-A2
SUMDIAM
Sum of Diameter
7
mm
7
7
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
7
EX01010
TR
90010
7
TARGET
R-A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
8
EX01010
TR
90010
8
TARGET
R-A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-59
%
-59
-59
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
9
EX01010
TR
90010
9
TARGET
R-A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-59
%
-59
-59
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
10
EX01010
TR
90010
10
NON-TARGET
R-A2
R-NT01
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
11
EX01010
TR
90010
11
NON-TARGET
R-A2
R-NT02
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
12
EX01010
TR
90010
12
TARGET
R-A3
R-T01
LDIAM
Longest Diameter
0
mm
0
0
mm
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
13
EX01010
TR
90010
13
TARGET
R-A3
SUMDIAM
Sum of Diameter
0
mm
0
0
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
14
EX01010
TR
90010
14
TARGET
R-A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-17
mm
-17
-17
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
15
EX01010
TR
90010
15
TARGET
R-A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-100
%
-100
-100
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
16
EX01010
TR
90010
16
TARGET
R-A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-100
%
-100
-100
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
17
EX01010
TR
90010
17
NON-TARGET
R-A3
R-NT01
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
18
EX01010
TR
90010
18
NON-TARGET
R-A3
R-NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
4.11 Example 11: Independent Assessment of Subject with Lymph Nodes as Target Lesions
This example shows response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data based on an independent assessment. In this example, 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 following table shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for 1 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 resposne (RSTESTCD = "NTRGRESP") tests and corresponding overall response (RSTESTCD = "OVRLRESP") at the week 6 assessment. RSLNKGRP is populated on the Overall Response record only, and 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.
Rows 13-20:
At week 36, the new lesion progression test (RSTESTCD = "NEWLPROG") 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
rs.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKGRP
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
EX11111
RS
90011
1
TRGRESP
Target Response
RECIST 1.1
NE
NE
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
2
EX11111
RS
90011
2
NTRGRESP
Non-Target Response
RECIST 1.1
NE
NE
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
3
EX11111
RS
90011
3
R-A2
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
4
EX11111
RS
90011
4
TRGRESP
Target Response
RECIST 1.1
SD
SD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
5
EX11111
RS
90011
5
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
6
EX11111
RS
90011
6
R-A3
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
7
EX11111
RS
90011
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
8
EX11111
RS
90011
8
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
9
EX11111
RS
90011
9
R-A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
10
EX11111
RS
90011
10
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-25
203
11
EX11111
RS
90011
11
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-25
203
12
EX11111
RS
90011
12
R-A5
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-25
203
13
EX11111
RS
90011
13
TRGRESP
Target Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
14
EX11111
RS
90011
14
NTRGRESP
Non-Target Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
15
EX11111
RS
90011
15
NEWLPROG
New Lesion Progression
RECIST 1.1
EQUIVOCAL
EQUIVOCAL
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
16
EX11111
RS
90011
16
R-A6
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
17
EX11111
RS
90011
17
TRGRESP
Target Response
RECIST 1.1
PD
PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
18
EX11111
RS
90011
18
NTRGRESP
Non-Target Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
19
EX11111
RS
90011
19
NEWLPROG
New Lesion Progression
RECIST 1.1
UNEQUIVOCAL
UNEQUIVOCAL
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
20
EX11111
RS
90011
20
R-A7
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
4.11.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 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 (TULNKID = "R-T01"-"R-T04") and 2 non-target lesions (TULNKID = "R-NT01" and "R-NT02") identified at screening. Target lesions R-T01 and R-T02 are located in the lymph nodes; R-T01 in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). 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. Laterality and directionality should not generally be added to TULOC unless in the controlled terminology.
Row 7:
Shows that, 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.
Rows 8-9:
Show that, 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
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TUREFID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TULOC
TULAT
TUDIR
TUMETHOD
TUNUM
TUEVAL
TUEVALID
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
EX11111
TU
90011
1
IMG-00001
R-T01
TUMIDENT
Tumor Identification
TARGET
TARGET
SUPRACLAVICULAR LYMPH NODE
RIGHT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
-3
2
EX11111
TU
90011
2
IMG-00002
R-T02
TUMIDENT
Tumor Identification
TARGET
TARGET
THORACIC LYMPH NODE
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
3
EX11111
TU
90011
3
IMG-00001
R-T03
TUMIDENT
Tumor Identification
TARGET
TARGET
THYROID GLAND
LEFT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
-3
4
EX11111
TU
90011
4
IMG-00003
R-T04
TUMIDENT
Tumor Identification
TARGET
TARGET
SKIN OF THE TRUNK
UPPER
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-03
-1
5
EX11111
TU
90011
5
IMG-00002
R-NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
MEDIASTINAL LYMPH NODE
RIGHT
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
6
EX11111
TU
90011
6
IMG-00001
R-NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CEREBELLUM
RIGHT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
1
7
EX11111
TU
90011
7
IMG-00020
R-NEW01
TUMIDENT
Tumor Identification
NEW
NEW
LUNG, LEFT LOWER LOBE
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
8
EX11111
TU
90011
8
IMG-00019
R-NEW02
TUMIDENT
Tumor Identification
NEW
NEW
CEREBELLUM
LEFT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-18
317
9
EX11111
TU
90011
9
IMG-00022
R-NEW03
TUMIDENT
Tumor Identification
NEW
NEW
FEMORAL LYMPH NODE
LEFT
ULTRASOUND
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-18
317
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
4.11.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. The example shows the data for 1 subject collected at the screening, week 6, week 12, and subsequent 8-week follow-up visits.
This example shows measurements (i.e., longest perpendicular) of lymph nodes as well as measurements (i.e., longest diameter) of other non-lymph node target tumors. 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".
In this example, 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, TRTESTCD = "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.
Row 16:
Shows a case where TRSTAT = "NOT DONE". TRREASND contains the reason for this result; for TRTEST = "Longest Diameter", the scan was 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 = "NOT DONE" and TRREASND contains the reason (in this case, at least 1 target lesion was not measured).
Rows 22-23:
Show that, at week 6, R-NT02 was not evaluable, while providing results for R-NT01 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
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRMETHOD
TRNAM
TREVAL
TREVALID
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
EX11111
TR
90011
1
TARGET
IMG-00001
R-A1
R-T01
LPERP
Longest Perpendicular
17
mm
17
17
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
-3
2
EX11111
TR
90011
2
TARGET
IMG-00001
R-A1
R-T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
-3
3
EX11111
TR
90011
3
TARGET
IMG-00002
R-A1
R-T02
LPERP
Longest Perpendicular
16
mm
16
16
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
4
EX11111
TR
90011
4
TARGET
IMG-00002
R-A1
R-T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
5
EX11111
TR
90011
5
TARGET
IMG-00001
R-A1
R-T03
LDIAM
Longest Diameter
15
mm
15
15
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
-3
6
EX11111
TR
90011
6
TARGET
IMG-00003
R-A1
R-T04
LDIAM
Longest Diameter
14
mm
14
14
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-03
-1
7
EX11111
TR
90011
7
TARGET
R-A1
SUMDIAM
Sum of Diameter
62
mm
62
62
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
8
EX11111
TR
90011
8
TARGET
R-A1
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
29
mm
29
29
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
9
EX11111
TR
90011
9
NON-TARGET
IMG-00002
R-A1
R-NT01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
10
EX11111
TR
90011
10
NON-TARGET
IMG-00001
R-A1
R-NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
-3
11
EX11111
TR
90011
11
TARGET
IMG-00004
R-A2
R-T01
LPERP
Longest Perpendicular
12
mm
12
12
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
12
EX11111
TR
90011
12
TARGET
IMG-00004
R-A2
R-T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
13
EX11111
TR
90011
13
TARGET
IMG-00005
R-A2
R-T02
LPERP
Longest Perpendicular
12
mm
12
12
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
14
EX11111
TR
90011
14
TARGET
IMG-00005
R-A2
R-T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
15
EX11111
TR
90011
15
TARGET
IMG-00004
R-A2
R-T03
LDIAM
Longest Diameter
14
mm
14
14
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
16
EX11111
TR
90011
16
TARGET
R-A2
R-T04
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
17
EX11111
TR
90011
17
TARGET
R-A2
SUMDIAM
Sum of Diameter
52
mm
52
52
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
18
EX11111
TR
90011
18
TARGET
R-A2
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
28
mm
28
28
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
19
EX11111
TR
90011
19
TARGET
R-R-A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
20
EX11111
TR
90011
20
TARGET
R-A2
PCBSD
Percent Change From Baseline in Sum of Diameter
NOT DONE
At least one target lesions was not measured
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
21
EX11111
TR
90011
21
TARGET
R-A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-16
%
-16
-16
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
22
EX11111
TR
90011
22
NON-TARGET
IMG-00005
R-A2
R-NT01
LNSTATE
Lymph Node State
NOT DONE
NOT EVALUABLE
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
23
EX11111
TR
90011
23
NON-TARGET
IMG-00004
R-A2
R-NT02
TUMSTATE
Tumor State
NOT DONE
NOT EVALUABLE
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
24
EX11111
TR
90011
24
TARGET
IMG-00007
R-A3
R-T01
LPERP
Longest Perpendicular
12
mm
12
12
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
25
EX11111
TR
90011
25
TARGET
IMG-00007
R-A3
R-T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
26
EX11111
TR
90011
26
TARGET
IMG-00008
R-A3
R-T02
LPERP
Longest Perpendicular
12
mm
12
12
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
27
EX11111
TR
90011
27
TARGET
IMG-00008
R-A3
R-T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
28
EX11111
TR
90011
28
TARGET
IMG-00007
R-A3
R-T03
LDIAM
Longest Diameter
15
mm
15
15
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
29
EX11111
TR
90011
29
TARGET
IMG-00009
R-A3
R-T04
LDIAM
Longest Diameter
8
mm
8
8
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-04-01
87
30
EX11111
TR
90011
30
TARGET
R-A3
SUMDIAM
Sum of Diameter
47
mm
47
47
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
31
EX11111
TR
90011
31
TARGET
R-A3
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
23
mm
23
23
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
32
EX11111
TR
90011
32
TARGET
R-R-A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-5
mm
-5
-5
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
33
EX11111
TR
90011
33
TARGET
R-A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-24
%
-24
-24
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
34
EX11111
TR
90011
34
TARGET
R-A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-9
%
-9
-9
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
35
EX11111
TR
90011
35
NON-TARGET
IMG-00008
R-A3
R-NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
36
EX11111
TR
90011
36
NON-TARGET
IMG-00007
R-A3
R-NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
37
EX11111
TR
90011
37
TARGET
IMG-00010
R-A4
R-T01
LPERP
Longest Perpendicular
9
mm
9
9
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
38
EX11111
TR
90011
38
TARGET
IMG-00010
R-A4
R-T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
39
EX11111
TR
90011
39
TARGET
IMG-00011
R-A4
R-T02
LPERP
Longest Perpendicular
12
mm
12
12
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
40
EX11111
TR
90011
40
TARGET
IMG-00011
R-A4
R-T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
41
EX11111
TR
90011
41
TARGET
IMG-00010
R-A4
R-T03
LDIAM
Longest Diameter
11
mm
11
11
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
42
EX11111
TR
90011
42
TARGET
IMG-00012
R-A4
R-T04
LDIAM
Longest Diameter
5
mm
5
5
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
43
EX11111
TR
90011
43
TARGET
R-A4
SUMDIAM
Sum of Diameter
37
mm
37
37
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
44
EX11111
TR
90011
44
TARGET
R-A4
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
16
mm
16
16
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
45
EX11111
TR
90011
45
TARGET
R-A4
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
46
EX11111
TR
90011
46
TARGET
R-A4
PCBSD
Percent Change From Baseline in Sum of Diameter
-40
%
-40
-40
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
47
EX11111
TR
90011
47
TARGET
R-A4
PCNSD
Percent Change From Nadir in Sum of Diameter
-21
%
-21
-21
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
48
EX11111
TR
90011
48
NON-TARGET
IMG-00011
R-A4
R-NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
49
EX11111
TR
90011
49
NON-TARGET
IMG-00010
R-A4
R-NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
50
EX11111
TR
90011
50
TARGET
IMG-00013
R-A5
R-T01
LPERP
Longest Perpendicular
9
mm
9
9
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
51
EX11111
TR
90011
51
TARGET
IMG-00013
R-A5
R-T01
LPERP
Longest Perpendicular
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
52
EX11111
TR
90011
52
TARGET
IMG-00014
R-A5
R-T02
LDIAM
Longest Diameter
8
mm
8
8
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
53
EX11111
TR
90011
53
TARGET
IMG-00014
R-A5
R-T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
54
EX11111
TR
90011
54
TARGET
IMG-00013
R-A5
R-T03
LDIAM
Longest Diameter
6
mm
6
6
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
55
EX11111
TR
90011
55
TARGET
IMG-00015
R-A5
R-T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-25
203
56
EX11111
TR
90011
56
TARGET
R-A5
SUMDIAM
Sum of Diameter
23
mm
23
23
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
57
EX11111
TR
90011
57
TARGET
R-A5
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
6
mm
6
6
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
58
EX11111
TR
90011
58
TARGET
R-A5
ACNSD
Absolute Change From Nadir in Sum of Diameter
-14
mm
-14
-14
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
59
EX11111
TR
90011
59
TARGET
R-A5
PCBSD
Percent Change From Baseline in Sum of Diameter
-62
%
-62
-62
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
60
EX11111
TR
90011
60
TARGET
R-A5
PCNSD
Percent Change From Nadir in Sum of Diameter
-37
%
-37
-37
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
61
EX11111
TR
90011
61
NON-TARGET
IMG-00014
R-A5
R-NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
62
EX11111
TR
90011
62
NON-TARGET
IMG-00013
R-A5
R-NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
63
EX11111
TR
90011
63
TARGET
IMG-00016
R-A6
R-T01
LPERP
Longest Perpendicular
8
mm
8
8
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
64
EX11111
TR
90011
64
TARGET
IMG-00016
R-A6
R-T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
65
EX11111
TR
90011
65
TARGET
IMG-00017
R-A6
R-T02
LPERP
Longest Perpendicular
9
mm
9
9
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
66
EX11111
TR
90011
66
TARGET
IMG-00017
R-A6
R-T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
67
EX11111
TR
90011
67
TARGET
IMG-00016
R-A6
R-T03
LDIAM
Longest Diameter
0
mm
0
0
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
68
EX11111
TR
90011
68
TARGET
IMG-00018
R-A6
R-T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
69
EX11111
TR
90011
69
TARGET
R-A6
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
70
EX11111
TR
90011
70
TARGET
R-A6
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
71
EX11111
TR
90011
71
TARGET
R-A6
ACNSD
Absolute Change From Nadir in Sum of Diameter
-6
mm
-6
-6
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
72
EX11111
TR
90011
72
TARGET
R-A6
PCBSD
Percent Change From Baseline in Sum of Diameter
-72
%
-72
-72
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
73
EX11111
TR
90011
73
TARGET
R-A6
PCNSD
Percent Change From Nadir in Sum of Diameter
-26
%
-26
-26
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
74
EX11111
TR
90011
74
NON-TARGET
IMG-00017
R-A6
R-NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
75
EX11111
TR
90011
75
NON-TARGET
IMG-00016
R-A6
R-NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
76
EX11111
TR
90011
76
NEW
IMG-00017
R-A6
R-NEW01
TUMSTATE
Tumor State
EQUIVOCAL
EQUIVOCAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
77
EX11111
TR
90011
77
TARGET
IMG-00019
R-A7
R-T01
LPERP
Longest Perpendicular
12
mm
12
12
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
78
EX11111
TR
90011
78
TARGET
IMG-00019
R-A7
R-T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
79
EX11111
TR
90011
79
TARGET
IMG-00020
R-A7
R-T02
LPERP
Longest Perpendicular
9
mm
9
9
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
80
EX11111
TR
90011
80
TARGET
IMG-00020
R-A7
R-T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
81
EX11111
TR
90011
81
TARGET
IMG-00019
R-A7
R-T03
LDIAM
Longest Diameter
0
mm
0
0
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
82
EX11111
TR
90011
82
TARGET
IMG-00021
R-A7
R-T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
83
EX11111
TR
90011
83
TARGET
R-A7
SUMDIAM
Sum of Diameter
21
mm
21
21
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
84
EX11111
TR
90011
84
TARGET
R-A7
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
85
EX11111
TR
90011
85
TARGET
R-A7
ACNSD
Absolute Change From Nadir in Sum of Diameter
4
mm
4
4
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
86
EX11111
TR
90011
86
TARGET
R-A7
PCBSD
Percent Change From Baseline in Sum of Diameter
-66
%
-66
-66
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
87
EX11111
TR
90011
87
TARGET
R-A7
PCNSD
Percent Change From Nadir in Sum of Diameter
23
%
23
23
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
88
EX11111
TR
90011
88
NON-TARGET
IMG-00020
R-A7
R-NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
89
EX11111
TR
90011
89
NON-TARGET
IMG-00019
R-A7
R-NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
90
EX11111
TR
90011
90
NEW
IMG-00020
R-A7
R-NEW01
LDIAM
Longest Diameter
8
mm
8
8
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
91
EX11111
TR
90011
91
NEW
IMG-00020
R-A7
R-NEW01
TUMSTATE
Tumor State
UNEQUIVOCAL
UNEQUIVOCAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
92
EX11111
TR
90011
92
NEW
IMG-00019
R-A7
R-NEW02
LDIAM
Longest Diameter
6
mm
6
6
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
93
EX11111
TR
90011
93
NEW
IMG-00019
R-A7
R-NEW02
TUMSTATE
Tumor State
UNEQUIVOCAL
UNEQUIVOCAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
94
EX11111
TR
90011
94
NEW
IMG-00022
R-A7
R-NEW03
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
ULTRASOUND
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The following supptr.xpt table shows the data for the reason that a tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
$titleHtml
supptr.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX11111
TR
90011
TRSEQ
22
TRREASNE
Reason Tumor/Lesion Not Evaluable
Motion issue
CRF
2
EX11111
TR
90011
TRSEQ
23
TRREASNE
Reason Tumor/Lesion Not Evaluable
Motion issue
CRF
$warningHtml
4.11.4 PR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for 1 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 performed at screening. The results of the scans are recorded in TU and TR.
Rows 4-21:
Show the scans performed at weeks 6, 12, 20, 28, 36, and 44. The results of the scans are recorded in TU and TR.
pr.xpt
pr.xpt
Row
STUDYID
DOMAIN
USUBJID
PRSEQ
PRREFID
PRLNKGRP
PRTRT
PRLOC
PRNAM
PREVAL
PREVALID
EPOCH
VISITNUM
VISIT
PRSTDTC
PRSTDY
1
EX11111
PR
90011
1
IMG-00001
R-A1
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-01
-3
2
EX11111
PR
90011
2
IMG-00002
R-A1
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-02
-2
3
EX11111
PR
90011
3
IMG-00003
R-A1
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREENING
2010-01-03
-1
4
EX11111
PR
90011
4
IMG-00004
R-A2
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
5
EX11111
PR
90011
5
IMG-00005
R-A2
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
6
EX11111
PR
90011
6
IMG-00007
R-A3
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
7
EX11111
PR
90011
7
IMG-00008
R-A3
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
8
EX11111
PR
90011
8
IMG-00009
R-A3
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-04-01
87
9
EX11111
PR
90011
9
IMG-00010
R-A4
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
10
EX11111
PR
90011
10
IMG-00011
R-A4
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
11
EX11111
PR
90011
11
IMG-00012
R-A4
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
12
EX11111
PR
90011
12
IMG-00013
R-A5
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
13
EX11111
PR
90011
13
IMG-00014
R-A5
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
14
EX11111
PR
90011
14
IMG-00015
R-A5
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-25
203
15
EX11111
PR
90011
15
IMG-00016
R-A6
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
16
EX11111
PR
90011
16
IMG-00017
R-A6
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
17
EX11111
PR
90011
17
IMG-00018
R-A6
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
18
EX11111
PR
90011
18
IMG-00019
R-A7
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
19
EX11111
PR
90011
19
IMG-00020
R-A7
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
20
EX11111
PR
90011
20
IMG-00021
R-A7
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
21
EX11111
PR
90011
21
IMG-00022
R-A7
ULTRASOUND
PELVIS
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
5 RELREC
This example shows how the RELREC dataset is used for RECIST 1.1 to represent related information between 2 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 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 2 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 2 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 2 rows form the relationship.
$titleHtml
relrec.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
RELTYPE
RELID
1
ABC12345
TU
TULNKID
One
TUTR1
2
ABC12345
TR
TRLNKID
Many
TUTR1
3
ABC12345
TR
TRLNKGRP
Many
TRRS1
4
ABC12345
RS
RSLNKGRP
One
TRRS1
5
ABC12345
PR
PRREFID
One
PRTU1
6
ABC12345
TU
TUREFID
Many
PRTU1
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
6 Non-Standard Variable (NSV) Suffix Names
The following table contains additional standard name codes for use in the Supplemental Qualifiers for SUPPRS, SUPPTU and SUPPPR datasets.