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Title | Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
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CDISC Reference | Disease Response Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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Criteria Short Name | |
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Criteria Permission Status | Exempt from Copyright |
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Team | CDISC Oncology Subteam |
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Supplement Version | 1.0 |
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Status | FINAL |
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Date | 2023-10-31 |
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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.
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Revision History
Date | Version |
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2023-10-31 | 1.0 Final |
© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
1 Introduction
This document describes the CDISC implementation of the Response 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 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 the disease response criteria are meant to be used in conjunction with the SDTMIG. All All CDISC QRS documentation QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.
The CDISC Intellectual Property Policy can be found on the CDISC web site at: https://www.cdisc.org/about/bylaws.
1.1 Representations and Warranties, Limitations of Liability, and Disclaimers
This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.
CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.
Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.
2 Copyright Status
The RECIST Working Group and European Journal of Cancer (EJC) own the copyright for the RECIST 1.1 guidelines and have made the guidelines available for non-commercial purposes exempt from copyright restrictions. All other rights are reserved. CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed data standards for tumor identification, tumor results, and disease response, and applied these to RECIST 1.1.
The CDISC documentation of the criteria consists of: (1) controlled terminology and (2) standard data structures with examples.
Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.
CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the criteria beyond the normal license fees charged by the copyright holder.
References for RECIST 1.1:
- E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij. New response evaluation criteria in solid tumours; Revised RECIST guideline (version 1.1). European Journal of Cancer 2009; 45:228-247.
- https://recist.eortc.org/recist-1-1-2/
3 The Oncology 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) is , a findings domain. The supporting tumor identification of RECIST 1.1 target, non-target, and new tumors are represented in the TU domain.
- Tumor/Lesion Results (TR) is , a findings domain. The The supporting tumor measurements and assessments of the RECIST 1.1 target, non-target, and new tumors are represented in the TR domain.
Note that the Procedures (PR) domain is not required for RECIST 1.1 but it may be used to represent scan data including medical photography data.
These domains are related using RSLNKGRP, TULNKID, TUREFID, TRLNKID, TRLNKGRP, TRREFID, and PRREFID. See Section 5, 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 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.
The CDISC Oncology Codetable (available at https://www.cdisc.org/standards/terminology/controlled-terminology) contains the valid value list for the tests in the TU, TR, and RS domains.
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 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 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 TRLNKIDs in the TR domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
4.1.1 RS Domain Model
The following rs.xpt following table shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain1 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.
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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. |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX11111 | RS | 90001 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 46 | 2 | EX11111 | RS | 90001 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 46 | 3 | EX11111 | RS | 90001 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 46 | 4 | EX11111 | RS | 90001 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-39 | 88 | 5 | EX11111 | RS | 90001 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 88 | 6 | EX11111 | RS | 90001 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 88 | 7 | EX11111 | RS | 90001 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 8 | EX11111 | RS | 90001 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 9 | EX11111 | RS | 90001 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 10 | EX11111 | RS | 90001 | 10 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 204 | 11 | EX11111 | RS | 90001 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 204 | 12 | EX11111 | RS | 90001 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 204 | 13 | EX11111 | RS | 90001 | 13 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 14 | EX11111 | RS | 90001 | 14 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 15 | EX11111 | RS | 90001 | 15 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | EQUIVOCAL | EQUIVOCAL | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 16 | EX11111 | RS | 90001 | 16 | A6 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 17 | EX11111 | RS | 90001 | 17 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 18 | EX11111 | RS | 90001 | 18 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 19 | EX11111 | RS | 90001 | 19 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | UNEQUIVOCAL | UNEQUIVOCAL | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 20 | EX11111 | RS | 90001 | 20 | A7 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 |
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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.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX11111 | RS | 90001 | RSSEQ | 3 | RSREASNE | Reason Response Not Evaluable | Imaging quality issues and not all scan performed | CRF |
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4.1.2 TU Domain Model
The following tu.xpt table shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain1 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.
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Rows 1-6: | Show a subject with 4 target lesions (TULNKIDs TULNKID = "T01"-"T04") and 2 non-target lesions (TULNKIDs TULNKID = "NT01" and , "NT02") identified at screening. "Target lesions T01 " and " T02 " target lesions are lymph nodes. "; T01 " is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). TULOC contains the location from the anatomical location terminology. Note that some locations in controlled terminology contain laterality and/or directionality (as shown in row 7). The laterality Laterality and directionality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality. | Row 7: | Shows that, at week 36, an equivocal new lesion (TULNKID = "NEW01") was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location. | Row 8-9: | Show that, at week 44, new unequivocal new lesions (TULNKID = "NEW02" and TULNKID = , "NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE"). |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUDIR | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX11111 | TU | 90001 | 1 | IMG-00001 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | SUPRACLAVICULAR LYMPH NODE | RIGHT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TU | 90001 | 2 | IMG-00002 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | THORACIC LYMPH NODE |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX11111 | TU | 90001 | 3 | IMG-00001 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | THYROID GLAND | LEFT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 4 | EX11111 | TU | 90001 | 4 | IMG-00003 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | SKIN OF THE TRUNK |
| UPPER | PHOTOGRAPHY | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 5 | EX11111 | TU | 90001 | 5 | IMG-00002 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | MEDIASTINAL LYMPH NODE | RIGHT |
| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 6 | EX11111 | TU | 90001 | 6 | IMG-00001 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | CEREBELLUM | RIGHT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | 1 | 7 | EX11111 | TU | 90001 | 7 | IMG-00020 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LUNG, LEFT LOWER LOBE |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 8 | EX11111 | TU | 90001 | 8 | IMG-00019 | NEW02 | TUMIDENT | Tumor Identification | NEW | NEW | CEREBELLUM | LEFT |
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 9 | EX11111 | TU | 90001 | 9 | IMG-00022 | NEW03 | TUMIDENT | Tumor Identification | NEW | NEW | FEMORAL LYMPH NODE | LEFT |
| ULTRASOUND | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 |
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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").
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Rows 1-3: | Show that the target lesions with TUSEQs equal to 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. |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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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 tr.xpt table shows the terminology used to implement RECIST 1.1 in the TR domain1 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.
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Rows 1-6: | Show the screening assessments of the target lesions. For lymph node target lesions " T01 " and " T02", the TRTESTCD used for the assessments are "LPREP" and "LNSTATE". For non-lymph node target lesions " T03 " and " T04", the TRTESTCD used for the assessments is "LDIAM". | Rows 7-8: | Show the results for the non-targets. " NT01 " is a lymph node where the TRTEST used for the assessments is "Lymph Node State" lymph node state (TRTESTCD = "LNSTATE"). " NT02 " is a non-lymph node where the TRTEST used for the assessments is "Tumor State" tumor state (TRTESTCD = "TUMSTATE"). | Row 14: | Shows a case where the scan was not performed at week 6 (TRTEST = "Longest Diameter", TRSTAT = "NOT DONE" with TRREASND = "SCAN NOT PERFORMED"). | Row 15: | Shows a case where the non-target " NT01 " was not evaluable (TRTEST = "Lymph Node State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE"). | Row 16: | Shows a case where the non-target " NT02 " was not evaluable (TRTEST = "Tumor State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE"). | Row 30: | Shows a that target lesion ("T04") which is T04 was too small to measure (TRORRES = "TOO SMALL TO MEASURE"; TRSTRESC and TRSTRESN are standardized to "5" with TRSTRESU as "mm"). The standardized value of "5" ensures that the sum of diameters includes a value for that lesion because it has not disappeared. The method of standardization of the TRSTRESC and TRSTRESN values is sponsor specific. | Row 58: | Shows a new lesion ("NEW01") which has a measurement of 4 mm. Note that this value is less than 5 mm and has not been reported as "TOO SMALL TO MEASURE"too small to measure. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
---|
1 | EX11111 | TR | 90001 | 1 | TARGET | IMG-00001 | A1 | T01 | LPERP | Longest Perpendicular | 17 | mm | 17 | 17 | mm |
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TR | 90001 | 2 | TARGET | IMG-00001 | A1 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX11111 | TR | 90001 | 3 | TARGET | IMG-00002 | A1 | T02 | LPERP | Longest Perpendicular | 16 | mm | 16 | 16 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 4 | EX11111 | TR | 90001 | 4 | TARGET | IMG-00002 | A1 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX11111 | TR | 90001 | 5 | TARGET | IMG-00001 | A1 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 6 | EX11111 | TR | 90001 | 6 | TARGET | IMG-00003 | A1 | T04 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
|
| PHOTOGRAPHY | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 7 | EX11111 | TR | 90001 | 7 | NON-TARGET | IMG-00002 | A1 | NT01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 8 | EX11111 | TR | 90001 | 8 | NON-TARGET | IMG-00001 | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 9 | EX11111 | TR | 90001 | 9 | TARGET | IMG-00004 | A2 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 10 | EX11111 | TR | 90001 | 10 | TARGET | IMG-00004 | A2 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 11 | EX11111 | TR | 90001 | 11 | TARGET | IMG-00005 | A2 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 12 | EX11111 | TR | 90001 | 12 | TARGET | IMG-00005 | A2 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 13 | EX11111 | TR | 90001 | 13 | TARGET | IMG-00004 | A2 | T03 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 14 | EX11111 | TR | 90001 | 14 | TARGET |
| A2 | T04 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 40 | WEEK 6 |
|
| 15 | EX11111 | TR | 90001 | 15 | NON-TARGET | IMG-00005 | A2 | NT01 | LNSTATE | Lymph Node State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 16 | EX11111 | TR | 90001 | 16 | NON-TARGET | IMG-00004 | A2 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 17 | EX11111 | TR | 90001 | 17 | TARGET | IMG-00007 | A3 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 18 | EX11111 | TR | 90001 | 18 | TARGET | IMG-00007 | A3 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 19 | EX11111 | TR | 90001 | 19 | TARGET | IMG-00008 | A3 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 20 | EX11111 | TR | 90001 | 20 | TARGET | IMG-00008 | A3 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 21 | EX11111 | TR | 90001 | 21 | TARGET | IMG-00007 | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 22 | EX11111 | TR | 90001 | 22 | TARGET | IMG-00009 | A3 | T04 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 23 | EX11111 | TR | 90001 | 23 | NON-TARGET | IMG-00008 | A3 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 24 | EX11111 | TR | 90001 | 24 | NON-TARGET | IMG-00007 | A3 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 25 | EX11111 | TR | 90001 | 25 | TARGET | IMG-00010 | A4 | T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 26 | EX11111 | TR | 90001 | 26 | TARGET | IMG-00010 | A4 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 27 | EX11111 | TR | 90001 | 27 | TARGET | IMG-00011 | A4 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 28 | EX11111 | TR | 90001 | 28 | TARGET | IMG-00011 | A4 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 29 | EX11111 | TR | 90001 | 29 | TARGET | IMG-00010 | A4 | T03 | LDIAM | Longest Diameter | 11 | mm | 11 | 11 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 30 | EX11111 | TR | 90001 | 30 | TARGET | IMG-00012 | A4 | T04 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm |
|
| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 31 | EX11111 | TR | 90001 | 31 | NON-TARGET | IMG-00011 | A4 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 32 | EX11111 | TR | 90001 | 32 | NON-TARGET | IMG-00010 | A4 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 33 | EX11111 | TR | 90001 | 33 | TARGET | IMG-00013 | A5 | T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 34 | EX11111 | TR | 90001 | 34 | TARGET | IMG-00013 | A5 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 35 | EX11111 | TR | 90001 | 35 | TARGET | IMG-00014 | A5 | T02 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 36 | EX11111 | TR | 90001 | 36 | TARGET | IMG-00014 | A5 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 37 | EX11111 | TR | 90001 | 37 | TARGET | IMG-00013 | A5 | T03 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 38 | EX11111 | TR | 90001 | 38 | TARGET | IMG-00015 | A5 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 39 | EX11111 | TR | 90001 | 39 | NON-TARGET | IMG-00014 | A5 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 40 | EX11111 | TR | 90001 | 40 | NON-TARGET | IMG-00013 | A5 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 41 | EX11111 | TR | 90001 | 41 | TARGET | IMG-00016 | A6 | T01 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 42 | EX11111 | TR | 90001 | 42 | TARGET | IMG-00016 | A6 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 43 | EX11111 | TR | 90001 | 43 | TARGET | IMG-00017 | A6 | T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 44 | EX11111 | TR | 90001 | 44 | TARGET | IMG-00017 | A6 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 45 | EX11111 | TR | 90001 | 45 | TARGET | IMG-00016 | A6 | T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 46 | EX11111 | TR | 90001 | 46 | TARGET | IMG-00018 | A6 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 47 | EX11111 | TR | 90001 | 47 | NON-TARGET | IMG-00017 | A6 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 48 | EX11111 | TR | 90001 | 48 | NON-TARGET | IMG-00016 | A6 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 49 | EX11111 | TR | 90001 | 49 | NEW | IMG-00017 | A6 | NEW01 | TUMSTATE | Tumor State | EQUIVOCAL |
| EQUIVOCAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 50 | EX11111 | TR | 90001 | 50 | TARGET | IMG-00019 | A7 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 51 | EX11111 | TR | 90001 | 51 | TARGET | IMG-00019 | A7 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 52 | EX11111 | TR | 90001 | 52 | TARGET | IMG-00020 | A7 | T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 53 | EX11111 | TR | 90001 | 53 | TARGET | IMG-00020 | A7 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 54 | EX11111 | TR | 90001 | 54 | TARGET | IMG-00019 | A7 | T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 55 | EX11111 | TR | 90001 | 55 | TARGET | IMG-00021 | A7 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 56 | EX11111 | TR | 90001 | 56 | NON-TARGET | IMG-00020 | A7 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 57 | EX11111 | TR | 90001 | 57 | NON-TARGET | IMG-00019 | A7 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 58 | EX11111 | TR | 90001 | 58 | NEW | IMG-00020 | A7 | NEW01 | LDIAM | Longest Diameter | 4 | mm | 4 | 4 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 59 | EX11111 | TR | 90001 | 59 | NEW | IMG-00020 | A7 | NEW01 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 60 | EX11111 | TR | 90001 | 60 | NEW | IMG-00019 | A7 | NEW02 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 61 | EX11111 | TR | 90001 | 61 | NEW | IMG-00019 | A7 | NEW02 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 62 | EX11111 | TR | 90001 | 62 | NEW | IMG-00022 | A7 | NEW03 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| ULTRASOUND | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 315 | |
|
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the in the case where the reason is collected.
Dataset wrap |
---|
|
Dataset2 |
---|
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX11111 | TR | 90001 | TRSEQ | 15 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Imaging quality issues | CRF | 2 | EX11111 | TR | 90001 | TRSEQ | 16 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF | 3 | EX11111 | TR | 90001 | TRSEQ | 24 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Imaging quality issues | CRF |
|
|
4.1.4 PR Domain Model
The following pr.xpt table shows table shows the terminology used to implement RECIST implement RECIST 1.1 in 1 in the PR domainPR 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.
Dataset wrap |
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|
Rowcaps |
---|
Rows 1-3: | Show the scans performed at screening. The results of the scans are in TU and TR. | Rows 4-6: | Show that the MRI and CT scan were performed (PROCCUR = "Y") and that the medical photography was not performed (PROCCUR = "N") at week 6. | Rows 7-22: | Show the scans performed at weeks 12, 20, 28, 36, and 44. The results of the scans are in TU and TR. In row 22, a non-RECIST 1.1 method was used and this example shows a way to represent the additional scan in PR (i.e., "ULTRASOUND"). |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRPRESP | PROCCUR | PRLOC | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
---|
1 | EX11111 | PR | 90001 | 1 | IMG-00001 | A1 | MRI | Y | Y | HEAD AND NECK | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | PR | 90001 | 2 | IMG-00002 | A1 | CT SCAN | Y | Y | CHEST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX11111 | PR | 90001 | 3 | IMG-00003 | A1 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 4 | EX11111 | PR | 90001 | 4 | IMG-00004 | A2 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 5 | EX11111 | PR | 90001 | 5 | IMG-00005 | A2 | CT SCAN | Y | Y | CHEST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 6 | EX11111 | PR | 90001 | 6 |
| A2 | PHOTOGRAPHY | Y | N | SKIN OF THE TRUNK | TREATMENT | 40 | WEEK 6 |
|
| 7 | EX11111 | PR | 90001 | 7 | IMG-00007 | A3 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 8 | EX11111 | PR | 90001 | 8 | IMG-00008 | A3 | CT SCAN | Y | Y | CHEST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 9 | EX11111 | PR | 90001 | 9 | IMG-00009 | A3 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 10 | EX11111 | PR | 90001 | 10 | IMG-00010 | A4 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 11 | EX11111 | PR | 90001 | 11 | IMG-00011 | A4 | CT SCAN | Y | Y | CHEST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 12 | EX11111 | PR | 90001 | 12 | IMG-00012 | A4 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 13 | EX11111 | PR | 90001 | 13 | IMG-00013 | A5 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 14 | EX11111 | PR | 90001 | 14 | IMG-00014 | A5 | CT SCAN | Y | Y | CHEST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 15 | EX11111 | PR | 90001 | 15 | IMG-00015 | A5 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 16 | EX11111 | PR | 90001 | 16 | IMG-00016 | A6 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 17 | EX11111 | PR | 90001 | 17 | IMG-00017 | A6 | CT SCAN | Y | Y | CHEST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 18 | EX11111 | PR | 90001 | 18 | IMG-00018 | A6 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 19 | EX11111 | PR | 90001 | 19 | IMG-00019 | A7 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 20 | EX11111 | PR | 90001 | 20 | IMG-00020 | A7 | CT SCAN | Y | Y | CHEST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 21 | EX11111 | PR | 90001 | 21 | IMG-00021 | A7 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 22 | EX11111 | PR | 90001 | 22 | IMG-00022 | A7 | ULTRASOUND |
|
| PELVIS | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
|
4.2 Example 2: Split and Merged Tumors
RECIST 1.1 example to show 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 The tumor identifier is in TULNKID and matches TRLNKIDs in the TR DomainTRLNKID in the TR domain.
4.2.1 RS Domain Model
The rs.xptfollowing table below shows the terminology used to implement implement RECIST 1.1 in the in the RS domaindomain. This example shows response data for one 1 subject collected at the week 8 and subsequent 8-week follow-up visits: Target Response target response (RSTESTCD = "TRGRESP"), Nonnon-Target Response target response (RSTESTCD = "NTRGRESP"), and Overall Response overall response (RSTESTCD = "OVRLRESP"). RSLNKGRP is used to link the Overall Response overall response to the underlying assessments in the TR domain which support the Overall Response overall response at the assessment.
Dataset wrap |
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|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX22222 | RS | 90002 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX22222 | RS | 90002 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX22222 | RS | 90002 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX22222 | RS | 90002 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 5 | EX22222 | RS | 90002 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX22222 | RS | 90002 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX22222 | RS | 90002 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 8 | EX22222 | RS | 90002 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 9 | EX22222 | RS | 90002 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 10 | EX22222 | RS | 90002 | 10 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | 11 | EX22222 | RS | 90002 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | 12 | EX22222 | RS | 90002 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 |
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4.2.2 TU Domain Model
The tu.xptfollowing table below shows the terminology used to implement implement RECIST 1.1 in the in the TU domaindomain. This example shows the data for one 1 subject collected at screening at screening and subsequent visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This example also shows TUREFID used to represent the image identifier and TUSPID used to represent a sponsors sponsor's internal tracking identifier.
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Rows 7-8: | Show the identification of a split tumor when it was first identified as split (fragmented). In this example, TULNKID = "T04" splits into two 2 tumors TULNKID = "T04.1" and TULNKID = "T04.2" with TUGRPID = "T04". TUGRPID = "T04" provides traceability and links the split tumor to its parent records. | Row 9: | Shows the identification of a merged tumor when it was first identified as merged (coalesced). In this example, TULNKID = "T02" and TULNKID = "T03" merged into tumor TULNKID = "T02/T03". The TULNKID is a combination of the child tumors and therefore provides the traceability back to the child tumors. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TUREFID | TUSPID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX22222 | TU | 90002 | 1 |
| IMG-00001 | TRG-SCR-01 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, RIGHT MIDDLE LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX22222 | TU | 90002 | 2 |
| IMG-00001 | TRG-SCR-02 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX22222 | TU | 90002 | 3 |
| IMG-00001 | TRG-SCR-03 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX22222 | TU | 90002 | 4 |
| IMG-00001 | TRG-SCR-04 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX22222 | TU | 90002 | 5 |
| IMG-00001 | NTG-SCR-01 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | LUNG | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX22222 | TU | 90002 | 6 |
| IMG-00001 | NTG-SCR-02 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | LIVER | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX22222 | TU | 90002 | 7 | T04 | IMG-00002 | TRG-W16-07 | T04.1 | TUSPLIT | Tumor Split | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 8 | EX22222 | TU | 90002 | 8 | T04 | IMG-00002 | TRG-W16-08 | T04.2 | TUSPLIT | Tumor Split | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 9 | EX22222 | TU | 90002 | 9 |
| IMG-00003 | TRG-W28-07 | T02/T03 | TUMERGE | Tumor Merged | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 10 | EX22222 | TU | 90002 | 10 |
| IMG-00004 | NWT-W32-01 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LIVER | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | |
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4.2.3 TR Domain Model
The tr.xpt table below shows The following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain1 in the TR domain. This example shows the data for one 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 with traceability with parent lesions. This example shows how to represent data on a single row when a target tumor becomes too small to measure. In terms of RECIST 1.1, the original results would be "TOO SMALL TO MEASURE" and the standard results (TRSTRESN and TRSTRESC) would be "5". In addition, the example represents a situation where a result was not provided because the image was obscured and the tumor was not assessable.
This example shows a situation where the Investigator investigator provided the summary values for Target target lesions as a group (TRGRPID = "TARGET"). The TRTESTCD = "SUMDIAM" is used for the assessments. Note that the sponsor sponsors should not derived these values if they were not part of the data capture.
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Row 11: | Shows the longest diameter of " T04 " at the assessment before it splits. | Rows 18-19: | Show the longest diameters of the split lesions "(T04.1 " and " T04.2" ) at week 16. | Rows 24-25: | Show that tumors " T02 " and " T03 " are no longer measured individually . The (TRSTAT = "NOT DONE" and the TRREASND = "TUMOR MERGED"). These rows are optional and can be included if part of the collection. In the case where a sponsor includes TUMSTATE for target lesions, TUMSTATE may be assigned to "TUMOR MERGED". | Row 26: | Shows the longest diameter of the newly merged " T02/T03 " tumor at week 24. | Rows 27-28: | Show the longest diameters of the split lesions " T04.1 " and " T04.2 " at week 24. | Row 33: | Shows the longest diameter of the newly merged " T02/T03 " tumor at week 32. Sponsors can continue to include individual tumors as not done as in rows 24-25. | Rows 34-35: | Show the longest diameters of the split lesions " T04.1 " and " T04.2 " at week 32. | Row 37: | Shows the Tumor State tumor state of the non-target " NT01 " as enlargement from nadir (TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). This Tumor State tumor state indicates that the non-Target target tumors in the "LUNG" lung have shown enlargement from their previous smallest state. | Rows 39-40: | Show the Tumor State tumor state of the a new tumor " NEW01 " and the its longest diameter of the new tumor. |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX22222 | TR | 90002 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 16 | mm | 16 | 16 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX22222 | TR | 90002 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 28 | mm | 28 | 28 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX22222 | TR | 90002 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 41 | mm | 41 | 41 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX22222 | TR | 90002 | 4 | TARGET | A1 | T04 | LDIAM | Longest Diameter | 83 | mm | 83 | 83 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX22222 | TR | 90002 | 5 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 168 | mm | 168 | 168 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| 6 | EX22222 | TR | 90002 | 6 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 7 | EX22222 | TR | 90002 | 7 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 8 | EX22222 | TR | 90002 | 8 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 9 | EX22222 | TR | 90002 | 9 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 10 | EX22222 | TR | 90002 | 10 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX22222 | TR | 90002 | 11 | TARGET | A2 | T04 | LDIAM | Longest Diameter | 65 | mm | 65 | 65 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 12 | EX22222 | TR | 90002 | 12 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 125 | mm | 125 | 125 | mm |
|
|
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 13 | EX22222 | TR | 90002 | 13 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 14 | EX22222 | TR | 90002 | 14 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 15 | EX22222 | TR | 90002 | 15 | TARGET | A3 | T01 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 16 | EX22222 | TR | 90002 | 16 | TARGET | A3 | T02 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 17 | EX22222 | TR | 90002 | 17 | TARGET | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 18 | EX22222 | TR | 90002 | 18 | TARGET | A3 | T04.1 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 19 | EX22222 | TR | 90002 | 19 | TARGET | A3 | T04.2 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 20 | EX22222 | TR | 90002 | 20 | TARGET | A3 |
| SUMDIAM | Sum of Diameter | 72 | mm | 72 | 72 | mm |
|
|
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| 21 | EX22222 | TR | 90002 | 21 | NON-TARGET | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 22 | EX22222 | TR | 90002 | 22 | NON-TARGET | A3 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 23 | EX22222 | TR | 90002 | 23 | TARGET | A4 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 24 | EX22222 | TR | 90002 | 24 | TARGET | A4 | T02 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | TUMOR MERGED | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 25 | EX22222 | TR | 90002 | 25 | TARGET | A4 | T03 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | TUMOR MERGED | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 26 | EX22222 | TR | 90002 | 26 | TARGET | A4 | T02/T03 | LDIAM | Longest Diameter | 35 | mm | 35 | 35 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 27 | EX22222 | TR | 90002 | 27 | TARGET | A4 | T04.1 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 28 | EX22222 | TR | 90002 | 28 | TARGET | A4 | T04.2 | LDIAM | Longest Diameter | 19 | mm | 19 | 19 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 29 | EX22222 | TR | 90002 | 29 | TARGET | A4 |
| SUMDIAM | Sum of Diameter | 84 | mm | 84 | 84 | mm |
|
|
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 |
|
| 30 | EX22222 | TR | 90002 | 30 | NON-TARGET | A4 | NT01 | TUMSTATE | Tumor State |
|
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| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 31 | EX22222 | TR | 90002 | 31 | NON-TARGET | A4 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 32 | EX22222 | TR | 90002 | 32 | TARGET | A5 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 33 | EX22222 | TR | 90002 | 33 | TARGET | A5 | T02/T03 | LDIAM | Longest Diameter | 80 | mm | 80 | 80 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 34 | EX22222 | TR | 90002 | 34 | TARGET | A5 | T04.1 | LDIAM | Longest Diameter | 49 | mm | 49 | 49 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 35 | EX22222 | TR | 90002 | 35 | TARGET | A5 | T04.2 | LDIAM | Longest Diameter | 26 | mm | 26 | 26 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 36 | EX22222 | TR | 90002 | 36 | TARGET | A5 |
| SUMDIAM | Sum of Diameter | 155 | mm | 155 | 155 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 37 | EX22222 | TR | 90002 | 37 | NON-TARGET | A5 | NT01 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 38 | EX22222 | TR | 90002 | 38 | NON-TARGET | A5 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 39 | EX22222 | TR | 90002 | 39 | NEW | A5 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 40 | EX22222 | TR | 90002 | 40 | NEW | A5 | NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 |
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The following supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the in the case where the reason is collected.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX22222 | TR | 90002 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
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4.3 Example 3 Example 3: Scans Either Not Done or Not Evaluable
RECIST 1.1 example to show 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 rs.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain1 in the RS domain. This example shows the data for one 1 subject collected at week 8 and subsequent 8-week follow-up visits. The Overall Response overall response (RSTESTCD = "OVRLRESP") has RSORRES = "NE" because the scans of the target and non-target lesions were not done.
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTAT | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX33333 | RS | 90003 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX33333 | RS | 90003 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX33333 | RS | 90003 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX33333 | RS | 90003 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 5 | EX33333 | RS | 90003 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX33333 | RS | 90003 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX33333 | RS | 90003 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 8 | EX33333 | RS | 90003 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 9 | EX33333 | RS | 90003 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 10 | EX33333 | RS | 90003 | 10 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| NOT DONE | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 11 | EX33333 | RS | 90003 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 |
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| NOT DONE | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
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| 12 | EX33333 | RS | 90003 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE |
| INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
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The following supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable) not evaluable (QNAM = "RSREASNE") in the case where it is collected.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX33333 | RS | 90005 | RSSEQ | 12 | RSREASNE | Reason Response Not Evaluable | Scans of target and non-target tumors were not performed | CRF |
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4.3.2 TU Domain Model
The tu.xpt table below following table below shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain1 in the TU domain. This example shows the identification of target and non-target tumors at screening. The The tumor identifier is in TULNKID and matches TRLNKIDs TRLNKID in the TR Domaindomain. This example shows a subject with 4 target lesions with (TULNKID = "T01"-"T04") and 3 non-target lesions with (TULNKID = "NT01"-"NT03") identified at screening. The subject did not have any new lesions.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUMETHOD | TUEVAL | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX33333 | TU | 90003 | 1 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LUNG, RIGHT MIDDLE LOBE |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX33333 | TU | 90003 | 2 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LIVER |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX33333 | TU | 90003 | 3 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LIVER |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX33333 | TU | 90003 | 4 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| KIDNEY, UPPER LOBE | RIGHT | CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX33333 | TU | 90003 | 5 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| LUNG |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX33333 | TU | 90003 | 6 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| ABDOMINAL CAVITY |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX33333 | TU | 90003 | 7 | NT03 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| CLAVICLE | RIGHT | SCINTIGRAPHY | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | |
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4.3.3 TR Domain Model
The trfollowing tr.xpt table below shows table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain. This 1 in the TR domain. This example represents a situation where a result was not provided because the scan was not performed.
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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. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX33333 | TR | 90003 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 16 | mm | 16 | 16 | mm |
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| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX33333 | TR | 90003 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 28 | mm | 28 | 28 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX33333 | TR | 90003 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 41 | mm | 41 | 41 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX33333 | TR | 90003 | 4 | TARGET | A1 | T04 | LDIAM | Longest Diameter | 82 | mm | 83 | 83 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX33333 | TR | 90003 | 5 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 167 | mm | 168 | 168 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| 6 | EX33333 | TR | 90003 | 6 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 7 | EX33333 | TR | 90003 | 7 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 8 | EX33333 | TR | 90003 | 8 | NON-TARGET | A1 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| SCINTIGRAPHY | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 9 | EX33333 | TR | 90003 | 9 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 10 | EX33333 | TR | 90003 | 10 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX33333 | TR | 90003 | 11 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 12 | EX33333 | TR | 90003 | 12 | TARGET | A2 | T04 | LDIAM | Longest Diameter | 65 | mm | 65 | 65 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 13 | EX33333 | TR | 90003 | 13 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 125 | mm | 125 | 125 | mm |
|
|
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 14 | EX33333 | TR | 90003 | 14 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 15 | EX33333 | TR | 90003 | 15 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 16 | EX33333 | TR | 90003 | 16 | NON-TARGET | A2 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 17 | EX33333 | TR | 90003 | 17 | TARGET | A3 | T01 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 18 | EX33333 | TR | 90003 | 18 | TARGET | A3 | T02 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 19 | EX33333 | TR | 90003 | 19 | TARGET | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 20 | EX33333 | TR | 90003 | 20 | TARGET | A3 | T04 | LDIAM | Longest Diameter | 40 | mm | 40 | 40 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 21 | EX33333 | TR | 90003 | 21 | TARGET | A3 |
| SUMDIAM | Sum of Diameter | 72 | mm | 72 | 72 | mm |
|
|
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| 22 | EX33333 | TR | 90003 | 22 | NON-TARGET | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 23 | EX33333 | TR | 90003 | 23 | NON-TARGET | A3 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 24 | EX33333 | TR | 90003 | 24 | NON-TARGET | A3 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| 25 | EX33333 | TR | 90003 | 25 | TARGET | A4 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 26 | EX33333 | TR | 90003 | 26 | TARGET | A4 | T02 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 27 | EX33333 | TR | 90003 | 27 | TARGET | A4 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 28 | EX33333 | TR | 90003 | 28 | TARGET | A4 | T04 | LDIAM | Longest Diameter | 36 | mm | 36 | 36 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 29 | EX33333 | TR | 90003 | 29 | TARGET | A4 |
| SUMDIAM | Sum of Diameter | 56 | mm | 56 | 56 | mm |
|
|
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 |
|
| 30 | EX33333 | TR | 90003 | 30 | NON-TARGET | A4 | NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 31 | EX33333 | TR | 90003 | 31 | NON-TARGET | A4 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 32 | EX33333 | TR | 90003 | 32 | NON-TARGET | A4 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 33 | EX33333 | TR | 90003 | 33 | TARGET | A5 | T01 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 34 | EX33333 | TR | 90003 | 34 | TARGET | A5 | T02 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 35 | EX33333 | TR | 90003 | 35 | TARGET | A5 | T03 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 36 | EX33333 | TR | 90003 | 36 | TARGET | A5 | T04 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 37 | EX33333 | TR | 90003 | 37 | NON-TARGET | A5 | NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 38 | EX33333 | TR | 90003 | 38 | NON-TARGET | A5 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 39 | EX33333 | TR | 90003 | 39 | NON-TARGET | A5 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
|
|
|
The following supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the in the case where the reason is collected.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX33333 | TR | 90003 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
|
|
4.4 Example 4 Example 4: Accepted Record Flag for Multiple Independent Assessors
RECIST 1.1 example to show 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 radiologist 1 and Radiologist radiologist 2) for the same timepoint.
4.4.1 RS Domain Model
The rs.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain. This 1 in the RS domain. This example shows the data for one 1 subject collected at week 8 and week 16.
This example shows the use of the The acceptance flag (RSACPTFL) is used to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist i.e., radiologist 1, radiologist 2) for the same timepoint, i.e. , RSACPTFL indicates the "selected" response when more than read 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 would select 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 best response assessment is provided by the data capture rather than derived.
This examples show data from an independent review where the RSNAM, RSEVAL and RSEVALID are used. The RSNAM contains the example uses RSNAM (name of the vendor), the RSEVAL contains (role of the person who provided providing the assessment, in this case, RSEVAL = ; i.e., "INDEPENDENT ASSESSOR"), and the RSEVALID contains the (specific type of medical reviewer who performed the independent assessment). In this case, two 2 radiologists independently reviewed the scans . The RSEVALID indicates the assessments by '(RSEVALID = "RADIOLOGIST 1" and , "RADIOLOGIST 2"). The acceptance flag (RSACPTFL) indicates that the "RADIOLOGIST 2" records are the accepted records in (rows 9-16). The Best Overall Response best overall response (RSTESTCD = "BESTRESP") is provided by the vendor in the data transfer in rows 4, 8, 12 and 16.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | RSACPTFL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX44444 | RS | 90004 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX44444 | RS | 90004 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX44444 | RS | 90004 | 3 | R1-A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX44444 | RS | 90004 | 4 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 5 | EX44444 | RS | 90004 | 5 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX44444 | RS | 90004 | 6 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX44444 | RS | 90004 | 7 | R1-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 8 | EX44444 | RS | 90004 | 8 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 9 | EX44444 | RS | 90004 | 9 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 10 | EX44444 | RS | 90004 | 10 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX44444 | RS | 90004 | 11 | R2-A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 12 | EX44444 | RS | 90004 | 12 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 13 | EX44444 | RS | 90004 | 13 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 14 | EX44444 | RS | 90004 | 14 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 15 | EX44444 | RS | 90004 | 15 | R2-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 16 | EX44444 | RS | 90004 | 16 |
| BESTRESP | Best Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | |
|
4.4.2 TU Domain Model
The tu.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. The 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 (Radiologist 1 and Radiologist i.e., radiologist 1, radiologist 2) for the same timepoint using RECIST 1. 1. The acceptance flag indicates records which are chosen by an adjudicator. Not all sponsors have both sets of independent reviews exported , (i.e., only the accepted records are transferred). It is It is not expected that the TUACPTFL flag would be populated by the sponsor. That ; this type of record selection or censoring would be part be part of the analysis dataset. The tumor The tumor identifier is in TULNKID and matches TRLNKIDs in the TR DomainTRLNKID in the TR domain.
Dataset wrap |
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Rowcaps |
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Rows 1-3: | Show the identification of two 2 target lesions "(R1-T01" and ", R1-T02") and one 1 non-target lesion "(R1-NT01" ) by independent radiologist 1 (TUEVALID = "RADIOLOGIST 1"). | Rows 4-6: | Show the identification of two 2 target lesions "R2(R1-T01" and "R2, R1-T02") and one 1 non-target lesion "(R2-NT01" ) by another independent radiologist 2 (TUEVALID = "RADIOLOGIST 2"). |
|
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUMETHOD | TUEVAL | TUEVALID | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX44444 | TU | 90004 | 1 | R1-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | LIVER |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX44444 | TU | 90004 | 2 | R1-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | KIDNEY, UPPER LOBE | LEFT | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX44444 | TU | 90004 | 3 | R1-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL INC. | ABDOMINAL CAVITY |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX44444 | TU | 90004 | 4 | R2-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | KIDNEY, UPPER LOBE | LEFT | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX44444 | TU | 90004 | 5 | R2-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | LIVER |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 6 | EX44444 | TU | 90004 | 6 | R2-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL INC. | ABDOMINAL CAVITY |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | |
|
The following supptu.xpt table below shows the textual data on the location detail (QNAM = "TULOCDTL").
Dataset wrap |
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Rowcaps |
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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. |
|
Dataset2 |
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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 tr.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain. This 1 in the TR domain. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist i.e., radiologist 1, radiologist 2) for the same timepoint using RECIST 1.1. It is . It is not expected that the TUACPTFL flag would be populated by the sponsor. That ; this type of record selection or censoring would be part be part of the analysis dataset.
This example shows that situation where the Independent Assessor independent assessor provided the summary values for Target target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "ACNSD", "PCBSD", and "PCNSD". Note that the sponsor sponsors should not derive these values if they were not part of the data capture or not provided in the transfer from the vendor.
Dataset wrap |
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Rowcaps |
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Rows 1-32: | Show that two 2 radiologists independently reviewed the scans. TRLNKGRP has values = "R1-A2" and , "R1-A3" to indicate the assessments by "RADIOLOGIST radiologist 1" , which are linked to the results determine by "RADIOLOGIST 1" determined by that radiologist in RS. Likewise, the values "R2-A2" and "R2-A3" to indicate the assessments by "RADIOLOGIST radiologist 2" , which are linked to the results determine by "RADIOLOGIST 2" determined by that radiologist in RS. | Rows 17-32: | Show that the results provided by "RADIOLOGIST radiologist 2 " are the accepted records (TRACPTFL). The accepted record flags are per the data transfer from the independent reviewer. |
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Dataset2 |
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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 | 11 | % | 11 | 11 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
|
| 32 | EX44444 | TR | 90004 | 32 | NON-TARGET | R2-A3 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 |
|
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4.5 Example 5 Example 5: Subject with One Target Tumor at Screening and an Unscheduled Assessment
RECIST 1.1 example to show 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 that who has one Target 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 rs.xpt table below following table below shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain. This 1 in the RS domain. This example shows investigator response data for a subject that who has only target tumors at screening. This includes an unscheduled assessment.
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Rows 1-2: | Show the Target Response target response (RSTESTCD = "TRGRESP") and Overall Response overall response (RSTESTCD = "OVRLRESP") of CR (Complete Response) at week 8. The subject only has one 1 target lesion and no non-targets. The Nonnon-target Response response (RSTESTCD = "NTRGRESP") is not applicable and ; a record may be included to represent this, if desired. | Rows 3-4: | Show an unscheduled response assessment at week 13, which was done to confirm the complete response ("CR"). The RSLNKGRP differentiates the assessment and the VISIT is = "UNSCHEDULED WEEK 13". | Rows 5-6: | Show Target Response that target response (RSTESTCD = "TRGRESP") of not evaluable ("NE") and Overall Response and overall response (RSTESTCD = "OVRLRESP") of were not evaluable (RSSTRESC = "NE") due to an unreadable image. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX55555 | RS | 90005 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX55555 | RS | 90005 | 2 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX55555 | RS | 90005 | 3 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 4 | EX55555 | RS | 90005 | 4 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 5 | EX55555 | RS | 90005 | 5 |
| TRGRESP | Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX55555 | RS | 90005 | 6 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX55555 | RS | 90005 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 8 | EX55555 | RS | 90005 | 8 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | |
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The following supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable) not evaluable (QNAM = "RSREASNE") in the case where it is collected.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX55555 | RS | 90005 | RSSEQ | 6 | RSREASNE | Reason Response Not Evaluable | Imaging Quality Issues | CRF |
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4.5.2 TU Domain Model
The tu.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. The 1 in the TU domain. The example shows a subject that who has only Target target tumors at screening. The tumor identifier is in TULNKID and matches TRLNKIDs TRLNKID in the TR Domaindomain.
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Row 1: | Shows that the subject has at least one 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 only has one 1 target lesion and no non-targets. | Row 4: | Shows new bone lesion identified at week 24. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX55555 | TU | 90005 | 1 |
| TIND | Target Indicator | Y | Y |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX55555 | TU | 90005 | 2 |
| NTIND | Non-Target Indicator | N | N |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX55555 | TU | 90005 | 3 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | BREAST | RIGHT | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX55555 | TU | 90005 | 4 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | BONE |
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | |
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4.5.3 TR Domain Model
The tr.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain1 in the TR domain. This example shows investigator tumor results for a subject that who has only target tumors at screening. This example includes an unscheduled assessment and an unreadable image.
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Rows 1-14: | Show the longest diameter and sum of longest diameter for the target lesion. The subject only has one 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 ABSENTabsent, if desired. | Row 15: | Shows a new lesion state at week 24. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX55555 | TR | 90005 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX55555 | TR | 90005 | 2 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 10 | mm | 10 | 10 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| 3 | EX55555 | TR | 90005 | 3 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX55555 | TR | 90005 | 4 | TARGET | A2 | T01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 5 | EX55555 | TR | 90005 | 5 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm |
|
|
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 6 | EX55555 | TR | 90005 | 6 | TARGET | A3 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 7 | EX55555 | TR | 90005 | 7 | TARGET | A3 | T01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 8 | EX55555 | TR | 90005 | 8 | TARGET | A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm |
|
|
| INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 |
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| 9 | EX55555 | TR | 90005 | 9 | TARGET | A4 | T01 | LDIAM | Longest Diameter |
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|
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| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 10 | EX55555 | TR | 90005 | 10 | TARGET | A4 | T01 | TUMSTATE | Tumor State |
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|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 11 | EX55555 | TR | 90005 | 11 | TARGET | A4 |
| SUMDIAM | Sum of Diameter |
|
|
|
|
| NOT DONE | MISSING DIAMETERS |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
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| 12 | EX55555 | TR | 90005 | 12 | TARGET | A5 | T01 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 13 | EX55555 | TR | 90005 | 13 | TARGET | A5 | T01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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|
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| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 14 | EX55555 | TR | 90005 | 14 | TARGET | A5 |
| SUMDIAM | Sum of Diameter | 5 | mm | 5 | 5 | mm |
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| INVESTIGATOR | TREATMENT | 7 | WEEK 24 |
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| 15 | EX55555 | TR | 90005 | 15 | NEW | A5 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 |
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The following supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the in the case where the reason is collected.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX55555 | TR | 90005 | TRSEQ | 9 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF | 2 | EX55555 | TR | 90005 | TRSEQ | 10 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF |
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4.6 Example 6 Example 6: Investigator-assessed RECIST 1.1 Measurements Along with Independent Assessor Volumetric Measurements
RECIST 1.1 example to show 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 rs.xpt table below following table below shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain. This 1 in the RS domain. This example shows investigator and independent radiologist's response data.
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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"). |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | RSACPTFL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX66666 | RS | 90006 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
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| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 2 | EX66666 | RS | 90006 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR |
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| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 3 | EX66666 | RS | 90006 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
|
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 4 | EX66666 | RS | 90006 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
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| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 5 | EX66666 | RS | 90006 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR |
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| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 6 | EX66666 | RS | 90006 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD |
| INVESTIGATOR |
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| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 7 | EX66666 | RS | 90006 | 7 | R1-A2 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | SD | SD | ACME VENDOR | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 8 | EX66666 | RS | 90006 | 8 | R1-A3 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | PD | PD | ACME VENDOR | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
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4.6.2 TU Domain Model
The tu.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. The 1 in the TU domain. This example shows investigator and independent radiologist's tumor identification. The example shows , and includes the identification of a new tumor where ; the investigator only identified the new tumor only , and the independent assessor identified and measured it. The tumor identifier is in TULNKID and matches TRLNKIDs TRLNKID in the TR Domaindomain.
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Rows 1-5: | Show the identification of three 3 target lesions "(T01", " T02" and ", T03"), and 2 non-target lesions "(NT01" and ", NT02" ) by the investigator. | Rows 6-7: | Show the identification of two 2 target lesions "(R-T01" and ", R-T02" ) by the independent radiologist. | Row 8: | Shows the identification of a new tumor "NEW01" by the investigator (NEW01). | Row 9: | Shows the identification of a new tumor "by the independent radiologist (R-NEW01" by independent radiologist). |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUDIR | TUMETHOD | TUEVAL | TUEVALID | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX66666 | TU | 90006 | 1 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| OCCIPITAL LOBE | LEFT | ANTERIOR | MRI | INVESTIGATOR |
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| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX66666 | TU | 90006 | 2 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| OCCIPITAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX66666 | TU | 90006 | 3 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| TEMPORAL LOBE | LEFT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX66666 | TU | 90006 | 4 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| FRONTAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX66666 | TU | 90006 | 5 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| CEREBELLUM | LEFT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX66666 | TU | 90006 | 6 | R1-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | OCCIPITAL LOBE | RIGHT | ANTERIOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX66666 | TU | 90006 | 7 | R1-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | TEMPORAL LOBE | LEFT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 8 | EX66666 | TU | 90006 | 8 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW |
| FRONTAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 9 | EX66666 | TU | 90006 | 9 | R1-NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | ACME VENDOR | FRONTAL LOBE | RIGHT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
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4.6.3 TR Domain Model
The tr.xpt table below shows the terminology following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain1 in the TR domain. This example shows both investigator and independent radiologist 's tumor results. The independent radiologist's tumor results are based on bi-dimensional bidimensional and volumetric measurements. The This example also includes the situation where new tumors are measured by the independent radiologist.
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Rows 1-6, 18-23, 38-39: | Show Longest Diameterlongest diameter, Sum sum of Longest Diameterlongest diameter, and Tumor State tumor state for investigator assessments at screening, cycle 2, and cycle 3 from the investigator. | Rows 7-17, 24-37, 40-44: | Show the volumetric measurements at screening, cycle 2, and cycle 3 from the independent radiologist. |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX66666 | TR | 90006 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX66666 | TR | 90006 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX66666 | TR | 90006 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX66666 | TR | 90006 | 4 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 25 | mm | 25 | 25 | mm |
|
| INVESTIGATOR |
| SCREEN | 1 | SCREENING |
|
| 5 | EX66666 | TR | 90006 | 5 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX66666 | TR | 90006 | 6 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX66666 | TR | 90006 | 7 | TARGET | R1-A1 | R1-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 8 | EX66666 | TR | 90006 | 8 | TARGET | R1-A1 | R1-T01 | LPERP | Longest Perpendicular | 5 | mm | 5 | 5 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 9 | EX66666 | TR | 90006 | 9 | TARGET | R1-A1 | R1-T01 | PPD | Product of Perpendicular Diameters | 50 | mm2 | 50 | 50 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 10 | EX66666 | TR | 90006 | 10 | TARGET | R1-A1 | R1-T01 | VOLUME | Volume | 250 | uL | 250 | 250 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 11 | EX66666 | TR | 90006 | 11 | TARGET | R1-A1 | R1-T02 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 12 | EX66666 | TR | 90006 | 12 | TARGET | R1-A1 | R1-T02 | LPERP | Longest Perpendicular | 10 | mm | 10 | 10 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 13 | EX66666 | TR | 90006 | 13 | TARGET | R1-A1 | R1-T02 | PPD | Product of Perpendicular Diameters | 70 | mm2 | 70 | 70 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 14 | EX66666 | TR | 90006 | 14 | TARGET | R1-A1 | R1-T02 | VOLUME | Volume | 350 | uL | 350 | 350 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 15 | EX66666 | TR | 90006 | 15 | TARGET | R1-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 16 | EX66666 | TR | 90006 | 16 | TARGET | R1-A1 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 120 | mm2 | 120 | 120 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 17 | EX66666 | TR | 90006 | 17 | TARGET | R1-A1 |
| SUMVOL | Sum of Volume | 600 | uL | 600 | 600 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 18 | EX66666 | TR | 90006 | 18 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 19 | EX66666 | TR | 90006 | 19 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 20 | EX66666 | TR | 90006 | 20 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 21 | EX66666 | TR | 90006 | 21 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 25 | mm | 25 | 25 | mm |
|
| INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 |
|
| 22 | EX66666 | TR | 90006 | 22 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 23 | EX66666 | TR | 90006 | 23 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 24 | EX66666 | TR | 90006 | 24 | TARGET | R1-A2 | R1-T01 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 25 | EX66666 | TR | 90006 | 25 | TARGET | R1-A2 | R1-T01 | LPERP | Longest Perpendicular | 7 | mm | 7 | 7 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 26 | EX66666 | TR | 90006 | 26 | TARGET | R1-A2 | R1-T01 | PPD | Product of Perpendicular Diameters | 84 | mm2 | 84 | 84 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 27 | EX66666 | TR | 90006 | 27 | TARGET | R1-A2 | R1-T01 | VOLUME | Volume | 420 | uL | 420 | 420 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 28 | EX66666 | TR | 90006 | 28 | TARGET | R1-A2 | R1-T02 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 29 | EX66666 | TR | 90006 | 29 | TARGET | R1-A2 | R1-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 30 | EX66666 | TR | 90006 | 30 | TARGET | R1-A2 | R1-T02 | PPD | Product of Perpendicular Diameters | 54 | mm2 | 54 | 54 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 31 | EX66666 | TR | 90006 | 31 | TARGET | R1-A2 | R1-T02 | VOLUME | Volume | 315 | uL | 315 | 315 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 32 | EX66666 | TR | 90006 | 32 | TARGET | R1-A2 |
| SUMDIAM | Sum of Diameter | 18 | mm | 18 | 18 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 33 | EX66666 | TR | 90006 | 33 | TARGET | R1-A2 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 138 | mm2 | 138 | 138 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 34 | EX66666 | TR | 90006 | 34 | TARGET | R1-A2 |
| SUMVOL | Sum of Volume | 735 | uL | 735 | 735 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 35 | EX66666 | TR | 90006 | 35 | TARGET | R1-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | 6 | % | 6 | 6 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 36 | EX66666 | TR | 90006 | 36 | TARGET | R1-A2 |
| PCBSPPD | Percent Change Baseline in Sum of PPD | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 37 | EX66666 | TR | 90006 | 37 | TARGET | R1-A2 |
| PCBSV | Percent Change From Baseline in Sum of Volume | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 38 | EX66666 | TR | 90006 | 38 | NEW | A3 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 39 | EX66666 | TR | 90006 | 39 | NEW | A3 | NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 40 | EX66666 | TR | 90006 | 40 | NEW | R1-A3 | R1-NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 41 | EX66666 | TR | 90006 | 41 | NEW | R1-A3 | R1-NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 42 | EX66666 | TR | 90006 | 42 | NEW | R1-A3 | R1-NEW01 | LPERP | Longest Perpendicular | 5 | mm | 5 | 5 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 43 | EX66666 | TR | 90006 | 43 | NEW | R1-A3 | R1-NEW01 | PPD | Product of Perpendicular Diameters | 45 | mm2 | 45 | 45 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 |
|
| 44 | EX66666 | TR | 90006 | 44 | NEW | R1-A3 | R1-NEW01 | VOLUME | Volume | 270 | uL | 270 | 270 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 |
|
|
4.7 Example 7 Example 7: Subject with Non-target Disease Only
RECIST 1.1 example to show 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 This example shows data for a subject with non-target disease only , (i.e., subject does not have target tumors). The tumor The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The 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 Domaindomain.
4.7.1 RS Domain Model
The rs.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain1 in the RS domain. This example shows non-target and overall responses for a subject who did does not have target lesions at baseline (target response is not applicable). This example also shows a an "NE" overall response due to an unreadable image.
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Rows 1-3: | Show the week 6 response assessment for a subject with non-target disease only. The Target Response 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 Nonnon-Target Response target response (RSTESTCD = "NTRGRESP") is non complete response/non progressive disease (NON-CR/NON-PD). The Overall Response overall response (RSTESTCD = "OVRLRESP") is non complete response/non progressive disease (NON-CR/NON-PD), which is a valid Overall Response 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 Nonnon-Target Response target response (RSTESTCD = "NTRGRESP") is NE (Not Evaluable) 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 overall response (RSTESTCD = "OVRLRESP") is "NE" (not evaluable). Note that "NE" is a valid Overall Response value per the RECIST 1.1 criteria which means it that ; RSORRES is "NE" rather than represented in RSSTAT. | Rows 7-9: | Show the week 20 assessment where the non-targets were enlarged from a previous smallest size. The Nonnon-Target Response target response (RSTESTCD = "NTRGRESP") is "PD" ( progressive disease) , which results in an Overall Response (RSTESTCD = "OVRLRESP") of "PD". |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY | RSSTAT | RSREASND |
---|
1 | EX77777 | RS | 90007 | 1 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | NOT DONE | Subject does not have target lesions | 2 | EX77777 | RS | 90007 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 |
|
| 3 | EX77777 | RS | 90007 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 |
|
| 4 | EX77777 | RS | 90007 | 4 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | NOT DONE | Subject does not have target lesions | 5 | EX77777 | RS | 90007 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 |
|
| 6 | EX77777 | RS | 90007 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 |
|
| 7 | EX77777 | RS | 90007 | 7 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | NOT DONE | Subject does not have target lesions | 8 | EX77777 | RS | 90007 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 |
|
| 9 | EX77777 | RS | 90007 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 |
|
| |
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The following supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable) not evaluable (QNAM = "RSREASNE") in the case where the reason is collected.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX77777 | RS | 90005 | RSSEQ | 5 | RSREASNE | Reason Response Not Evaluable | Imaging Quality Issues | CRF |
|
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4.7.2 TU Domain Model
The tu.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain. The example shows a subject that 1 in the TU domain. The example shows a subject who has only non-target tumors at screening.
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Row 1: | Shows that the subject has no target tumors (TUTESTCD = "TIND"), i.e., the subject does not have measurable disease. | Row 2: | Shows that the subject has non-target tumors (TUTESTCD = "NTIND"). The subject has non-measurable only disease. | Rows 3-5: | Show the identification of 3 non-target lesions for a subject with non-target disease only. See below for details on on the tumor presentation type (QNAM = "TUPRTYP") supplemental qualifier. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX77777 | TU | 90007 | 1 |
|
| TIND | Target Indicator | N | N |
|
| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 2 | EX77777 | TU | 90007 | 2 |
|
| NTIND | Non-Target Indicator | Y | Y |
|
| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 3 | EX77777 | TU | 90007 | 3 | IMG-00001 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | BRAIN | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 4 | EX77777 | TU | 90007 | 4 | IMG-00002 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | SKELETAL MUSCLE TISSUE | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 5 | EX77777 | TU | 90007 | 5 | IMG-00002 | NT03 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | PERICARDIUM | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | |
|
The following supptu.xpt table below shows the data to describe describing the disease presentation of a non-target tumor, when neededtumors. The tumor presentation type (QNAM = "TUPRTYP") supplemental supplemental qualifier is used and controlled terminology is available (DSPRTYP). In addition, this example shows the plane of measurement and the slice number where the lesions was identified, when needed.
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Row 1: | Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e., ; for the non-target site in the brain (TULNKID = "NT01"), the QVAL is = "LEPTOMENINGEAL DISEASE". | Rows 2-3: | Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified. | Rows 4-5: | Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the skeletal muscle tissue non-target lesion (TULNKID = "NT02") was identified. | Row 6: | Shows that the presentation of the disease in the pericardium is effusion, i.e., ; for the non-target site in the pericardium (TULNKID = "NT03"), the QVAL is = "EFFUSION". |
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX77777 | TU | 90007 | TUSEQ | 3 | TUPRTYP | Tumor or Lesion Presentation Type | LEPTOMENINGEAL DISEASE | CRF | 2 | EX77777 | TU | 90007 | TUSEQ | 3 | TUANTPLN | Anatomical Plane | SAGITTAL | CRF | 3 | EX77777 | TU | 90007 | TUSEQ | 3 | TUSLNUM | Slice Number | 55 | CRF | 4 | EX77777 | TU | 90007 | TUSEQ | 4 | TUANTPLN | Anatomical Plane | SAGITTAL | CRF | 5 | EX77777 | TU | 90007 | TUSEQ | 4 | TUSLNUM | Slice Number | 88-91 | CRF | 6 | EX77777 | TU | 90007 | TUSEQ | 4 | TUPRTYP | Tumor or Lesion Presentation Type | EFFUSION | CRF |
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4.7.3 TR Domain Model
The tr.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR 1 in the TR domain. This This example shows the data for one 1 subject with assessments of non-target tumors only at screening, week 6, week 12, and subsequent 8-week follow-up visits.
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Rows 1-6: | Show the qualitative assessments of the tumor state of the 3 non-target lesions "(NT01", " NT02", and " NT03" ) at screening and week 6. | Rows 7-9: | Show the week 12 assessments. Row 7 shows the assessment of "NT01" non-target lesion NT01 in the brain whereas ; rows 8 and 9 illustrate the indicate that assessments of the non-target lesions " NT02 " and " NT03 " in the skeletal muscle tissue and pericardium, respectively, were not done. This is because the non-target lesions were obscured on the MRI and not assessable (TRSTAT = "NOT DONE" and TRREASND = "NOT EVALUABLE: Lesion obscured"). | Rows 10-11: | Show that at the week 20 assessment, the " NT01 " and " NT02 " were enlarged from a previous smallest size , (i.e., TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX77777 | TR | 90007 | 1 | NON-TARGET | IMG-00001 | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 2 | EX77777 | TR | 90007 | 2 | NON-TARGET | IMG-00001 | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 3 | EX77777 | TR | 90007 | 3 | NON-TARGET | IMG-00001 | A1 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 4 | EX77777 | TR | 90007 | 4 | NON-TARGET | IMG-00003 | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | 5 | EX77777 | TR | 90007 | 5 | NON-TARGET | IMG-00003 | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | 6 | EX77777 | TR | 90007 | 6 | NON-TARGET | IMG-00003 | A2 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | 7 | EX77777 | TR | 90007 | 7 | NON-TARGET | IMG-00005 | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | 8 | EX77777 | TR | 90007 | 8 | NON-TARGET | IMG-00005 | A3 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | 9 | EX77777 | TR | 90007 | 9 | NON-TARGET | IMG-00005 | A3 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | 10 | EX77777 | TR | 90007 | 10 | NON-TARGET | IMG-00007 | A4 | NT01 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 11 | EX77777 | TR | 90007 | 11 | NON-TARGET | IMG-00007 | A4 | NT02 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 12 | EX77777 | TR | 90007 | 12 | NON-TARGET | IMG-00007 | A4 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | |
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The following supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the in the case where the reason is collected.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX77777 | TR | 90007 | TRSEQ | 8 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Scan blurry | CRF | 2 | EX77777 | TR | 90007 | TRSEQ | 9 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Scan blurry | CRF |
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4.7.4 PR Domain Model
The pr.xpt table below shows The following table shows the terminology used to implement RECIST implement RECIST 1.1 in 1 in the PR domainPR domain. This example shows the data for one 1 subject collected at the screening, week 6, week 12, and subsequent 8-week follow-up visits. The The example shows an MRI of the head and chest (PRTRT = "MRI" and PRLOC = "MULTIPLE") at each disease assessment timepoint. Pre Per protocol, non-target lesions in the "BRAIN" are assessed using "MRI" brain were assessed using MRI as the primary method of assessment for RECIST 1.1. Correlative imaging is used in addition to the primary method for the RECIST 1.1 evaluation in order to assess the brain lesion(s)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 of the HEADscan) is represented only in the PR domain. The The image identifier is in PRREFID.
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Rows 1-2: | Show the scans preformed at the screening disease assessment. The MRI is the primary method used to assess the lesions for RECIST 1.1 and the results are in TU and TR. Row 2 shows the correlative imaging of the brain (i.e., CT SCAN scan of the HEADhead). | Rows 3-8: | Show the scans preformed at the disease assessments at weeks 6, 12, and 20. |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRPRESP | PROCCUR | PRLOC | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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1 | EX77777 | PR | 90007 | 1 | IMG-00001 | A1 | MRI | Y | Y | MULTIPLE | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX77777 | PR | 90007 | 2 | IMG-00002 | A1 | CT SCAN | Y | Y | HEAD | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX77777 | PR | 90007 | 3 | IMG-00003 | A2 | MRI | Y | Y | MULTIPLE | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 4 | EX77777 | PR | 90007 | 4 | IMG-00004 | A2 | CT SCAN | Y | Y | HEAD | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 5 | EX77777 | PR | 90007 | 5 | IMG-00005 | A3 | MRI | Y | Y | MULTIPLE | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 6 | EX77777 | PR | 90007 | 6 | IMG-00006 | A3 | CT SCAN | Y | Y | HEAD | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 7 | EX77777 | PR | 90007 | 7 | IMG-00007 | A4 | MRI | Y | Y | MULTIPLE | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 8 | EX77777 | PR | 90007 | 8 | IMG-00008 | A4 | CTSCAN | Y | Y | HEAD | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | |
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The following supppr.xpt table below shows the data to represent the multiple locations covered by the MRI. The Anatomical Location 1 and Anatomical Location 2 anatomical location supplemental qualifiers (QNAM = "PRLOC1" and QNAM = , "PRLOC2") supplemental qualifiers are used and controlled terminology is available (LOC).
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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". |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 2 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 3 | EX77777 | PR | 90007 | PRSEQ | 1 | PRSLTHK | Slice Thickness | 5 mm | CRF | 4 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 5 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 6 | EX77777 | PR | 90007 | PRSEQ | 3 | PRSLTHK | Slice Thickness | 5 mm | CRF | 7 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 8 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 9 | EX77777 | PR | 90007 | PRSEQ | 5 | PRSLTHK | Slice Thickness | 5 mm | CRF | 10 | EX77777 | PR | 90007 | PRSEQ | 5 | PROIQ | Overall Image Quality | Motion issues and lesions where obscured | CRF | 11 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 12 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 13 | EX77777 | PR | 90007 | PRSEQ | 7 | PRSLTHK | Slice Thickness | 5 mm | CRF |
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4.8 Example 8 Example 8: Bone Scans Not Scans Not Required at Each Disease Assessment
RECIST 1.1 example to show 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 The tumor identifier is in TULNKID and matches TRLNKIDs in the TR DomainTRLNKID in the TR domain.
4.8.1 RS Domain Model
The rs.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the RS domain1 in the RS domain. This example shows the data for one 1 subject collected at the week at weeks 12 and week 24.
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Rows 1-3: | Show the response assessments at week 12. The target lesion showed 59% decrease from screening, so the Target Response target response (RSTESTCD = "TRGRESP") is a partial response (RSSTRESC = "PR"). In the protocol, scintigraphy is only to be performed every 6 months or in order to verify CR (Complete Response)complete response. Therefore, the Nonnon-target Response response (RSTESTCD = "NTRGRESP") is not evaluable (RSSTRESC = "NE") because scintigraphy of the bone was not performed at week 12, this visit (i.e., not all non-target lesions were evaluated). The Overall Response 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 target response (RSTESTCD = "TRGRESP"), Nonnon-target Response response (RSTESTCD = "NTRGRESP") and Overall Response overall response (RSTESTCD = "OVRLRESP") are CR (Complete Response). |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX88888 | RS | 90008 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 2 | EX88888 | RS | 90008 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 3 | EX88888 | RS | 90008 | 3 | R-A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 4 | EX88888 | RS | 90008 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | 5 | EX88888 | RS | 90008 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | 6 | EX88888 | RS | 90008 | 6 | R-A3 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | |
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4.8.2 TU Domain Model
The tu.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TU domain1 in the TU domain. This example shows the data for one 1 subject collected at screening, including the identification of a "target tumor (R-T01" target tumor ) in the "LIVER" liver and the assessment of the 2 non-target tumors "(R-NT01" and ", R-NT02" ) in the "BONE" and "PLEURAL CAVITY" bone and pleural cavity, respectively, at screening.
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TUMETHOD | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX88888 | TU | 90008 | 1 | IMG-00001 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | VENDOR1 | LIVER | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 2 | EX88888 | TU | 90008 | 2 | IMG-00002 | R-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | VENDOR1 | BONE | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX88888 | TU | 90008 | 3 | IMG-00001 | R-NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | VENDOR1 | PLEURAL CAVITY | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | |
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The following supptu.xpt table below shows the data to describe describing the disease presentation of a non-target tumor, when needed. The tumor presentation type supplemental qualifier (QNAM = "TUPRTYP") supplemental qualifier is used and controlled terminology is available (DSPRTYP). The presentation of the disease in the pleural cavity is effusion, i.e., ; for the non-target site in the pleural cavity (TULOC = "PLEURAL CAVITY" and TULNKID = "NT02"), the QVAL is = "EFFUSION".
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX88888 | TU | 900080 | TUSEQ | 3 | TUPRTYP | Tumor or Lesion Presentation Type | EFFUSION | CRF |
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4.8.3 TR Domain Model
The tr.xpt table below shows following table shows the terminology used to implement RECIST implement RECIST 1.1 in the TR domain1 in the TR domain. This example shows the data for one 1 subject collected at the screening, week 12, and week 24 visits. The This example also shows that the tumor state for the non-target in the pleural cavity is an assessment of the pleural effusion. "SCINTIGRAPHY" Scintigraphy of the "BONE" bone was not required at every disease assessment per protocol. The image identifier is in TRREFID.
This example shows that a situation where the Independent Assessor 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 Note that the sponsor sponsors should not derived these values if they were not part of the data capture or not provided in the transfer from the vendorthe vendor.
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Rows 1-4: | Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-target lesions "R-NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" at screening. | Rows 5-11: | Show the measurement of the "R-T01" target tumor and the tumor state of the "R-NT02" non-target in the "PLEURAL CAVITY" at week 12. In the protocol, "SCINTIGRAPHY" is only to be performed every 6 months or in order to verify a CR (Complete Response). Therefore, the "SCINTIGRAPHY" of "R-NT01" non-target in the "BONE" was not performed at week 12 (TRSTAT = "NOT DONE" and TRREASND = "SCAN NOT PERFORMED"). | Rows 12-18: | Show at week 24, the "R-T01" target lesion was absent (i.e., DIAMETER = "0") and the non-targets R-"NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" were absent (TRTESTCD = "TUMSTATE" with TRORRES = "ABSENT"). The "SCINTIGRAPHY" was performed in order to verify the Overall Response of CR (Complete Response). |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRNAM | TRMETHOD | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX88888 | TR | 90008 | 1 | TARGET | IMG-00001 | R-A1 | R-T01 | LDIAM | Longest Diameter | 17 | mm | 17 | 17 | mm |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 2 | EX88888 | TR | 90008 | 2 | TARGET |
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| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX88888 | TR | 90008 | 3 | NON-TARGET | IMG-00002 | R-A1 | R-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| VENDOR1 | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 4 | EX88888 | TR | 90008 | 4 | NON-TARGET | IMG-00001 | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX88888 | TR | 90008 | 5 | TARGET | IMG-00004 | R-A2 | R-T01 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 6 | EX88888 | TR | 90008 | 6 | TARGET |
| R-A2 |
| SUMDIAM | Sum of Diameter | 7 | mm | 7 | 7 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| 7 | EX88888 | TR | 90008 | 7 | TARGET |
| R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| 8 | EX88888 | TR | 90008 | 8 | TARGET |
| R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -59 | % | -59 | -59 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| 9 | EX88888 | TR | 90008 | 9 | TARGET |
| R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -59 | % | -59 | -59 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| 10 | EX88888 | TR | 90008 | 10 | NON-TARGET |
| R-A2 | R-NT01 | TUMSTATE | Tumor State |
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| NOT DONE | SCAN NOT PERFORMED | VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| 11 | EX88888 | TR | 90008 | 11 | NON-TARGET | IMG-00004 | R-A2 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 12 | EX88888 | TR | 90008 | 12 | TARGET | IMG-00005 | R-A3 | R-T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | 13 | EX88888 | TR | 90008 | 13 | TARGET |
| R-A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| 14 | EX88888 | TR | 90008 | 14 | TARGET |
| R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -17 | mm | -17 | -17 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| 15 | EX88888 | TR | 90008 | 15 | TARGET |
| R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -100 | % | -100 | -100 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| 16 | EX88888 | TR | 90008 | 16 | TARGET |
| R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -100 | % | -100 | -100 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| 17 | EX88888 | TR | 90008 | 17 | NON-TARGET | IMG-00006 | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| VENDOR1 | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | 18 | EX88888 | TR | 90008 | 18 | NON-TARGET | IMG-00005 | R-A3 | R-NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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