Text in black is part of the template used to create this document and is not under review. Please review the blue text and all examples; this text represents the changes made to the template that are specific to this disease response criteria.
Title
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
CDISC Reference
Disease ResponseSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
Criteria Short Name
RECIST 1.1
Criteria Permission Status
Public Domain
Team
CDISC Oncology Therapeutic Area Subteam
Supplement Version
1.0
Status
DRAFT
Date
2019-06-21
Notes
This supplement is intended to be used with other CDISC User Guides for specific Therapeutic/Disease Areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
This document describes the CDISC implementation of the Response Evaluation Criteria in Solid Tumors 1.1 Version (RECIST 1.1) disease response criteria.
I removed the statement, "CDISC does not modify QRS instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards." because we are not currently using a CRF; however, I recommend including the CDASH statement if/when CRFs are used for disease response criteria. I am recommending we use the following instead when we are not using a CRF:
CDISC is not including an annotated case report form (CRF) for this disease response supplement as the primary purpose of the supplement is to show examples of how to implement the disease response criteria in CDISC data standards domains.
The representation of data collected for this disease response criteria is based on the Study Data Tabulation Model Implementation Guide (SDTMIG), which can be found at the CDISC website at: (https://www.cdisc.org/standards/foundational/sdtmig).
These specific implementation details for this disease response criteria are meant to be used in conjunction with the SDTMIG. All CDISC Disease Response documentation packages can be found on the CDISC web site at: (https://www.cdisc.org/foundational/qrs).
1.1 Representations and Warranties, Limitations of Liability, and Disclaimers
This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.
CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.
2 Copyright Status
The RECIST Working Group owns the copyright for the RECIST 1.1 disease response criteria. CDISC has developed data standards for tumor identification and response and applied these to RECIST 1.1. Examples were developed to represent RECIST 1.1 and include in the CDISC library of QRS data standards supplements. There may be many versions of this criteria in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.
The CDISC documentation of this criteria consists of: (1) controlled terminology and (2) standard database structure with examples.
Note: CDISC controlled terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website (https://www.cdisc.org/standards/semantics/terminology).
CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the criteria beyond the normal license fees charged by the copyright holder.
CDISC acknowledges the RECIST Working Group and the European Journal of Cancer (EJC) for having the RECIST 1.1 available for free.
References for the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1):
E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij. New response evaluation criteria in solid tumours; Revised RECIST guideline (version 1.1). European Journal of Cancer 2009; 45:228-247.
3 TheOncology Disease ResponseDomains Model for RECIST 1.1
3.1 Assumptions for theOncology Disease ResponseDomains
All assumptions and business rules described in the SDTMIG are applicable to this supplement. Additional assumptions specific to the RECIST 1.1 are listed below.
RECIST 1.1 is a set of criteria used to evaluate the activity and efficacy of new cancer therapeutics in solid tumors.
RSORRES is populated with the original result and the standardized result represented in the standardized character result variable RSSTRESC.
TUORRES and TUSTRESC are populated with the original tumor identification result.
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 theOncology Disease ResponseDomains
In the case, where no evidence of disease was found at baseline, this can be represented by a RS record with RSTEST=Overall Response and RSORRES=NED and RSSTRESC=NED.
We are unable to make examples consistently show blue in the Wiki. All examples are updated for each disease response supplement so we ask that you please review the examples below.
RS Example being developed.
4 Examples for the Oncology Disease ResponseDomains Model for RECIST 1.1
4.1 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.
4.1.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
Rows 1-3: Show the Target Response and Non-target Response tests and corresponding Overall Response at the Week 6 assessment. The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP is used to associate underlying data in other domains to the Overall Response.
Rows 4-13: Show the Week 12, Week 20 and Week 28 responses.
Row 14-21: At Week 36, the NEWLPROG test is used to represent an EQUIVOCAL new lesion and to represent at Week 44 that there are UNEQUIVOCAL new lesions. There are different methods of collecting data when there is a EQUIVOCAL new lesion. Some sponsors update the Overall Response when EQUIVOCAL evidence of a new lesion has been later been confirmed (i.e., documented as UNEQUIVOCAL). Other sponsors during the analysis programmatically derive the new lesion progression date as the date when the new lesion was first identified.
Note: Sponsor may include the NEWLIND test at every timepoint if the new lesion yes or no question is part of the data collection.
rs.xpt
rs.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKGRP
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSEVAL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
JKL12345
RS
40070
1
TRGRESP
Target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
2
JKL12345
RS
40070
2
NTRGRESP
Non-target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
3
JKL12345
RS
40070
3
A2
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
4
JKL12345
RS
40070
4
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
5
JKL12345
RS
40070
5
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
6
JKL12345
RS
40070
6
A3
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
7
JKL12345
RS
40070
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
8
JKL12345
RS
40070
8
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
9
JKL12345
RS
40070
9
A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
10
JKL12345
RS
40070
10
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
11
JKL12345
RS
40070
11
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
12
JKL12345
RS
40070
12
A5
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
13
JKL12345
RS
40070
13
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
14
JKL12345
RS
40070
14
NTRGRESP
Non-target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
15
JKL12345
RS
40070
15
NEWLPROG
New Lesion Progression
RECIST 1.1
EQUIVOCAL
EQUIVOCAL
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
16
JKL12345
RS
40070
16
A6
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
17
JKL12345
RS
40070
17
TRGRESP
Target Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
18
JKL12345
RS
40070
18
NTRGRESP
Non-target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
19
JKL12345
RS
40070
19
NEWLPROG
New Lesion Progression
RECIST 1.1
UNEQUIVOCAL
UNEQUIVOCAL
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
20
JKL12345
RS
40070
20
A7
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
$warningHtml
4.1.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows lymph nodes as target tumors identified at screening. The image identifier is in TRREFID and matches a PRREFID in the PR Domain.
Rows 1-6: Show a subject with 4 target lesions with TULNKID T01-T04 and 2 non-target lesions with TULNKID NT01-NT02 identified at screening. T01 and T02 target lesions are lymph nodes. T01 is located in the TULOC=SUPRACLAVICULAR LYMPH NODE on the TULAT=RIGHT side. The TULOC contains the location from the anatomical location terminology. Note that some locations contain in the anatomical location controlled terminology contain laterality and/or directionality. The laterality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality.
Row 7: Shows at week 36, an EQUIVOCAL new lesion (NEW01) was identified in the LUNG, LEFT LOWER LOBE. In this instance, LUNG, LEFT LOWER LOBE is a published controlled term for anatomical location.
Row 8-9: Show at week 44, new UNEQUIVOCAL new lesions (NEW02 and NEW03) were identified in the CEREBELLUM and FEMORAL LYMPH NODE.
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TUREFID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
JKL12345
TU
40070
1
IMG-00002
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
SUPRACLAVICULAR LYMPH NODE
RIGHT
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
2
JKL12345
TU
40070
2
IMG-00002
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
CELIAC LYMPH NODE
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
3
JKL12345
TU
40070
3
IMG-00001
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
THYROID GLAND
LEFT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
4
JKL12345
TU
40070
4
IMG-00003
T04
TUMIDENT
Tumor Identification
TARGET
TARGET
SKIN OF THE TRUNK
UPPER
PHOTOGRAPHY
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-03
-1
5
JKL12345
TU
40070
5
IMG-00001
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
MEDIASTINAL LYMPH NODE
RIGHT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
6
JKL12345
TU
40070
6
IMG-00001
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CEREBELLUM
RIGHT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
7
JKL12345
TU
40070
7
IMG-00017
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
LUNG, LEFT LOWER LOBE
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
8
JKL12345
TU
40070
8
IMG-00019
NEW02
TUMIDENT
Tumor Identification
NEW
NEW
CEREBELLUM
LEFT
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
9
JKL12345
TU
40070
9
IMG-00019
NEW03
TUMIDENT
Tumor Identification
NEW
NEW
FEMORAL LYMPH NODE
LEFT
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
$warningHtml
The supptu.xpt table below shows the data on whether a tumor was previously irradiated (QNAM.PREVIR) and whether that tumor was shown to be progressing since it was irradiated (QNAM.PREVIRP).
Rows 1-3: Show that the 1st, 2nd and 3rd target lesions where not previously irradiated.
Rows 4-5: Show that that 4th target lesions as previously irradiated and shown to be progressing since it was irradiated.
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
JKL12345
TU
40070
TUSEQ
1
PREVIR
Previously Irradiated Indicator
N
CRF
2
JKL12345
TU
40070
TUSEQ
2
PREVIR
Previously Irradiated Indicator
N
CRF
3
JKL12345
TU
40070
TUSEQ
3
PREVIR
Previously Irradiated Indicator
N
CRF
4
JKL12345
TU
40070
TUSEQ
4
PREVIR
Previously Irradiated Indicator
Y
CRF
5
JKL12345
TU
40070
TUSEQ
4
PREVIRP
Previously Irradiated Progression
Y
CRF
$warningHtml
4.1.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
The table below shows measurements (i.e., short axis) of lymph nodes as well as measurements of other non-lymph node target tumors (i.e., longest diameter). In this example, when TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL", it indicates that the lymph node lesion was not pathological, i.e. the diameter has reduced below 10mm. The assessment of a lymph node is represented with TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL" when that all target lymph node lesions have short axis less than 10mm or TRORRES = "PATHOLOGICAL" when at least one target lymph node lesion has short axis greater than or equal to 10mm.
Rows 1-6: Show the screening identification of the target and non-target lesions. For lymph node target lesions T01 and T02 the TRTESTCD used are LPREP and LNSTATE. For non-lymph node target lesions T03 and T04 the TRTESTCD use is LDIAM.
Rows 7-8: Show the results for the target lesions as a group (TRGRPID=TARGET). The TRTESTCDs are SUMDIAM and SUMNLNLD.
Rows 9-10: Show the results for the non-targets. NT01 is a lymph node where the TRTESTCD is LNSTATE. NT02 is a non-lymph node where the TRTESTCD is TUMSTATE.
Row 16: Shows a case where TRSTAT is NOT DONE with the reason for the result being not done as TRTEST of Longest Diameter with TRREASND as NOT EVALUABLE.
Rows 17-21: Show the Week 6 results for the target lesions as a group (TRGRPID=TARGET). The TRTESTCDs are SUMDIAM, SUMNLNLD, ACNSD, PCBSD and PCNSD. Within Row 20, the PCBSD could not be calculated because T04 was not measured. TRSTAT is assigned NOT DONE and TRREASND contains the reason, in this case at least one target lesions was not measured.
Rows 22-23: Show the week 6 that NT02 was not scanned and the results the NT01 non-target lesion using TRTESTCD as TUMSTATE.
Row 25: Shows target tumor T04 was photographed at Week 6 but the tumor was not assessable. When there is no result TRSTAT is assigned NOT DONE and TRREASND contains the reason, in this case NOT EVALUABLE.
Row 36: Shows a case where TRSTAT as NOT DONE with different possible reasons for the result being not done. In row 36, the TRTEST is Tumor State and the TRREASND is SCAN NOT PERFORMED
Row 93: Shows a case where TRSTAT as NOT DONE with different possible reasons for the result being not done. x. In row 93, the TRTEST is Longest Diameter with TRREASND as NOT ASSESSABLE: Image obscured
Row 42: Shows a target lesion T04 which is too small to measure. The TRORRES is TOO SMALL TO MEASURE, and the TRSTRESC and TRSTRESN are standardized to 5 with TRSTRESU as mm.
tr.xpt
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRMETHOD
TREVAL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
JKL12345
TR
40070
1
TARGET
IMG-00001
A1
T01
LPERP
Longest Perpendicular
17
mm
17
17
mm
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
2
JKL12345
TR
40070
2
TARGET
IMG-00001
A1
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
3
JKL12345
TR
40070
3
TARGET
IMG-00002
A1
T02
LPERP
Longest Perpendicular
16
mm
16
16
mm
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
4
JKL12345
TR
40070
4
TARGET
IMG-00002
A1
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
5
JKL12345
TR
40070
5
TARGET
IMG-00001
A1
T03
LDIAM
Longest Diameter
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
6
JKL12345
TR
40070
6
TARGET
IMG-00003
A1
T04
LDIAM
Longest Diameter
PHOTOGRAPHY
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-03
-1
7
JKL12345
TR
40070
7
TARGET
A1
SUMDIAM
Sum of Diameter
62
mm
62
62
mm
INVESTIGATOR
SCREEN
10
SCREEN
8
JKL12345
TR
40070
8
TARGET
A1
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
29
mm
29
29
mm
INVESTIGATOR
SCREEN
10
SCREEN
9
JKL12345
TR
40070
9
NON-TARGET
IMG-00002
A1
NT01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
10
JKL12345
TR
40070
10
NON-TARGET
IMG-00001
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
11
JKL12345
TR
40070
11
TARGET
IMG-00004
A2
T01
LPERP
Longest Perpendicular
12
mm
12
12
mm
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-15
43
12
JKL12345
TR
40070
12
TARGET
IMG-00004
A2
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
13
JKL12345
TR
40070
13
TARGET
IMG-00005
A2
T02
LPERP
Longest Perpendicular
12
mm
12
12
mm
CT SCAN
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-16
44
14
JKL12345
TR
40070
14
TARGET
IMG-00005
A2
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
40
WEEK 6
15
JKL12345
TR
40070
15
TARGET
IMG-00004
A2
T03
LDIAM
Longest Diameter
14
mm
14
14
mm
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-15
43
16
JKL12345
TR
40070
16
TARGET
IMG-00006
A2
T04
LDIAM
Longest Diameter
NOT DONE
NOT EVALUABLE
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-17
45
17
JKL12345
TR
40070
17
TARGET
A2
SUMDIAM
Sum of Diameter
52
mm
52
52
mm
INVESTIGATOR
TREATMENT
40
WEEK 6
18
JKL12345
TR
40070
18
TARGET
A2
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
28
mm
28
28
mm
INVESTIGATOR
TREATMENT
40
WEEK 6
19
JKL12345
TR
40070
19
TARGET
A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
INVESTIGATOR
TREATMENT
40
WEEK 6
20
JKL12345
TR
40070
20
TARGET
A2
PCBSD
Percent Change From Baseline in Sum of Diameter
NOT DONE
at least one target lesions was not measured
INVESTIGATOR
TREATMENT
40
WEEK 6
21
JKL12345
TR
40070
21
TARGET
A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-16
%
-16
-16
%
INVESTIGATOR
TREATMENT
40
WEEK 6
22
JKL12345
TR
40070
22
NON-TARGET
IMG-00002
A2
NT01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-16
44
23
JKL12345
TR
40070
23
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
24
JKL12345
TR
40070
24
TARGET
IMG-00007
A3
T01
LDIAM
Longest Diameter
12
mm
12
12
mm
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-29
85
25
JKL12345
TR
40070
25
TARGET
IMG-00007
A3
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-29
85
26
JKL12345
TR
40070
26
TARGET
IMG-00008
A3
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
CT SCAN
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-30
86
27
JKL12345
TR
40070
27
TARGET
IMG-00008
A3
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-30
86
28
JKL12345
TR
40070
28
TARGET
IMG-00007
A3
T03
LDIAM
Longest Diameter
15
mm
15
15
mm
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-29
85
29
JKL12345
TR
40070
29
TARGET
IMG-00009
A3
T04
LDIAM
Longest Diameter
8
mm
8
8
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-01
87
30
JKL12345
TR
40070
30
TARGET
A3
SUMDIAM
Sum of Diameter
47
mm
47
47
mm
INVESTIGATOR
TREATMENT
60
WEEK 12
31
JKL12345
TR
40070
31
TARGET
A3
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
23
mm
23
23
mm
INVESTIGATOR
TREATMENT
60
WEEK 12
32
JKL12345
TR
40070
32
TARGET
A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-5
mm
-5
-5
mm
INVESTIGATOR
TREATMENT
60
WEEK 12
33
JKL12345
TR
40070
33
TARGET
A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-24
%
-24
-24
%
INVESTIGATOR
TREATMENT
60
WEEK 12
34
JKL12345
TR
40070
34
TARGET
A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-9
%
-9
-9
%
INVESTIGATOR
TREATMENT
60
WEEK 12
35
JKL12345
TR
40070
35
NON-TARGET
IMG-00008
A3
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-30
86
36
JKL12345
TR
40070
36
NON-TARGET
A3
NT02
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
37
JKL12345
TR
40070
37
TARGET
IMG-00010
A4
T01
LDIAM
Longest Diameter
9
mm
9
9
mm
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
38
JKL12345
TR
40070
38
TARGET
IMG-00010
A4
T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
39
JKL12345
TR
40070
39
TARGET
IMG-00011
A4
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
CT SCAN
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-28
145
40
JKL12345
TR
40070
40
TARGET
IMG-00011
A4
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-28
145
41
JKL12345
TR
40070
41
TARGET
IMG-00010
A4
T03
LDIAM
Longest Diameter
11
mm
11
11
mm
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
42
JKL12345
TR
40070
42
TARGET
IMG-00012
A4
T04
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
43
JKL12345
TR
40070
43
TARGET
A4
SUMDIAM
Sum of Diameter
37
mm
37
37
mm
INVESTIGATOR
TREATMENT
80
WEEK 20
44
JKL12345
TR
40070
44
TARGET
A4
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
16
mm
16
16
mm
INVESTIGATOR
TREATMENT
80
WEEK 20
45
JKL12345
TR
40070
45
TARGET
A4
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
INVESTIGATOR
TREATMENT
80
WEEK 20
46
JKL12345
TR
40070
46
TARGET
A4
PCBSD
Percent Change From Baseline in Sum of Diameter
-40
%
-40
-40
%
INVESTIGATOR
TREATMENT
80
WEEK 20
47
JKL12345
TR
40070
47
TARGET
A4
PCNSD
Percent Change From Nadir in Sum of Diameter
-21
%
-21
-21
%
INVESTIGATOR
TREATMENT
80
WEEK 20
48
JKL12345
TR
40070
48
NON-TARGET
IMG-00011
A4
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-28
145
49
JKL12345
TR
40070
49
NON-TARGET
IMG-00010
A4
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
50
JKL12345
TR
40070
50
TARGET
IMG-00013
A5
T01
LDIAM
Longest Diameter
9
mm
9
9
mm
MRI
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-23
201
51
JKL12345
TR
40070
51
TARGET
IMG-00013
A5
T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-23
201
52
JKL12345
TR
40070
52
TARGET
IMG-00014
A5
T02
LDIAM
Longest Diameter
8
mm
8
8
mm
CT SCAN
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-24
202
53
JKL12345
TR
40070
53
TARGET
IMG-00014
A5
T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-24
202
54
JKL12345
TR
40070
54
TARGET
IMG-00013
A5
T03
LDIAM
Longest Diameter
6
mm
6
6
mm
MRI
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-23
201
55
JKL12345
TR
40070
55
TARGET
IMG-00015
A5
T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-25
203
56
JKL12345
TR
40070
56
TARGET
A5
SUMDIAM
Sum of Diameter
23
mm
23
23
mm
INVESTIGATOR
TREATMENT
100
WEEK 28
57
JKL12345
TR
40070
57
TARGET
A5
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
6
mm
6
6
mm
INVESTIGATOR
TREATMENT
100
WEEK 28
58
JKL12345
TR
40070
58
TARGET
A5
ACNSD
Absolute Change From Nadir in Sum of Diameter
-14
mm
-14
-14
mm
INVESTIGATOR
TREATMENT
100
WEEK 28
59
JKL12345
TR
40070
59
TARGET
A5
PCBSD
Percent Change From Baseline in Sum of Diameter
-62
%
-62
-62
%
INVESTIGATOR
TREATMENT
100
WEEK 28
60
JKL12345
TR
40070
60
TARGET
A5
PCNSD
Percent Change From Nadir in Sum of Diameter
-37
%
-37
-37
%
INVESTIGATOR
TREATMENT
100
WEEK 28
61
JKL12345
TR
40070
61
NON-TARGET
IMG-00014
A5
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-24
202
62
JKL12345
TR
40070
62
NON-TARGET
A5
NT02
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
63
JKL12345
TR
40070
63
TARGET
IMG-00016
A6
T01
LDIAM
Longest Diameter
8
mm
8
8
mm
MRI
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
64
JKL12345
TR
40070
64
TARGET
IMG-00016
A6
T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
65
JKL12345
TR
40070
65
TARGET
IMG-00017
A6
T02
LDIAM
Longest Diameter
9
mm
9
9
mm
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
66
JKL12345
TR
40070
66
TARGET
IMG-00017
A6
T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
67
JKL12345
TR
40070
67
TARGET
IMG-00016
A6
T03
LDIAM
Longest Diameter
0
mm
0
0
mm
MRI
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
68
JKL12345
TR
40070
68
TARGET
IMG-00018
A6
T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
69
JKL12345
TR
40070
69
TARGET
A6
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
INVESTIGATOR
TREATMENT
120
WEEK 36
70
JKL12345
TR
40070
70
TARGET
A6
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
120
WEEK 36
71
JKL12345
TR
40070
71
TARGET
A6
ACNSD
Absolute Change From Nadir in Sum of Diameter
-6
mm
-6
-6
mm
INVESTIGATOR
TREATMENT
120
WEEK 36
72
JKL12345
TR
40070
72
TARGET
A6
PCBSD
Percent Change From Baseline in Sum of Diameter
-72
%
-72
-72
%
INVESTIGATOR
TREATMENT
120
WEEK 36
73
JKL12345
TR
40070
73
TARGET
A6
PCNSD
Percent Change From Nadir in Sum of Diameter
-26
%
-26
-26
%
INVESTIGATOR
TREATMENT
120
WEEK 36
74
JKL12345
TR
40070
74
NON-TARGET
IMG-00017
A6
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
75
JKL12345
TR
40070
75
NON-TARGET
IMG-00016
A6
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
MRI
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-19
259
76
JKL12345
TR
40070
76
NEW
IMG-00017
A6
NEW01
LDIAM
Longest Diameter
NOT DONE
NOT EVALUABLE
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
77
JKL12345
TR
40070
77
NEW
IMG-00017
A6
NEW01
TUMSTATE
Tumor State
EQUIVOCAL
EQUIVOCAL
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
78
JKL12345
TR
40070
78
TARGET
IMG-00019
A7
T01
LDIAM
Longest Diameter
12
mm
12
12
mm
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-15
314
79
JKL12345
TR
40070
79
TARGET
IMG-00019
A7
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-15
314
80
JKL12345
TR
40070
80
TARGET
IMG-00020
A7
T02
LDIAM
Longest Diameter
9
mm
9
9
mm
CT SCAN
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
81
JKL12345
TR
40070
81
TARGET
IMG-00020
A7
T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
82
JKL12345
TR
40070
82
TARGET
IMG-00019
A7
T03
LDIAM
Longest Diameter
0
mm
0
0
mm
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-15
314
83
JKL12345
TR
40070
83
TARGET
IMG-00021
A7
T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-16
315
84
JKL12345
TR
40070
84
TARGET
A7
SUMDIAM
Sum of Diameter
21
mm
21
21
mm
INVESTIGATOR
TREATMENT
140
WEEK 44
85
JKL12345
TR
40070
85
TARGET
A7
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
140
WEEK 44
86
JKL12345
TR
40070
86
TARGET
A7
ACNSD
Absolute Change From Nadir in Sum of Diameter
4
mm
4
4
mm
INVESTIGATOR
TREATMENT
140
WEEK 44
87
JKL12345
TR
40070
87
TARGET
A7
PCBSD
Percent Change From Baseline in Sum of Diameter
-66
%
-66
-66
%
INVESTIGATOR
TREATMENT
140
WEEK 44
88
JKL12345
TR
40070
88
TARGET
A7
PCNSD
Percent Change From Nadir in Sum of Diameter
23
%
23
23
%
INVESTIGATOR
TREATMENT
140
WEEK 44
89
JKL12345
TR
40070
89
NON-TARGET
IMG-00020
A7
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
90
JKL12345
TR
40070
90
NON-TARGET
IMG-00019
A7
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
91
JKL12345
TR
40070
91
NEW
IMG-00020
A7
NEW01
LDIAM
Longest Diameter
8
mm
8
8
mm
CT SCAN
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
92
JKL12345
TR
40070
92
NEW
IMG-00020
A7
NEW01
TUMSTATE
Tumor State
UNEQUIVOCAL
UNEQUIVOCAL
CT SCAN
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
93
JKL12345
TR
40070
93
NEW
IMG-00019
A7
NEW02
LDIAM
Longest Diameter
NOT DONE
NOT ASSESSABLE: Image obscured
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
94
JKL12345
TR
40070
94
NEW
IMG-00019
A7
NEW02
TUMSTATE
Tumor State
UNEQUIVOCAL
UNEQUIVOCAL
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
95
JKL12345
TR
40070
95
NEW
IMG-00019
A7
NEW03
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
Dataset Debug Message
Please remove all paragraph and/or line breaks.
4.1.4 PR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
The table below shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin and trunk (PRTRT = "PHOTOGRAPHY" and PROLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.
The above paragraph was originally as follows in the spreadsheet. Please confirm I have not changed the meaning or intent:
Example shows an MRI of the 'HEAD AND NECK', CT SCAN of the 'CHEST' and medical PHOTOGRAPHY of the 'SKIN OF THE TRUNK' at each disease assessment timepoint. The image identifier is in PRREFID.
Rows 1-3: Show the scans preformed at the screening disease assessment. The results of the scans are record in TU and TR.
Rows 4-21: Show the scans preformed at the disease assessments at Weeks 6, 12, 20, 28, 36 and 44. The results of the scans are record in TU and TR.
pr.xpt
pr.xpt
ROW
STUDYID
DOMAIN
USUBJID
PRSEQ
PRREFID
PRLNKGRP
PRTRT
PRPRESP
PROCCUR
PRLOC
EPOCH
VISITNUM
VISIT
PRSTDTC
PRSTDY
1
JKL12345
PR
40070
1
IMG-00001
A1
MRI
Y
Y
HEAD AND NECK
SCREEN
10
SCREEN
2010-01-01
-3
2
JKL12345
PR
40070
2
IMG-00002
A1
CT SCAN
Y
Y
CHEST
SCREEN
10
SCREEN
2010-01-02
-2
3
JKL12345
PR
40070
3
IMG-00003
A1
PHOTOGRAPHY
SKIN OF THE TRUNK
SCREEN
10
SCREEN
2010-01-03
-1
4
JKL12345
PR
40070
4
IMG-00004
A2
MRI
Y
Y
HEAD AND NECK
TREATMENT
40
WEEK 6
2010-02-15
43
5
JKL12345
PR
40070
5
IMG-00005
A2
CT SCAN
Y
Y
CHEST
TREATMENT
40
WEEK 6
2010-02-16
44
6
JKL12345
PR
40070
6
IMG-00006
A2
PHOTOGRAPHY
SKIN OF THE TRUNK
TREATMENT
40
WEEK 6
2010-02-17
45
7
JKL12345
PR
40070
7
IMG-00007
A3
MRI
Y
Y
HEAD AND NECK
TREATMENT
60
WEEK 12
2010-03-29
85
8
JKL12345
PR
40070
8
IMG-00008
A3
CT SCAN
Y
Y
CHEST
TREATMENT
60
WEEK 12
2010-03-30
86
9
JKL12345
PR
40070
9
IMG-00009
A3
PHOTOGRAPHY
SKIN OF THE TRUNK
TREATMENT
60
WEEK 12
2010-04-01
87
10
JKL12345
PR
40070
10
IMG-00010
A4
MRI
Y
Y
HEAD AND NECK
TREATMENT
80
WEEK 20
2010-05-27
144
11
JKL12345
PR
40070
11
IMG-00011
A4
CT SCAN
Y
Y
CHEST
TREATMENT
80
WEEK 20
2010-05-28
145
12
JKL12345
PR
40070
12
IMG-00012
A4
PHOTOGRAPHY
SKIN OF THE TRUNK
TREATMENT
80
WEEK 20
2010-05-30
147
13
JKL12345
PR
40070
13
IMG-00013
A5
MRI
Y
Y
HEAD AND NECK
TREATMENT
100
WEEK 28
2010-07-23
201
14
JKL12345
PR
40070
14
IMG-00014
A5
CT SCAN
Y
Y
CHEST
TREATMENT
100
WEEK 28
2010-07-24
202
15
JKL12345
PR
40070
15
IMG-00015
A5
PHOTOGRAPHY
SKIN OF THE TRUNK
TREATMENT
100
WEEK 28
2010-07-25
203
16
JKL12345
PR
40070
16
IMG-00016
A6
MRI
Y
Y
HEAD AND NECK
TREATMENT
120
WEEK 36
2010-09-17
257
17
JKL12345
PR
40070
17
IMG-00017
A6
CT SCAN
Y
Y
CHEST
TREATMENT
120
WEEK 36
2010-09-19
259
18
JKL12345
PR
40070
18
IMG-00018
A6
PHOTOGRAPHY
SKIN OF THE TRUNK
TREATMENT
120
WEEK 36
2010-09-17
257
19
JKL12345
PR
40070
19
IMG-00019
A7
MRI
Y
Y
HEAD AND NECK
TREATMENT
140
WEEK 44
2010-11-15
314
20
JKL12345
PR
40070
20
IMG-00020
A7
CT SCAN
Y
Y
CHEST
TREATMENT
140
WEEK 44
2010-11-14
313
21
JKL12345
PR
40070
21
IMG-00021
A7
PHOTOGRAPHY
SKIN OF THE TRUNK
TREATMENT
140
WEEK 44
2010-11-16
315
$warningHtml
4.1.5 TD Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TD domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
The table below shows three distinct disease-assessment schedule patterns. A single anchor date variable (TDANCVAR) provides the anchor date for each pattern. The offset variable (TDSTOFF) used in conjunction with the anchor date variable provides the start point of each pattern of assessments.
Row 1: The 1st schedule starts at reference start date and repeats every 8 weeks for 6 repeats (i.e., Week 8, 16, 24, 32, 40, and 48).
Row 2: The 2nd schedule starts from Week 48 and repeats every 12 weeks for 4 repeats ( i.e., Week 60, 72, 84, 96).
Row 3: The 3rd schedule starts from Week 96 and repeats every 24 weeks (i.e. Week 120, 144, etc.).
td.xpt
td.xpt
Row
STUDYID
DOMAIN
TDORDER
TDANCVAR
TDSTOFF
TDTGTPAI
TDMINPAI
TDMAXPAI
TDNUMRPT
1
ABC123
TD
1
ANCH1DT
P0D
P8W
P53D
P9W
6
2
ABC123
TD
2
ANCH1DT
P60W
P12W
P11W
P13W
4
3
ABC123
TD
3
ANCH1DT
P120W
P24W
P23W
P25W
12
$warningHtml
4.2 Example 2: RECIST 1.1 example to show independent assessor response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example shows the preferred representation of split (fragmented) and merged (coalesced) tumors.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.2.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
Rows 1-11: For data from an independent assessor the RSNAM, RSEVAL and RSEVALID are used. The RSNAM contains the name of the vendor, the RSEVAL contains role of the person who provided the assessment, in this case, INDEPENDENT ASSESSOR, and the RSEVALID contains the specific type of medical reviewer who performed the independent assessment, in this case, RADIOLOGIST 1.
Row 12: Shows a protocol defined response which is outside of RECIST 1.1. In this case, it is symptomatic deterioration. The RSORRES contains the actual symptomatic deterioration results which is standardized to PD in RSSTRESC.
rs.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
RSACPTFL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
CDE12345
RS
40004
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
300%
WEEK 8
3914000%
5600%
2
CDE12345
RS
40004
2
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
3
CDE12345
RS
40004
3
R-A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
4
CDE12345
RS
40004
4
TRGRESP
Target Response
RECIST 1.1
PR
PR
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
5
CDE12345
RS
40004
5
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
6
CDE12345
RS
40004
6
R-A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
7
CDE12345
RS
40004
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
7
WEEK 24
2009-06-19
168
8
CDE12345
RS
40004
8
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
7
WEEK 24
2009-06-19
168
9
CDE12345
RS
40004
9
R-A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
7
WEEK 24
2009-06-19
168
10
CDE12345
RS
40004
10
TRGRESP
Target Response
RECIST 1.1
PD
PD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
9
WEEK 32
2009-08-14
224
11
CDE12345
RS
40004
11
NTRGRESP
Non-target Response
RECIST 1.1
PD
PD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
9
WEEK 32
2009-08-14
224
12
CDE12345
RS
40004
12
SYMPTDTR
Symptomatic Deterioration
PROTOCOL DEFINED RESPONSE CRITERIA
Increased shortness of breath
PD
INVESTIGATOR
TREATMENT
9
WEEK 32
2009-08-12
222
13
CDE12345
RS
40004
13
R-A5
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
ACE IMAGING
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
9
WEEK 32
2009-08-14
224
$warningHtml
4.2.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject collected at screening, the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors.
The tu.xpt table below shows lymph nodes as target tumors identified at screening.
Rows 7-8: Show the identification of a split tumor when it was first identified as split. In this example, TULNKID=T04 split into two tumors TULNKID=T04.1 and TULNKID=T04.2.
Row 9: Shows the identification of a merged tumor when it was first identified as merged. In this example, TULNKID=T02 and TULNKID=T03 merged into tumor TULNKID=T02/T03.
tu.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
CDE12345
TU
40004
1
IMG-00001
TRG-SCR-01
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
ACE IMAGING
LUNG, RIGHT MIDDLE LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
2
CDE12345
TU
40004
2
IMG-00001
TRG-SCR-02
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
ACE IMAGING
LUNG, LEFT LOWER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
3
CDE12345
TU
40004
3
IMG-00001
TRG-SCR-03
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
ACE IMAGING
LUNG, LEFT LOWER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
4
CDE12345
TU
40004
4
IMG-00001
TRG-SCR-04
T04
TUMIDENT
Tumor Identification
TARGET
TARGET
ACE IMAGING
KIDNEY, UPPER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
5
CDE12345
TU
40004
5
IMG-00001
NTG-SCR-01
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
ACE IMAGING
LUNG
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
6
CDE12345
TU
40004
6
IMG-00001
NTG-SCR-02
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
ACE IMAGING
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
7
CDE12345
TU
40004
7
T04
IMG-00002
TRG-W16-07
T04.1
TUSPLIT
Tumor Split
TARGET
TARGET
ACE IMAGING
KIDNEY, UPPER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
8
CDE12345
TU
40004
8
T04
IMG-00002
TRG-W16-08
T04.2
TUSPLIT
Tumor Split
TARGET
TARGET
ACE IMAGING
KIDNEY, UPPER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
9
CDE12345
TU
40004
9
IMG-00003
TRG-W28-07
T02/T03
TUMERGE
Tumor Merged
TARGET
TARGET
ACE IMAGING
LUNG, LEFT LOWER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
7
WEEK 24
2009-06-19
168
10
CDE12345
TU
40004
10
IMG-00004
NWT-W32-01
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
ACE IMAGING
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
9
WEEK 32
2009-08-14
224
Dataset Debug Message
There are 20 leading, trailing, or non-breaking spaces in the dataset.
4.2.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors.
Row 11: Shows the longest diameter of T04 at the assessment before it splits.
Rows 19-20: Show the longest diameters of the split lesions T04.1 and T04.2 at Week 16.
Rows 25-26: Show that tumors T02 and T03 are no longer measured individually. The TRSTAT=NOT DONE and the TRREASND=TUMOR MERGED.
Row 27: Shows the longest diameter of the newly merged T02/T03 tumor at Week 24.
Rows 29-30: Show the longest diameters of the split lesions T04.1 and T04.2 at Week 24.
Row 37: Shows the longest diameter of the newly merged T02/T03 tumor at Week 32.
Rows 38-39: Show the longest diameters of the split lesions T04.1 and T04.2 at Week 32.
Row 42: Shows the Tumor State of the non-target NT01 as ENLARGEMENT FROM NADIR. This Tumor State indicates that the non-target tumors in the LUNG have shown enlargement from their previous smallest state.
Rows 44-45: Shows the Tumor State of the a new tumor NEW01 and the longest diameter of the new tumor.
tr.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
CDE12345
TR
40004
1
TARGET
R-A1
T01
LDIAM
Longest Diameter
16
mm
16
16
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
2
CDE12345
TR
40004
2
TARGET
R-A1
T02
LDIAM
Longest Diameter
28
mm
28
28
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
3
CDE12345
TR
40004
3
TARGET
R-A1
T03
LDIAM
Longest Diameter
41
mm
41
41
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
4
CDE12345
TR
40004
4
TARGET
R-A1
T04
LDIAM
Longest Diameter
83
mm
83
83
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
5
CDE12345
TR
40004
5
TARGET
R-A1
SUMLDIAM
Sum of Longest Diameter
168
mm
168
168
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
6
CDE12345
TR
40004
6
NON-TARGET
R-A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
7
CDE12345
TR
40004
7
NON-TARGET
R-A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
8
CDE12345
TR
40004
8
TARGET
R-A2
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
9
CDE12345
TR
40004
9
TARGET
R-A2
T02
LDIAM
Longest Diameter
20
mm
20
20
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
10
CDE12345
TR
40004
10
TARGET
R-A2
T03
LDIAM
Longest Diameter
30
mm
30
30
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
11
CDE12345
TR
40004
11
TARGET
R-A2
T04
LDIAM
Longest Diameter
65
mm
65
65
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
12
CDE12345
TR
40004
12
TARGET
R-A2
SUMLDIAM
Sum of Longest Diameter
125
mm
125
125
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
13
CDE12345
TR
40004
13
NON-TARGET
R-A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
14
CDE12345
TR
40004
14
NON-TARGET
R-A2
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
15
CDE12345
TR
40004
15
TARGET
R-A3
T01
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
16
CDE12345
TR
40004
16
TARGET
R-A3
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
17
CDE12345
TR
40004
17
TARGET
R-A3
T03
LDIAM
Longest Diameter
15
mm
15
15
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
18
CDE12345
TR
40004
18
TARGET
R-A3
T04.1
LDIAM
Longest Diameter
30
mm
30
30
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
19
CDE12345
TR
40004
19
TARGET
R-A3
T04.2
LDIAM
Longest Diameter
10
mm
10
10
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
20
CDE12345
TR
40004
20
TARGET
R-A3
SUMLDIAM
Sum of Longest Diameter
72
mm
72
72
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
21
CDE12345
TR
40004
21
NON-TARGET
R-A3
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
22
CDE12345
TR
40004
22
NON-TARGET
R-A3
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
23
CDE12345
TR
40004
23
TARGET
R-A4
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
24
CDE12345
TR
40004
24
TARGET
R-A4
T02
LDIAM
Longest Diameter
NOT DONE
TUMOR MERGED
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
25
CDE12345
TR
40004
25
TARGET
R-A4
T03
LDIAM
Longest Diameter
NOT DONE
TUMOR MERGED
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
26
CDE12345
TR
40004
26
TARGET
R-A4
T02/T03
LDIAM
Longest Diameter
35
mm
35
35
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
27
CDE12345
TR
40004
27
TARGET
R-A4
T04.1
LDIAM
Longest Diameter
30
mm
30
30
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
28
CDE12345
TR
40004
28
TARGET
R-A4
T04.2
LDIAM
Longest Diameter
19
mm
19
19
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
29
CDE12345
TR
40004
29
TARGET
R-A4
SUMLDIAM
Sum of Longest Diameter
84
mm
84
84
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
30
CDE12345
TR
40004
30
NON-TARGET
R-A4
NT01
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE: Image obscured
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
31
CDE12345
TR
40004
31
NON-TARGET
R-A4
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
32
CDE12345
TR
40004
32
TARGET
R-A5
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
33
CDE12345
TR
40004
33
TARGET
R-A5
T02/T03
LDIAM
Longest Diameter
80
mm
80
80
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
34
CDE12345
TR
40004
34
TARGET
R-A5
T04.1
LDIAM
Longest Diameter
49
mm
49
49
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
35
CDE12345
TR
40004
35
TARGET
R-A5
T04.2
LDIAM
Longest Diameter
26
mm
26
26
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
36
CDE12345
TR
40004
36
TARGET
R-A5
SUMLDIAM
Sum of Longest Diameter
155
mm
155
155
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
37
CDE12345
TR
40004
37
NON-TARGET
R-A5
NT01
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
38
CDE12345
TR
40004
38
NON-TARGET
R-A5
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
39
CDE12345
TR
40004
39
NEW
R-A5
NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
40
CDE12345
TR
40004
40
NEW
R-A5
NEW01
LDIAM
Longest Diameter
9
mm
9
9
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
Dataset Debug Message
There are 12 leading, trailing, or non-breaking spaces in the dataset.
4.3 Example 3: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example also shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.3.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
The table represents the items from the RECIST 1.1 criteria.
Rows 12-13: Show RSCAT= PROTOCOL DEFINED RESPONSE CRITERIA . The RSORE
rs.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
RSACPTFL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
SUPPRS.RSREASNE
1
CDE12345
RS
40003
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
2
CDE12345
RS
40003
2
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
3
CDE12345
RS
40003
3
A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
4
CDE12345
RS
40003
4
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
5
CDE12345
RS
40003
5
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
6
CDE12345
RS
40003
6
A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
7
CDE12345
RS
40003
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
8
CDE12345
RS
40003
8
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
9
CDE12345
RS
40003
9
A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
10
CDE12345
RS
40003
10
TRGRESP
Target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
9
WEEK 32
Insufficient Images/Anatomy
11
CDE12345
RS
40003
11
NTRGRESP
Non-target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
9
WEEK 32
Insufficient Images/Anatomy
12
CDE12345
RS
40003
12
SYMPTDTR
Symptomatic Deterioration
PROTOCOL DEFINED RESPONSE CRITERIA
Increased weakness and weight loss
PD
INVESTIGATOR
TREATMENT
9
WEEK 32
2009-08-12
226
13
CDE12345
RS
40003
13
A5
OVRLRESP
Overall Response
PROTOCOL DEFINED RESPONSE CRITERIA
PD
PD
INVESTIGATOR
TREATMENT
9
WEEK 32
2009-08-12
226
$warningHtml
4.3.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator.
The tu.xpt table below shows lymph nodes as target tumors identified at screening.
tu.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
CDE12345
TU
40003
1
R1-T01
TUMIDENT
Tumor Identification
TARGET
TARGET
LUNG, RIGHT MIDDLE LOBE
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
2
CDE12345
TU
40003
2
R1-T02
TUMIDENT
Tumor Identification
TARGET
TARGET
LIVER
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
3
CDE12345
TU
40003
3
R1-T03
TUMIDENT
Tumor Identification
TARGET
TARGET
LIVER
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
4
CDE12345
TU
40003
4
R1-T04
TUMIDENT
Tumor Identification
TARGET
TARGET
KIDNEY, UPPER LOBE
RIGHT
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
5
CDE12345
TU
40003
5
R1-NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
LUNG
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
6
CDE12345
TU
40003
6
R1-NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
ABDOMINAL CAVITY
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
7
CDE12345
TU
40003
7
R1-NT03
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CLAVICLE
RIGHT
SCINTIGRAPHY
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
8
CDE12345
TU
40003
8
T04
TUMIDENT
Tumor Identification
TARGET
TARGET
LUNG, LEFT LOWER LOBE
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
9
10CDE12345
TU
40003
9
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
LUNG, RIGHT MIDDLE LOBE
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
10
CDE12345
TU
40003
10
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
LUNG, LEFT LOWER LOBE
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
Dataset Debug Message
There are 20 leading, trailing, or non-breaking spaces in the dataset.
4.3.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example also shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator.
tr.xpt
xx.xpt
TRSEQ
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
CDE12345
TR
40003
1
TARGET
A1
T01
LDIAM
Longest Diameter
16
mm
16
16
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
2
CDE12345
TR
40003
2
TARGET
A1
T02
LDIAM
Longest Diameter
28
mm
28
28
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
3
CDE12345
TR
40003
3
TARGET
A1
T03
LDIAM
Longest Diameter
41
mm
41
41
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
4
CDE12345
TR
40003
4
TARGET
A1
T04
LDIAM
Longest Diameter
82
mm
83
83
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
5
CDE12345
TR
40003
5
TARGET
A1
SUMLDIAM
Sum of Longest Diameter
167
mm
168
168
mm
ACE IMAGING
INVESTIGATOR
SCREEN
1
SCREEN
6
CDE12345
TR
40003
6
NON-TARGET
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
7
CDE12345
TR
40003
7
NON-TARGET
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
8
CDE12345
TR
40003
8
NON-TARGET
A1
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
SCINTIGRAPHY
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
9
CDE12345
TR
40003
9
TARGET
A2
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
10
CDE12345
TR
40003
10
TARGET
A2
T01
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
11
CDE12345
TR
40003
11
TARGET
A2
T02
LDIAM
Longest Diameter
20
mm
20
20
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
12
CDE12345
TR
40003
12
TARGET
A2
T02
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
13
CDE12345
TR
40003
13
TARGET
A2
T03
LDIAM
Longest Diameter
30
mm
30
30
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
14
CDE12345
TR
40003
14
TARGET
A2
T03
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
15
CDE12345
TR
40003
15
TARGET
A2
T04
LDIAM
Longest Diameter
65
mm
65
65
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
16
CDE12345
TR
40003
16
TARGET
A2
T04
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
17
CDE12345
TR
40003
17
TARGET
A2
SUMLDIAM
Sum of Longest Diameter
125
mm
125
125
mm
ACE IMAGING
INVESTIGATOR
TREATMENT
3
WEEK 8
18
CDE12345
TR
40003
18
TARGET
A2
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
-25
%
-25
-25
%
ACE IMAGING
INVESTIGATOR
TREATMENT
3
WEEK 8
19
CDE12345
TR
40003
19
TARGET
A2
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
-25
%
-25
-25
%
ACE IMAGING
INVESTIGATOR
TREATMENT
3
WEEK 8
20
CDE12345
TR
40003
20
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
21
CDE12345
TR
40003
21
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
22
CDE12345
TR
40003
22
NON-TARGET
A2
NT03
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
3
WEEK 8
23
CDE12345
TR
40003
23
TARGET
A3
T01
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
39196
112
24
CDE12345
TR
40003
24
TARGET
A3
T01
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
25
CDE12345
TR
40003
25
TARGET
A3
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
26
CDE12345
TR
40003
26
TARGET
A3
T02
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
27
CDE12345
TR
40003
27
TARGET
A3
T03
LDIAM
Longest Diameter
15
mm
15
15
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
28
CDE12345
TR
40003
28
TARGET
A3
T03
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
29
CDE12345
TR
40003
29
TARGET
A3
SUMLDIAM
Sum of Longest Diameter
72
mm
72
72
mm
ACE IMAGING
INVESTIGATOR
TREATMENT
5
WEEK 16
30
CDE12345
TR
40003
30
TARGET
A3
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
-56
%
-56
-56
%
ACE IMAGING
INVESTIGATOR
TREATMENT
5
WEEK 16
31
CDE12345
TR
40003
31
TARGET
A3
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
-42
%
-42
-42
%
ACE IMAGING
INVESTIGATOR
TREATMENT
5
WEEK 16
32
CDE12345
TR
40003
32
NON-TARGET
A3
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
33
CDE12345
TR
40003
33
NON-TARGET
A3
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
34
CDE12345
TR
40003
34
NON-TARGET
A3
NT03
TUMSTATE
Tumor State
NOT DONE
DISEASE ASSESSMENT NOT PERFORMED
ACE IMAGING
SCINTIGRAPHY
INVESTIGATOR
TREATMENT
5
WEEK 16
35
CDE12345
TR
40003
35
TARGET
A4
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
36
CDE12345
TR
40003
36
TARGET
A4
T01
TUMSTATE
Tumor State
ABSENT
ABSENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
37
CDE12345
TR
40003
37
TARGET
A4
T02
LDIAM
Longest Diameter
15
mm
15
15
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
38
CDE12345
TR
40003
38
TARGET
A4
T03
LDIAM
Longest Diameter
5
mm
5
5
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
39
CDE12345
TR
40003
39
TARGET
A4
T04
LDIAM
Longest Diameter
36
mm
36
36
mm
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
40
CDE12345
TR
40003
40
TARGET
A4
SUMLDIAM
Sum of Longest Diameter
56
mm
56
56
mm
ACE IMAGING
INVESTIGATOR
TREATMENT
7
WEEK 24
41
CDE12345
TR
40003
41
TARGET
A4
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
-66
%
-66
-66
%
ACE IMAGING
INVESTIGATOR
TREATMENT
7
WEEK 24
42
CDE12345
TR
40003
42
TARGET
A4
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
-22
%
-22
-22
%
ACE IMAGING
INVESTIGATOR
TREATMENT
7
WEEK 24
43
CDE12345
TR
40003
43
NON-TARGET
A4
NT01
TUMSTATE
Tumor State
NOT DONE
NOT EVALUABLE
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
44
CDE12345
TR
40003
44
NON-TARGET
A4
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
ACE IMAGING
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
45
CDE12345
TR
40003
45
NON-TARGET
A4
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
ACE IMAGING
SCINTIGRAPHY
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-26
175
46
CDE12345
TR
40003
46
TARGET
A5
T01
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
47
CDE12345
TR
40003
47
TARGET
A5
T01
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
48
CDE12345
TR
40003
48
TARGET
A5
T02
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
49
CDE12345
TR
40003
49
TARGET
A5
T02
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
50
CDE12345
TR
40003
50
TARGET
A5
T03
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
51
CDE12345
TR
40003
51
TARGET
A5
T03
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
52
CDE12345
TR
40003
52
TARGET
A5
T04
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
53
CDE12345
TR
40003
53
TARGET
A5
T04
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
54
CDE12345
TR
40003
54
NON-TARGET
A5
NT01
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
55
CDE12345
TR
40003
55
NON-TARGET
A5
NT02
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
56
CDE12345
TR
40003
56
NON-TARGET
A5
NT03
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
ACE IMAGING
INVESTIGATOR
TREATMENT
9
WEEK 32
Dataset Debug Messages
There are 28 leading, trailing, or non-breaking spaces in the dataset.
There is a duplicate variable (TRSEQ) in the dataset.
4.4 Example 4: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR) data. Example to show the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.4.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1.
The table represents the items from the RECIST 1.1 criteria.
Rows 1-16: Show that two radiologists independently reviewed the scans. The RSEVALID indicates the assessments by RADIOLOGIST 1 and RADIOLOGIST 2. The acceptance flag (RSACPTFL) indicates that the RADIOLOGIST 2 records are the accepted records in rows 9-16.
rs.xpt
rs.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
RSACPTFL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
FGH12345
RS
40050
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
2
FGH12345
RS
40050
2
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
3
FGH12345
RS
40050
3
R1-A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
4
FGH12345
RS
40050
4
BESTRESP
Best Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
5
FGH12345
RS
40050
5
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
6
FGH12345
RS
40050
6
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
7
FGH12345
RS
40050
7
R1-A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
8
FGH12345
RS
40050
8
BESTRESP
Best Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
9
FGH12345
RS
40050
9
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
10
FGH12345
RS
40050
10
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
11
FGH12345
RS
40050
11
R2-A2
OVRLRESP
Overall Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
12
FGH12345
RS
40050
12
BESTRESP
Best Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
13
FGH12345
RS
40050
13
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
14
FGH12345
RS
40050
14
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
15
FGH12345
RS
40050
15
R2-A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
16
FGH12345
RS
40050
16
BESTRESP
Best Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
$warningHtml
4.4.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1. The acceptance flag indicates records which are chosen by an adjudicator. Not all sponsors have both sets of independent reviews exported, i.e., only the accepted records are transferred.
The tu.xpt table below shows lymph nodes as target tumors identified at screening.
Rows 1-32: Show that two radiologists independently reviewed the scans. TRLNKGRP has values R1-A2 and R1-A3 to indicate the assessments by RADIOLOGIST 1 which are linked to the results determine by RADIOLOGIST 1 in RS. Likewise, the values R2-A2 and R2-A3 to indicate the assessments by RADIOLOGIST 2 which are linked to the results determine by RADIOLOGIST 2 in RS.
Rows 17-32: Show that the results provided by RADIOLOGIST 2 are the accepted records (TUACPTFL). The accepted record flags are per the data transfer from the independent reviewer.
tu.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
QNAM.LOCDTL (location detail)
1
FGH12345
TU
40050
1
R1-T01
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
2
FGH12345
TU
40050
2
R1-T02
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
KIDNEY, UPPER LOBE
LEFT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
3
FGH12345
TU
40050
3
R1-NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL INC.
ABDOMINAL CAVITY
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
4
FGH12345
TU
40050
4
R2-T01
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
KIDNEY, UPPER LOBE
LEFT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
5
FGH12345
TU
40050
5
R2-T02
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
6
FGH12345
TU
40050
6
R2-NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL INC.
ABDOMINAL CAVITY
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
Dataset Debug Message
There are 12 leading, trailing, or non-breaking spaces in the dataset.
4.4.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to show the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1.
Rows 1-32: Show that two radiologists independently reviewed the scans. TRLNKGRP has values R1-A2 and R1-A3 to indicate the assessments by RADIOLOGIST 1 which are linked to the results determine by RADIOLOGIST 1 in RS. Likewise, the values R2-A2 and R2-A3 to indicate the assessments by RADIOLOGIST 2 which are linked to the results determine by RADIOLOGIST 2 in RS.
Rows 17-32: Show that the results provided by RADIOLOGIST 2 are the accepted records (TRACPTFL). The accepted record flags are per the data transfer from the independent reviewer.
tr.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
FGH12345
TR
40050
1
TARGET
R1-A1
R1-T01
LDIAM
Longest Diameter
15
mm
15
15
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
2
FGH12345
TR
40050
2
TARGET
R1-A1
R1-T02
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
3
FGH12345
TR
40050
3
TARGET
R1-A1
SUMLDIAM
Sum of Longest Diameter
40
mm
40
40
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
4
FGH12345
TR
40050
4
NON-TARGET
R1-A1
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
5
FGH12345
TR
40050
5
TARGET
R1-A2
R1-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
6
FGH12345
TR
40050
6
TARGET
R1-A2
R1-T02
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
7
FGH12345
TR
40050
7
TARGET
R1-A2
SUMLDIAM
Sum of Longest Diameter
35
mm
35
35
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
8
FGH12345
TR
40050
8
TARGET
R1-A2
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
-13
%
-13
-13
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
9
FGH12345
TR
40050
9
TARGET
R1-A2
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
-13
%
-13
-13
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
10
FGH12345
TR
40050
10
NON-TARGET
R1-A2
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
11
FGH12345
TR
40050
11
TARGET
R1-A3
R1-T01
LDIAM
Longest Diameter
5
mm
5
5
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
12
FGH12345
TR
40050
12
TARGET
R1-A3
R1-T02
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
13
FGH12345
TR
40050
13
TARGET
R1-A3
SUMLDIAM
Sum of Longest Diameter
15
mm
15
15
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
14
FGH12345
TR
40050
14
TARGET
R1-A3
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
-63
%
-63
-63
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
15
FGH12345
TR
40050
15
TARGET
R1-A3
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
-57
%
-57
-57
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
16
FGH12345
TR
40050
16
NON-TARGET
R1-A3
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
17
FGH12345
TR
40050
17
TARGET
R2-A1
R2-T01
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
18
FGH12345
TR
40050
18
TARGET
R2-A1
R2-T02
LDIAM
Longest Diameter
20
mm
20
20
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
19
FGH12345
TR
40050
19
TARGET
R2-A1
SUMLDIAM
Sum of Longest Diameter
45
mm
45
45
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
20
FGH12345
TR
40050
20
NON-TARGET
R2-A1
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
21
FGH12345
TR
40050
21
TARGET
R2-A2
R2-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
22
FGH12345
TR
40050
22
TARGET
R2-A2
R2-T02
LDIAM
Longest Diameter
8
mm
8
8
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
23
FGH12345
TR
40050
23
TARGET
R2-A2
SUMLDIAM
Sum of Longest Diameter
18
mm
18
18
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
24
FGH12345
TR
40050
24
TARGET
R2-A2
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
-60
%
-60
-60
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
25
FGH12345
TR
40050
25
TARGET
R2-A2
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
-60
%
-60
-60
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
26
FGH12345
TR
40050
26
NON-TARGET
R2-A2
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
27
FGH12345
TR
40050
27
TARGET
R2-A3
R2-T01
LDIAM
Longest Diameter
15
mm
15
15
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
28
FGH12345
TR
40050
28
TARGET
R2-A3
R2-T02
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
29
FGH12345
TR
40050
29
TARGET
R2-A3
SUMLDIAM
Sum of Longest Diameter
20
mm
20
20
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
30
FGH12345
TR
40050
30
TARGET
R2-A3
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
-56
%
-56
-56
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
31
FGH12345
TR
40050
31
TARGET
R2-A3
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
11
%
11
11
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
32
FGH12345
TR
40050
32
NON-TARGET
R2-A3
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
Dataset Debug Message
There are seven leading, trailing, or non-breaking spaces in the dataset.
4.5 Example 5: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the data for a subject that has only target tumors at screening. This example includes an unscheduled assessment.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.5.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to show investigator tumor identification, tumor results and response data using RECIST 1.1 for a subject that have only target tumors at screening. This includes an unscheduled assessment.
Rows 1-2: Show the target response and overall response of CR at Week 8. The subject only has one target lesion and no non-targets.
Rows 3-4: Show an unscheduled response assessment which was done to confirm the CR. The RSLNKGRP differentiates the assessment and the VISIT is 'UNSCHEDULED WEEK 13'.
rs.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
RSACPTFL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
SUPPRS.RSREASNE
1
IJK12345
RS
40060
1
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
2
IJK12345
RS
40060
2
A2
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
3
IJK12345
RS
40060
3
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
4
IJK12345
RS
40060
4
A3
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
5
IJK12345
RS
40060
5
TRGRESP
Target Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
6
IJK12345
RS
40060
6
A5
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
$warningHtml
4.5.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain
The tu.xpt table below shows a subject that has only target tumors at screening. This example includes an unscheduled assessment.
Row 1: Shows the single target lesion in the breast. The subject only has one target lesion and no non-targets.
Row 2: Shows new bone lesion identified at Week 24.
tu.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
IJK12345
TU
40060
1
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
BREAST
RIGHT
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
2
IJK12345
TU
40060
2
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
BONE
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
Dataset Debug Message
There are two leading, trailing, or non-breaking spaces in the dataset.
4.5.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to show investigator tumor identification, tumor results and response data using RECIST 1.1 for a subject that have only target tumors at screening. This includes an unscheduled assessment.
Rows 1-11: Show the longest diameter and sum of longest diameter for the target lesion. The subject only has one target lesion and no non-targets. Rows 3-6 Show assessment where the target lesion is absent. The longest diameter is shown as 0. If a sponsor collects that the tumor is absent rather than entering the longest diameter as 0, then the sponsor may optionally derive the longest diameter as 0 and represent the tumor state as ABSENT, if desired.
Row 12: Shows a new lesion state at Week 24.
tr.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
IJK12345
TR
40060
1
TARGET
A1
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
2
IJK12345
TR
40060
2
TARGET
A1
SUMLDIAM
Sum of Longest Diameter
10
mm
10
10
mm
INVESTIGATOR
SCREEN
1
SCREEN
3
IJK12345
TR
40060
3
TARGET
A2
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
4
IJK12345
TR
40060
4
TARGET
A2
T01
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
5
IJK12345
TR
40060
5
TARGET
A2
SUMLDIAM
Sum of Longest Diameter
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
3
WEEK 8
6
IJK12345
TR
40060
6
TARGET
A3
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
7
IJK12345
TR
40060
7
TARGET
A3
T01
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
8
IJK12345
TR
40060
8
TARGET
A3
SUMLDIAM
Sum of Longest Diameter
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
9
IJK12345
TR
40060
9
TARGET
A4
T01
LDIAM
Longest Diameter
NOT DONE
NOT ASSESSABLE: Image obscured
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
10
IJK12345
TR
40060
10
TARGET
A4
T01
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE: Poor Contrast
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
11
IJK12345
TR
40060
11
TARGET
A4
SUMLDIAM
Sum of Longest Diameter
NOT DONE
NOT ASSESSABLE: Motion issue
INVESTIGATOR
TREATMENT
5
WEEK 16
12
IJK12345
TR
40060
12
TARGET
A5
T01
LDIAM
Longest Diameter
5
mm
5
5
mm
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
13
IJK12345
TR
40060
13
TARGET
A5
T01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
14
IJK12345
TR
40060
14
TARGET
A5
SUMLDIAM
Sum of Longest Diameter
5
mm
5
5
mm
INVESTIGATOR
TREATMENT
7
WEEK 24
15
IJK12345
TR
40060
15
NEW
A5
NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
Dataset Debug Message
There are six leading, trailing, or non-breaking spaces in the dataset.
4.6 Example 6: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.6.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to show investigator tumor identification, tumor results, and response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements.
Rows 1-6: Show response assessments at the end of Cycle 1 and Cycle 2 from the investigator following RECIST 1.1.
Rows 7-8: Show response assessments at the end of Cycle 1 and Cycle 2 from the independent radiologist using PROTOCOL DEFINED RESPONSE CRITERIA based on volumetric measurements.
rs.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
RSACPTFL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
RST63421
RS
70001
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
2
RST63421
RS
70001
2
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
3
RST63421
RS
70001
3
A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
4
RST63421
RS
70001
4
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
5
RST63421
RS
70001
5
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
6
RST63421
RS
70001
6
A3
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
7
RST63421
RS
70001
7
R1-A2
OVRLRESP
Overall Response
PROTOCOL DEFINED RESPONSE CRITERIA
SD
SD
ACME VENDOR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
8
RST63421
RS
70001
8
R1-A3
OVRLRESP
Overall Response
PROTOCOL DEFINED RESPONSE CRITERIA
PD
PD
ACME VENDOR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
$warningHtml
4.6.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain.
The tu.xpt table below shows investigator tumor identification, tumor results, and response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements.
Rows 1-5: Show the identification of three target lesions and 2 non-target lesions by investigator.
Rows 6-7: Show the identification of two target lesions by the independent radiologist.
Row 8: Shows the identification of a new tumor by investigator.
Row 9: Shows the identification of a new tumor by independent radiologist.
tu.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
RST63421
TU
70001
1
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
OCCIPITAL LOBE
LEFT
ANTERIOR
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
2
RST63421
TU
70001
2
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
OCCIPITAL LOBE
RIGHT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
3
RST63421
TU
70001
3
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
TEMPORAL LOBE
LEFT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
4
RST63421
TU
70001
4
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
FRONTAL LOBE
RIGHT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
5
RST63421
TU
70001
5
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CEREBELLUM
LEFT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
6
RST63421
TU
70001
6
R-T01
TUMIDENT
Tumor Identification
TARGET
TARGET
ACME VENDOR
OCCIPITAL LOBE
RIGHT
ANTERIOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-01
1
7
RST63421
TU
70001
7
R-T02
TUMIDENT
Tumor Identification
TARGET
TARGET
ACME VENDOR
TEMPORAL LOBE
LEFT
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-01
1
8
RST63421
TU
70001
8
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
FRONTAL LOBE
RIGHT
MRI
INVESTIGATOR
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
9
RST63421
TU
70001
9
R-NEW01
TUMIDENT
Tumor Identification
NEW
NEW
ACME VENDOR
FRONTAL LOBE
RIGHT
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
Dataset Debug Message
There are 20 leading, trailing, or non-breaking spaces in the dataset.
4.6.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to shows investigator tumor identification, tumor results, and response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements.
Rows 1-6: Show response assessments at the end of Cycle 1 and Cycle 2 from the investigator following RECIST 1.1.
Rows 7-8: Show response assessments at the end of Cycle 1 and Cycle 2 from the independent radiologist using PROTOCOL DEFINED RESPONSE CRITERIA based on volumetric measurements.
$titleHtml
xx.xpt
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
RST63421
TR
70001
1
TARGET
A1
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
2
TARGET
A1
T02
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
3
TARGET
A1
T03
LDIAM
Longest Diameter
5
mm
5
5
mm
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
4
TARGET
A1
SUMLDIAM
Sum of Longest Diameter
25
mm
25
25
mm
INVESTIGATOR
SCREEN
1
SCREEN
RST63421
TR
70001
5
NON-TARGET
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
6
NON-TARGET
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
7
TARGET
R1-A1
R1-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
8
TARGET
R1-A1
R1-T01
LPERP
Longest Perpendicular
5
mm
5
5
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
9
TARGET
R1-A1
R1-T01
PPD
Product of Perpendicular Diameters
50
mm2
50
50
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
10
TARGET
R1-A1
R1-T01
VOLUME
Volume
250
mm3
250
250
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
11
TARGET
R1-A1
R1-T02
LDIAM
Longest Diameter
7
mm
7
7
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
12
TARGET
R1-A1
R1-T02
LPERP
Longest Perpendicular
10
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
13
TARGET
R1-A1
R1-T02
PPD
Product of Perpendicular Diameters
70
mm2
70
70
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
14
TARGET
R1-A1
R1-T02
VOLUME
Volume
350
mm3
350
350
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
RST63421
TR
70001
15
TARGET
R1-A1
SUMLDIAM
Sum of Longest Diameter
17
mm
17
17
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
RST63421
TR
70001
16
TARGET
R1-A1
SUMPPD
Sum of Products of Perpendicular Diameters
120
mm2
120
120
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
RST63421
TR
70001
17
TARGET
R1-A1
SUMVOL
Sum of Volume
600
mm3
600
600
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
RST63421
TR
70001
18
TARGET
A2
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
19
TARGET
A2
T02
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
20
TARGET
A2
T03
LDIAM
Longest Diameter
5
mm
5
5
mm
MRI
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
21
TARGET
A2
SUMLDIAM
Sum of Longest Diameter
25
mm
25
25
mm
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
RST63421
TR
70001
22
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
30
TARGET
R1-A2
R1-T01
LDIAM
Longest Diameter
12
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
31
TARGET
R1-A2
R1-T01
LPERP
Longest Perpendicular
7
mm
5
5
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
32
TARGET
R1-A2
R1-T01
PPD
Product of Perpendicular Diameters
84
mm2
50
50
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
33
TARGET
R1-A2
R1-T01
VOLUME
Volume
420
mm3
250
250
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
34
TARGET
R1-A2
R1-T02
LDIAM
Longest Diameter
6
mm
7
7
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
35
TARGET
R1-A2
R1-T02
LPERP
Longest Perpendicular
9
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
36
TARGET
R1-A2
R1-T02
PPD
Product of Perpendicular Diameters
63
mm2
70
70
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
37
TARGET
R1-A2
R1-T02
VOLUME
Volume
315
mm3
350
350
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
2007-01-28
28
RST63421
TR
70001
38
TARGET
R1-A2
SUMLDIAM
Sum of Longest Diameter
18
mm
17
17
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
RST63421
TR
70001
39
TARGET
R1-A2
SUMPPD
Sum of Products of Perpendicular Diameters
147
mm2
120
120
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
RST63421
TR
70001
40
TARGET
R1-A2
SUMVOL
Sum of Volume
735
mm3
600
600
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
RST63421
TR
70001
41
TARGET
R1-A2
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
6
%
0
0
%
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
RST63421
TR
70001
42
TARGET
R1-A2
PCBSPPD
Percent Change Baseline in Sum of PPD
23
%
0
0
%
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
RST63421
TR
70001
43
TARGET
R1-A2
PCBSV
Percent Change From Baseline in Sum of Volume
23
%
0
0
%
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 1 Week 4
RST63421
TR
70001
44
NEW
A3
NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
RST63421
TR
70001
45
NEW
A3
NEW01
LDIAM
Longest Diameter
9
mm
9
9
mm
MRI
INVESTIGATOR
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
RST63421
TR
70001
46
NEW
R1-A3
R1-NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
RST63421
TR
70001
47
NEW
R1-A3
R1-NEW01
LDIAM
Longest Diameter
9
mm
9
9
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
RST63421
TR
70001
48
NEW
R1-A3
R1-NEW01
LPERP
Longest Perpendicular
5
mm
5
5
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
RST63421
TR
70001
49
NEW
R1-A3
R1-NEW01
PPD
Product of Perpendicular Diameters
45
mm2
45
45
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
RST63421
TR
70001
50
NEW
R1-A3
R1-NEW01
VOLUME
Volume
270
mm3
270
270
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 1 Week 8
2007-02-26
56
$warningHtml
4.7 Example 7: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows data for a subject with non-target disease only.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.7.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to show investigator tumor identification, tumor results and response data using RECIST 1.1 for a subject with non-target disease only.
rs.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
RSACPTFL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
SUPPRS.RSREASNE
QNAM.PFREFID
RSSTAT
RSREASND
1
MNO3333
RS
67676
1
TRGRESP
Target Response
RECIST 1.1
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
NOT DONE
Subject does not have target lesions
2
MNO3333
RS
567676
2
NTRGRESP
Non-target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
3
MNO3333
RS
67676
3
A2
OVRLRESP
Overall Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
4
MNO3333
RS
67676
4
NTRGRESP
Non-target Response
RECIST 1.1
NOT ALL EVALUATED
NOT ALL EVALUATED
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
5
MNO3333
RS
67676
5
A3
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
Poor Scan Quality/Imaging Quality Issues
6
MNO3333
RS
67676
6
NTRGRESP
Non-target Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
7
MNO3333
RS
67676
7
A4
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
Dataset Debug Message
There are seven leading, trailing, or non-breaking spaces in the dataset.
4.7.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain.
The tu.xpt table below shows a subject that has only target tumors at screening.
tu.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
QNAM.LOCDTL (location detail)
QNAM.PRTYP (Disease presentation type)
1
MNO3333
TU
67676
1
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
BRAIN
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
LEPTOMENINGEAL DISEASE
2
MNO3333
TU
67676
2
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
SKELETAL MUSCLE TISSUE
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
3
MNO3333
TU
67676
3
NT03
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
PERICARDIUM
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
EFFUSION
Dataset Debug Message
There are six leading, trailing, or non-breaking spaces in the dataset.
4.7.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain.
This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
$titleHtml
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
MNO3333
TR
67676
1
NON-TARGET
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
MNO3333
TR
67676
2
NON-TARGET
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
MNO3333
TR
67676
3
NON-TARGET
A1
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
MNO3333
TR
67676
4
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
MNO3333
TR
67676
5
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
MNO3333
TR
67676
6
NON-TARGET
A2
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
MNO3333
TR
67676
7
NON-TARGET
A3
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
MNO3333
TR
67676
8
NON-TARGET
A3
NT02
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE: Lesion obscured
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
MNO3333
TR
67676
9
NON-TARGET
A3
NT03
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE: Lesion obscured
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
MNO3333
TR
67676
10
NON-TARGET
A4
NT01
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
MNO3333
TR
67676
11
NON-TARGET
A4
NT02
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
MNO3333
TR
67676
12
NON-TARGET
A4
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
$warningHtml
4.8 Example 8: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows data from a breast cancer study in a metastatic setting.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.8.1 RS Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
The table represents the items from the RECIST 1.1 criteria.
rs.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
RSACPTFL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
VWX7777
RS
90000
1
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
20
WEEK 12
2010-03-29
85
2
VWX7777
RS
90000
2
NTRGRESP
Non-target Response
RECIST 1.1
NOT ALL EVALUATED
NOT ALL EVALUATED
INVESTIGATOR
TREATMENT
20
WEEK 12
2010-03-29
85
3
VWX7777
RS
90000
3
A2
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
20
WEEK 12
2010-03-29
85
4
VWX7777
RS
90000
4
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
30
WEEK 24
2010-06-23
171
5
VWX7777
RS
90000
5
NTRGRESP
Non-target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
30
WEEK 24
2010-06-23
171
6
VWX7777
RS
90000
6
A3
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
30
WEEK 24
2010-06-23
171
Dataset Debug Message
There are six leading, trailing, or non-breaking spaces in the dataset.
4.8.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject collected at screening, the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
The tu.xpt table below shows lymph nodes as target tumors identified at screening.
tu.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
VWX7777
TU
90000
1
IMG-00002
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
BONE
SCINTIGRAPHY
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
2
VWX7777
TU
90000
2
IMG-00001
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
PLEURAL CAVITY
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
Dataset Debug Message
There are four leading, trailing, or non-breaking spaces in the dataset.
4.8.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
$titleHtml
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
TRACPTFL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
VWX7777
TR
90000
1
TARGET
IMG-00001
A1
T01
LDIAM
Longest Diameter
17
mm
17
17
mm
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
VWX7777
TR
90000
3
TARGET
A1
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
INVESTIGATOR
SCREEN
10
SCREEN
VWX7777
TR
90000
4
NON-TARGET
IMG-00002
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
SCINTIGRAPHY
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
VWX7777
TR
90000
5
NON-TARGET
IMG-00001
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
VWX7777
TR
90000
6
TARGET
IMG-00003
A2
T01
LDIAM
Longest Diameter
7
mm
7
7
mm
CT SCAN
INVESTIGATOR
TREATMENT
20
WEEK 12
2010-03-29
85
VWX7777
TR
90000
8
TARGET
A2
SUMDIAM
Sum of Diameter
7
mm
7
7
mm
INVESTIGATOR
TREATMENT
20
WEEK 12
VWX7777
TR
90000
9
TARGET
A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
INVESTIGATOR
TREATMENT
20
WEEK 12
VWX7777
TR
90000
10
TARGET
A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-59
%
-59
-59
%
INVESTIGATOR
TREATMENT
20
WEEK 12
VWX7777
TR
90000
11
TARGET
A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-59
%
-59
-59
%
INVESTIGATOR
TREATMENT
20
WEEK 12
VWX7777
TR
90000
12
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
20
WEEK 12
VWX7777
TR
90000
13
NON-TARGET
IMG-00003
A2
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
TREATMENT
20
WEEK 12
2010-03-29
85
VWX7777
TR
90000
14
TARGET
IMG-00005
A3
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INVESTIGATOR
TREATMENT
30
WEEK 24
2010-06-23
171
VWX7777
TR
90000
16
TARGET
A3
SUMDIAM
Sum of Diameter
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
30
WEEK 24
VWX7777
TR
90000
17
TARGET
A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-17
mm
-17
-17
mm
INVESTIGATOR
TREATMENT
30
WEEK 24
VWX7777
TR
90000
18
TARGET
A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-100
%
-100
-100
%
INVESTIGATOR
TREATMENT
30
WEEK 24
VWX7777
TR
90000
19
TARGET
A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-100
%
-100
-100
%
INVESTIGATOR
TREATMENT
30
WEEK 24
VWX7777
TR
90000
20
NON-TARGET
IMG-00006
A3
NT01
TUMSTATE
Tumor State
ABSENT
ABSENT
SCINTIGRAPHY
INVESTIGATOR
TREATMENT
30
WEEK 24
2010-06-24
172
VWX7777
TR
90000
21
NON-TARGET
IMG-00005
A3
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
30
WEEK 24
2010-06-23
171
$warningHtml
4.9 Example 9: Add example - where enlargement from nadir does not mean RS non-target response=PD
4.9.1 RS Domain Model
$warningHtml
4.9.2 TU Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject collected at screening, the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
The tu.xpt table below shows lymph nodes as target tumors identified at screening.
$warningHtml
4.9.3 TR Domain Model
The example below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the Week 6 visit and subsequent 8-week follow-up visits for RECIST 1.1.
$warningHtml
5 RELREC
This example shows how the RELREC dataset is used for RECIST 1.1 to represent related information between two domains which have a one-to-many relationship. This example represents dataset to dataset relationships where records in one domain are being related to records in another domain using the IDVAR as the join key. Both USUBJID and IDVARVAL are null when representing dataset to dataset relationships. Specifically, this example shows the relationship between TU and TR using --LNKID and the relationship between TR and RS using --LNKGRP.
$titleHtml
relrec.xpt
Row
STUDYID
RDOMAIN
IDVAR
RELTYPE
RELID
1
ABC12345
TU
TULNKID
One
A
2
ABC12345
TR
TRLNKID
Many
A
3
ABC12345
TR
TRLNKGRP
Many
B
4
ABC12345
RS
RSLNKGRP
One
B
5
ABC12345
PR
PRREFID
One
C
6
ABC12345
TU
TUREFID
Many
C
7
ABC123
PR
PRLNKGRP
MANY
D
8
ABC123
RS
RSLNKGRP
ONE
D
$warningHtml
6 Supplemental Qualifier Name Codes
The following table contains additional standard name codes for use in the Supplement Qualifiers for the TU domain special purpose dataset.
QNAM
RDOMAIN
QLABEL
QVAL
PREVIR
TU
Previously Irradiated Indicator
Yes/No
PREVIRP
TU
Previously Irradiated Progression
Yes/No
To set up your dataset wrapper, row caption, dataset combination when in edit mode:
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Now you can select your table from Excel, copy, and then paste (control v) into the dataset box. To be sure there are no extraneous formats, if you click the grey bar at the top of the dataset macro, it will select all of the data in the table. You can now go to the top of the edit window, click on the down arrow by the A and click "Clear formatting" to clean up the table.
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