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 instrument 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 instrument 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.
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.
3.2 Example 1: Example to show investigator tumor identification (TU), tumor results (TR) and response (RS) data using RECIST 1.1.
This example shows investigator tumor identification, tumor results and response data using RECIST 1.1. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.
3.2.1 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. 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.
Row 7: At week 36, an EQUIVOCAL new lesion (NEW01) was identified in the LUNG, LEFT LOWER LOBE.
Row 8-9: 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
3.2.2 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 1-10: Show the screening results for 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.
#### add NOT EVALUABLE , TOO SMALL TO MEASURE
Rows 11-16: Show the week 6 results for the target lesions.
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.
Rows -16: Show the week 6 that NT02 was not scanned and the results the NT01 non-target lesion using TRTESTCD as TUMSTATE.
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
3
TARGET
IMG-00001
A1
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
3
JKL12345
TR
40070
4
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
6
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
7
TARGET
IMG-00001
A1
T03
LDIAM
Longest Diameter
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
6
JKL12345
TR
40070
9
TARGET
IMG-00003
A1
T04
LDIAM
Longest Diameter
PHOTOGRAPHY
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-03
-1
7
JKL12345
TR
40070
11
TARGET
A1
SUMDIAM
Sum of Diameter
62
mm
62
62
mm
INVESTIGATOR
SCREEN
10
SCREEN
8
JKL12345
TR
40070
12
TARGET
A1
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
29
mm
29
29
mm
INVESTIGATOR
SCREEN
10
SCREEN
9
JKL12345
TR
40070
14
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
15
NON-TARGET
IMG-00001
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
11
JKL12345
TR
40070
16
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
18
TARGET
IMG-00004
A2
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
13
JKL12345
TR
40070
19
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
21
TARGET
IMG-00005
A2
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
INVESTIGATOR
TREATMENT
40
WEEK 6
15
JKL12345
TR
40070
22
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
25
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
27
TARGET
A2
SUMDIAM
Sum of Diameter
52
mm
52
52
mm
INVESTIGATOR
TREATMENT
40
WEEK 6
18
JKL12345
TR
40070
28
TARGET
A2
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
28
mm
28
28
mm
INVESTIGATOR
TREATMENT
40
WEEK 6
19
JKL12345
TR
40070
29
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
30
TARGET
A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-16
%
-16
-16
%
NOT DONE
at least one target lesions was not measured
INVESTIGATOR
TREATMENT
40
WEEK 6
21
JKL12345
TR
40070
31
TARGET
A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-16
%
-16
-16
%
INVESTIGATOR
TREATMENT
40
WEEK 6
22
JKL12345
TR
40070
32
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
33
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
34
TARGET
IMG-00007
A3
T01
DIAMETER
Diameter
12
mm
12
12
mm
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-29
85
25
JKL12345
TR
40070
36
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
37
TARGET
IMG-00008
A3
T02
DIAMETER
Diameter
12
mm
12
12
mm
CT SCAN
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-30
86
27
JKL12345
TR
40070
40
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
41
TARGET
IMG-00007
A3
T03
DIAMETER
Diameter
15
mm
15
15
mm
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-03-29
85
29
JKL12345
TR
40070
43
TARGET
IMG-00009
A3
T04
DIAMETER
Diameter
8
mm
8
8
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-01
87
30
JKL12345
TR
40070
45
TARGET
A3
SUMDIAM
Sum of Diameter
47
mm
47
47
mm
INVESTIGATOR
TREATMENT
60
WEEK 12
31
JKL12345
TR
40070
46
TARGET
A3
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
23
mm
23
23
mm
INVESTIGATOR
TREATMENT
60
WEEK 12
32
JKL12345
TR
40070
45
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
46
TARGET
A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-24
%
-24
-24
%
INVESTIGATOR
TREATMENT
60
WEEK 12
34
JKL12345
TR
40070
47
TARGET
A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-9
%
-9
-9
%
INVESTIGATOR
TREATMENT
60
WEEK 12
35
JKL12345
TR
40070
49
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
50
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
51
TARGET
IMG-00010
A4
T01
DIAMETER
Diameter
9
mm
9
9
mm
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
38
JKL12345
TR
40070
53
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
55
TARGET
IMG-00011
A4
T02
DIAMETER
Diameter
12
mm
12
12
mm
CT SCAN
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-28
145
40
JKL12345
TR
40070
57
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
58
TARGET
IMG-00010
A4
T03
DIAMETER
Diameter
11
mm
11
11
mm
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
42
JKL12345
TR
40070
60
TARGET
IMG-00012
A4
T04
DIAMETER
Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
43
JKL12345
TR
40070
61
TARGET
A4
SUMDIAM
Sum of Diameter
37
mm
37
37
mm
INVESTIGATOR
TREATMENT
80
WEEK 20
44
JKL12345
TR
40070
62
TARGET
A4
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
16
mm
16
16
mm
INVESTIGATOR
TREATMENT
80
WEEK 20
45
JKL12345
TR
40070
63
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
64
TARGET
A4
PCBSD
Percent Change From Baseline in Sum of Diameter
-40
%
-40
-40
%
INVESTIGATOR
TREATMENT
80
WEEK 20
47
JKL12345
TR
40070
64
TARGET
A4
PCNSD
Percent Change From Nadir in Sum of Diameter
-21
%
-21
-21
%
INVESTIGATOR
TREATMENT
80
WEEK 20
48
JKL12345
TR
40070
66
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
67
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
68
TARGET
IMG-00013
A5
T01
DIAMETER
Diameter
9
mm
9
9
mm
MRI
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-23
201
51
JKL12345
TR
40070
71
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
72
TARGET
IMG-00014
A5
T02
DIAMETER
Diameter
8
mm
8
8
mm
CT SCAN
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-24
202
53
JKL12345
TR
40070
74
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
75
TARGET
IMG-00013
A5
T03
DIAMETER
Diameter
6
mm
6
6
mm
MRI
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-23
201
55
JKL12345
TR
40070
77
TARGET
IMG-00015
A5
T04
DIAMETER
Diameter
0
mm
0
0
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-25
203
56
JKL12345
TR
40070
79
TARGET
A5
SUMDIAM
Sum of Diameter
23
mm
23
23
mm
INVESTIGATOR
TREATMENT
100
WEEK 28
57
JKL12345
TR
40070
80
TARGET
A5
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
6
mm
6
6
mm
INVESTIGATOR
TREATMENT
100
WEEK 28
58
JKL12345
TR
40070
81
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
82
TARGET
A5
PCBSD
Percent Change From Baseline in Sum of Diameter
-62
%
-62
-62
%
INVESTIGATOR
TREATMENT
100
WEEK 28
60
JKL12345
TR
40070
82
TARGET
A5
PCNSD
Percent Change From Nadir in Sum of Diameter
-37
%
-37
-37
%
INVESTIGATOR
TREATMENT
100
WEEK 28
61
JKL12345
TR
40070
84
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
85
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
87
TARGET
IMG-00016
A6
T01
DIAMETER
Diameter
8
mm
8
8
mm
MRI
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
64
JKL12345
TR
40070
89
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
90
TARGET
IMG-00017
A6
T02
DIAMETER
Diameter
9
mm
9
9
mm
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
66
JKL12345
TR
40070
92
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
93
TARGET
IMG-00016
A6
T03
DIAMETER
Diameter
0
mm
0
0
mm
MRI
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
68
JKL12345
TR
40070
95
TARGET
IMG-00018
A6
T04
DIAMETER
Diameter
0
mm
0
0
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
69
JKL12345
TR
40070
97
TARGET
A6
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
INVESTIGATOR
TREATMENT
120
WEEK 36
70
JKL12345
TR
40070
98
TARGET
A6
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
120
WEEK 36
71
JKL12345
TR
40070
99
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
100
TARGET
A6
PCBSD
Percent Change From Baseline in Sum of Diameter
-72
%
-72
-72
%
INVESTIGATOR
TREATMENT
120
WEEK 36
73
JKL12345
TR
40070
100
TARGET
A6
PCNSD
Percent Change From Nadir in Sum of Diameter
-26
%
-26
-26
%
INVESTIGATOR
TREATMENT
120
WEEK 36
74
JKL12345
TR
40070
102
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
103
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
105
NEW
IMG-00017
A6
NEW01
DIAMETER
Diameter
NOT DONE
UNKNOWN
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
77
JKL12345
TR
40070
106
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
107
TARGET
IMG-00019
A7
T01
DIAMETER
Diameter
12
mm
12
12
mm
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-15
314
79
JKL12345
TR
40070
109
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
110
TARGET
IMG-00020
A7
T02
DIAMETER
Diameter
9
mm
9
9
mm
CT SCAN
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
81
JKL12345
TR
40070
112
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
113
TARGET
IMG-00019
A7
T03
DIAMETER
Diameter
0
mm
0
0
mm
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-15
314
83
JKL12345
TR
40070
115
TARGET
IMG-00021
A7
T04
DIAMETER
Diameter
0
mm
0
0
mm
PHOTOGRAPHY
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-16
315
84
JKL12345
TR
40070
117
TARGET
A7
SUMDIAM
Sum of Diameter
21
mm
21
21
mm
INVESTIGATOR
TREATMENT
140
WEEK 44
85
JKL12345
TR
40070
118
TARGET
A7
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
140
WEEK 44
86
JKL12345
TR
40070
119
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
120
TARGET
A7
PCBSD
Percent Change From Baseline in Sum of Diameter
-66
%
-66
-66
%
INVESTIGATOR
TREATMENT
140
WEEK 44
88
JKL12345
TR
40070
120
TARGET
A7
PCNSD
Percent Change From Nadir in Sum of Diameter
23
%
23
23
%
INVESTIGATOR
TREATMENT
140
WEEK 44
89
JKL12345
TR
40070
122
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
123
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
124
NEW
IMG-00020
A7
NEW01
DIAMETER
Diameter
8
mm
8
8
mm
CT SCAN
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
92
JKL12345
TR
40070
125
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
126
NEW
IMG-00019
A7
NEW02
DIAMETER
Diameter
NOT DONE
UNKNOWN
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
94
JKL12345
TR
40070
127
NEW
IMG-00019
A7
NEW02
TUMSTATE
Tumor State
UNEQUIVOCAL
UNEQUIVOCAL
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
95
JKL12345
TR
40070
128
NEW
IMG-00019
A7
NEW03
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
$warningHtml
3.2.3 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 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).
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
SD
SD
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
2
JKL12345
RS
40070
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
JKL12345
RS
40070
3
A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
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
15
NEWLPROG
New Lesion Progression
RECIST 1.1
NO
NO
INVESTIGATOR
TREATMENT
120
WEEK 28
2010-09-17
257
13
JKL12345
RS
40070
12
A5
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
14
JKL12345
RS
40070
13
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
15
JKL12345
RS
40070
14
NTRGRESP
Non-target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
16
JKL12345
RS
40070
15
NEWLPROG
New Lesion Progression
RECIST 1.1
EQUIVOCAL
EQUIVOCAL
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
17
JKL12345
RS
40070
16
A6
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
18
JKL12345
RS
40070
17
TRGRESP
Target Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
19
JKL12345
RS
40070
18
NTRGRESP
Non-target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
20
JKL12345
RS
40070
19
NEWLPROG
New Lesion Progression
RECIST 1.1
UNEQUIVOCAL
UNEQUIVOCAL
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
21
JKL12345
RS
40070
20
A7
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
$warningHtml
3.2.4 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.
Row xx:
Rows xx-xx:
Row xx:
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
3.2.4 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).
Rows 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
3.2.4 Relrec
This example shows how the RELREC dataset is used for RECIST 1.1 to represent related information between two domains which have a one-to-many relationship. This example represents dataset to dataset relationships where records in one domain are being related to records in another domain using the IDVAR as the join key. Both USUBJID and IDVARVAL are null when representing dataset to dataset relationships. Specifically, this example shows the relationship between TU and TR using --LNKID and the relationship between TR and RS using --LNKGRP.
$titleHtml
relrec.xpt
Row
STUDYID
RDOMAIN
IDVAR
RELTYPE
RELID
1
ABC12345
TU
TULNKID
One
A
2
ABC12345
TR
TRLNKID
Many
A
3
ABC12345
TR
TRLNKGRP
Many
B
4
ABC12345
RS
RSLNKGRP
One
B
5
ABC12345
PR
PRREFID
One
C
6
ABC12345
TU
TUREFID
Many
C
7
ABC123
PR
PRLNKGRP
MANY
D
8
ABC123
RS
RSLNKGRP
ONE
D
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5 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.