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 Response Supplement 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 Subteam
Supplement Version
1.0
Status
DRAFT
Date
2019-06-21
Notes
This supplement is intended to be used with other CDISC User Guides and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
This document describes the CDISC implementation of the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) disease response criteria. CDISC is not including an annotated case report form (CRF) for this disease response supplement as the primary purpose of the supplement is to show examples of how to implement the disease response criteria in CDISC data standards domains.
The representation of data collected for 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, tumor assessments 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
The examples in this disease response supplement are based on assumptions about the data collection forms. It is understood that existing data collection form cannot be updated mid study. However, the preferred SDTM data is shown in the examples.
The examples in this disease response supplement use the TRTESTCDs of LDIAM (Longest Diameter) for measurements of non-lymph node target tumors and LPERP (Longest Perpendicular) for measurements in the short axis of lymph node target tumors. The SDTMIG uses the TRTESTCD DIAMETER (Diameter) for measurements of target tumors, i.e., the TRTESTCD of DIAMETER can be used for measurements of both lymph nodes and non-lymph nodes. Either representation is acceptable for RECIST 1.1 in SDTM. The latter approach requires looking at the anatomical location in conjunction with the TRTESTCD in order to know whether the diameter was measured in the longest diameter or the short axis. The LDIAM and LPERP tests provide more specificity in the TRTESTCD itself and does not required looking to the anatomical location. In addition, LDIAM and LPERP are tests used in other disease response criteria so the use of these two tests provides standardization that work across criteria for the same measurement. Some sponsors much prefer the approach used within this disease response supplement due to these reasons.
The examples in this disease response supplement use the RSTESTCD "NEWLPROG" (New Lesion Progression) in order to indicate whether a new lesion is equivocal or unequivocal. There are different methods of collecting data when there is a equivocal new lesion. Some sponsors update the Overall Response when unequivocal 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. The RSTESTCD "NEWLSIND" can have "Y" or "N" RSORRES values only. This test can be used if the sponsor collects yes and no responses to indicate new lesion(s) were identified at the disease assessment timepoint.
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.
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), procedure (PR) data and trial disease assessment (TD) data.
The example shows the case where lymph nodes are selected as target lesions. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
4.1.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 6 visit, the week 12 visits and subsequent 8-week follow-up visits.
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. Note that NE is a valid Overall Response value per the RECIST 1.1 criteria which means it that RSORRES is NE rather than represented in RSSTAT.
Rows 4-13: Show the week 12, week 20 and week 28 responses.
Row 14-21: At week 36, the New Lesion Progression test is used to represent an equivocal new lesion (TRTESTCD = "NEWLPROG" and TRORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (TRTESTCD = "NEWLPROG" and TRORRES = "UNEQUIVOCAL"). 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 New Lesion Indicator test (TRTESTCD = "NEWLIND") 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
EX11111
RS
90001
1
TRGRESP
Target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
2
EX11111
RS
90001
2
NTRGRESP
Non-Target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
3
EX11111
RS
90001
3
A2
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
4
EX11111
RS
90001
4
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
5
EX11111
RS
90001
5
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
6
EX11111
RS
90001
6
A3
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
7
EX11111
RS
90001
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
8
EX11111
RS
90001
8
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
9
EX11111
RS
90001
9
A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-30
147
10
EX11111
RS
90001
10
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
11
EX11111
RS
90001
11
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
12
EX11111
RS
90001
12
A5
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
100
WEEK 28
2010-07-26
204
13
EX11111
RS
90001
13
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
14
EX11111
RS
90001
14
NTRGRESP
Non-Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
15
EX11111
RS
90001
15
NEWLPROG
New Lesion Progression
RECIST 1.1
EQUIVOCAL
EQUIVOCAL
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
16
EX11111
RS
90001
16
A6
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
17
EX11111
RS
90001
17
TRGRESP
Target Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
18
EX11111
RS
90001
18
NTRGRESP
Non-Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
19
EX11111
RS
90001
19
NEWLPROG
New Lesion Progression
RECIST 1.1
UNEQUIVOCAL
UNEQUIVOCAL
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
20
EX11111
RS
90001
20
A7
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-14
313
$warningHtml
The supprs.xpt table below shows the data on the reason that the response was Not Evaluable (NE) (QNAM.RSREASNE) in
the case where it is collected.
Row 1: Show that the QVAL for Reason Response Not Evaluable (QNAM = "RSREASNE").
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX11111
RS
90005
RSSEQ
3
RSREASNE
Reason Response Not Evaluable
Imaging Quality Issues and not all scan performed
CRF
Dataset Debug Messages
There is a leading, trailing, or non-breaking space in the dataset.
The tu.xpt table below shows the terminology used to implementRECIST 1.1in theTUdomain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors. In RECIST 1.1, target lymph node tumors are measured in the short axis (TRTESTCD = "LPERP" and TRTEST = "Longest Perpendicular"). The image identifier is in TUREFID and matches a PRREFID in the PR Domain.
Rows 1-6: Show a subject with 4 target lesions with TULNKID 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 supraclavicular lymph node (TULOC=SUPRACLAVICULAR LYMPH NODE) on the right side (TULAT = "RIGHT"). The TULOC contains the location from the anatomical location terminology. Note that some locations contain in the anatomical location controlled terminology contain laterality and/or directionality. The laterality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality.
Row 7: Shows at week 36, an equivocal new lesion (NEW01) was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location.
Row 8-9: Show at week 44, new unequivocal new lesions (NEW02 and NEW03) were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE").
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TUREFID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
EX11111
TU
90001
1
IMG-00001
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
SUPRACLAVICULAR LYMPH NODE
RIGHT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
2
EX11111
TU
90001
2
IMG-00002
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
THORACIC LYMPH NODE
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
3
EX11111
TU
90001
3
IMG-00001
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
THYROID GLAND
LEFT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
-3
4
EX11111
TU
90001
4
IMG-00003
T04
TUMIDENT
Tumor Identification
TARGET
TARGET
SKIN OF THE TRUNK
UPPER
PHOTOGRAPHY
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-03
-1
5
EX11111
TU
90001
5
IMG-00002
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
MEDIASTINAL LYMPH NODE
RIGHT
CT SCAN
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-02
-2
6
EX11111
TU
90001
6
IMG-00001
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CEREBELLUM
RIGHT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-01
1
7
EX11111
TU
90001
7
IMG-00020
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
LUNG, LEFT LOWER LOBE
CT SCAN
INVESTIGATOR
TREATMENT
120
WEEK 36
2010-09-17
257
8
EX11111
TU
90001
8
IMG-00019
NEW02
TUMIDENT
Tumor Identification
NEW
NEW
CEREBELLUM
LEFT
MRI
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
317
9
EX11111
TU
90001
9
IMG-00022
NEW03
TUMIDENT
Tumor Identification
NEW
NEW
FEMORAL LYMPH NODE
LEFT
ULTRASOUND
INVESTIGATOR
TREATMENT
140
WEEK 44
2010-11-18
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 target lesions with TUSEQ equals 1, 2 and 3 where not previously irradiated.
Rows 4-5: Show that that target lesion with TUSEQ=4 was previously irradiated and shown to be progressing since it was irradiated.
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX11111
TU
90001
TUSEQ
1
PREVIR
Previously Irradiated Indicator
N
CRF
2
EX11111
TU
90001
TUSEQ
2
PREVIR
Previously Irradiated Indicator
N
CRF
3
EX11111
TU
90001
TUSEQ
3
PREVIR
Previously Irradiated Indicator
N
CRF
4
EX11111
TU
90001
TUSEQ
4
PREVIR
Previously Irradiated Indicator
Y
CRF
5
EX11111
TU
90001
TUSEQ
4
PREVIRP
Previously Irradiated Progression
Y
CRF
$warningHtml
4.1.3 TR Domain Model
Thetr.xpt table below shows the data for one subject collected at week 6 visit, week 12 visit and subsequent 8-week follow-up visits.
The example 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 tumor has short axis greater than or equal to 10mm. The image identifier is in TRREFID and matches a PRREFID in the PR Domain.
Rows 1-6: Show the screening identification of the target and non-target lesions. For lymph node target lesions T01 and T02 the TRTESTCD used for the assessments are LPREP and LNSTATE. For non-lymph node target lesions T03 and T04 the TRTESTCD used for the assessments is LDIAM.
Rows 7-8: Show the results for the non-targets. NT01 is a lymph node where the TRTESTCD used for the assessments is Lymph Note State (TRTESTCD = "LNSTATE"). NT02 is a non-lymph node where the TRTESTCD used for the assessments is Tumor State (TRTESTCD = "TUMSTATE").
Row 14: Shows a case where the scan was not performed at week 6 (for TRTEST=Longest Diameter, TRSTAT=NOT DONE with TRREASND=SCAN NOT PERFORMED).
Row 15: Shows a case where the non-target NT01 was not evaluable (for TRTEST=Lymph Node State, TRSTAT=NOT DONE with TRREASND=NOT EVALUABLE).
Row 16: Shows a case where the non-target NT02 was not evaluable (for TRTEST=Tumor State, TRSTAT=NOT DONE with TRREASND=NOT ASSESSABLE: Image obscured).
Row 30: Shows a target lesion T04 which is too small to measure. The TRORRES=TOO SMALL TO MEASURE, and the TRSTRESC and TRSTRESN are standardized to 5 with TRSTRESU as mm.
Thepr.xpt table below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at the week 6 visit and subsequent 8-week follow-up visits. The example shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin and trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.
Rows 1-3: Show the scans preformed at screening. The results of the scans are record in TU and TR.
Rows 4-6: Show that the MRI and CT scan were performed (PROCCUR=Y) and that the medical photography was not performed (PROCCUR=N) at week 6.
Rows 7-22: Show the scans preformed at weeks 12, 20, 28, 36 and 44. The results of the scans are record in TU and TR. In row 22, a non-RECIST 1.1 method was used and this example shows a way to represent the additional scan in PR, i.e., ULTRASOUND.
pr.xpt
pr.xpt
ROW
STUDYID
DOMAIN
USUBJID
PRSEQ
PRREFID
PRLNKGRP
PRTRT
PRPRESP
PROCCUR
PRLOC
EPOCH
VISITNUM
VISIT
PRSTDTC
PRSTDY
1
EX11111
PR
90001
1
IMG-00001
A1
MRI
Y
Y
HEAD AND NECK
SCREEN
10
SCREEN
2010-01-01
-3
2
EX11111
PR
90001
2
IMG-00002
A1
CT SCAN
Y
Y
CHEST
SCREEN
10
SCREEN
2010-01-02
-2
3
EX11111
PR
90001
3
IMG-00003
A1
PHOTOGRAPHY
Y
Y
SKIN OF THE TRUNK
SCREEN
10
SCREEN
2010-01-03
-1
4
EX11111
PR
90001
4
IMG-00004
A2
MRI
Y
Y
HEAD AND NECK
TREATMENT
40
WEEK 6
2010-02-15
43
5
EX11111
PR
90001
5
IMG-00005
A2
CT SCAN
Y
Y
CHEST
TREATMENT
40
WEEK 6
2010-02-16
44
6
EX11111
PR
90001
6
A2
PHOTOGRAPHY
Y
N
SKIN OF THE TRUNK
TREATMENT
40
WEEK 6
7
EX11111
PR
90001
7
IMG-00007
A3
MRI
Y
Y
HEAD AND NECK
TREATMENT
60
WEEK 12
2010-03-29
85
8
EX11111
PR
90001
8
IMG-00008
A3
CT SCAN
Y
Y
CHEST
TREATMENT
60
WEEK 12
2010-03-30
86
9
EX11111
PR
90001
9
IMG-00009
A3
PHOTOGRAPHY
Y
Y
SKIN OF THE TRUNK
TREATMENT
60
WEEK 12
2010-04-01
87
10
EX11111
PR
90001
10
IMG-00010
A4
MRI
Y
Y
HEAD AND NECK
TREATMENT
80
WEEK 20
2010-05-27
144
11
EX11111
PR
90001
11
IMG-00011
A4
CT SCAN
Y
Y
CHEST
TREATMENT
80
WEEK 20
2010-05-28
145
12
EX11111
PR
90001
12
IMG-00012
A4
PHOTOGRAPHY
Y
Y
SKIN OF THE TRUNK
TREATMENT
80
WEEK 20
2010-05-30
147
13
EX11111
PR
90001
13
IMG-00013
A5
MRI
Y
Y
HEAD AND NECK
TREATMENT
100
WEEK 28
2010-07-23
201
14
EX11111
PR
90001
14
IMG-00014
A5
CT SCAN
Y
Y
CHEST
TREATMENT
100
WEEK 28
2010-07-24
202
15
EX11111
PR
90001
15
IMG-00015
A5
PHOTOGRAPHY
Y
Y
SKIN OF THE TRUNK
TREATMENT
100
WEEK 28
2010-07-25
203
16
EX11111
PR
90001
16
IMG-00016
A6
MRI
Y
Y
HEAD AND NECK
TREATMENT
120
WEEK 36
2010-09-17
257
17
EX11111
PR
90001
17
IMG-00017
A6
CT SCAN
Y
Y
CHEST
TREATMENT
120
WEEK 36
2010-09-17
257
18
EX11111
PR
90001
18
IMG-00018
A6
PHOTOGRAPHY
Y
Y
SKIN OF THE TRUNK
TREATMENT
120
WEEK 36
2010-09-17
257
19
EX11111
PR
90001
19
IMG-00019
A7
MRI
Y
Y
HEAD AND NECK
TREATMENT
140
WEEK 44
2010-11-14
313
20
EX11111
PR
90001
20
IMG-00020
A7
CT SCAN
Y
Y
CHEST
TREATMENT
140
WEEK 44
2010-11-15
314
21
EX11111
PR
90001
21
IMG-00021
A7
PHOTOGRAPHY
Y
Y
SKIN OF THE TRUNK
TREATMENT
140
WEEK 44
2010-11-16
315
22
EX11111
PR
90001
22
IMG-00022
A7
ULTRASOUND
PELVIS
TREATMENT
140
WEEK 44
2010-11-16
315
$warningHtml
4.1.5 TD Domain Model
Thetd.xpt table below shows the terminology used to implement RECIST 1.1 in the TD domain. The TD domain is a trial design domain so it does not contain subject level data. The example 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
EX11111
TD
1
ANCH1DT
P0D
P8W
P53D
P9W
6
2
EX11111
TD
2
ANCH1DT
P60W
P12W
P11W
P13W
4
3
EX11111
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 rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 8 visit and subsequent 8-week follow-up visits.
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.
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
EX22222
RS
90002
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
300%
WEEK 8
3914000%
5600%
2
EX22222
RS
90002
2
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
3
EX22222
RS
90002
3
R-A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
4
EX22222
RS
90002
4
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
5
EX22222
RS
90002
5
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
6
EX22222
RS
90002
6
R-A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
7
EX22222
RS
90002
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2009-06-19
168
8
EX22222
RS
90002
8
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2009-06-19
168
9
EX22222
RS
90002
9
R-A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2009-06-19
168
10
EX22222
RS
90002
10
TRGRESP
Target Response
RECIST 1.1
PD
PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2009-08-14
224
11
EX22222
RS
90002
11
NTRGRESP
Non-Target Response
RECIST 1.1
PD
PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2009-08-14
224
12
EX22222
RS
90002
12
R-A5
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2009-08-14
224
$warningHtml
4.2.2 TU Domain Model
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject collected at screening and subsequent visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This example also shows TUREFID used to represent the image identifier and TUSPID used to represent a sponsors internal tracking identifier.
Rows 7-8: Show the identification of a split tumor when it was first identified as split (fragmented). In this example, TULNKID = "T04" splits into two tumors TULNKID = "T04.1" and TULNKID = "T04.2" with TUGRPID = "T04". TUGRPID = "T04" provides traceability and links the split tumor to its parent records.
Row 9: Shows the identification of a merged tumor when it was first identified as merged (coalesced). In this example, TULNKID = "T02" and TULNKID = "T03" merged into tumor TULNKID = "T02/T03". The TULNKID is a combination of the child tumors before more and therefore provides the transability back to the child tumors.
tu.xpt
tu.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
EX22222
TU
90002
1
IMG-00001
TRG-SCR-01
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
LUNG, RIGHT MIDDLE LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
2
EX22222
TU
90002
2
IMG-00001
TRG-SCR-02
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
LUNG, LEFT LOWER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
3
EX22222
TU
90002
3
IMG-00001
TRG-SCR-03
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
LUNG, LEFT LOWER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
4
EX22222
TU
90002
4
IMG-00001
TRG-SCR-04
T04
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
KIDNEY, UPPER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
5
EX22222
TU
90002
5
IMG-00001
NTG-SCR-01
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL INC.
LUNG
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
6
EX22222
TU
90002
6
IMG-00001
NTG-SCR-02
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL INC.
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
7
EX22222
TU
90002
7
T04
IMG-00002
TRG-W16-07
T04.1
TUSPLIT
Tumor Split
TARGET
TARGET
RADIOL INC.
KIDNEY, UPPER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
8
EX22222
TU
90002
8
T04
IMG-00002
TRG-W16-08
T04.2
TUSPLIT
Tumor Split
TARGET
TARGET
RADIOL INC.
KIDNEY, UPPER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
9
EX22222
TU
90002
9
IMG-00003
TRG-W28-07
T02/T03
TUMERGE
Tumor Merged
TARGET
TARGET
RADIOL INC.
LUNG, LEFT LOWER LOBE
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
7
WEEK 24
2009-06-19
168
10
EX22222
TU
90002
10
IMG-00004
NWT-W32-01
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
RADIOL INC.
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
9
WEEK 32
2009-08-14
224
$warningHtml
4.2.3 TR Domain Model
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the week 6 visit and subsequent 8-week follow-up visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This preferred approach provides transparent with traceability with parent lesions. This example shows how to represent data on a single row when a target tumor becomes too small to measure. In terms of RECIST, the original results would be 'TOO SMALL TO MEASURE' and the standard results (TRSTRESN and TRSTRESC) would be 5. In addition, the example represents a situations where a result was not provided because the image was obscured and the tumor was not assessable.
This examples shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs used for the assessments are: SUMDIAM, ACNSD, PCBSD and PCNSD. Note that the sponsor should not derived these values if they were not part of the data capture or not provided in the transfer from the vendor.
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 24-25: Show that tumors T02 and T03 are no longer measured individually. The TRSTAT=NOT DONE and the TRREASND=TUMOR MERGED. These rows are optional and can be included if part of the collection.
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
tr.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
TREVALID
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
EX22222
TR
90002
1
TARGET
R-A1
T01
LDIAM
Longest Diameter
16
mm
16
16
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
2
EX22222
TR
90002
2
TARGET
R-A1
T02
LDIAM
Longest Diameter
28
mm
28
28
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
3
EX22222
TR
90002
3
TARGET
R-A1
T03
LDIAM
Longest Diameter
41
mm
41
41
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
4
EX22222
TR
90002
4
TARGET
R-A1
T04
LDIAM
Longest Diameter
83
mm
83
83
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
5
EX22222
TR
90002
5
TARGET
R-A1
SUMLDIAM
Sum of Longest Diameter
168
mm
168
168
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
6
EX22222
TR
90002
6
NON-TARGET
R-A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
7
EX22222
TR
90002
7
NON-TARGET
R-A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
1
SCREEN
2007-01-02
1
8
EX22222
TR
90002
8
TARGET
R-A2
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
9
EX22222
TR
90002
9
TARGET
R-A2
T02
LDIAM
Longest Diameter
20
mm
20
20
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
10
EX22222
TR
90002
10
TARGET
R-A2
T03
LDIAM
Longest Diameter
30
mm
30
30
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
11
EX22222
TR
90002
11
TARGET
R-A2
T04
LDIAM
Longest Diameter
65
mm
65
65
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
12
EX22222
TR
90002
12
TARGET
R-A2
SUMLDIAM
Sum of Longest Diameter
125
mm
125
125
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
13
EX22222
TR
90002
13
TARGET
R-A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-43
mm
-43
-43
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
14
EX22222
TR
90002
14
TARGET
R-A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-26
mm
-26
-26
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
15
EX22222
TR
90002
15
TARGET
R-A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-26
%
-26
-26
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
16
EX22222
TR
90002
16
NON-TARGET
R-A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
17
EX22222
TR
90002
17
NON-TARGET
R-A2
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
WEEK 8
2007-02-27
56
18
EX22222
TR
90002
18
TARGET
R-A3
T01
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
19
EX22222
TR
90002
19
TARGET
R-A3
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
20
EX22222
TR
90002
20
TARGET
R-A3
T03
LDIAM
Longest Diameter
15
mm
15
15
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
21
EX22222
TR
90002
21
TARGET
R-A3
T04.1
LDIAM
Longest Diameter
30
mm
30
30
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
22
EX22222
TR
90002
22
TARGET
R-A3
T04.2
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
23
EX22222
TR
90002
23
TARGET
R-A3
SUMLDIAM
Sum of Longest Diameter
72
mm
72
72
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
24
EX22222
TR
90002
24
TARGET
R-A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-96
mm
-96
-96
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
25
EX22222
TR
90002
25
TARGET
R-A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-57
mm
-57
-57
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
26
EX22222
TR
90002
26
TARGET
R-A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-42
%
-42
-42
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
27
EX22222
TR
90002
27
NON-TARGET
R-A3
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
28
EX22222
TR
90002
28
NON-TARGET
R-A3
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
5
WEEK 16
2007-04-24
112
29
EX22222
TR
90002
29
TARGET
R-A4
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
30
EX22222
TR
90002
30
TARGET
R-A4
T02
LDIAM
Longest Diameter
NOT DONE
TUMOR MERGED
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
31
EX22222
TR
90002
31
TARGET
R-A4
T03
LDIAM
Longest Diameter
NOT DONE
TUMOR MERGED
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
32
EX22222
TR
90002
32
TARGET
R-A4
T02/T03
LDIAM
Longest Diameter
35
mm
35
35
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
33
EX22222
TR
90002
33
TARGET
R-A4
T04.1
LDIAM
Longest Diameter
30
mm
30
30
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
34
EX22222
TR
90002
34
TARGET
R-A4
T04.2
LDIAM
Longest Diameter
19
mm
19
19
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
35
EX22222
TR
90002
35
TARGET
R-A4
SUMLDIAM
Sum of Longest Diameter
84
mm
84
84
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
36
EX22222
TR
90002
36
TARGET
R-A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
12
mm
12
12
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
37
EX22222
TR
90002
37
TARGET
R-A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-50
mm
-50
-50
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
38
EX22222
TR
90002
38
TARGET
R-A3
PCNSD
Percent Change From Nadir in Sum of Diameter
17
%
17
17
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
39
EX22222
TR
90002
39
NON-TARGET
R-A4
NT01
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE: Image obscured
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
40
EX22222
TR
90002
40
NON-TARGET
R-A4
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
7
WEEK 24
2007-06-19
168
41
EX22222
TR
90002
41
TARGET
R-A5
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
42
EX22222
TR
90002
42
TARGET
R-A5
T02/T03
LDIAM
Longest Diameter
80
mm
80
80
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
43
EX22222
TR
90002
43
TARGET
R-A5
T04.1
LDIAM
Longest Diameter
49
mm
49
49
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
44
EX22222
TR
90002
44
TARGET
R-A5
T04.2
LDIAM
Longest Diameter
26
mm
26
26
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
45
EX22222
TR
90002
45
TARGET
R-A5
SUMLDIAM
Sum of Longest Diameter
155
mm
155
155
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
46
EX22222
TR
90002
46
TARGET
R-A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
83
mm
83
83
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
47
EX22222
TR
90002
47
TARGET
R-A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-8
mm
-8
-8
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
48
EX22222
TR
90002
48
TARGET
R-A3
PCNSD
Percent Change From Nadir in Sum of Diameter
115
%
115
-42
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
49
EX22222
TR
90002
49
NON-TARGET
R-A5
NT01
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
50
EX22222
TR
90002
50
NON-TARGET
R-A5
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
51
EX22222
TR
90002
51
NEW
R-A5
NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
52
EX22222
TR
90002
52
NEW
R-A5
NEW01
LDIAM
Longest Diameter
9
mm
9
9
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
9
WEEK 32
2007-08-14
224
$warningHtml
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 rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 8 visit and subsequent 8-week follow-up visits. The investigator also indicated that there was symptomatic deterioration indicating progression based on a clinical assessment that is not part of the response criteria (RSCAT='PROTOCOL DEFINED RESPONSE CRITERIA'). The actual symptomatic deterioration is represented in the RSORRES value and the standardize representation (RSSTRESC) is PD. The Symptomatic Deterioration (SYMPTDTR) test should only be used when this information is collected as part of the response forms and it is expected that the subject continues having disease assessments until objective evidence of progression is documented.
Row 12: Shows RSCAT=RECIST 1.1. The RSTEST=Overall Response with RSORRES=NE because the scans of the target and non-target lesions were not done.
Row 13: Shows a protocol defined response which is outside of RECIST 1.1. In this case, it is symptomatic deterioration. The RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA" and RSTEST = "Symptomatic Deterioration" with RSORRES = "Increased weakness and weight loss". The RSORRES contains the actual symptomatic deterioration results. The RSSTRESC = "PD" is a standardized representation of the symptomatic deterioration response.
Row 14: Shows RSCAT= "PROTOCOL DEFINED RESPONSE CRITERIA". The RSTEST = "Overall Response" with RSORRES=PD.
rs.xpt
rs.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSGRPID
RSLNKGRP
RSLNKID
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSEVAL
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
RSSTAT
1
EX33333
RS
90003
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
2
EX33333
RS
90003
2
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
3
EX33333
RS
90003
3
A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
4
EX33333
RS
90003
4
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
5
EX33333
RS
90003
5
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
6
EX33333
RS
90003
6
A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
7
EX33333
RS
90003
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
8
EX33333
RS
90003
8
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
9
EX33333
RS
90003
9
A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
10
EX33333
RS
90003
10
TRGRESP
Target Response
RECIST 1.1
INVESTIGATOR
TREATMENT
9
WEEK 32
NOT DONE
11
EX33333
RS
90003
11
NTRGRESP
Non-Target Response
RECIST 1.1
INVESTIGATOR
TREATMENT
9
WEEK 32
NOT DONE
12
EX33333
RS
90003
12
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
9
WEEK 32
13
EX33333
RS
90003
13
SYMPTDTR
Symptomatic Deterioration
PROTOCOL DEFINED RESPONSE CRITERIA
Increased weakness and weight loss
PD
INVESTIGATOR
TREATMENT
9
WEEK 32
2009-08-12
226
14
EX33333
RS
90003
14
A5
OVRLRESP
Overall Response
PROTOCOL DEFINED RESPONSE CRITERIA
PD
PD
INVESTIGATOR
TREATMENT
9
WEEK 32
2009-08-12
226
$warningHtml
The supprs.xpt table below shows the data on the reason that the response was Not Evaluable (NE) (QNAM.RSREASNE) in the case where it is collected
Row 1: Show that the QVAL for Reason Response Not Evaluable (QNAM = "RSREASNE").
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX33333
RS
90005
RSSEQ
12
RSREASNE
Reason Response Not Evaluable
Scans of target and non-target tumors were not performed
CRF
Dataset Debug Messages
There is a leading, trailing, or non-breaking space in the dataset.
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the identification of target and non-target tumors at screening.
Rows 1-7: Show a subject with 4 target lesions with TULNKID T01-T04 and 3 non-target lesions with TULNKID NT01-NT03 identified at screening. The subject did not have any new lesions.
tu.xpt
tu.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUCAT
TUSCAT
TUGRPID
TULNKGRP
TUREFID
TUSPID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
EX33333
TU
90003
1
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
LUNG, RIGHT MIDDLE LOBE
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
2
EX33333
TU
90003
2
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
LIVER
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
3
EX33333
TU
90003
3
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
LIVER
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
4
EX33333
TU
90003
4
T04
TUMIDENT
Tumor Identification
TARGET
TARGET
KIDNEY, UPPER LOBE
RIGHT
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
5
EX33333
TU
90003
5
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
LUNG
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
6
EX33333
TU
90003
6
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
ABDOMINAL CAVITY
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
7
EX33333
TU
90003
7
NT03
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CLAVICLE
RIGHT
SCINTIGRAPHY
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
$warningHtml
4.3.3 TR Domain Model
The tr.xpt tablebelow shows the terminology used to implement RECIST 1.1 in the TR domain. This example also shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator. In addition, the example represents a situations where a result was not provided because the scan was performed.
Rows 1-32: Show RECIST 1.1 assessments of target and non-target lesions at screening, week 8, week 16 and week 24.
Rows 33-39: Show that the scans of target and non-target lesions were not done at week 32.
tr.xpt
tr.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRNAM
TRMETHOD
TREVAL
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
EX33333
TR
90003
1
TARGET
A1
T01
LDIAM
Longest Diameter
16
mm
16
16
mm
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
2
EX33333
TR
90003
2
TARGET
A1
T02
LDIAM
Longest Diameter
28
mm
28
28
mm
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
3
EX33333
TR
90003
3
TARGET
A1
T03
LDIAM
Longest Diameter
41
mm
41
41
mm
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
4
EX33333
TR
90003
4
TARGET
A1
T04
LDIAM
Longest Diameter
82
mm
83
83
mm
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
5
EX33333
TR
90003
5
TARGET
A1
SUMLDIAM
Sum of Longest Diameter
167
mm
168
168
mm
INVESTIGATOR
SCREEN
1
SCREEN
6
EX33333
TR
90003
6
NON-TARGET
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
7
EX33333
TR
90003
7
NON-TARGET
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
8
EX33333
TR
90003
8
NON-TARGET
A1
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
SCINTIGRAPHY
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
9
EX33333
TR
90003
9
TARGET
A2
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
10
EX33333
TR
90003
10
TARGET
A2
T02
LDIAM
Longest Diameter
20
mm
20
20
mm
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
11
EX33333
TR
90003
11
TARGET
A2
T03
LDIAM
Longest Diameter
30
mm
30
30
mm
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
12
EX33333
TR
90003
12
TARGET
A2
T04
LDIAM
Longest Diameter
65
mm
65
65
mm
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
13
EX33333
TR
90003
13
TARGET
A2
SUMLDIAM
Sum of Longest Diameter
125
mm
125
125
mm
INVESTIGATOR
TREATMENT
3
WEEK 8
14
EX33333
TR
90003
14
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
15
EX33333
TR
90003
15
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
16
EX33333
TR
90003
16
NON-TARGET
A2
NT03
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
3
WEEK 8
17
EX33333
TR
90003
17
TARGET
A3
T01
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
39196
112
18
EX33333
TR
90003
18
TARGET
A3
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
19
EX33333
TR
90003
19
TARGET
A3
T03
LDIAM
Longest Diameter
15
mm
15
15
mm
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
20
EX33333
TR
90003
20
TARGET
A3
T04
LDIAM
Longest Diameter
40
mm
40
40
mm
21
EX33333
TR
90003
21
TARGET
A3
SUMLDIAM
Sum of Longest Diameter
72
mm
72
72
mm
INVESTIGATOR
TREATMENT
5
WEEK 16
22
EX33333
TR
90003
22
NON-TARGET
A3
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
23
EX33333
TR
90003
23
NON-TARGET
A3
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
24
EX33333
TR
90003
24
NON-TARGET
A3
NT03
TUMSTATE
Tumor State
NOT DONE
DISEASE ASSESSMENT NOT PERFORMED
SCINTIGRAPHY
INVESTIGATOR
TREATMENT
5
WEEK 16
25
EX33333
TR
90003
25
TARGET
A4
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
26
EX33333
TR
90003
26
TARGET
A4
T02
LDIAM
Longest Diameter
15
mm
15
15
mm
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
27
EX33333
TR
90003
27
TARGET
A4
T03
LDIAM
Longest Diameter
5
mm
5
5
mm
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
28
EX33333
TR
90003
28
TARGET
A4
T04
LDIAM
Longest Diameter
36
mm
36
36
mm
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
29
EX33333
TR
90003
29
TARGET
A4
SUMLDIAM
Sum of Longest Diameter
56
mm
56
56
mm
INVESTIGATOR
TREATMENT
7
WEEK 24
30
EX33333
TR
90003
30
NON-TARGET
A4
NT01
TUMSTATE
Tumor State
NOT DONE
NOT EVALUABLE
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
31
EX33333
TR
90003
31
NON-TARGET
A4
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
32
EX33333
TR
90003
32
NON-TARGET
A4
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
SCINTIGRAPHY
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-26
175
33
EX33333
TR
90003
33
TARGET
A5
T01
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
9
WEEK 32
34
EX33333
TR
90003
34
TARGET
A5
T02
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
9
WEEK 32
35
EX33333
TR
90003
35
TARGET
A5
T03
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
9
WEEK 32
36
EX33333
TR
90003
36
TARGET
A5
T04
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
9
WEEK 32
37
EX33333
TR
90003
37
NON-TARGET
A5
NT01
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
9
WEEK 32
38
EX33333
TR
90003
38
NON-TARGET
A5
NT02
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
9
WEEK 32
39
EX33333
TR
90003
39
NON-TARGET
A5
NT03
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INVESTIGATOR
TREATMENT
9
WEEK 32
$warningHtml
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 rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 6 visit and subsequent 8-week follow-up visits.
This example shows the use of the acceptance flag (RSACPTFL) to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint, i.e., RSACPTFL indicates the "selected" response when more than read is performed. In some instances a vendor may only supply a single response record for the "selected" response either because there was adjudication or the vendor would select the appropriate response. This alternative approach would result in only the "selected" response records in the RS domain. It is not expected that the RSACPTFL flag would be populated by the sponsor. That type of record selection or censoring would by part of the analysis dataset.
This example also includes the situation where the Best Response assessment is provided by the data capture rather than derived.
Rows 1-16: Show 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. The Best Overall Response (TRTESTCD = "BESTRESP") is provided by the vendor in the data transfer in rows 4, 8, 12 and 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
EX44444
RS
90004
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
2
EX44444
RS
90004
2
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
3
EX44444
RS
90004
3
R1-A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
4
EX44444
RS
90004
4
BESTRESP
Best Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
5
EX44444
RS
90004
5
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
6
EX44444
RS
90004
6
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
7
EX44444
RS
90004
7
R1-A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
8
EX44444
RS
90004
8
BESTRESP
Best Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
9
EX44444
RS
90004
9
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
10
EX44444
RS
90004
10
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
11
EX44444
RS
90004
11
R2-A2
OVRLRESP
Overall Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
12
EX44444
RS
90004
12
BESTRESP
Best Overall Response
RECIST 1.1
SD
SD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
13
EX44444
RS
90004
13
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
14
EX44444
RS
90004
14
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
15
EX44444
RS
90004
15
R2-A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
16
EX44444
RS
90004
16
BESTRESP
Best Overall Response
RECIST 1.1
PR
PR
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
$warningHtml
4.4.2 TU Domain Model
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain.
The example shows the use of the acceptance flag (TUACPTFL) to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint using RECIST 1.1. The acceptance flag indicates records which are chosen by an adjudicator. Not all sponsors have both sets of independent reviews exported, i.e., only the accepted records are transferred. It is not expected that the TUACPTFL flag would be populated by the sponsor. That type of record selection or censoring would by part of the analysis dataset.
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
tu.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
EX44444
TU
90004
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
EX44444
TU
90004
2
R1-T02
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
KIDNEY, UPPER LOBE
LEFT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
3
EX44444
TU
90004
3
R1-NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL INC.
ABDOMINAL CAVITY
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
4
EX44444
TU
90004
4
R2-T01
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
KIDNEY, UPPER LOBE
LEFT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
5
EX44444
TU
90004
5
R2-T02
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL INC.
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
6
EX44444
TU
90004
6
R2-NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL INC.
ABDOMINAL CAVITY
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
$warningHtml
4.4.3 TR Domain Model
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain.
This example 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. It is not expected that the TUACPTFL flag would be populated by the sponsor. That type of record selection or censoring would by part of the analysis dataset.
This examples shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs used for the assessments are: SUMDIAM, ACNSD, PCBSD and PCNSD. Note that the sponsor should not derived these values if they were not part of the data capture or not provided in the transfer from the vendor.
Rows 1-32: 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
tr.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
EX44444
TR
90004
1
TARGET
R1-A1
R1-T01
LDIAM
Longest Diameter
15
mm
15
15
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
2
EX44444
TR
90004
2
TARGET
R1-A1
R1-T02
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
3
EX44444
TR
90004
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
EX44444
TR
90004
4
NON-TARGET
R1-A1
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-02
1
5
EX44444
TR
90004
5
TARGET
R1-A2
R1-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
6
EX44444
TR
90004
6
TARGET
R1-A2
R1-T02
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
7
EX44444
TR
90004
7
TARGET
R1-A2
SUMLDIAM
Sum of Longest Diameter
35
mm
35
35
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
8
EX44444
TR
90004
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
EX44444
TR
90004
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
EX44444
TR
90004
10
NON-TARGET
R1-A2
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
WEEK 8
2007-02-27
56
11
EX44444
TR
90004
11
TARGET
R1-A3
R1-T01
LDIAM
Longest Diameter
5
mm
5
5
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
12
EX44444
TR
90004
12
TARGET
R1-A3
R1-T02
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
13
EX44444
TR
90004
13
TARGET
R1-A3
SUMLDIAM
Sum of Longest Diameter
15
mm
15
15
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
14
EX44444
TR
90004
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
EX44444
TR
90004
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
EX44444
TR
90004
16
NON-TARGET
R1-A3
R1-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
5
WEEK 16
2007-04-24
112
17
EX44444
TR
90004
17
TARGET
R2-A1
R2-T01
LDIAM
Longest Diameter
25
mm
25
25
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
18
EX44444
TR
90004
18
TARGET
R2-A1
R2-T02
LDIAM
Longest Diameter
20
mm
20
20
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
19
EX44444
TR
90004
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
EX44444
TR
90004
20
NON-TARGET
R2-A1
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
SCREEN
1
SCREEN
2007-01-02
1
21
EX44444
TR
90004
21
TARGET
R2-A2
R2-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
22
EX44444
TR
90004
22
TARGET
R2-A2
R2-T02
LDIAM
Longest Diameter
8
mm
8
8
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
23
EX44444
TR
90004
23
TARGET
R2-A2
SUMLDIAM
Sum of Longest Diameter
18
mm
18
18
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
24
EX44444
TR
90004
24
TARGET
R2-A2
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
EX44444
TR
90004
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
EX44444
TR
90004
26
NON-TARGET
R2-A2
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
3
WEEK 8
2007-02-27
56
27
EX44444
TR
90004
27
TARGET
R2-A3
R2-T01
LDIAM
Longest Diameter
15
mm
15
15
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
28
EX44444
TR
90004
28
TARGET
R2-A3
R2-T02
LDIAM
Longest Diameter
TOO SMALL TO MEASURE
mm
5
5
mm
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
29
EX44444
TR
90004
29
TARGET
R2-A3
SUMLDIAM
Sum of Longest Diameter
20
mm
20
20
mm
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
30
EX44444
TR
90004
30
TARGET
R2-A3
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
EX44444
TR
90004
31
TARGET
R2-A3
PCNSLD
Percent Change From Nadir in Sum of Longest Diameter
11
%
11
11
%
RADIOL INC.
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
32
EX44444
TR
90004
32
NON-TARGET
R2-A3
R2-NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST 2
Y
TREATMENT
5
WEEK 16
2007-04-24
112
$warningHtml
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 rs.xpt table 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. The Non-target response is not applicable.
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'.
Rows 5-6: Show 'NE' target response and 'NE' overall response due to an unreadable image.
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
EX55555
RS
90005
1
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
2
EX55555
RS
90005
2
A2
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
3
EX55555
RS
90005
3
TRGRESP
Target Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
4
EX55555
RS
90005
4
A3
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
5
EX55555
RS
90005
5
TRGRESP
Target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
6
EX55555
RS
90005
6
A5
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
5
WEEK 16
2007-04-24
112
7
EX55555
RS
90005
7
TRGRESP
Target Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
8
EX55555
RS
90005
8
A5
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
$warningHtml
The supprs.xpt table below shows the data on the reason that the response was Not Evaluable (NE) (QNAM.RSREASNE) in the case where it is collected.
Row 1: Shows that the QVAL for RSSEQ = "6" for Reason Response Not Evaluable (QNAM = "RSREASNE").
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX55555
RS
90005
RSSEQ
6
RSREASNE
Reason Response Not Evaluable
Imaging Quality Issues
CRF
$warningHtml
4.5.2 TU Domain Model
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject that has only Target tumors at screening.
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
tu.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
EX55555
TU
90005
1
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
BREAST
RIGHT
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
2
EX55555
TU
90005
2
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
BONE
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
$warningHtml
4.5.3 TR Domain Model
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example 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 and an unreadable image.
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
tr.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
EX55555
TR
90005
1
TARGET
A1
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
CT SCAN
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-02
1
2
EX55555
TR
90005
2
TARGET
A1
SUMLDIAM
Sum of Longest Diameter
10
mm
10
10
mm
INVESTIGATOR
SCREEN
1
SCREEN
3
EX55555
TR
90005
3
TARGET
A2
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
4
EX55555
TR
90005
4
TARGET
A2
T01
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
3
WEEK 8
2007-02-27
56
5
EX55555
TR
90005
5
TARGET
A2
SUMLDIAM
Sum of Longest Diameter
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
3
WEEK 8
6
EX55555
TR
90005
6
TARGET
A3
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
7
EX55555
TR
90005
7
TARGET
A3
T01
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
2007-04-03
91
8
EX55555
TR
90005
8
TARGET
A3
SUMLDIAM
Sum of Longest Diameter
0
mm
0
0
mm
INVESTIGATOR
TREATMENT
4.1
UNCHEDULED WEEK 13
9
EX55555
TR
90005
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
EX55555
TR
90005
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
EX55555
TR
90005
11
TARGET
A4
SUMLDIAM
Sum of Longest Diameter
NOT DONE
NOT ASSESSABLE: Motion issue
INVESTIGATOR
TREATMENT
5
WEEK 16
12
EX55555
TR
90005
12
TARGET
A5
T01
LDIAM
Longest Diameter
5
mm
5
5
mm
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
13
EX55555
TR
90005
13
TARGET
A5
T01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
14
EX55555
TR
90005
14
TARGET
A5
SUMLDIAM
Sum of Longest Diameter
5
mm
5
5
mm
INVESTIGATOR
TREATMENT
7
WEEK 24
15
EX55555
TR
90005
15
NEW
A5
NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INVESTIGATOR
TREATMENT
7
WEEK 24
2009-06-19
168
$warningHtml
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 rs.xpt table 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 cycle 2 and cycle 3 from the investigator following RECIST 1.1.
Rows 7-8: Show response assessments at cycle 2 and cycle 3 from the independent radiologist using protocol specified response criteria based on volumetric measurements (RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA").
rs.xpt
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
EX66666
RS
90006
1
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
2
EX66666
RS
90006
2
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
3
EX66666
RS
90006
3
A2
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
4
EX66666
RS
90006
4
TRGRESP
Target Response
RECIST 1.1
SD
SD
INVESTIGATOR
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
5
EX66666
RS
90006
5
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
6
EX66666
RS
90006
6
A3
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
7
EX66666
RS
90006
7
R1-A2
OVRLRESP
Overall Response
PROTOCOL DEFINED RESPONSE CRITERIA
SD
SD
ACME VENDOR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
8
EX66666
RS
90006
8
R1-A3
OVRLRESP
Overall Response
PROTOCOL DEFINED RESPONSE CRITERIA
PD
PD
ACME VENDOR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
$warningHtml
4.6.2 TU Domain Model
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows investigator 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. The example shows the identification of a new tumor where the investigator identified the new tumor only and the independent assessor identified and measured it.
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
tu.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
EX66666
TU
90006
1
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
OCCIPITAL LOBE
LEFT
ANTERIOR
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
2
EX66666
TU
90006
2
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
OCCIPITAL LOBE
RIGHT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
3
EX66666
TU
90006
3
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
TEMPORAL LOBE
LEFT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
4
EX66666
TU
90006
4
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
FRONTAL LOBE
RIGHT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
5
EX66666
TU
90006
5
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CEREBELLUM
LEFT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
6
EX66666
TU
90006
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
EX66666
TU
90006
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
EX66666
TU
90006
8
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
FRONTAL LOBE
RIGHT
MRI
INVESTIGATOR
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
9
EX66666
TU
90006
9
R-NEW01
TUMIDENT
Tumor Identification
NEW
NEW
ACME VENDOR
FRONTAL LOBE
RIGHT
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
$warningHtml
4.6.3 TR Domain Model
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example 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. The example also includes the situation where new tumors are measured by the independent radiologist.
Rows 1-6: Show response assessments at cycle 2 and cycle 3 from the investigator following RECIST 1.1.
Rows 7-8: Show response assessments at cycle 2 and cycle 3 from the independent radiologist using PROTOCOL DEFINED RESPONSE CRITERIA based on volumetric measurements.
$titleHtml
tr.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
EX66666
TR
90006
1
TARGET
A1
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
2
TARGET
A1
T02
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
3
TARGET
A1
T03
LDIAM
Longest Diameter
5
mm
5
5
mm
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
4
TARGET
A1
SUMLDIAM
Sum of Longest Diameter
25
mm
25
25
mm
INVESTIGATOR
SCREEN
1
SCREEN
EX66666
TR
90006
5
NON-TARGET
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
6
NON-TARGET
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
7
TARGET
R1-A1
R1-T01
LDIAM
Longest Diameter
10
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
8
TARGET
R1-A1
R1-T01
LPERP
Longest Perpendicular
5
mm
5
5
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
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
EX66666
TR
90006
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
EX66666
TR
90006
11
TARGET
R1-A1
R1-T02
LDIAM
Longest Diameter
7
mm
7
7
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
12
TARGET
R1-A1
R1-T02
LPERP
Longest Perpendicular
10
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
2007-01-01
1
EX66666
TR
90006
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
EX66666
TR
90006
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
EX66666
TR
90006
15
TARGET
R1-A1
SUMLDIAM
Sum of Longest Diameter
17
mm
17
17
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
EX66666
TR
90006
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
EX66666
TR
90006
17
TARGET
R1-A1
SUMVOL
Sum of Volume
600
mm3
600
600
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
SCREEN
1
SCREEN
EX66666
TR
90006
18
TARGET
A2
T01
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
19
TARGET
A2
T02
LDIAM
Longest Diameter
10
mm
10
10
mm
MRI
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
20
TARGET
A2
T03
LDIAM
Longest Diameter
5
mm
5
5
mm
MRI
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
21
TARGET
A2
SUMLDIAM
Sum of Longest Diameter
25
mm
25
25
mm
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
EX66666
TR
90006
22
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
30
TARGET
R1-A2
R1-T01
LDIAM
Longest Diameter
12
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
31
TARGET
R1-A2
R1-T01
LPERP
Longest Perpendicular
7
mm
5
5
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
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 2 Day 1
2007-01-28
28
EX66666
TR
90006
33
TARGET
R1-A2
R1-T01
VOLUME
Volume
420
mm3
250
250
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
34
TARGET
R1-A2
R1-T02
LDIAM
Longest Diameter
6
mm
7
7
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
35
TARGET
R1-A2
R1-T02
LPERP
Longest Perpendicular
9
mm
10
10
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
36
TARGET
R1-A2
R1-T02
PPD
Product of Perpendicular Diameters
54
mm2
70
70
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
37
TARGET
R1-A2
R1-T02
VOLUME
Volume
315
mm3
350
350
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
2007-01-28
28
EX66666
TR
90006
38
TARGET
R1-A2
SUMLDIAM
Sum of Longest Diameter
18
mm
17
17
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
EX66666
TR
90006
39
TARGET
R1-A2
SUMPPD
Sum of Products of Perpendicular Diameters
138
mm2
120
120
mm2
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
EX66666
TR
90006
40
TARGET
R1-A2
SUMVOL
Sum of Volume
735
mm3
600
600
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
EX66666
TR
90006
41
TARGET
R1-A2
PCBSLD
Percent Change From Baseline in Sum of Longest Diameter
6
%
6
6
%
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
EX66666
TR
90006
42
TARGET
R1-A2
PCBSPPD
Percent Change Baseline in Sum of PPD
23
%
23
23
%
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
Cycle 2 Day 1
EX66666
TR
90006
43
TARGET
R1-A2
PCBSV
Percent Change From Baseline in Sum of Volume
23
%
23
23
%
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
3
EX66666
TR
90006
44
NEW
A3
NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
EX66666
TR
90006
45
NEW
A3
NEW01
LDIAM
Longest Diameter
9
mm
9
9
mm
MRI
INVESTIGATOR
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
EX66666
TR
90006
46
NEW
R1-A3
R1-NEW01
TUMSTATE
Tumor State
PRESENT
PRESENT
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
EX66666
TR
90006
47
NEW
R1-A3
R1-NEW01
LDIAM
Longest Diameter
9
mm
9
9
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
EX66666
TR
90006
48
NEW
R1-A3
R1-NEW01
LPERP
Longest Perpendicular
5
mm
5
5
mm
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 3 Day 1
2007-02-26
56
EX66666
TR
90006
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 3 Day 1
2007-02-26
56
EX66666
TR
90006
50
NEW
R1-A3
R1-NEW01
VOLUME
Volume
270
mm3
270
270
mm3
ACME VENDOR
MRI
INDEPENDENT ASSESSOR
RADIOLOGIST 1
TREATMENT
4
Cycle 3 Day 1
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. The procedure (PR) data shows the scans performed for the disease assessment. This example shows data for a subject with non-target disease only.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
4.7.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to shows RECIST 1.1 non-target and overall responses for a subject who did not have target lesions at baseline (target response is not applicable). This example also shows a 'NE' overall response due to an unreadable image with RSREASNE='Poor Scan Quality/Imaging Quality Issues'.
Rows 1-3: Show the week 6 response assessment for a subject with non-target disease only. The Target Response (RSTESTCD=TRGRESP) is not applicable for subjects with non-target disease only. This can be represented as RSSTAT=NOT DONE and RSREASND=Subject does not have Target lesions. The Non-Target Response (RSTESTCD=NTRGRESP) is NON-CR/NON-PD. The Overall Response (RSTESTCD=OVRLRESP) is NON-CR/NON-PD which is a valid Overall Response in RECIST 1.1 for subjects with non-target disease only.
Rows 4-5: Show the week 12 response assessment for a subject with non-target disease only. The Non-Target Response (RSTESTCD=NTRGRESP) is NE because not all non-Target lesions were evaluated and none of the evaluated non-targets showed progression. The BRAIN did not show progression and the assessments of the non-Target lesions in the SKELETAL MUSCLE TISSUE and PERICARDIUM were NOT DONE because the non-Target lesions were obscured on the MRI and not assessable. Therefore, the Overall Response (RSTESTCD=OVRLRESP) is NE (Not Evaluable). Note that NE is a valid Overall Response value per the RECIST 1.1 criteria which means it that RSORRES is NE rather than represented in RSSTAT.
Rows 6-7: Show the week 20 assessment where the non-targets were enlarged from a previous smallest size. The Non-Target Response (RSTESTCD=NTRGRESP) is PD which results in an Overall Response (RSTESTCD=OVRLRESP) of PD.
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
RSSTAT
RSREASND
1
EX77777
RS
90007
1
TRGRESP
Target Response
RECIST 1.1
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
NOT DONE
Subject does not have Target lesions
2
EX77777
RS
90007
2
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
3
EX77777
RS
90007
3
A2
OVRLRESP
Overall Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
4
EX77777
RS
90007
4
NTRGRESP
Non-Target Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
5
EX77777
RS
90007
5
A3
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
6
EX77777
RS
90007
6
NTRGRESP
Non-Target Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
7
EX77777
RS
90007
7
A4
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
$warningHtml
The supprs.xpt table below shows the data on the reason that the response was Not Evaluable (NE) (QNAM.RSREASNE) in the case where it is collected.
Row 1: Shows that the QVAL for RSSEQ = "5" for Reason Response Not Evaluable (QNAM = "RSREASNE").
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX77777
RS
90005
RSSEQ
5
RSREASNE
Reason Response Not Evaluable
Imaging Quality Issues
CRF
$warningHtml
4.7.2 TU Domain Model
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject that has only non-Target tumors at screening.
Rows 1-3: Show the identification of 3 non-Target lesions for a subject with non-target disease only. See below for details on on the QNAM.TUPRTYP (Disease presentation type) supplemental qualifier.
tu.xpt
tu.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
EX77777
TU
90007
1
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
BRAIN
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
2
EX77777
TU
90007
2
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
SKELETAL MUSCLE TISSUE
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
3
EX77777
TU
90007
3
NT03
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
PERICARDIUM
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
$warningHtml
The supptu.xpt table below shows the data to describe the disease presentation of a non-Target tumor, when needed. The supplemental qualifier QNAM.TUPRTYP (Disease presentation type) is used and controlled terminology is available.
Rows 1: Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e., for the non-target site in the BRAIN (TULNKID=NT01), the QVAL is LEPTOMENINGEAL DISEASE.
Rows 2: Shows that the presentation of the disease in the pericardium is effusion, i.e., for the non-target site in the PERICARDIUM (TULNKID=NT03), the QVAL is EFFUSION.
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX77777
TU
90007
TUSEQ
1
TUPRTYP
Disease Presentation Type
LEPTOMENINGEAL DISEASE
CRF
3
EX77777
TU
90007
TUSEQ
3
TUPRTYP
Disease Presentation Type
EFFUSION
CRF
$warningHtml
4.7.3 TR Domain Model
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject with assessments of non-target tumors only at week 6 visit and subsequent 8-week follow-up visits.
Rows 1-6: Show the qualitative assessments of the tumor state of the 3 non-target lesions at screening and week 6.
Rows 7-9: Show the week 12 assessment of the NT01 non-Target lesion in the BRAIN, but assessments of the non-Target lesions NT02 and NT03, in the SKELETAL MUSCLE TISSUE and PERICARDIUM, respectively, were NOT DONE because the non-Target lesions were obscured on the MRI and not assessable. This is represented with TRSTAT=NOT DONE and TRREASND=NOT ASSESSABLE: Lesion obscured.
Rows 10-11: Show that at the week 20 assessment, the NT01 and NT02 were enlarged from a previous smallest size, i.e., TRTESTCD=TUMSTATE and TRORRES=ENLARGEMENT FROM NADIR.
$titleHtml
tr.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
EX77777
TR
90007
1
NON-TARGET
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
EX77777
TR
90007
2
NON-TARGET
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
EX77777
TR
90007
3
NON-TARGET
A1
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
SCREEN
10
SCREEN
2010-01-04
1
EX77777
TR
90007
4
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
EX77777
TR
90007
5
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
EX77777
TR
90007
6
NON-TARGET
A2
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
40
WEEK 6
2010-02-18
46
EX77777
TR
90007
7
NON-TARGET
A3
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
EX77777
TR
90007
8
NON-TARGET
A3
NT02
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE: Lesion obscured
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
EX77777
TR
90007
9
NON-TARGET
A3
NT03
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE: Lesion obscured
MRI
INVESTIGATOR
TREATMENT
60
WEEK 12
2010-04-02
88
EX77777
TR
90007
10
NON-TARGET
A4
NT01
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
EX77777
TR
90007
11
NON-TARGET
A4
NT02
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
EX77777
TR
90007
12
NON-TARGET
A4
NT03
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
INVESTIGATOR
TREATMENT
80
WEEK 20
2010-05-27
144
$warningHtml
4.7.4 PR Domain Model
The pr.xpt table below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at the week 6 visit and subsequent 8-week follow-up visits. The example shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin and trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.
Rows 1-3: Show the scans preformed at 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
EX77777
PR
90007
1
IMG-00001
A1
MRI
Y
Y
HEAD AND NECK
SCREEN
10
SCREEN
2010-01-01
-3
2
EX77777
PR
90007
2
IMG-00002
A1
3
EX77777
PR
90007
3
IMG-00004
A2
MRI
Y
Y
HEAD AND NECK
TREATMENT
40
WEEK 6
2010-02-15
43
4
EX77777
PR
90007
4
iMG-00004
A2
5
EX77777
PR
90007
5
IMG-00007
A3
MRI
Y
Y
HEAD AND NECK
TREATMENT
60
WEEK 12
2010-03-29
85
6
EX77777
PR
90007
6
IMG-00007
A3
7
EX77777
PR
90007
7
IMG-00010
A4
MRI
Y
Y
HEAD AND NECK
TREATMENT
80
WEEK 20
2010-05-27
144
8
EX77777
PR
90007
8
IMG-00010
a4
Dataset Debug Message
Please remove all paragraph and/or line breaks.
The supppr.xpt table below shows the data to describe the disease presentation of a non-Target tumor, when needed. The supplemental qualifier QNAM.TUPRTYP (Disease presentation type) is used and controlled terminology is available.
Rows 1: Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e., for the non-target site in the BRAIN (TULNKID=NT01), the QVAL is LEPTOMENINGEAL DISEASE.
Rows 2: Shows that the presentation of the disease in the pericardium is effusion, i.e., for the non-target site in the PERICARDIUM (TULNKID=NT03), the QVAL is EFFUSION.
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX77777
TU
90007
TUSEQ
1
TUPRTYP
Disease Presentation Type
LEPTOMENINGEAL DISEASE
CRF
3
EX77777
TU
90007
TUSEQ
3
TUPRTYP
Disease Presentation Type
EFFUSION
CRF
$warningHtml
4.8 Example 8: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. This example shows data from a breast cancer study in a metastatic setting.
The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain.
4.8.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 12 visit and subsequent 12-week follow-up visits.
The table represents the items from the RECIST 1.1 criteria.
Rows 1-3: Show the response assessments at week 12. The target lesion showed 59% decrease from screening so the Target Response (RSTESTCD=TRGRESP) with RSORRES=PR (Partial Response). In the protocol, SCINTIGRAPHY is only to be performed every 6 months or in order to verify CR. Therefore, the Non-target Response (RSTESTCD=NTRGRESP) is RSORRES=NE because SCINTIGRAPHY of the BONE was not performed at week 12, i.e., not all non-target lesions were evaluated. The Overall Response (RSTESTCD=OVRLRESP) is RSORRES=PR based on the target lesions and protocol requirements.
Rows 4-6: Show the response assessments at week 24 where the target lesion and the non-targets were absent. The Target Response, Non-target Response and Overall Response are CR (Complete Response).
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
EX88888
RS
90008
1
TRGRESP
Target Response
RECIST 1.1
PR
PR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
2
EX88888
RS
90008
2
NTRGRESP
Non-Target Response
RECIST 1.1
NE
NE
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
3
EX88888
RS
90008
3
A2
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
4
EX88888
RS
90008
4
TRGRESP
Target Response
RECIST 1.1
CR
CR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
5
EX88888
RS
90008
5
NTRGRESP
Non-Target Response
RECIST 1.1
CR
CR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
6
EX88888
RS
90008
6
A3
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
$warningHtml
4.8.2 TU Domain Model
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject collected at screening.
Rows 1-2: Show the identification of a T01 Target tumor in the LIVER and the assessment of the 2 non-Target lesions in the BONE and PLEURAL CAVITY at screening.
tu.xpt
tu.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TUREFID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TULAT
TUDIR
TUMETHOD
TUEVAL
TUEVALID
TUACPTFL
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
EX88888
TU
90008
1
IMG-00001
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
2
EX88888
TU
90008
2
IMG-00002
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
BONE
SCINTIGRAPHY
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
3
EX88888
TU
90008
3
IMG-00001
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
PLEURAL CAVITY
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
$warningHtml
The supptu.xpt table below shows the data to describe the disease presentation of a non-Target tumor, when needed. The supplemental qualifier QNAM.TUPRTYP (Disease presentation type) is used and controlled terminology is available.
The supplemental qualifier QNAM.PRTYP (Disease presentation type) is used to describe the disease presentation of a non-target tumor when needed.
Row 1: Shows that the presentation of the disease in the pleural cavity is effusion, i.e., for the non-target site in the pleural cavity (TULOC = "PLEURAL CAVITY" and TULNKID = "NT02"), the QVAL is "EFFUSION".
$titleHtml
supptu.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
1
EX88888
TU
900080
TUSEQ
3
TUPRTYP
Disease Presentation Type
EFFUSION
CRF
$warningHtml
4.8.3 TR Domain Model
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the week 6 visit and subsequent 8-week follow-up visits. The example also shows that the tumor state for the non-target in the pleural cavity is an assessment of the pleural effusion. SCINTIGRAPHY of the BONE was not required at every disease assessment per protocol. The image identifier is in TRREFID.
This examples shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs used for the assessments are: SUMDIAM, ACNSD, PCBSD and PCNSD. Note that the sponsor should not derived these values if they were not part of the data capture or not provided in the transfer from the vendor.
Rows 1-4: Show the measurements of the T01 target tumor in the LIVER and the assessments of the 2 non-target lesions in the BONE and PLEURAL CAVITY at screening.
Rows 5-11: Show the measurement of the T01 target tumor and the tumor state of the NT02 non-target in the PLEURAL CAVITY at week 12. In the protocol, SCINTIGRAPHY is only to be performed every 6 months or in order to verify CR. Therefore, the SCINTIGRAPHY of NT01 non-target in the BONE was not performed at week 12 (TRSTAT = "NOT DONE" and TRREASND = "SCAN NOT PERFORMED").
Rows 12- At week 24, the T01 target lesion was absent (i.e., DIAMETER=0) and the non-targets NT01 and NT02 in the BONE and PLEURAL CAVITY, respectively, were TRTESTCD=TUMSTATE with TRORRES=ABSENT. The SCINTIGRAPHY was performed in order to verify the Overall Response of CR.
$titleHtml
tr.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
EX88888
TR
90008
1
TARGET
IMG-00001
A1
T01
LDIAM
Longest Diameter
17
mm
17
17
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
EX88888
TR
90008
3
TARGET
A1
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
EX88888
TR
90008
4
NON-TARGET
IMG-00002
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
SCINTIGRAPHY
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
EX88888
TR
90008
5
NON-TARGET
IMG-00001
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
EX88888
TR
90008
6
TARGET
IMG-00003
A2
T01
LDIAM
Longest Diameter
7
mm
7
7
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
EX88888
TR
90008
8
TARGET
A2
SUMDIAM
Sum of Diameter
7
mm
7
7
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
EX88888
TR
90008
9
TARGET
A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
EX88888
TR
90008
10
TARGET
A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-59
%
-59
-59
%
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
EX88888
TR
90008
11
TARGET
A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-59
%
-59
-59
%
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
EX88888
TR
90008
12
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
NOT DONE
SCAN NOT PERFORMED
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
EX88888
TR
90008
13
NON-TARGET
IMG-00003
A2
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
EX88888
TR
90008
14
TARGET
IMG-00005
A3
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
EX88888
TR
90008
16
TARGET
A3
SUMDIAM
Sum of Diameter
0
mm
0
0
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
EX88888
TR
90008
17
TARGET
A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-17
mm
-17
-17
mm
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
EX88888
TR
90008
18
TARGET
A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-100
%
-100
-100
%
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
EX88888
TR
90008
19
TARGET
A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-100
%
-100
-100
%
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
EX88888
TR
90008
20
NON-TARGET
IMG-00006
A3
NT01
TUMSTATE
Tumor State
ABSENT
ABSENT
SCINTIGRAPHY
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-24
172
EX88888
TR
90008
21
NON-TARGET
IMG-00005
A3
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
$warningHtml
4.9 Example 9: RECIST 1.1 example to show an assessment where independent radiologist found no evidence of disease at baseline.
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at screening. In this example, there are no data in TU or TR because no tumors were identified.
4.9.1 RS Domain Model
Row 1: Shows a case where scans the an independent radiologist found no evidence of disease at baseline. This a rare case where a response assessment would be recorded based on the screening assessment.
rs.xpt
rs.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKGRP
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
EX99999
RS
90009
1
A1
OVRLRESP
Overall Response
RECIST 1.1
NED
NED
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-03-29
1
$warningHtml
4.10 Example 10: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. This example shows the situation where enlargement from nadir of a single Non-target does not mean that the Non-Target Response is PD.
4.10.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at week 12 visit and a subsequent 12-week follow-up visit. .
Rows 1-3: Show the Target Response, Non-Target Response and Overall Response at week 12. The Target Response of PR is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. The Non-Target Response of SD is based on the judgement of the non-target lesions/tumors taken collectively. In this case at week 12, one of the non-targets is absent and one of the non-targets has enlarged from nadir. The Overall Response is PR.
Rows 4-6: Show the Target Response, Non-Target Response and Overall Response at week 24. The Target Response of CR is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. The Non-Target Response of SD is based on the judgement of the non-target lesions/tumors taken collectively. In this case at week 24, one of the non-targets is absent and one of the non-targets is still present. The Overall Response is PR.
rs.xpt
xx.xpt
ROW
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKGRP
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
EX01010
RS
90010
1
A2
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
2
EX01010
RS
90010
2
A2
NTRGRESP
Non-Target Response
RECIST 1.1
SD
SD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
3
EX01010
RS
90010
3
A2
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
4
EX01010
RS
90010
4
A3
TRGRESP
Target Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
5
EX01010
RS
90010
5
A3
NRGRESP
Non-Target Response
RECIST 1.1
SD
SD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
6
EX01010
RS
90010
6
A3
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
$warningHtml
4.10.2 TU Domain Model
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject with target and non-target tumors identified at screening.
Rows 1-3: Shows a subject with 1 target lesion with TULNKID T01 and 2 non-target lesions/sites with TULNKID NT01-NT02 identified at screening. T01 is located in the liver (TULOC=LIVER), NT01 is also located in the liver and NT02 is located in the chest wall (TULOC = "CHEST WALL").
tu.xpt
tu.xpt
ROW
STUDYID
DOMAIN
USUBJID
TUSEQ
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TUNAM
TULOC
TUMETHOD
TUEVAL
TUEVALID
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
EX01010
TU
90010
1
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
RADIOL. INC.
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
2
EX01010
TU
90010
2
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL. INC.
LIVER
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
3
EX01010
TU
90010
3
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
RADIOL. INC.
CHEST WALL
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
$warningHtml
4.10.3 TR Domain Model
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for one subject collected at the week 12 visit and subsequent 12-week follow-up visits.
This examples shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs used for the assessments are: SUMDIAM, ACNSD, PCBSD and PCNSD. Note that the sponsor should not derived these values if they were not part of the data capture or not provided in the transfer from the vendor.
Rows 1-4: Show the measurements of the T01 target tumor in the LIVER and the assessments of the 2 non-Target lesions/sites in the LIVER and CHEST WALL at screening.
Rows 5-11: Show the measurement of the T01 target tumor and the tumor states of NT01 and NT02 non-targets at week 12. T01 showed a decrease from 17mm at baseline to 7mm which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. NT01 has a TUMSTATE=ABSENT and NT02 has a TUMSTATE=ENLARGEMENT FROM NADIR.
Rows 12-18: Show the measurement of the T01 target tumor and the tumor states of NT01 and NT02 non-targets at week 24. T01 was absent (LDIAM=0) which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. NT01 remained TUMSTATE=ABSENT and NT02 has a TUMSTATE=PRESENT.
tr.xpt
tr.xpt
ROW
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRNAM
TRMETHOD
TREVAL
TREVALID
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
EX01010
TR
90010
1
TARGET
A1
T01
LDIAM
Longest Diameter
17
mm
17
17
mm
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
2
EX01010
TR
90010
2
TARGET
A1
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
3
EX01010
TR
90010
3
NON-TARGET
A1
NT01
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
4
EX01010
TR
90010
4
NON-TARGET
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
5
EX01010
TR
90010
5
TARGET
A2
T01
LDIAM
Longest Diameter
7
mm
7
7
mm
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
6
EX01010
TR
90010
6
TARGET
A2
SUMDIAM
Sum of Diameter
7
mm
7
7
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
7
EX01010
TR
90010
7
TARGET
A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
8
EX01010
TR
90010
8
TARGET
A2
PCBSD
Percent Change From Baseline in Sum of Diameter
-59
%
-59
-59
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
9
EX01010
TR
90010
9
TARGET
A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-59
%
-59
-59
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
10
EX01010
TR
90010
10
NON-TARGET
A2
NT01
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
11
EX01010
TR
90010
11
NON-TARGET
A2
NT02
TUMSTATE
Tumor State
ENLARGEMENT FROM NADIR
ENLARGEMENT FROM NADIR
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
20
WEEK 12
2010-03-29
85
12
EX01010
TR
90010
12
TARGET
A3
T01
LDIAM
Longest Diameter
0
mm
0
0
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
13
EX01010
TR
90010
13
TARGET
A3
SUMDIAM
Sum of Diameter
0
mm
0
0
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
14
EX01010
TR
90010
14
TARGET
A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-17
mm
-17
-17
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
15
EX01010
TR
90010
15
TARGET
A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-100
%
-100
-100
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
16
EX01010
TR
90010
16
TARGET
A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-100
%
-100
-100
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
17
EX01010
TR
90010
17
NON-TARGET
A3
NT01
TUMSTATE
Tumor State
ABSENT
ABSENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
18
EX01010
TR
90010
18
NON-TARGET
A3
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
RADIOL. INC.
CT SCAN
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
30
WEEK 24
2010-06-23
171
$warningHtml
44.11 Example 11: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data based on an independent assessment.
The example shows the case where lymph nodes are selected as target lesions. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
4.11.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 6 visit, the week 12 visits and subsequent 8-week follow-up visits.
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 New Lesion Progression test is used to represent an equivocal new lesion (TRTESTCD = "NEWLPROG" and TRORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (TRTESTCD = "NEWLPROG" and TRORRES = "UNEQUIVOCAL").
rs.xpt
rs.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
RSLNKGRP
RSTESTCD
RSTEST
RSCAT
RSORRES
RSSTRESC
RSNAM
RSEVAL
RSEVALID
EPOCH
VISITNUM
VISIT
RSDTC
RSDY
1
EX11111
RS
90011
1
TRGRESP
Target Response
RECIST 1.1
NE
NE
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-18
46
2
EX11111
RS
90011
2
NTRGRESP
Non-Target Response
RECIST 1.1
NE
NE
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-18
46
3
EX11111
RS
90011
3
A2
OVRLRESP
Overall Response
RECIST 1.1
NE
NE
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-18
46
4
EX11111
RS
90011
4
TRGRESP
Target Response
RECIST 1.1
SD
SD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-04-02
88
5
EX11111
RS
90011
5
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-04-02
88
6
EX11111
RS
90011
6
A3
OVRLRESP
Overall Response
RECIST 1.1
SD
SD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-04-02
88
7
EX11111
RS
90011
7
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
8
EX11111
RS
90011
8
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
9
EX11111
RS
90011
9
A4
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
10
EX11111
RS
90011
10
TRGRESP
Target Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-26
204
11
EX11111
RS
90011
11
NTRGRESP
Non-Target Response
RECIST 1.1
NON-CR/NON-PD
NON-CR/NON-PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-26
204
12
EX11111
RS
90011
12
A5
OVRLRESP
Overall Response
RECIST 1.1
PR
PR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-26
204
13
EX11111
RS
90011
13
TRGRESP
Target Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
14
EX11111
RS
90011
14
NTRGRESP
Non-Target Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
15
EX11111
RS
90011
15
NEWLPROG
New Lesion Progression
RECIST 1.1
EQUIVOCAL
EQUIVOCAL
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
16
EX11111
RS
90011
16
A6
OVRLRESP
Overall Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
17
EX11111
RS
90011
17
TRGRESP
Target Response
RECIST 1.1
PD
PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
18
EX11111
RS
90011
18
NTRGRESP
Non-Target Response
RECIST 1.1
CR
CR
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
19
EX11111
RS
90011
19
NEWLPROG
New Lesion Progression
RECIST 1.1
UNEQUIVOCAL
UNEQUIVOCAL
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
20
EX11111
RS
90011
20
A7
OVRLRESP
Overall Response
RECIST 1.1
PD
PD
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
$warningHtml
4.11.2 TU Domain Model
The tu.xpt table below shows the terminology used to implementRECIST 1.1in theTUdomain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors. In RECIST 1.1, target lymph node tumors are measured in the short axis (TRTESTCD = "LPERP" and TRTEST = "Longest Perpendicular"). The image identifier is in TUREFID and matches a PRREFID in the PR Domain.
Rows 1-6: Show a subject with 4 target lesions with TULNKID 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 supraclavicular lymph node (TULOC=SUPRACLAVICULAR LYMPH NODE) on the right side (TULAT = "RIGHT"). The TULOC contains the location from the anatomical location terminology. Note that some locations contain in the anatomical location controlled terminology contain laterality and/or directionality. The laterality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality.
Row 7: Shows at week 36, an equivocal new lesion (NEW01) was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location.
Row 8-9: Show at week 44, new unequivocal new lesions (NEW02 and NEW03) were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE").
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TUREFID
TULNKID
TUTESTCD
TUTEST
TUORRES
TUSTRESC
TULOC
TULAT
TUDIR
TUMETHOD
TUNUM
TUEVAL
TUEVALID
EPOCH
VISITNUM
VISIT
TUDTC
TUDY
1
EX11111
TU
90011
1
IMG-00001
T01
TUMIDENT
Tumor Identification
TARGET
TARGET
SUPRACLAVICULAR LYMPH NODE
RIGHT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
2
EX11111
TU
90011
2
IMG-00002
T02
TUMIDENT
Tumor Identification
TARGET
TARGET
THORACIC LYMPH NODE
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
3
EX11111
TU
90011
3
IMG-00001
T03
TUMIDENT
Tumor Identification
TARGET
TARGET
THYROID GLAND
LEFT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
4
EX11111
TU
90011
4
IMG-00003
T04
TUMIDENT
Tumor Identification
TARGET
TARGET
SKIN OF THE TRUNK
UPPER
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-03
-1
5
EX11111
TU
90011
5
IMG-00002
NT01
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
MEDIASTINAL LYMPH NODE
RIGHT
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
6
EX11111
TU
90011
6
IMG-00001
NT02
TUMIDENT
Tumor Identification
NON-TARGET
NON-TARGET
CEREBELLUM
RIGHT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
1
7
EX11111
TU
90011
7
IMG-00020
NEW01
TUMIDENT
Tumor Identification
NEW
NEW
LUNG, LEFT LOWER LOBE
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
8
EX11111
TU
90011
8
IMG-00019
NEW02
TUMIDENT
Tumor Identification
NEW
NEW
CEREBELLUM
LEFT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-18
317
9
EX11111
TU
90011
9
IMG-00022
NEW03
TUMIDENT
Tumor Identification
NEW
NEW
FEMORAL LYMPH NODE
LEFT
ULTRASOUND
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-18
317
$warningHtml
4.11.3 TR Domain Model
The tr.xpt table below shows the data for one subject collected at week 6 visit, week 12 visit and subsequent 8-week follow-up visits.
The example 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 tumor has short axis greater than or equal to 10mm.
This examples shows that situation where the Independent Assessor provided the summary values for Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs used for the assessments are: SUMDIAM, SUMNLNLD, ACNSD, PCBSD and PCNSD.
The image identifier is in TRREFID and matches a PRREFID in the PR Domain.
Rows 1-6: Show the screening identification of the target and non-target lesions. For lymph node target lesions T01 and T02 the TRTESTCD used for the assessments are LPREP and LNSTATE. For non-lymph node target lesions T03 and T04 the TRTESTCD used for the assessments is LDIAM.
Rows 7-8: Show the results for the Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs are Sum of Diameter (TRTESTCD = "SUMDIAM") and Sum Diameters of Non Lymph Note Tumors (TRTESTCD = "SUMNLNLD").
Rows 9-10: Show the results for the non-targets. NT01 is a lymph node where the TRTESTCD used for the assessments is Lymph Note State (TRTESTCD = "LNSTATE"). NT02 is a non-lymph node where the TRTESTCD used for the assessments is Tumor State (TRTESTCD = "TUMSTATE").
Row 16: Shows a case where TRSTAT is NOT DONE with the reason for the result being not done as TRTEST of Longest Diameter with TRREASND as SCAN NOT PERFORMED.
Rows 17-21: Show the week 6 results for the Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs used for the assessments are: SUMDIAM, SUMNLNLD, ACNSD, PCBSD and PCNSD. Within Row 20, the PCBSD could not be calculated because T04 was not measured. TRSTAT is assigned NOT DONE and TRREASND contains the reason, in this case at least one target lesion was not measured.
Rows 22-23: Show the week 6 that NT02 was not not evaluable and the results the NT01 non-target lesion using TRTESTCD as TUMSTATE.
Rows 30-34: Show the week 12 results for the Target lesions as a group (TRGRPID=TARGET). The TRTESTCDs used for the assessments are: SUMDIAM, SUMNLNLD, ACNSD, PCBSD and PCNSD.
Row 70: Shows the Sum Diameters of Non Lymph Note Tumors (TRTESTCD = "SUMNLNLD") is 0. This means that the non-lymph node target tumors are all absent.
tr.xpt
tr.xpt
Row
STUDYID
DOMAIN
USUBJID
TRSEQ
TRGRPID
TRREFID
TRLNKGRP
TRLNKID
TRTESTCD
TRTEST
TRORRES
TRORRESU
TRSTRESC
TRSTRESN
TRSTRESU
TRSTAT
TRREASND
TRMETHOD
TRNAM
TREVAL
TREVALID
EPOCH
VISITNUM
VISIT
TRDTC
TRDY
1
EX11111
TR
90011
1
TARGET
IMG-00001
A1
T01
LPERP
Longest Perpendicular
17
mm
17
17
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
2
EX11111
TR
90011
2
TARGET
IMG-00001
A1
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
3
EX11111
TR
90011
3
TARGET
IMG-00002
A1
T02
LPERP
Longest Perpendicular
16
mm
16
16
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
4
EX11111
TR
90011
4
TARGET
IMG-00002
A1
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
5
EX11111
TR
90011
5
TARGET
IMG-00001
A1
T03
LDIAM
Longest Diameter
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
6
EX11111
TR
90011
6
TARGET
IMG-00003
A1
T04
LDIAM
Longest Diameter
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-03
-1
7
EX11111
TR
90011
7
TARGET
A1
SUMDIAM
Sum of Diameter
62
mm
62
62
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
8
EX11111
TR
90011
8
TARGET
A1
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
29
mm
29
29
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
9
EX11111
TR
90011
9
NON-TARGET
IMG-00002
A1
NT01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
10
EX11111
TR
90011
10
NON-TARGET
IMG-00001
A1
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
11
EX11111
TR
90011
11
TARGET
IMG-00004
A2
T01
LPERP
Longest Perpendicular
12
mm
12
12
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
12
EX11111
TR
90011
12
TARGET
IMG-00004
A2
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
13
EX11111
TR
90011
13
TARGET
IMG-00005
A2
T02
LPERP
Longest Perpendicular
12
mm
12
12
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
14
EX11111
TR
90011
14
TARGET
IMG-00005
A2
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
15
EX11111
TR
90011
15
TARGET
IMG-00004
A2
T03
LDIAM
Longest Diameter
14
mm
14
14
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
16
EX11111
TR
90011
16
TARGET
A2
T04
LDIAM
Longest Diameter
NOT DONE
SCAN NOT PERFORMED
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-17
45
17
EX11111
TR
90011
17
TARGET
A2
SUMDIAM
Sum of Diameter
52
mm
52
52
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
18
EX11111
TR
90011
18
TARGET
A2
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
28
mm
28
28
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
19
EX11111
TR
90011
19
TARGET
A2
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
20
EX11111
TR
90011
20
TARGET
A2
PCBSD
Percent Change From Baseline in Sum of Diameter
NOT DONE
at least one Target lesions was not measured
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
21
EX11111
TR
90011
21
TARGET
A2
PCNSD
Percent Change From Nadir in Sum of Diameter
-16
%
-16
-16
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
22
EX11111
TR
90011
22
NON-TARGET
IMG-00005
A2
NT01
LNSTATE
Lymph Node State
NOT DONE
NOT EVALUABLE
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
23
EX11111
TR
90011
23
NON-TARGET
IMG-00004
A2
NT02
TUMSTATE
Tumor State
NOT DONE
NOT ASSESSABLE Image obscured
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
24
EX11111
TR
90011
24
TARGET
IMG-00007
A3
T01
LDIAM
Longest Diameter
12
mm
12
12
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
25
EX11111
TR
90011
25
TARGET
IMG-00007
A3
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
26
EX11111
TR
90011
26
TARGET
IMG-00008
A3
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
27
EX11111
TR
90011
27
TARGET
IMG-00008
A3
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
28
EX11111
TR
90011
28
TARGET
IMG-00007
A3
T03
LDIAM
Longest Diameter
15
mm
15
15
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
29
EX11111
TR
90011
29
TARGET
IMG-00009
A3
T04
LDIAM
Longest Diameter
8
mm
8
8
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-04-01
87
30
EX11111
TR
90011
30
TARGET
A3
SUMDIAM
Sum of Diameter
47
mm
47
47
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
31
EX11111
TR
90011
31
TARGET
A3
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
23
mm
23
23
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
32
EX11111
TR
90011
32
TARGET
A3
ACNSD
Absolute Change From Nadir in Sum of Diameter
-5
mm
-5
-5
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
33
EX11111
TR
90011
33
TARGET
A3
PCBSD
Percent Change From Baseline in Sum of Diameter
-24
%
-24
-24
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
34
EX11111
TR
90011
34
TARGET
A3
PCNSD
Percent Change From Nadir in Sum of Diameter
-9
%
-9
-9
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
35
EX11111
TR
90011
35
NON-TARGET
IMG-00008
A3
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
36
EX11111
TR
90011
36
NON-TARGET
IMG-00007
A3
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
37
EX11111
TR
90011
37
TARGET
IMG-00010
A4
T01
LDIAM
Longest Diameter
9
mm
9
9
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
38
EX11111
TR
90011
38
TARGET
IMG-00010
A4
T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
39
EX11111
TR
90011
39
TARGET
IMG-00011
A4
T02
LDIAM
Longest Diameter
12
mm
12
12
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
40
EX11111
TR
90011
40
TARGET
IMG-00011
A4
T02
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
41
EX11111
TR
90011
41
TARGET
IMG-00010
A4
T03
LDIAM
Longest Diameter
11
mm
11
11
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
42
EX11111
TR
90011
42
TARGET
IMG-00012
A4
T04
LDIAM
Longest Diameter
5
mm
5
5
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
43
EX11111
TR
90011
43
TARGET
A4
SUMDIAM
Sum of Diameter
37
mm
37
37
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
44
EX11111
TR
90011
44
TARGET
A4
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
16
mm
16
16
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
45
EX11111
TR
90011
45
TARGET
A4
ACNSD
Absolute Change From Nadir in Sum of Diameter
-10
mm
-10
-10
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
46
EX11111
TR
90011
46
TARGET
A4
PCBSD
Percent Change From Baseline in Sum of Diameter
-40
%
-40
-40
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
47
EX11111
TR
90011
47
TARGET
A4
PCNSD
Percent Change From Nadir in Sum of Diameter
-21
%
-21
-21
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
48
EX11111
TR
90011
48
NON-TARGET
IMG-00011
A4
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
49
EX11111
TR
90011
49
NON-TARGET
IMG-00010
A4
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
50
EX11111
TR
90011
50
TARGET
IMG-00013
A5
T01
LDIAM
Longest Diameter
9
mm
9
9
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
51
EX11111
TR
90011
51
TARGET
IMG-00013
A5
T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
52
EX11111
TR
90011
52
TARGET
IMG-00014
A5
T02
LDIAM
Longest Diameter
8
mm
8
8
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
53
EX11111
TR
90011
53
TARGET
IMG-00014
A5
T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
54
EX11111
TR
90011
54
TARGET
IMG-00013
A5
T03
LDIAM
Longest Diameter
6
mm
6
6
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
55
EX11111
TR
90011
55
TARGET
IMG-00015
A5
T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-25
203
56
EX11111
TR
90011
56
TARGET
A5
SUMDIAM
Sum of Diameter
23
mm
23
23
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
57
EX11111
TR
90011
57
TARGET
A5
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
6
mm
6
6
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
58
EX11111
TR
90011
58
TARGET
A5
ACNSD
Absolute Change From Nadir in Sum of Diameter
-14
mm
-14
-14
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
59
EX11111
TR
90011
59
TARGET
A5
PCBSD
Percent Change From Baseline in Sum of Diameter
-62
%
-62
-62
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
60
EX11111
TR
90011
60
TARGET
A5
PCNSD
Percent Change From Nadir in Sum of Diameter
-37
%
-37
-37
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
61
EX11111
TR
90011
61
NON-TARGET
IMG-00014
A5
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
62
EX11111
TR
90011
62
NON-TARGET
IMG-00013
A5
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
63
EX11111
TR
90011
63
TARGET
IMG-00016
A6
T01
LDIAM
Longest Diameter
8
mm
8
8
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
64
EX11111
TR
90011
64
TARGET
IMG-00016
A6
T01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
65
EX11111
TR
90011
65
TARGET
IMG-00017
A6
T02
LDIAM
Longest Diameter
9
mm
9
9
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
66
EX11111
TR
90011
66
TARGET
IMG-00017
A6
T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
67
EX11111
TR
90011
67
TARGET
IMG-00016
A6
T03
LDIAM
Longest Diameter
0
mm
0
0
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
68
EX11111
TR
90011
68
TARGET
IMG-00018
A6
T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
69
EX11111
TR
90011
69
TARGET
A6
SUMDIAM
Sum of Diameter
17
mm
17
17
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
70
EX11111
TR
90011
70
TARGET
A6
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
71
EX11111
TR
90011
71
TARGET
A6
ACNSD
Absolute Change From Nadir in Sum of Diameter
-6
mm
-6
-6
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
72
EX11111
TR
90011
72
TARGET
A6
PCBSD
Percent Change From Baseline in Sum of Diameter
-72
%
-72
-72
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
73
EX11111
TR
90011
73
TARGET
A6
PCNSD
Percent Change From Nadir in Sum of Diameter
-26
%
-26
-26
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
74
EX11111
TR
90011
74
NON-TARGET
IMG-00017
A6
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
75
EX11111
TR
90011
75
NON-TARGET
IMG-00016
A6
NT02
TUMSTATE
Tumor State
ABSENT
ABSENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
76
EX11111
TR
90011
76
NEW
IMG-00017
A6
NEW01
TUMSTATE
Tumor State
EQUIVOCAL
EQUIVOCAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
77
EX11111
TR
90011
77
TARGET
IMG-00019
A7
T01
LDIAM
Longest Diameter
12
mm
12
12
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
78
EX11111
TR
90011
78
TARGET
IMG-00019
A7
T01
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
79
EX11111
TR
90011
79
TARGET
IMG-00020
A7
T02
LDIAM
Longest Diameter
9
mm
9
9
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
80
EX11111
TR
90011
80
TARGET
IMG-00020
A7
T02
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
81
EX11111
TR
90011
81
TARGET
IMG-00019
A7
T03
LDIAM
Longest Diameter
0
mm
0
0
mm
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
82
EX11111
TR
90011
82
TARGET
IMG-00021
A7
T04
LDIAM
Longest Diameter
0
mm
0
0
mm
PHOTOGRAPHY
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
83
EX11111
TR
90011
83
TARGET
A7
SUMDIAM
Sum of Diameter
21
mm
21
21
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
84
EX11111
TR
90011
84
TARGET
A7
SUMNLNLD
Sum Diameters of Non Lymph Node Tumors
0
mm
0
0
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
85
EX11111
TR
90011
85
TARGET
A7
ACNSD
Absolute Change From Nadir in Sum of Diameter
4
mm
4
4
mm
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
86
EX11111
TR
90011
86
TARGET
A7
PCBSD
Percent Change From Baseline in Sum of Diameter
-66
%
-66
-66
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
87
EX11111
TR
90011
87
TARGET
A7
PCNSD
Percent Change From Nadir in Sum of Diameter
23
%
23
23
%
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
88
EX11111
TR
90011
88
NON-TARGET
IMG-00020
A7
NT01
LNSTATE
Lymph Node State
NON-PATHOLOGICAL
NON-PATHOLOGICAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
89
EX11111
TR
90011
89
NON-TARGET
IMG-00019
A7
NT02
TUMSTATE
Tumor State
PRESENT
PRESENT
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
90
EX11111
TR
90011
90
NEW
IMG-00020
A7
NEW01
LDIAM
Longest Diameter
8
mm
8
8
mm
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
91
EX11111
TR
90011
91
NEW
IMG-00020
A7
NEW01
TUMSTATE
Tumor State
UNEQUIVOCAL
UNEQUIVOCAL
CT SCAN
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
92
EX11111
TR
90011
92
NEW
IMG-00019
A7
NEW02
LDIAM
Longest Diameter
NOT DONE
NOT ASSESSABLE Image obscured
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
93
EX11111
TR
90011
93
NEW
IMG-00019
A7
NEW02
TUMSTATE
Tumor State
UNEQUIVOCAL
UNEQUIVOCAL
MRI
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
94
EX11111
TR
90011
94
NEW
IMG-00022
A7
NEW03
LNSTATE
Lymph Node State
PATHOLOGICAL
PATHOLOGICAL
ULTRASOUND
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
$warningHtml
4.11.4 PR Domain Model
The pr.xpt table below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at the week 6 visit and subsequent 8-week follow-up visits. The example shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin and trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.
Rows 1-3: Show the scans preformed at screening. The results of the scans are record in TU and TR.
Rows 4-21: Show the scans preformed at weeks 6, 12, 20, 28, 36 and 44. The results of the scans are record in TU and TR.
pr.xpt
pr.xpt
ROW
STUDYID
DOMAIN
USUBJID
PRSEQ
PRREFID
PRLNKGRP
PRTRT
PRLOC
PRNAM
PREVAL
PREVALID
EPOCH
VISITNUM
VISIT
PRSTDTC
PRSTDY
1
EX11111
PR
90011
1
IMG-00001
A1
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-01
-3
2
EX11111
PR
90011
2
IMG-00002
A1
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-02
-2
3
EX11111
PR
90011
3
IMG-00003
A1
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
SCREEN
10
SCREEN
2010-01-03
-1
4
EX11111
PR
90011
4
IMG-00004
A2
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-15
43
5
EX11111
PR
90011
5
IMG-00005
A2
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
40
WEEK 6
2010-02-16
44
6
EX11111
PR
90011
6
IMG-00007
A3
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-29
85
7
EX11111
PR
90011
7
IMG-00008
A3
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-03-30
86
8
EX11111
PR
90011
8
IMG-00009
A3
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
60
WEEK 12
2010-04-01
87
9
EX11111
PR
90011
9
IMG-00010
A4
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-27
144
10
EX11111
PR
90011
10
IMG-00011
A4
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-28
145
11
EX11111
PR
90011
11
IMG-00012
A4
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
80
WEEK 20
2010-05-30
147
12
EX11111
PR
90011
12
IMG-00013
A5
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-23
201
13
EX11111
PR
90011
13
IMG-00014
A5
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-24
202
14
EX11111
PR
90011
14
IMG-00015
A5
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
100
WEEK 28
2010-07-25
203
15
EX11111
PR
90011
15
IMG-00016
A6
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
16
EX11111
PR
90011
16
IMG-00017
A6
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
17
EX11111
PR
90011
17
IMG-00018
A6
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
120
WEEK 36
2010-09-17
257
18
EX11111
PR
90011
18
IMG-00019
A7
MRI
HEAD AND NECK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-14
313
19
EX11111
PR
90011
19
IMG-00020
A7
CT SCAN
CHEST
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-15
314
20
EX11111
PR
90011
20
IMG-00021
A7
PHOTOGRAPHY
SKIN OF THE TRUNK
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
21
EX11111
PR
90011
21
IMG-00022
A7
ULTRASOUND
PELVIS
RADIOL. INC.
INDEPENDENT ASSESSOR
RADIOLOGIST
TREATMENT
140
WEEK 44
2010-11-16
315
$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
End of Document
5
To set up your dataset wrapper, row caption, dataset combination when in edit mode:
Type "{dataset" (no quotes)
Choose "Dataset Wrapper" and hit return.
Then place your cursor in the grey box, type "{row" (no quotes) and choose "Row Captions" and hit return.
Finally place the cursor below that box and do the same with "{dataset" and clicking "Dataset".
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.
Feel free to delete this info box whenever you'd like