...
4 Examples for the Oncology Disease Response Domains 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, week 12 and subsequent 8-week follow-up visits.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
Rows 1-3: Show the scans performed at screening. The results of the scans are in TU and TR. Rows 4-6: Show that the MRI and CT scan were performed (PROCCUR = "Y") and that the medical photography was not performed (PROCCUR = "N") at week 6. Rows 7-22: Show the scans performed at weeks 12, 20, 28, 36 and 44. The results of the scans are in TU and TR. In row 22, a non-RECIST 1.1 method was used and this example shows a way to represent the additional scan in PR, i.e., "ULTRASOUND".
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRPRESP | PROCCUR | PRLOC | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY | | 1 | EX11111 | PR | 90001 | 1 | IMG-00001 | A1 | MRI | Y | Y | HEAD AND NECK | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 2 | EX11111 | PR | 90001 | 2 | IMG-00002 | A1 | CT SCAN | Y | Y | CHEST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 3 | EX11111 | PR | 90001 | 3 | IMG-00003 | A1 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | | 4 | EX11111 | PR | 90001 | 4 | IMG-00004 | A2 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | | 5 | EX11111 | PR | 90001 | 5 | IMG-00005 | A2 | CT SCAN | Y | Y | CHEST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | | 6 | EX11111 | PR | 90001 | 6 |
| A2 | PHOTOGRAPHY | Y | N | SKIN OF THE TRUNK | TREATMENT | 40 | WEEK 6 |
|
| | 7 | EX11111 | PR | 90001 | 7 | IMG-00007 | A3 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | | 8 | EX11111 | PR | 90001 | 8 | IMG-00008 | A3 | CT SCAN | Y | Y | CHEST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | | 9 | EX11111 | PR | 90001 | 9 | IMG-00009 | A3 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | | 10 | EX11111 | PR | 90001 | 10 | IMG-00010 | A4 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | | 11 | EX11111 | PR | 90001 | 11 | IMG-00011 | A4 | CT SCAN | Y | Y | CHEST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | | 12 | EX11111 | PR | 90001 | 12 | IMG-00012 | A4 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | | 13 | EX11111 | PR | 90001 | 13 | IMG-00013 | A5 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | | 14 | EX11111 | PR | 90001 | 14 | IMG-00014 | A5 | CT SCAN | Y | Y | CHEST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | | 15 | EX11111 | PR | 90001 | 15 | IMG-00015 | A5 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | | 16 | EX11111 | PR | 90001 | 16 | IMG-00016 | A6 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 17 | EX11111 | PR | 90001 | 17 | IMG-00017 | A6 | CT SCAN | Y | Y | CHEST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 18 | EX11111 | PR | 90001 | 18 | IMG-00018 | A6 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | | 19 | EX11111 | PR | 90001 | 19 | IMG-00019 | A7 | MRI | Y | Y | HEAD AND NECK | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | | 20 | EX11111 | PR | 90001 | 20 | IMG-00020 | A7 | CT SCAN | Y | Y | CHEST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | | 21 | EX11111 | PR | 90001 | 21 | IMG-00021 | A7 | PHOTOGRAPHY | Y | Y | SKIN OF THE TRUNK | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | | 22 | EX11111 | PR | 90001 | 22 | IMG-00022 | A7 | ULTRASOUND |
|
| PELVIS | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
|
4.2 Example 2: 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 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 and subsequent 8-week follow-up visits.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
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. |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | 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 | SCREENING | 2007-01-02 | 1 | | 2 | EX33333 | TR | 90003 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 28 | mm | 28 | 28 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 3 | EX33333 | TR | 90003 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 41 | mm | 41 | 41 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 4 | EX33333 | TR | 90003 | 4 | TARGET | A1 | T04 | LDIAM | Longest Diameter | 82 | mm | 83 | 83 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 5 | EX33333 | TR | 90003 | 5 | TARGET | A1 |
| SUMLDIAM | Sum of Longest Diameter | 167 | mm | 168 | 168 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| | 6 | EX33333 | TR | 90003 | 6 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 7 | EX33333 | TR | 90003 | 7 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 8 | EX33333 | TR | 90003 | 8 | NON-TARGET | A1 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| SCINTIGRAPHY | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 9 | EX33333 | TR | 90003 | 9 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 10 | EX33333 | TR | 90003 | 10 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 11 | EX33333 | TR | 90003 | 11 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 12 | EX33333 | TR | 90003 | 12 | TARGET | A2 | T04 | LDIAM | Longest Diameter | 65 | mm | 65 | 65 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 13 | EX33333 | TR | 90003 | 13 | TARGET | A2 |
| 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 | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| | 17 | EX33333 | TR | 90003 | 17 | TARGET | A3 | T01 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 18 | EX33333 | TR | 90003 | 18 | TARGET | A3 | T02 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 19 | EX33333 | TR | 90003 | 19 | TARGET | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 20 | EX33333 | TR | 90003 | 20 | TARGET | A3 | T04 | LDIAM | Longest Diameter | 40 | mm | 40 | 40 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 21 | EX33333 | TR | 90003 | 21 | TARGET | A3 |
| 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 | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| | 25 | EX33333 | TR | 90003 | 25 | TARGET | A4 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | | 26 | EX33333 | TR | 90003 | 26 | TARGET | A4 | T02 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | | 27 | EX33333 | TR | 90003 | 27 | TARGET | A4 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | | 28 | EX33333 | TR | 90003 | 28 | TARGET | A4 | T04 | LDIAM | Longest Diameter | 36 | mm | 36 | 36 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | | 29 | EX33333 | TR | 90003 | 29 | TARGET | A4 |
| 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 | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 34 | EX33333 | TR | 90003 | 34 | TARGET | A5 | T02 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 35 | EX33333 | TR | 90003 | 35 | TARGET | A5 | T03 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 36 | EX33333 | TR | 90003 | 36 | TARGET | A5 | T04 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 37 | EX33333 | TR | 90003 | 37 | NON-TARGET | A5 | NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 38 | EX33333 | TR | 90003 | 38 | NON-TARGET | A5 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 39 | EX33333 | TR | 90003 | 39 | NON-TARGET | A5 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| |
|
4.4 Example 4: RECIST 1.1 example to show
...
independent assessor response (RS) data and the underlying tumor identification (TU), tumor results (TR) data. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint.
4.4.1 RS Domain Model
The 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 8 and week 16.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
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. |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | 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 | SCREENING | 2007-01-02 | 1 | | 2 | EX55555 | TR | 90005 | 2 | TARGET | A1 |
| SUMLDIAM | Sum of Longest Diameter | 10 | mm | 10 | 10 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| | 3 | EX55555 | TR | 90005 | 3 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 4 | EX55555 | TR | 90005 | 4 | TARGET | A2 | T01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| 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 EVALUABLE: Motion issue | 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 EVALUABLE: Motion issue | 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 |
|
| 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 | |
|
4.6 Example 6: RECIST 1.1 example to show investigator and independent assessor response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the investigator tumor identification, tumor results, and response data using RECIST 1.1 along with the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.
4.6.1 RS Domain Model
The rs.xpt table below 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.
...