...
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 1 | EX22222 | TR | 90002 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
|
|
4.3 Example 3:
...
Scans Either Not Done or Not Evaluable
RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data.
...
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 1 | EX33333 | TR | 90003 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
|
|
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 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.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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. |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | TRACPTFL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
|---|
| 1 | EX44444 | TR | 90004 | 1 | TARGET | R1-A1 | R1-T01 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 2 | EX44444 | TR | 90004 | 2 | TARGET | R1-A1 | R1-T02 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 3 | EX44444 | TR | 90004 | 3 | TARGET | R1-A1 |
| SUMDIAM | Sum of Diameter | 40 | mm | 40 | 40 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 4 | EX44444 | TR | 90004 | 4 | NON-TARGET | R1-A1 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 5 | EX44444 | TR | 90004 | 5 | TARGET | R1-A2 | R1-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 6 | EX44444 | TR | 90004 | 6 | TARGET | R1-A2 | R1-T02 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 7 | EX44444 | TR | 90004 | 7 | TARGET | R1-A2 |
| SUMDIAM | Sum of Diameter | 35 | mm | 35 | 35 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
|
| | 8 | EX44444 | TR | 90004 | 8 | TARGET | R1-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -13 | % | -13 | -13 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
|
| | 9 | EX44444 | TR | 90004 | 9 | TARGET | R1-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -13 | % | -13 | -13 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
|
| | 10 | EX44444 | TR | 90004 | 10 | NON-TARGET | R1-A2 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 11 | EX44444 | TR | 90004 | 11 | TARGET | R1-A3 | R1-T01 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 12 | EX44444 | TR | 90004 | 12 | TARGET | R1-A3 | R1-T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 13 | EX44444 | TR | 90004 | 13 | TARGET | R1-A3 |
| SUMDIAM | Sum of Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
|
| | 14 | EX44444 | TR | 90004 | 14 | TARGET | R1-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -63 | % | -63 | -63 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
|
| | 15 | EX44444 | TR | 90004 | 15 | TARGET | R1-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -57 | % | -57 | -57 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
|
| | 16 | EX44444 | TR | 90004 | 16 | NON-TARGET | R1-A3 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 17 | EX44444 | TR | 90004 | 17 | TARGET | R2-A1 | R2-T01 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 18 | EX44444 | TR | 90004 | 18 | TARGET | R2-A1 | R2-T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 19 | EX44444 | TR | 90004 | 19 | TARGET | R2-A1 |
| SUMDIAM | Sum of Diameter | 45 | mm | 45 | 45 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING |
|
| | 20 | EX44444 | TR | 90004 | 20 | NON-TARGET | R2-A1 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 21 | EX44444 | TR | 90004 | 21 | TARGET | R2-A2 | R2-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 22 | EX44444 | TR | 90004 | 22 | TARGET | R2-A2 | R2-T02 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 23 | EX44444 | TR | 90004 | 23 | TARGET | R2-A2 |
| SUMDIAM | Sum of Diameter | 18 | mm | 18 | 18 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
|
| | 24 | EX44444 | TR | 90004 | 24 | TARGET | R2-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -60 | % | -60 | -60 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
|
| | 25 | EX44444 | TR | 90004 | 25 | TARGET | R2-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -60 | % | -60 | -60 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
|
| | 26 | EX44444 | TR | 90004 | 26 | NON-TARGET | R2-A2 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 27 | EX44444 | TR | 90004 | 27 | TARGET | R2-A3 | R2-T01 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 28 | EX44444 | TR | 90004 | 28 | TARGET | R2-A3 | R2-T02 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 29 | EX44444 | TR | 90004 | 29 | TARGET | R2-A3 |
| SUMDIAM | Sum of Diameter | 20 | mm | 20 | 20 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
|
| | 30 | EX44444 | TR | 90004 | 30 | TARGET | R2-A3 |
| PCBSD | Percent Change From Baseline in Sum of Longest Diameter | -56 | % | -56 | -56 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
|
| | 31 | EX44444 | TR | 90004 | 31 | TARGET | R2-A3 |
| PCNSLD | Percent Change From Nadir in Sum of Longest Diameter | 11 | % | 11 | 11 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
|
| | 32 | EX44444 | TR | 90004 | 32 | NON-TARGET | R2-A3 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 |
|
|
4.5 Example 5: Subject with
...
One Target
...
Tumor at Screening and an Unscheduled Assessment
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 one Target tumor and no non-targets at screening, i.e., a subject with target tumors only. This example includes an unscheduled assessment.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-2: | Rows 1-2: Show the Target Response (RSTESTCD = "TRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") of CR (Complete Response) at week 8. The subject only has one target lesion and no non-targets. The Non-target Response (RSTESTCD = "NTRGRESP") is not applicable and a record may be included to represent this, if desired. | | Rows 3-4: | Show an unscheduled response assessment which was done to confirm the complete response ("CR"). The RSLNKGRP differentiates the assessment and the VISIT is "UNSCHEDULED WEEK 13". | | Rows 5-6: | Show Target Response (RSTESTCD = "TRGRESP") of not evaluable ("NE") and Overall Response (RSTESTCD = "OVRLRESP") of not evaluable ("NE") due to an unreadable image. |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | 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 | |
|
...
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 1 | EX55555 | TR | 90005 | TRSEQ | 9 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF | | 2 | EX55555 | TR | 90005 | TRSEQ | 10 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF |
|
|
4.6 Example 6: Investigator-assessed RECIST 1.1
...
Measurements Along with Independent Assessor Volumetric Measurements
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 measurements along with the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.
...
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, i.e., subject does not have target tumors. 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.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
Rows 1-2: Show the 2 locations of the MRI at screening for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 3: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at screening for PRSEQ = "1". Rows 4-5: Show the 2 locations of the MRI at week 6 for PRSEQ = "3" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 6: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 6 for PRSEQ = "3". Rows 7-8: Show the 2 locations of the MRI at week 12 for PRSEQ = "5" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 9: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 12 for PRSEQ = "5". Row 10: Shows the overall image quality issue (QNAM = "PROIQ") of the MRI at week 12 for PRSEQ = "5". |
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 1 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 2 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 3 | EX77777 | PR | 90007 | PRSEQ | 1 | PRSLTHK | Slice Thickness | 5 mm | CRF | | 4 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 5 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 6 | EX77777 | PR | 90007 | PRSEQ | 3 | PRSLTHK | Slice Thickness | 5 mm | CRF | | 7 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 8 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 9 | EX77777 | PR | 90007 | PRSEQ | 5 | PRSLTHK | Slice Thickness | 5 mm | CRF | | 10 | EX77777 | PR | 90007 | PRSEQ | 5 | PROIQ | Overall Image Quality | Motion issues and lesions where obscured | CRF | | 11 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | | 12 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | | 13 | EX77777 | PR | 90007 | PRSEQ | 7 | PRSLTHK | Slice Thickness | 5 mm | CRF |
|
|
...
4.8 Example 8: Bone Scans
...
Not Required at Each Disease Assessment
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.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
Row 1: Shows a case where the independent radiologist found no evidence of disease (RSSTRESC = "NED") at baseline. This a rare case where a response assessment would be recorded based on the screening assessment. RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA" was used to indicate that this result is not based on RECIST 1.1. |
| Dataset2 |
|---|
| 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 ResponseRECIST 1.1 | PROTOCOL DEFINED RESPONSE CRITERIA | NED | NED | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-03-29 | 1 | |
|
...