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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 shows investigator response data using RECIST 1.1 for a subject that have has only target tumors at screening. This includes an unscheduled assessment.
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The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to show shows investigator tumor identification, tumor results and response data using RECIST 1.1 for a subject that have has only target tumors at screening. This includes an unscheduled assessment and an unreadable image.
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| Rowcaps |
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Rows 1-1114: 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 1215: Shows a new lesion state at week 24. |
| Dataset2 |
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| 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 | |
|
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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 shows investigator response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements.
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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 The example also includes the situation where new tumors are measured by the independent radiologist.
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| Rowcaps |
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Rows 1-6: Show response assessments at , 18-23 and 38-39: Show Longest Diameter, Sum of Longest Diameter, and Tumor State for assessments at screening, cycle 2 and cycle 3 from the investigator following RECIST 1.1. Rows 7-8: Show response assessments at -17, 24-37 and 40-44: Show the volumetric measurements at screening, cycle 2 and cycle 3 from the independent radiologist using "PROTOCOL DEFINED RESPONSE CRITERIA" based on volumetric measurements. |
| Dataset2 |
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| 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 | EX66666 | TR | 90006 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 2 | EX66666 | TR | 90006 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 3 | EX66666 | TR | 90006 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 4 | EX66666 | TR | 90006 | 4 | TARGET | A1 |
| SUMLDIAM | Sum of Longest Diameter | 25 | mm | 25 | 25 | mm |
|
| INVESTIGATOR |
| SCREEN | 1 | SCREENING |
|
| | 5 | EX66666 | TR | 90006 | 5 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 6 | EX66666 | TR | 90006 | 6 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 7 | 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 | SCREENING | 2007-01-01 | 1 | | 8 | 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 | SCREENING | 2007-01-01 | 1 | | 9 | EX66666 | TR | 90006 | 9 | TARGET | R1-A1 | R1-T01 | PPD | Product of Perpendicular Diameters | 50 | mm2 | 50 | 50 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| | 10 | EX66666 | TR | 90006 | 10 | TARGET | R1-A1 | R1-T01 | VOLUME | Volume | 250 | mm3uL | 250 | 250 | mm3uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 11 | 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 | SCREENING | 2007-01-01 | 1 | | 12 | 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 | SCREENING | 2007-01-01 | 1 | | 13 | EX66666 | TR | 90006 | 13 | TARGET | R1-A1 | R1-T02 | PPD | Product of Perpendicular Diameters | 70 | mm2 | 70 | 70 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| | 14 | EX66666 | TR | 90006 | 14 | TARGET | R1-A1 | R1-T02 | VOLUME | Volume | 350 | mm3uL | 350 | 350 | mm3uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 15 | EX66666 | TR | 90006 | 15 | TARGET | R1-A1 |
| SUMLDIAM | Sum of Longest Diameter | 17 | mm | 17 | 17 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| | 16 | EX66666 | TR | 90006 | 16 | TARGET | R1-A1 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 120 | mm2 | 120 | 120 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| | 17 | EX66666 | TR | 90006 | 17 | TARGET | R1-A1 |
| SUMVOL | Sum of Volume | 600 | mm3uL | 600 | 600 | mm3uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| | 18 | 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 | | 19 | 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 | | 20 | 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 | | 21 | EX66666 | TR | 90006 | 21 | TARGET | A2 |
| SUMLDIAM | Sum of Longest Diameter | 25 | mm | 25 | 25 | mm |
|
| INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 22 | 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 | | 23 | EX66666 | TR | 90006 | 23 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 24 | EX66666 | TR | 90006 | 24 | TARGET | R1-A2 | R1-T01 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 25 | EX66666 | TR | 90006 | 25 | TARGET | R1-A2 | R1-T01 | LPERP | Longest Perpendicular | 7 | mm | 7 | 7 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 26 | EX66666 | TR | 90006 | 26 | TARGET | R1-A2 | R1-T01 | PPD | Product of Perpendicular Diameters | 84 | mm2 | 84 | 84 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 27 | EX66666 | TR | 90006 | 27 | TARGET | R1-A2 | R1-T01 | VOLUME | Volume | 420 | mm3uL | 420 | 420 | mm3uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 28 | EX66666 | TR | 90006 | 28 | TARGET | R1-A2 | R1-T02 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 29 | EX66666 | TR | 90006 | 29 | TARGET | R1-A2 | R1-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 30 | EX66666 | TR | 90006 | 30 | TARGET | R1-A2 | R1-T02 | PPD | Product of Perpendicular Diameters | 54 | mm2 | 54 | 54 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 31 | EX66666 | TR | 90006 | 31 | TARGET | R1-A2 | R1-T02 | VOLUME | Volume | 315 | mm3uL | 315 | 315 | mm3uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | | 32 | EX66666 | TR | 90006 | 32 | TARGET | R1-A2 |
| SUMLDIAM | Sum of Longest Diameter | 18 | mm | 18 | 18 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 33 | EX66666 | TR | 90006 | 33 | TARGET | R1-A2 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 138 | mm2 | 138 | 138 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 34 | EX66666 | TR | 90006 | 34 | TARGET | R1-A2 |
| SUMVOL | Sum of Volume | 735 | mm3uL | 735 | 735 | mm3uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 35 | EX66666 | TR | 90006 | 35 | TARGET | R1-A2 |
| PCBSLD | Percent Change From Baseline in Sum of Longest Diameter | 6 | % | 6 | 6 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 36 | EX66666 | TR | 90006 | 36 | TARGET | R1-A2 |
| PCBSPPD | Percent Change Baseline in Sum of PPD | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 37 | EX66666 | TR | 90006 | 37 | TARGET | R1-A2 |
| PCBSV | Percent Change From Baseline in Sum of Volume | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| | 38 | EX66666 | TR | 90006 | 38 | NEW | A3 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | | 39 | EX66666 | TR | 90006 | 39 | NEW | A3 | NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | | 40 | EX66666 | TR | 90006 | 40 | 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 | | 41 | EX66666 | TR | 90006 | 41 | 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 | | 42 | EX66666 | TR | 90006 | 42 | 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 | | 43 | EX66666 | TR | 90006 | 43 | NEW | R1-A3 | R1-NEW01 | PPD | Product of Perpendicular Diameters | 45 | mm2 | 45 | 45 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 |
|
| | 44 | EX66666 | TR | 90006 | 44 | NEW | R1-A3 | R1-NEW01 | VOLUME | Volume | 270 | mm3uL | 270 | 270 | mm3uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
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