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In RECIST1.1, the following calculations are used in determination of the target response: sum of the diameters of target tumors (target sum), percentage change from baseline in the target sum, and percentage change from nadir in the target sum (smallest target sum at any assessment). These are referred to as summary values in the examples below. These summary values are not typically collected/calculated in investigator CRFs but they are usually provided by independent assessors. When not derived in EDC, Summary summary values not in the collected data may be derived in the analysis datasets (i.e., ADaM).
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This example shows a situation where the Investigator provided the summary values for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCD = "DIAMSUMDIAM" is used for the assessments. Note that the sponsor should not derived these values if they were not part of the data capture.
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| Rows 1-3: | Show the response assessments at week 12. The target lesion showed 59% decrease from screening so the Target Response (RSTESTCD = "TRGRESP") is a partial response (RSSTRESC = "PR"). In the protocol, scintigraphy is only to be performed every 6 months or in order to verify CR (Complete Response). Therefore, the Non-target Response (RSTESTCD = "NTRGRESP") is not evaluable (RSSTRESC = "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 a partial response (RSSTRESC = "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-target lesions were absent. The Target Response (RSTESTCD = "TRGRESP"), Non-target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") are CR (Complete Response). |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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| 1 | EX88888 | RS | 90008 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | VENDOR1 | 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 | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 3 | EX88888 | RS | 90008 | 3 | R-A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 4 | EX88888 | RS | 90008 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | | 5 | EX88888 | RS | 90008 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | | 6 | EX88888 | RS | 90008 | 6 | R-A3 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | |
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| Rows 1-4: | Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-target lesions "R-NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" at screening. | | Rows 5-11: | Show the measurement of the "R-T01" target tumor and the tumor state of the "R-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 a CR (Complete Response). Therefore, the "SCINTIGRAPHY" of "R-NT01" non-target in the "BONE" was not performed at week 12 (TRSTAT = "NOT DONE" and TRREASND = "SCAN NOT PERFORMED"). | | Rows 12-18: | Show at week 24, the "R-T01" target lesion was absent (i.e., DIAMETER = "0") and the non-targets R-"NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" were absent (TRTESTCD = "TUMSTATE" with TRORRES = "ABSENT"). The "SCINTIGRAPHY" was performed in order to verify the Overall Response of CR (Complete Response). |
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| Dataset2 |
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| 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 |
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| 1 | EX88888 | TR | 90008 | 1 | TARGET | IMG-00001 | R-A1 | R-T01 | LDIAM | Longest Diameter | 17 | mm | 17 | 17 | mm |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 2 | EX88888 | TR | 90008 | 2 | TARGET |
| R-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 3 | EX88888 | TR | 90008 | 3 | NON-TARGET | IMG-00002 | R-A1 | R-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| VENDOR1 | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 4 | EX88888 | TR | 90008 | 4 | NON-TARGET | IMG-00001 | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 5 | EX88888 | TR | 90008 | 5 | TARGET | IMG-00004 | R-A2 | R-T01 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 6 | EX88888 | TR | 90008 | 6 | TARGET |
| R-A2 |
| SUMDIAM | Sum of Diameter | 7 | mm | 7 | 7 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 7 | EX88888 | TR | 90008 | 7 | TARGET |
| R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 8 | EX88888 | TR | 90008 | 8 | TARGET |
| R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -59 | % | -59 | -59 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 9 | EX88888 | TR | 90008 | 9 | TARGET |
| R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -59 | % | -59 | -59 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 10 | EX88888 | TR | 90008 | 10 | NON-TARGET |
| R-A2 | R-NT01 | TUMSTATE | Tumor State |
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| NOT DONE | SCAN NOT PERFORMED | VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 11 | EX88888 | TR | 90008 | 11 | NON-TARGET | IMG-00004 | R-A2 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 12 | EX88888 | TR | 90008 | 12 | TARGET | IMG-00005 | R-A3 | R-T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | | 13 | EX88888 | TR | 90008 | 13 | TARGET |
| R-A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 14 | EX88888 | TR | 90008 | 14 | TARGET |
| R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -17 | mm | -17 | -17 | mm |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 15 | EX88888 | TR | 90008 | 15 | TARGET |
| R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -100 | % | -100 | -100 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 16 | EX88888 | TR | 90008 | 16 | TARGET |
| R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -100 | % | -100 | -100 | % |
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| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 17 | EX88888 | TR | 90008 | 17 | NON-TARGET | IMG-00006 | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| VENDOR1 | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | | 18 | EX88888 | TR | 90008 | 18 | NON-TARGET | IMG-00005 | R-A3 | R-NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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| Rows 1-3: | Show the scans performed at screening. The CT SCAN and SCINTIGRAPHY are the primary methods used to assess the target and non-target lesion for RECIST 1.1 and the results are in TU and TR. Row 3 shows the correlative imaging (i.e., MRI) of the bone lesion in the FEMUR. | | Rows 4-6: | Show that the CT scan was performed (PROCCUR = "Y") and that the scintigraphy and MRI were not performed (PROCCUR = "N") at week 12. | | Rows 7-9: | Show the scans performed at week 24. |
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| Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRLOC | PRPRESP | PROCCUR | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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| 1 | EX88888 | PR | 90008 | 1 | IMG-00001 | A1 | CT SCAN | MULTIPLE | Y | Y | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 2 | EX88888 | PR | 90008 | 2 | IMG-00002 | A1 | SCINTIGRAPHY | BONE | Y | Y | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 3 | EX88888 | PR | 90008 | 3 | IMG-00003 | A1 | MRI | FEMUR | Y | Y | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | | 4 | EX88888 | PR | 90008 | 4 | IMG-00004 | A2 | CT SCAN | MULTIPLE | Y | Y | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 5 | EX88888 | PR | 90008 | 5 |
| A2 | SCINTIGRAPHY | BONE | Y | N | TREATMENT | 20 | WEEK 12 |
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| | 6 | EX88888 | PR | 90008 | 6 |
| A2 | MRI | FEMUR | Y | N | TREATMENT | 20 | WEEK 12 |
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| | 7 | EX88888 | PR | 90008 | 7 | IMG-00005 | A3 | CT SCAN | MULTIPLE | Y | Y | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | | 8 | EX88888 | PR | 90008 | 8 | IMG-00006 | A3 | SCINTIGRAPHY | BONE | Y | Y | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | | 9 | EX88888 | PR | 90008 | 9 | IMG-00007 | A3 | MRI | FEMUR | Y | Y | TREATMENT | 30 | WEEK 24 | 2010-06-25 | 173 | |
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| Rows 1-2: | Show the 2 locations of the CT SCAN for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "CHEST" and QNAM = "PRLOC2" with QVAL = "ABDOMEN". | | Rows 3-6: | Show the 2 locations of the CT SCAN for PRSEQ 4 and 7. |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX88888 | PR | 90008 | PRSEQ | 1 | PRLOC1 | Anatomical Location 1 | CHEST | eDC | | 2 | EX88888 | PR | 90008 | PRSEQ | 1 | PRLOC2 | Anatomical Location 2 | ABDOMEN | eDC | | 3 | EX88888 | PR | 90008 | PRSEQ | 4 | PRLOC1 | Anatomical Location 1 | CHEST | eDC | | 4 | EX88888 | PR | 90008 | PRSEQ | 4 | PRLOC2 | Anatomical Location 2 | ABDOMEN | eDC | | 5 | EX88888 | PR | 90008 | PRSEQ | 7 | PRLOC1 | Anatomical Location 1 | CHEST | eDC | | 6 | EX88888 | PR | 90008 | PRSEQ | 7 | PRLOC2 | Anatomical Location 2 | ABDOMEN | eDC |
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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 and a subsequent 12-week follow-up visit.
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| Rows 1-3: | Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 12. The Target Response of PR (Partial Response) is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. The Non-Target Response of SD (Stable Disease) 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 (Partial Response). | | Rows 4-6: | Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 24. The Target Response of CR (Complete Response) is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. The Non-Target Response of SD (Stable Disease) 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 (Partial Response). |
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| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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| 1 | EX01010 | RS | 90010 | 1 |
| 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 |
| 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 | R-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 |
| 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 |
| 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 | R-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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| Rows 1-4: | Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-Target lesions/sites "R-NT01" and "R-NT02" in the "LIVER" and "CHEST WALL" at screening. | | Rows 5-11: | Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 12. "R-T01" shows a decrease from 17mm at baseline to 7mm which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. "R-NT01" has a TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "ENLARGEMENT FROM NADIR". | | Rows 12-18: | Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 24. "R-T01" is absent (LDIAM = "0") which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. "R-NT01" remains TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "PRESENT". |
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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 |
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| 1 | EX01010 | TR | 90010 | 1 | TARGET | R-A1 | R-T01 | LDIAM | Longest Diameter | 17 | mm | 17 | 17 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 2 | EX01010 | TR | 90010 | 2 | TARGET | R-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
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| | 3 | EX01010 | TR | 90010 | 3 | NON-TARGET | R-A1 | R-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 4 | EX01010 | TR | 90010 | 4 | NON-TARGET | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 5 | EX01010 | TR | 90010 | 5 | TARGET | R-R-A2 | R-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 | R-A2 |
| SUMDIAM | Sum of Diameter | 7 | mm | 7 | 7 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 7 | EX01010 | TR | 90010 | 7 | TARGET | R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 8 | EX01010 | TR | 90010 | 8 | TARGET | R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -59 | % | -59 | -59 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 9 | EX01010 | TR | 90010 | 9 | TARGET | R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -59 | % | -59 | -59 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
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| | 10 | EX01010 | TR | 90010 | 10 | NON-TARGET | R-A2 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 11 | EX01010 | TR | 90010 | 11 | NON-TARGET | R-A2 | R-NT02 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | | 12 | EX01010 | TR | 90010 | 12 | TARGET | R-A3 | R-T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | | 13 | EX01010 | TR | 90010 | 13 | TARGET | R-A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 14 | EX01010 | TR | 90010 | 14 | TARGET | R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -17 | mm | -17 | -17 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 15 | EX01010 | TR | 90010 | 15 | TARGET | R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -100 | % | -100 | -100 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 16 | EX01010 | TR | 90010 | 16 | TARGET | R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -100 | % | -100 | -100 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
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| | 17 | EX01010 | TR | 90010 | 17 | NON-TARGET | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | | 18 | EX01010 | TR | 90010 | 18 | NON-TARGET | R-A3 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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