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| Dataset wrap |
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| Rowcaps |
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| 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 complete response/non progressive disease (NON-CR/NON-PD). The Overall Response (RSTESTCD = "OVRLRESP") is non complete response/non progressive disease (NON-CR/NON-PD) which is a valid Overall Response in RECIST 1.1 for subjects with non-target disease only. | | Rows 4-6: | Show the week 12 response assessment for a subject with non-target disease only. The Non-Target Response (RSTESTCD = "NTRGRESP") is NE (Not Evaluable) 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 7-9: | Show the week 20 assessment where the non-targets were enlarged from a previous smallest size. The Non-Target Response (RSTESTCD = "NTRGRESP") is "PD" (progressive disease) which results in an Overall Response (RSTESTCD = "OVRLRESP") of "PD". |
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| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | 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 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | NOT DONE | Subject does not have target lesions | | 5 | EX77777 | RS | 90007 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 |
|
| | 6 | EX77777 | RS | 90007 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 |
|
| | 7 | EX77777 | RS | 90007 | 7 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | NOT DONE | Subject does not have target lesions | | 8 | EX77777 | RS | 90007 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 |
|
| | 9 | EX77777 | RS | 90007 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 |
|
| |
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| Dataset wrap |
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| Rowcaps |
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| Row 1: | Shows that the subject has no target tumors (TUTESTCD = "TIND"), i.e., the subject does not have measurable disease. | | Row 2: | Shows that the subject has non-target tumors (TUTESTCD = "NTIND"). The subject has non-measurable only disease. | | Rows 3-5: | Show the identification of 3 non-target lesions for a subject with non-target disease only. See below for details on on the tumor presentation type (QNAM = "TUPRTYP") supplemental qualifier. |
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| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
|---|
| 1 | EX77777 | TU | 90007 | 1 |
|
| TIND | Target Indicator | N | N |
|
| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 2 | EX77777 | TU | 90007 | 2 |
|
| NTIND | Non-Target Indicator | Y | Y |
|
| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 3 | EX77777 | TU | 90007 | 3 | IMG-00001 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | BRAIN | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 4 | EX77777 | TU | 90007 | 4 | IMG-00002 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | SKELETAL MUSCLE TISSUE | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 5 | EX77777 | TU | 90007 | 5 | IMG-00002 | NT03 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | PERICARDIUM | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | |
|
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| Dataset wrap |
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| Rowcaps |
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| Row 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 2-3: | Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified. | | Rows 4-5: | Show the anatomical plane (QNAM = "TUANTPLN") and the slice number (QNAM = "TUSLNUM") where the skeletal muscle tissue non-target lesion (TULNKID = "NT02") was identified. | | Row 6: | 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". |
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| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 1 | EX77777 | TU | 90007 | TUSEQ | 3 | TUPRTYP | Tumor or Lesion Presentation Type | LEPTOMENINGEAL DISEASE | CRF | | 2 | EX77777 | TU | 90007 | TUSEQ | 3 | TUANTPLN | Anatomical Plane | SAGITTAL | CRF | | 3 | EX77777 | TU | 90007 | TUSEQ | 3 | TUSLNUM | Slice Number | 55 | CRF | | 4 | EX77777 | TU | 90007 | TUSEQ | 4 | TUANTPLN | Anatomical Plane | SAGITTAL | CRF | | 5 | EX77777 | TU | 90007 | TUSEQ | 4 | TUSLNUM | Slice Number | 88-91 | CRF | | 6 | EX77777 | TU | 90007 | TUSEQ | 4 | TUPRTYP | Tumor or Lesion Presentation Type | EFFUSION | CRF |
|
|
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| Dataset wrap |
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| Rowcaps |
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| Rows 1-6: | Show the qualitative assessments of the tumor state of the 3 non-target lesions "NT01", "NT02", and "NT03" at screening and week 6. | | Rows 7-9: | Show the week 12 assessments. Row 7 shows the assessment of "NT01" non-target lesion in the brain whereas rows 8 and 9 illustrate the assessments of the non-target lesions "NT02" and "NT03" in the skeletal muscle tissue and pericardium, respectively, were not done. This is because the non-target lesions were obscured on the MRI and not assessable (TRSTAT = "NOT DONE" and TRREASND = "NOT EVALUABLE: 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". |
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| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
|---|
| 1 | EX77777 | TR | 90007 | 1 | NON-TARGET | IMG-00001 | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 2 | EX77777 | TR | 90007 | 2 | NON-TARGET | IMG-00001 | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 3 | EX77777 | TR | 90007 | 3 | NON-TARGET | IMG-00001 | A1 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 4 | EX77777 | TR | 90007 | 4 | NON-TARGET | IMG-00003 | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | | 5 | EX77777 | TR | 90007 | 5 | NON-TARGET | IMG-00003 | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | | 6 | EX77777 | TR | 90007 | 6 | NON-TARGET | IMG-00003 | A2 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | | 7 | EX77777 | TR | 90007 | 7 | NON-TARGET | IMG-00005 | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | | 8 | EX77777 | TR | 90007 | 8 | NON-TARGET | IMG-00005 | A3 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | | 9 | EX77777 | TR | 90007 | 9 | NON-TARGET | IMG-00005 | A3 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | | 10 | EX77777 | TR | 90007 | 10 | NON-TARGET | IMG-00007 | A4 | NT01 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | | 11 | EX77777 | TR | 90007 | 11 | NON-TARGET | IMG-00007 | A4 | NT02 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | | 12 | EX77777 | TR | 90007 | 12 | NON-TARGET | IMG-00007 | A4 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | |
|
...
| Dataset wrap |
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| Rowcaps |
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| Rows 1-2: | Show the scans preformed at the screening disease assessment. The MRI is the primary method used to assess the lesions for RECIST 1.1 and the results are in TU and TR. Row 2 shows the correlative imaging of the brain (i.e., CT SCAN of the HEAD). | | Rows 3-8: | Show the scans preformed at the disease assessments at weeks 6, 12 and 20. |
|
| Dataset2 |
|---|
| 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 | MULTIPLE | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 2 | EX77777 | PR | 90007 | 2 | IMG-00002 | A1 | CT SCAN | Y | Y | HEAD | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 3 | EX77777 | PR | 90007 | 3 | IMG-00003 | A2 | MRI | Y | Y | MULTIPLE | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | | 4 | EX77777 | PR | 90007 | 4 | IMG-00004 | A2 | CT SCAN | Y | Y | HEAD | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | | 5 | EX77777 | PR | 90007 | 5 | IMG-00005 | A3 | MRI | Y | Y | MULTIPLE | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | | 6 | EX77777 | PR | 90007 | 6 | IMG-00006 | A3 | CT SCAN | Y | Y | HEAD | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | | 7 | EX77777 | PR | 90007 | 7 | IMG-00007 | A4 | MRI | Y | Y | MULTIPLE | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | | 8 | EX77777 | PR | 90007 | 8 | IMG-00008 | A4 | CTSCAN | Y | Y | HEAD | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | |
|
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| Dataset wrap |
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| Rowcaps |
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| 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". |
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| 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 |
|
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| Dataset wrap |
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| Rowcaps |
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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 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
|---|
| 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 | |
|
...
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.
...
...
at screening, including the identification of a "R-T01" target tumor in the "LIVER" and the assessment of the 2 non-target tumors "R-NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" at screening.
| Dataset wrap |
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| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TUMETHOD | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
|---|
| 1 | EX88888 | TU | 90008 | 1 | IMG-00001 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | VENDOR1 | LIVER | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 2 | EX88888 | TU | 90008 | 2 | IMG-00002 | R-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | VENDOR1 | BONE | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | | 3 | EX88888 | TU | 90008 | 3 | IMG-00001 | R-NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | VENDOR1 | PLEURAL CAVITY | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | |
|
The supptu.xpt table below shows the data to describe the disease presentation of a non-target tumor, when needed. The tumor presentation type (QNAM = "TUPRTYP") supplemental supplemental qualifier is used and controlled terminology is available (DSPRTYP).
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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".
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 1 | EX88888 | TU | 900080 | TUSEQ | 3 | TUPRTYP | Tumor or Lesion Presentation Type | EFFUSION | CRF |
|
|
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| Dataset wrap |
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| Rowcaps |
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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 |
|---|
| 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 | EX88888 | TR | 90008 | 1 | TARGET | IMG-00001 | R-A1 | R-T01 | LDIAM | Longest Diameter | 17 | mm | 17 | 17 | mm |
|
| 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 |
|
| 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 |
|
|
|
| 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 |
|
|
|
| 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 |
|
| 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 |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| | 7 | EX88888 | TR | 90008 | 7 | TARGET |
| R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| | 8 | EX88888 | TR | 90008 | 8 | TARGET |
| R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -59 | % | -59 | -59 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| | 9 | EX88888 | TR | 90008 | 9 | TARGET |
| R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -59 | % | -59 | -59 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| | 10 | EX88888 | TR | 90008 | 10 | NON-TARGET |
| R-A2 | R-NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| | 11 | EX88888 | TR | 90008 | 11 | NON-TARGET | IMG-00004 | R-A2 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| 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 |
|
| 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 |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| | 14 | EX88888 | TR | 90008 | 14 | TARGET |
| R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -17 | mm | -17 | -17 | mm |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| | 15 | EX88888 | TR | 90008 | 15 | TARGET |
| R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -100 | % | -100 | -100 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| | 16 | EX88888 | TR | 90008 | 16 | TARGET |
| R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -100 | % | -100 | -100 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| | 17 | EX88888 | TR | 90008 | 17 | NON-TARGET | IMG-00006 | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| 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 |
|
|
|
| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
|
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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. |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRLOC | PRPRESP | PROCCUR | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
|---|
| 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 |
|
| | 6 | EX88888 | PR | 90008 | 6 |
| A2 | MRI | FEMUR | Y | N | TREATMENT | 20 | WEEK 12 |
|
| | 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 | |
|
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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. |
|
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 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 |
|
|
...
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data collected for one subject collected at screening. In this example, there are no data in TU or TR because no tumors were identified.
...
...
at screening for which the independent radiologist found no evidence of disease at baseline (RSSTRESC = "NED")
...
. 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. In this example, there are no data in TU or TR, because no tumors were identified.
| Dataset wrap |
|---|
|
| 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 Response | PROTOCOL DEFINED RESPONSE CRITERIA | NED | NED | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-03-29 | 1 | |
|
...
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.
| Dataset wrap |
|---|
| Rowcaps |
|---|
| 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). |
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
|---|
| 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 | |
|
...
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.
...
...
The subject has 1 target lesion with TULNKID "R-T01" and 2 non-target lesions/sites with TULNKID "R-NT01" and "R-NT02" identified at screening. "T01"
...
and "R-NT01"
...
are located in the
...
"LIVER" and "R-NT02" is located in the "CHEST WALL".
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| 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 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL. INC. | LIVER | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 2 | EX01010 | TU | 90010 | 2 | R-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL. INC. | LIVER | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | | 3 | EX01010 | TU | 90010 | 3 | R-NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL. INC. | CHEST WALL | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | |
|
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| 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". |
|
| Dataset2 |
|---|
| 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 | 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 |
|
| | 3 | EX01010 | TR | 90010 | 3 | NON-TARGET | R-A1 | R-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| 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 |
|
| 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 |
|
| | 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 |
|
| | 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 |
|
| | 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 |
|
| | 10 | EX01010 | TR | 90010 | 10 | NON-TARGET | R-A2 | R-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 | R-A2 | R-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 | 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 |
|
| | 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 |
|
| | 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 |
|
| | 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 |
|
| | 17 | EX01010 | TR | 90010 | 17 | NON-TARGET | R-A3 | R-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 | R-A3 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
|
...