...
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX11111 | RS | 90001 | RSSEQ | 3 | RSREASNE | Reason Response Not Evaluable | Imaging quality issues and not all scan performed | CRF |
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4.1.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 subject at screening and at weeks 36 and 44, where new lesions are identified. In this example, lymph nodes are selected as target tumors. In RECIST 1.1, target lymph node tumors are measured in the longest perpendicular (TRTESTCD = "LPERP") in the TR domain. The image identifier is in TUREFID and matches a PRREFID in the PR domain.
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Rows 1-6: | Show a subject with 4 target lesions (TULNKID = "T01"-"T04") and 2 non-target lesions (TULNKID = "NT01", "NT02") identified at screening. Target lesions T01 and T02 are lymph nodes; T01 is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). TULOC contains the location from the anatomical location terminology. Note that some locations in controlled terminology contain laterality and/or directionality (as shown in row 7). Laterality and directionality should not generally be added to TULOC unless in the controlled terminology. | Row 7: | Shows that, at week 36, an equivocal new lesion (TULNKID = "NEW01") was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location. | Row 8-9: | Show that, at week 44, new unequivocal new lesions (TULNKID = "NEW02", "NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE"). |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUDIR | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX11111 | TU | 90001 | 1 | IMG-00001 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | SUPRACLAVICULAR LYMPH NODE | RIGHT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TU | 90001 | 2 | IMG-00002 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | THORACIC LYMPH NODE |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX11111 | TU | 90001 | 3 | IMG-00001 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | THYROID GLAND | LEFT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 4 | EX11111 | TU | 90001 | 4 | IMG-00003 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | SKIN OF THE TRUNK |
| UPPER | PHOTOGRAPHY | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 5 | EX11111 | TU | 90001 | 5 | IMG-00002 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | MEDIASTINAL LYMPH NODE | RIGHT |
| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 6 | EX11111 | TU | 90001 | 6 | IMG-00001 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | CEREBELLUM | RIGHT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | 1 | 7 | EX11111 | TU | 90001 | 7 | IMG-00020 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LUNG, LEFT LOWER LOBE |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 8 | EX11111 | TU | 90001 | 8 | IMG-00019 | NEW02 | TUMIDENT | Tumor Identification | NEW | NEW | CEREBELLUM | LEFT |
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 9 | EX11111 | TU | 90001 | 9 | IMG-00022 | NEW03 | TUMIDENT | Tumor Identification | NEW | NEW | FEMORAL LYMPH NODE | LEFT |
| ULTRASOUND | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 |
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The following supptu.xpt table shows the data on whether a tumor was previously irradiated (QNAM = "TUPRVIR") and whether that tumor was shown to be progressing since it was irradiated (QNAM = "TUPRVIRP").
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Rows 1-3: | Show that the target lesions with TUSEQ = "1", "2", and "3" were not previously irradiated. | Rows 4-5: | Show that that target lesion with TUSEQ = "4" was previously irradiated and shown to be progressing since it was irradiated. |
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX11111 | TU | 90001 | TUSEQ | 1 | TUPRVIR | Previously Irradiated Indicator | N | CRF | 2 | EX11111 | TU | 90001 | TUSEQ | 2 | TUPRVIR | Previously Irradiated Indicator | N | CRF | 3 | EX11111 | TU | 90001 | TUSEQ | 3 | TUPRVIR | Previously Irradiated Indicator | N | CRF | 4 | EX11111 | TU | 90001 | TUSEQ | 4 | TUPRVIR | Previously Irradiated Indicator | Y | CRF | 5 | EX11111 | TU | 90001 | TUSEQ | 4 | TUPRVIRP | Previously Irradiated Progression | Y | CRF |
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4.1.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at screening, week 6, week 12, and subsequent 8-week follow-up visits. This example shows measurements (i.e., longest perpendicular) of lymph nodes as well as measurements of other non-lymph node target tumors (i.e., longest diameter). In this example, when TRTEST = "Lymph Node State" and TRORRES = "NON-PATHOLOGICAL", it indicates that the lymph node tumor is less than 10mm. When a target lymph node tumor has longest perpendicular greater than or equal to 10mm, the assessment is represented with TRTEST = "Lymph Node State" and TRORRES = "PATHOLOGICAL". The image identifier is in TRREFID and matches a PRREFID in the PR domain.
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Rows 1-6: | Show the screening assessments of the target lesions. For lymph node target lesions T01 and T02, the TRTESTCD used for the assessments are "LPREP" and "LNSTATE". For non-lymph node target lesions T03 and T04, the TRTESTCD used for the assessments is "LDIAM". | Rows 7-8: | Show the results for the non-targets. NT01 is a lymph node where the TRTEST used for the assessments is lymph node state (TRTESTCD = "LNSTATE"). NT02 is a non-lymph node where the TRTEST used for the assessments is tumor state (TRTESTCD = "TUMSTATE"). | Row 14: | Shows a case where the scan was not performed at week 6 (TRTEST = "Longest Diameter", TRSTAT = "NOT DONE" with TRREASND = "SCAN NOT PERFORMED"). | Row 15: | Shows a case where the non-target NT01 was not evaluable (TRTEST = "Lymph Node State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE"). | Row 16: | Shows a case where the non-target NT02 was not evaluable (TRTEST = "Tumor State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE"). | Row 30: | Shows that target lesion T04 was too small to measure (TRORRES = "TOO SMALL TO MEASURE"; TRSTRESC and TRSTRESN are standardized to "5" with TRSTRESU as "mm"). The standardized value of "5" ensures that the sum of diameters includes a value for that lesion because it has not disappeared. The method of standardization of the TRSTRESC and TRSTRESN values is sponsor specific. | Row 58: | Shows a new lesion (NEW01) which has a measurement of 4 mm. Note that this value is less than 5 mm and has not been reported as too small to measure. |
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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 | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX11111 | TR | 90001 | 1 | TARGET | IMG-00001 | A1 | T01 | LPERP | Longest Perpendicular | 17 | mm | 17 | 17 | mm |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TR | 90001 | 2 | TARGET | IMG-00001 | A1 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX11111 | TR | 90001 | 3 | TARGET | IMG-00002 | A1 | T02 | LPERP | Longest Perpendicular | 16 | mm | 16 | 16 | mm |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 4 | EX11111 | TR | 90001 | 4 | TARGET | IMG-00002 | A1 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX11111 | TR | 90001 | 5 | TARGET | IMG-00001 | A1 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 6 | EX11111 | TR | 90001 | 6 | TARGET | IMG-00003 | A1 | T04 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 7 | EX11111 | TR | 90001 | 7 | NON-TARGET | IMG-00002 | A1 | NT01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 8 | EX11111 | TR | 90001 | 8 | NON-TARGET | IMG-00001 | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 9 | EX11111 | TR | 90001 | 9 | TARGET | IMG-00004 | A2 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 10 | EX11111 | TR | 90001 | 10 | TARGET | IMG-00004 | A2 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 11 | EX11111 | TR | 90001 | 11 | TARGET | IMG-00005 | A2 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 12 | EX11111 | TR | 90001 | 12 | TARGET | IMG-00005 | A2 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 13 | EX11111 | TR | 90001 | 13 | TARGET | IMG-00004 | A2 | T03 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 14 | EX11111 | TR | 90001 | 14 | TARGET |
| A2 | T04 | LDIAM | Longest Diameter |
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| NOT DONE | SCAN NOT PERFORMED | PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 40 | WEEK 6 |
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| 15 | EX11111 | TR | 90001 | 15 | NON-TARGET | IMG-00005 | A2 | NT01 | LNSTATE | Lymph Node State |
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| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 16 | EX11111 | TR | 90001 | 16 | NON-TARGET | IMG-00004 | A2 | NT02 | TUMSTATE | Tumor State |
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| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 17 | EX11111 | TR | 90001 | 17 | TARGET | IMG-00007 | A3 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 18 | EX11111 | TR | 90001 | 18 | TARGET | IMG-00007 | A3 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 19 | EX11111 | TR | 90001 | 19 | TARGET | IMG-00008 | A3 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 20 | EX11111 | TR | 90001 | 20 | TARGET | IMG-00008 | A3 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 21 | EX11111 | TR | 90001 | 21 | TARGET | IMG-00007 | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 22 | EX11111 | TR | 90001 | 22 | TARGET | IMG-00009 | A3 | T04 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 23 | EX11111 | TR | 90001 | 23 | NON-TARGET | IMG-00008 | A3 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 24 | EX11111 | TR | 90001 | 24 | NON-TARGET | IMG-00007 | A3 | NT02 | TUMSTATE | Tumor State |
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| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 25 | EX11111 | TR | 90001 | 25 | TARGET | IMG-00010 | A4 | T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 26 | EX11111 | TR | 90001 | 26 | TARGET | IMG-00010 | A4 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 27 | EX11111 | TR | 90001 | 27 | TARGET | IMG-00011 | A4 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 28 | EX11111 | TR | 90001 | 28 | TARGET | IMG-00011 | A4 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 29 | EX11111 | TR | 90001 | 29 | TARGET | IMG-00010 | A4 | T03 | LDIAM | Longest Diameter | 11 | mm | 11 | 11 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 30 | EX11111 | TR | 90001 | 30 | TARGET | IMG-00012 | A4 | T04 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 31 | EX11111 | TR | 90001 | 31 | NON-TARGET | IMG-00011 | A4 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 32 | EX11111 | TR | 90001 | 32 | NON-TARGET | IMG-00010 | A4 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 33 | EX11111 | TR | 90001 | 33 | TARGET | IMG-00013 | A5 | T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 34 | EX11111 | TR | 90001 | 34 | TARGET | IMG-00013 | A5 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 35 | EX11111 | TR | 90001 | 35 | TARGET | IMG-00014 | A5 | T02 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 36 | EX11111 | TR | 90001 | 36 | TARGET | IMG-00014 | A5 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 37 | EX11111 | TR | 90001 | 37 | TARGET | IMG-00013 | A5 | T03 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 38 | EX11111 | TR | 90001 | 38 | TARGET | IMG-00015 | A5 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 39 | EX11111 | TR | 90001 | 39 | NON-TARGET | IMG-00014 | A5 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 40 | EX11111 | TR | 90001 | 40 | NON-TARGET | IMG-00013 | A5 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 41 | EX11111 | TR | 90001 | 41 | TARGET | IMG-00016 | A6 | T01 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 42 | EX11111 | TR | 90001 | 42 | TARGET | IMG-00016 | A6 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
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| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 43 | EX11111 | TR | 90001 | 43 | TARGET | IMG-00017 | A6 | T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 44 | EX11111 | TR | 90001 | 44 | TARGET | IMG-00017 | A6 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 45 | EX11111 | TR | 90001 | 45 | TARGET | IMG-00016 | A6 | T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 46 | EX11111 | TR | 90001 | 46 | TARGET | IMG-00018 | A6 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 47 | EX11111 | TR | 90001 | 47 | NON-TARGET | IMG-00017 | A6 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 48 | EX11111 | TR | 90001 | 48 | NON-TARGET | IMG-00016 | A6 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 49 | EX11111 | TR | 90001 | 49 | NEW | IMG-00017 | A6 | NEW01 | TUMSTATE | Tumor State | EQUIVOCAL |
| EQUIVOCAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 50 | EX11111 | TR | 90001 | 50 | TARGET | IMG-00019 | A7 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 51 | EX11111 | TR | 90001 | 51 | TARGET | IMG-00019 | A7 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 52 | EX11111 | TR | 90001 | 52 | TARGET | IMG-00020 | A7 | T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 53 | EX11111 | TR | 90001 | 53 | TARGET | IMG-00020 | A7 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
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| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 54 | EX11111 | TR | 90001 | 54 | TARGET | IMG-00019 | A7 | T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 55 | EX11111 | TR | 90001 | 55 | TARGET | IMG-00021 | A7 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 56 | EX11111 | TR | 90001 | 56 | NON-TARGET | IMG-00020 | A7 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
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| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 57 | EX11111 | TR | 90001 | 57 | NON-TARGET | IMG-00019 | A7 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
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| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 58 | EX11111 | TR | 90001 | 58 | NEW | IMG-00020 | A7 | NEW01 | LDIAM | Longest Diameter | 4 | mm | 4 | 4 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 59 | EX11111 | TR | 90001 | 59 | NEW | IMG-00020 | A7 | NEW01 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
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| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 60 | EX11111 | TR | 90001 | 60 | NEW | IMG-00019 | A7 | NEW02 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 61 | EX11111 | TR | 90001 | 61 | NEW | IMG-00019 | A7 | NEW02 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
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| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 62 | EX11111 | TR | 90001 | 62 | NEW | IMG-00022 | A7 | NEW03 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
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| ULTRASOUND | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 315 | |
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The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
...
Dataset wrap |
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Rowcaps |
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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 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"). |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRPRESP | PROCCUR | PRLOC | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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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: Split and Merged Tumors
...
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX22222 | RS | 90002 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX22222 | RS | 90002 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX22222 | RS | 90002 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX22222 | RS | 90002 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 5 | EX22222 | RS | 90002 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX22222 | RS | 90002 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX22222 | RS | 90002 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 8 | EX22222 | RS | 90002 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 9 | EX22222 | RS | 90002 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 10 | EX22222 | RS | 90002 | 10 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | 11 | EX22222 | RS | 90002 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | 12 | EX22222 | RS | 90002 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 |
|
|
4.2.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 subject collected at screening and subsequent visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This example also shows TUREFID used to represent the image identifier and TUSPID used to represent a sponsor's internal tracking identifier.
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Rowcaps |
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Rows 7-8: | Show the identification of a split tumor when it was first identified as split (fragmented). In this example, tumor T04 splits into 2 tumors (T04.1, T04.2); TUGRPID = "T04" provides traceability and links the split tumor to its parent record. | Row 9: | Shows the identification of a merged tumor when it was first identified as merged (coalesced). In this example, tumors T02 and T03 merged into tumor T02/T03; TULNKID = "T02/T03" is a combination of the child tumors and provides the traceability back to the child tumors. |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TUREFID | TUSPID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX22222 | TU | 90002 | 1 |
| IMG-00001 | TRG-SCR-01 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, RIGHT MIDDLE LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX22222 | TU | 90002 | 2 |
| IMG-00001 | TRG-SCR-02 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX22222 | TU | 90002 | 3 |
| IMG-00001 | TRG-SCR-03 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX22222 | TU | 90002 | 4 |
| IMG-00001 | TRG-SCR-04 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX22222 | TU | 90002 | 5 |
| IMG-00001 | NTG-SCR-01 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | LUNG | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX22222 | TU | 90002 | 6 |
| IMG-00001 | NTG-SCR-02 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | LIVER | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX22222 | TU | 90002 | 7 | T04 | IMG-00002 | TRG-W16-07 | T04.1 | TUSPLIT | Tumor Split | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 8 | EX22222 | TU | 90002 | 8 | T04 | IMG-00002 | TRG-W16-08 | T04.2 | TUSPLIT | Tumor Split | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 9 | EX22222 | TU | 90002 | 9 |
| IMG-00003 | TRG-W28-07 | T02/T03 | TUMERGE | Tumor Merged | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 10 | EX22222 | TU | 90002 | 10 |
| IMG-00004 | NWT-W32-01 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LIVER | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | |
|
4.2.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at screening, week 6, and subsequent 8-week follow-up visits. The example shows the preferred representation of split (fragmented) and merged (coalesced) tumors. This preferred approach provides transparent traceability with parent lesions. This example shows how to represent data on a single row when a target tumor becomes too small to measure. In terms of RECIST 1.1, the original results would be "TOO SMALL TO MEASURE" and the standard results (TRSTRESN and TRSTRESC) would be "5". In addition, the example represents a situation where a result was not provided because the image was obscured and the tumor was not assessable.
...
Dataset wrap |
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Rowcaps |
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Row 11: | Shows the longest diameter of T04 at the assessment before it splits. | Rows 18-19: | Show the longest diameters of the split lesions (T04.1 and T04.2) at week 16. | Rows 24-25: | Show that tumors T02 and T03 are no longer measured individually (TRSTAT = "NOT DONE" and TRREASND = "TUMOR MERGED"). These rows are optional and can be included if part of the collection. In the case where a sponsor includes TUMSTATE for target lesions, TUMSTATE may be assigned to "TUMOR MERGED". | Row 26: | Shows the longest diameter of the newly merged T02/T03 tumor at week 24. | Rows 27-28: | Show the longest diameters of the split lesions T04.1 and T04.2 at week 24. | Row 33: | Shows the longest diameter of the newly merged T02/T03 tumor at week 32. Sponsors can continue to include individual tumors as not done as in rows 24-25. | Rows 34-35: | Show the longest diameters of the split lesions T04.1 and T04.2 at week 32. | Row 37: | Shows the tumor state of the non-target NT01 as enlargement from nadir (TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). This tumor state indicates that the non-target tumors in the lung have shown enlargement from their previous smallest state. | Rows 39-40: | Show the tumor state of the new tumor NEW01 and its longest diameter. |
|
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 | EX22222 | TR | 90002 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 16 | mm | 16 | 16 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX22222 | TR | 90002 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 28 | mm | 28 | 28 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX22222 | TR | 90002 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 41 | mm | 41 | 41 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX22222 | TR | 90002 | 4 | TARGET | A1 | T04 | LDIAM | Longest Diameter | 83 | mm | 83 | 83 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX22222 | TR | 90002 | 5 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 168 | mm | 168 | 168 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| 6 | EX22222 | TR | 90002 | 6 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 7 | EX22222 | TR | 90002 | 7 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 8 | EX22222 | TR | 90002 | 8 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 9 | EX22222 | TR | 90002 | 9 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 10 | EX22222 | TR | 90002 | 10 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX22222 | TR | 90002 | 11 | TARGET | A2 | T04 | LDIAM | Longest Diameter | 65 | mm | 65 | 65 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 12 | EX22222 | TR | 90002 | 12 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 125 | mm | 125 | 125 | mm |
|
|
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 13 | EX22222 | TR | 90002 | 13 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 14 | EX22222 | TR | 90002 | 14 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 15 | EX22222 | TR | 90002 | 15 | 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 | 16 | EX22222 | TR | 90002 | 16 | TARGET | A3 | T02 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 17 | EX22222 | TR | 90002 | 17 | TARGET | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 18 | EX22222 | TR | 90002 | 18 | TARGET | A3 | T04.1 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 19 | EX22222 | TR | 90002 | 19 | TARGET | A3 | T04.2 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 20 | EX22222 | TR | 90002 | 20 | TARGET | A3 |
| SUMDIAM | Sum of Diameter | 72 | mm | 72 | 72 | mm |
|
|
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| 21 | EX22222 | TR | 90002 | 21 | NON-TARGET | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 22 | EX22222 | TR | 90002 | 22 | NON-TARGET | A3 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 23 | EX22222 | TR | 90002 | 23 | TARGET | A4 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 24 | EX22222 | TR | 90002 | 24 | TARGET | A4 | T02 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | TUMOR MERGED | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 25 | EX22222 | TR | 90002 | 25 | TARGET | A4 | T03 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | TUMOR MERGED | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 26 | EX22222 | TR | 90002 | 26 | TARGET | A4 | T02/T03 | LDIAM | Longest Diameter | 35 | mm | 35 | 35 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 27 | EX22222 | TR | 90002 | 27 | TARGET | A4 | T04.1 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 28 | EX22222 | TR | 90002 | 28 | TARGET | A4 | T04.2 | LDIAM | Longest Diameter | 19 | mm | 19 | 19 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 29 | EX22222 | TR | 90002 | 29 | TARGET | A4 |
| SUMDIAM | Sum of Diameter | 84 | mm | 84 | 84 | mm |
|
|
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 |
|
| 30 | EX22222 | TR | 90002 | 30 | NON-TARGET | A4 | NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 31 | EX22222 | TR | 90002 | 31 | NON-TARGET | A4 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | 32 | EX22222 | TR | 90002 | 32 | TARGET | A5 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 33 | EX22222 | TR | 90002 | 33 | TARGET | A5 | T02/T03 | LDIAM | Longest Diameter | 80 | mm | 80 | 80 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 34 | EX22222 | TR | 90002 | 34 | TARGET | A5 | T04.1 | LDIAM | Longest Diameter | 49 | mm | 49 | 49 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 35 | EX22222 | TR | 90002 | 35 | TARGET | A5 | T04.2 | LDIAM | Longest Diameter | 26 | mm | 26 | 26 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 36 | EX22222 | TR | 90002 | 36 | TARGET | A5 |
| SUMDIAM | Sum of Diameter | 155 | mm | 155 | 155 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 37 | EX22222 | TR | 90002 | 37 | NON-TARGET | A5 | NT01 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 38 | EX22222 | TR | 90002 | 38 | NON-TARGET | A5 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 39 | EX22222 | TR | 90002 | 39 | NEW | A5 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | 40 | EX22222 | TR | 90002 | 40 | NEW | A5 | NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 |
|
|
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTAT | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX33333 | RS | 90003 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX33333 | RS | 90003 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX33333 | RS | 90003 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX33333 | RS | 90003 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 5 | EX33333 | RS | 90003 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX33333 | RS | 90003 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX33333 | RS | 90003 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 8 | EX33333 | RS | 90003 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 9 | EX33333 | RS | 90003 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 10 | EX33333 | RS | 90003 | 10 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| NOT DONE | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 11 | EX33333 | RS | 90003 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 |
|
| NOT DONE | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 12 | EX33333 | RS | 90003 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE |
| INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
|
|
|
The following supprs.xpt table shows the data on the reason that the response was not evaluable (QNAM = "RSREASNE") in the case where it is collected.
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Dataset2 |
---|
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX33333 | RS | 90005 | RSSEQ | 12 | RSREASNE | Reason Response Not Evaluable | Scans of target and non-target tumors were not performed | CRF |
|
|
4.3.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the identification of target and non-target tumors at screening. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain. This example shows a subject with 4 target lesions (TULNKID = "T01"-"T04") and 3 non-target lesions (TULNKID = "NT01"-"NT03") identified at screening. The subject did not have any new lesions.
Dataset wrap |
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|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUMETHOD | TUEVAL | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX33333 | TU | 90003 | 1 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LUNG, RIGHT MIDDLE LOBE |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX33333 | TU | 90003 | 2 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LIVER |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX33333 | TU | 90003 | 3 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LIVER |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX33333 | TU | 90003 | 4 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| KIDNEY, UPPER LOBE | RIGHT | CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX33333 | TU | 90003 | 5 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| LUNG |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX33333 | TU | 90003 | 6 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| ABDOMINAL CAVITY |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX33333 | TU | 90003 | 7 | NT03 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| CLAVICLE | RIGHT | SCINTIGRAPHY | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | |
|
4.3.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example represents a situation where a result was not provided because the scan was not performed.
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 |
| SUMDIAM | Sum of 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 |
| SUMDIAM | Sum of 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 |
| SUMDIAM | Sum of 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 |
| SUMDIAM | Sum of 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 |
|
|
|
|
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
...
Dataset wrap |
---|
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | RSACPTFL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX44444 | RS | 90004 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX44444 | RS | 90004 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX44444 | RS | 90004 | 3 | R1-A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX44444 | RS | 90004 | 4 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 5 | EX44444 | RS | 90004 | 5 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX44444 | RS | 90004 | 6 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX44444 | RS | 90004 | 7 | R1-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 8 | EX44444 | RS | 90004 | 8 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 9 | EX44444 | RS | 90004 | 9 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 10 | EX44444 | RS | 90004 | 10 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX44444 | RS | 90004 | 11 | R2-A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 12 | EX44444 | RS | 90004 | 12 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 13 | EX44444 | RS | 90004 | 13 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 14 | EX44444 | RS | 90004 | 14 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 15 | EX44444 | RS | 90004 | 15 | R2-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 16 | EX44444 | RS | 90004 | 16 |
| BESTRESP | Best Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | |
|
4.4.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the use of the acceptance flag (TUACPTFL) to identify records when multiple assessments are performed by independent assessors (i.e., radiologist 1, radiologist 2) for the same timepoint. The acceptance flag indicates records which are chosen by an adjudicator. Not all sponsors have both sets of independent reviews exported (i.e., only accepted records are transferred). It is not expected that TUACPTFL would be populated by the sponsor; this type of record selection or censoring would be part of the analysis dataset. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain.
Dataset wrap |
---|
|
Rowcaps |
---|
Rows 1-3: | Show the identification of 2 target lesions (R1-T01, R1-T02) and 1 non-target lesion (R1-NT01) by radiologist 1 (TUEVALID). | Rows 4-6: | Show the identification of 2 target lesions (R1-T01, R1-T02) and 1 non-target lesion (R2-NT01) by radiologist 2 (TUEVALID). |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUMETHOD | TUEVAL | TUEVALID | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX44444 | TU | 90004 | 1 | R1-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | LIVER |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX44444 | TU | 90004 | 2 | R1-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | KIDNEY, UPPER LOBE | LEFT | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX44444 | TU | 90004 | 3 | R1-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL INC. | ABDOMINAL CAVITY |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX44444 | TU | 90004 | 4 | R2-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | KIDNEY, UPPER LOBE | LEFT | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX44444 | TU | 90004 | 5 | R2-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | LIVER |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 6 | EX44444 | TU | 90004 | 6 | R2-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL INC. | ABDOMINAL CAVITY |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | |
|
The following supptu.xpt table shows the textual data on the location detail (QNAM = "TULOCDTL").
Dataset wrap |
---|
|
Rowcaps |
---|
Row 1: | Shows that the target lesion in the liver with TUSEQ = "1" is located in segment 5 of the liver as described by radiologist 1. | Row 2: | Shows that the non-target lesion in the abdominal cavity with TUSEQ = "3" is located in the back of the abdomen as described by radiologist 1. | Row 3: | Shows that the target lesion in the liver with TUSEQ = "5" is located in the lower part of segment 5 as described by radiologist 2. |
|
Dataset2 |
---|
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX44444 | TU | 90004 | TUSEQ | 1 | TULOCDTL | Location Detail | Segment 5 | CRF | 2 | EX44444 | TU | 90004 | TUSEQ | 3 | TULOCDTL | Location Detail | Back of the abdomen | CRF | 3 | EX44444 | TU | 90004 | TUSEQ | 5 | TULOCDTL | Location Detail | Lower part of Segment 5 | CRF |
|
|
4.4.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (i.e., radiologist 1, radiologist 2) for the same timepoint. It is not expected that TUACPTFL would be populated by the sponsor; this type of record selection or censoring would be part of the analysis dataset.
...
Dataset wrap |
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|
Rowcaps |
---|
Rows 1-32: | Show that 2 radiologists independently reviewed the scans. TRLNKGRP = "R1-A2", "R1-A3" indicate assessments by radiologist 1, which are linked to the results determined by that radiologist in RS. Likewise, the values "R2-A2" and "R2-A3" indicate assessments by radiologist 2, which are linked to the results determined by that radiologist 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
...
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Rows 1-2: | Show the target response (RSTESTCD = "TRGRESP") and overall response (RSTESTCD = "OVRLRESP") of CR (Complete Response) at week 8. The subject has 1 target lesion and no non-targets. The non-target response (RSTESTCD = "NTRGRESP") is not applicable; a record may be included to represent this, if desired. | Rows 3-4: | Show an unscheduled response assessment at week 13, which was done to confirm the complete response ("CR"). The RSLNKGRP differentiates the assessment and VISIT = "UNSCHEDULED WEEK 13". | Rows 5-6: | Show that target response (RSTESTCD = "TRGRESP") and overall response (RSTESTCD = "OVRLRESP") were not evaluable (RSSTRESC = "NE") due to an unreadable image. |
|
Dataset2 |
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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 | |
|
The following supprs.xpt table shows the data on the reason that the response was not evaluable (QNAM = "RSREASNE") in the case where it is collected.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX55555 | RS | 90005 | RSSEQ | 6 | RSREASNE | Reason Response Not Evaluable | Imaging Quality Issues | CRF |
|
|
4.5.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject who has only target tumors at screening. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain.
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Rowcaps |
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Row 1: | Shows that the subject has at least 1 target tumor (TUTESTCD = "TIND"), i.e., the subject has measurable disease. Prior to SDTMIG 3.4, this row would not be included. However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU. | Row 2: | Shows that the subject does not have any non-target tumors (TUTESTCD = "NTIND"). Prior to SDTMIG 3.4, this row would not be included. However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU. | Row 3: | Shows the single target lesion in the breast. The subject has 1 target lesion and no non-targets. | Row 4: | Shows new bone lesion identified at week 24. |
|
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX55555 | TU | 90005 | 1 |
| TIND | Target Indicator | Y | Y |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX55555 | TU | 90005 | 2 |
| NTIND | Non-Target Indicator | N | N |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX55555 | TU | 90005 | 3 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | BREAST | RIGHT | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX55555 | TU | 90005 | 4 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | BONE |
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | |
|
4.5.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows investigator tumor results for a subject who has only target tumors at screening. This example includes an unscheduled assessment and an unreadable image.
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Rows 1-14: | Show the longest diameter and sum of longest diameter for the target lesion. The subject has 1 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 15: | 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 |
| SUMDIAM | Sum of 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 |
| SUMDIAM | Sum of 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 |
| SUMDIAM | Sum of 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 | 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 | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 11 | EX55555 | TR | 90005 | 11 | TARGET | A4 |
| SUMDIAM | Sum of Diameter |
|
|
|
|
| NOT DONE | MISSING DIAMETERS |
| 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 |
| SUMDIAM | Sum of 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 |
|
|
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
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Dataset2 |
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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
...
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Rows 1-6: | Show response assessments at cycle 2 and cycle 3 from the investigator following RECIST 1.1. | Rows 7-8: | Show response assessments at cycle 2 and cycle 3 from the independent radiologist using protocol specified response criteria based on volumetric measurements (RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA"). |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | RSACPTFL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX66666 | RS | 90006 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
|
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 2 | EX66666 | RS | 90006 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR |
|
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 3 | EX66666 | RS | 90006 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
|
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 4 | EX66666 | RS | 90006 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 5 | EX66666 | RS | 90006 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 6 | EX66666 | RS | 90006 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD |
| INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 7 | EX66666 | RS | 90006 | 7 | R1-A2 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | SD | SD | ACME VENDOR | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 8 | EX66666 | RS | 90006 | 8 | R1-A3 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | PD | PD | ACME VENDOR | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
|
4.6.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows investigator and independent radiologist's tumor identification, and includes the identification of a new tumor; the investigator only identified the new tumor, and the independent assessor identified and measured it. The tumor identifier is in TULNKID and matches TRLNKID in the TR domain.
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Rows 1-5: | Show the identification of 3 target lesions (T01, T02, T03), and 2 non-target lesions (NT01, NT02) by the investigator. | Rows 6-7: | Show the identification of 2 target lesions (R-T01, R-T02) by the independent radiologist. | Row 8: | Shows the identification of a new tumor by the investigator (NEW01). | Row 9: | Shows the identification of a new tumor by the independent radiologist (R-NEW01). |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUDIR | TUMETHOD | TUEVAL | TUEVALID | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX66666 | TU | 90006 | 1 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| OCCIPITAL LOBE | LEFT | ANTERIOR | MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX66666 | TU | 90006 | 2 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| OCCIPITAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX66666 | TU | 90006 | 3 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| TEMPORAL LOBE | LEFT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX66666 | TU | 90006 | 4 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| FRONTAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX66666 | TU | 90006 | 5 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| CEREBELLUM | LEFT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX66666 | TU | 90006 | 6 | R1-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | OCCIPITAL LOBE | RIGHT | ANTERIOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX66666 | TU | 90006 | 7 | R1-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | TEMPORAL LOBE | LEFT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 8 | EX66666 | TU | 90006 | 8 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW |
| FRONTAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 9 | EX66666 | TU | 90006 | 9 | R1-NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | ACME VENDOR | FRONTAL LOBE | RIGHT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
|
4.6.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows both investigator and independent radiologist tumor results. The independent radiologist's tumor results are based on bidimensional and volumetric measurements. This example also includes the situation where new tumors are measured by the independent radiologist.
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Rows 1-6, 18-23, 38-39: | Show longest diameter, sum of longest diameter, and tumor state for investigator assessments at screening, cycle 2, and cycle 3. | Rows 7-17, 24-37, 40-44: | Show the volumetric measurements at screening, cycle 2, and cycle 3 from the independent radiologist. |
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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 |
| SUMDIAM | Sum of 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 | uL | 250 | 250 | uL | 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 | uL | 350 | 350 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 15 | EX66666 | TR | 90006 | 15 | TARGET | R1-A1 |
| SUMDIAM | Sum of 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 | uL | 600 | 600 | uL | 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 |
| SUMDIAM | Sum of 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 | uL | 420 | 420 | uL | 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 | uL | 315 | 315 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 32 | EX66666 | TR | 90006 | 32 | TARGET | R1-A2 |
| SUMDIAM | Sum of 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 | uL | 735 | 735 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 35 | EX66666 | TR | 90006 | 35 | TARGET | R1-A2 |
| PCBSD | Percent Change From Baseline in Sum of 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 | uL | 270 | 270 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 |
|
|
4.7 Example 7: Subject with Non-target Disease Only
...
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Rows 1-3: | Show the week 6 response assessment for a subject with non-target disease only. 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 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". Note that "NE" is a valid Overall Response value per the RECIST 1.1 criteria; 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 progressive disease, which results in an Overall Response (RSTESTCD = "OVRLRESP") of "PD". |
|
Dataset2 |
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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 |
|
| |
|
The following supprs.xpt table shows the data on the reason that the response was not evaluable (QNAM = "RSREASNE") in the case where the reason is collected.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX77777 | RS | 90005 | RSSEQ | 5 | RSREASNE | Reason Response Not Evaluable | Imaging Quality Issues | CRF |
|
|
4.7.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject who has only non-target tumors at screening.
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Rowcaps |
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Row 1: | Shows that the subject has no target tumors (TUTESTCD = "TIND"). | Row 2: | Shows that the subject has non-target tumors (TUTESTCD = "NTIND"). | 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 |
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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 | |
|
The following supptu.xpt table shows the data describing the disease presentation of non-target tumors. The tumor presentation type (QNAM = "TUPRTYP") supplemental qualifier is used and controlled terminology is available (DSPRTYP). In addition, this example shows the plane of measurement and the slice number where the lesions was identified.
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Row 1: | Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis; for the non-target site in the brain (TULNKID = "NT01"), QVAL = "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; for the non-target site in the pericardium (TULNKID = "NT03"), QVAL = "EFFUSION". |
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Dataset2 |
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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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4.7.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject with assessments of non-target tumors only at screening, week 6, week 12, and subsequent 8-week follow-up visits.
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Rows 1-6: | Show the qualitative assessments of the tumor state of the 3 non-target lesions (NT01, NT02, NT03) at screening and week 6. | Rows 7-9: | Show the week 12 assessments. Row 7 shows the assessment of non-target lesion NT01 in the brain; rows 8 and 9 indicate that assessments of 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"). | Rows 10-11: | Show that at the week 20 assessment, NT01 and NT02 were enlarged from a previous smallest size (i.e., TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). |
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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 | 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 | |
|
The following supptr.xpt table shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX77777 | TR | 90007 | TRSEQ | 8 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Scan blurry | CRF | 2 | EX77777 | TR | 90007 | TRSEQ | 9 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Scan blurry | CRF |
|
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4.7.4 PR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for 1 subject collected at screening, week 6, week 12, and subsequent 8-week follow-up visits. The example shows an MRI of the head and chest (PRTRT = "MRI" and PRLOC = "MULTIPLE") at each disease assessment timepoint. Per protocol, non-target lesions in the brain were assessed using MRI as the primary method of assessment. Correlative imaging is used in addition to the primary method for the RECIST 1.1 evaluation in order to assess brain lesions. The primary method of assessment (i.e., MRI) in represented in the TU and TR domains, along with assessment results. Correlative imaging (e.g., CT scan) is represented only in the PR domain. The image identifier is in PRREFID.
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Rowcaps |
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Rows 1-2: | Show the scans performed 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 performed at the disease assessments at weeks 6, 12, and 20. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRPRESP | PROCCUR | PRLOC | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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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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The following supppr.xpt table shows the data to represent the multiple locations covered by the MRI. The anatomical location supplemental qualifiers (QNAM = "PRLOC1", "PRLOC2") are used and controlled terminology is available (LOC).
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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 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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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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4.8 Example 8: Bone Scans Not Required at Each Disease Assessment
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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 complete response. Therefore, the non-target response (RSTESTCD = "NTRGRESP") is not evaluable (RSSTRESC = "NE") because scintigraphy of the bone was not performed at this visit (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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4.8.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 subject collected at screening, including the identification of a target tumor (R-T01) in the liver and the assessment of 2 non-target tumors (R-NT01, R-NT02) in the bone and pleural cavity, respectively, at screening.
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TUMETHOD | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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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 | |
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The following supptu.xpt table shows the data describing the disease presentation of a non-target tumor. The tumor presentation type supplemental qualifier (QNAM = "TUPRTYP") is used and controlled terminology is available (DSPRTYP). The presentation of the disease in the pleural cavity is effusion; for the non-target site in the pleural cavity (TULOC = "PLEURAL CAVITY" and TULNKID = "NT02"), QVAL = "EFFUSION".
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX88888 | TU | 900080 | TUSEQ | 3 | TUPRTYP | Tumor or Lesion Presentation Type | EFFUSION | CRF |
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4.8.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at screening, week 12, and week 24. This example also shows that the tumor state for the non-target in the pleural cavity is an assessment of the pleural effusion. Scintigraphy of the bone was not required at every disease assessment per protocol. The image identifier is in TRREFID.
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Rows 1-4: | Show the measurements of the target tumor (R-T01) in the liver and the assessments of the 2 non-target lesions (R-NT01, R-NT02) in the bone and pleural cavity at screening. | Rows 5-11: | Show the measurement of the target tumor (R-T01) and the tumor state of 1 non-target tumor (R-NT02) in the pleural cavity at week 12. Per protocol, scintigraphy was only to be performed every 6 months or in order to verify a complete response; therefore, scintigraphy of non-target R-NT01 in the bone was not performed at week 12 (TRSTAT = "NOT DONE" and TRREASND = "SCAN NOT PERFORMED"). | Rows 12-18: | Show that, at week 24, the target lesion (R-T01) was absent (i.e., DIAMETER = "0"); non-targets R-NT01 and R-NT02 also were absent (TRTESTCD = "TUMSTATE" with TRORRES = "ABSENT"). 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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4.8.4 PR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for 1 subject collected at screening, week 12, and week 24. Per protocol, non-target lesions in the bone were assessed using scintigraphy as the primary method of assessment. Correlative imaging was used in addition to the primary method for the RECIST 1.1 evaluation in order to more closely assess bone lesion(s). The primary method of assessment (i.e., scintigraphy) is represented in TU and TR domains along with assessment results. Correlative imaging (e.g., MRI of the femur) is represented only in the PR domain. Scintigraphy and correlative imaging were not required at every disease assessment per protocol. However, often correlative imaging is performed at every disease assessment timepoint because the same scans cover lesions that are assessed at every disease assessment timepoint. The image identifier is in PRREFID.
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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 ; 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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The following supppr.xpt table shows the data to represent the multiple locations covered by the CT SCAN. The anatomical location supplemental qualifiers (QNAM = "PRLOC1" and QNAM = "PRLOC2") are used and controlled terminology is available (LOC).
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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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4.9 Example 9: No Evidence of Disease at Baseline
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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 | 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 | |
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4.10 Example 10: Enlargement from Nadir of a Single Non-target
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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 assessment of the non-target lesions/tumors taken collectively. In this case, 1 of the non-targets is absent and 1 of the non-targets has enlarged from nadir. The overall response is PR (Partial Response). | Rows 4-6: | Show the target response, non-target response, and overall response at week 24. The target response of CR (Complete Response) is based on the PCBSD of -100%. The non-target response of SD (Stable Disease) is based on assessment of the non-target lesions/tumors taken collectively. In this case, 1 of the non-targets is absent and 1 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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4.10.2 TU Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for 1 subject with target and non-target tumors identified at screening. The subject has 1 target lesion (TULNKID = "R-T01") and 2 non-target lesions/sites (R-NT01, R-NT02) identified at screening. T01 and R-NT01 are located in the liver, and R-NT02 is located in the chest wall.
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TUMETHOD | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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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 | |
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4.10.3 TR Domain Model
The following table shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows the data for 1 subject collected at the screening, week 12, and subsequent 12-week follow-up visits.
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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/sites R-NT01 and R-NT02 in the liver and chest wall at screening. | Rows 5-11: | Show the measurement of the target tumor and the tumor states of the non-targets at week 12. R-T01 shows a decrease from 17mm at baseline to 7mm, which is a 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 the non-targets at week 24. R-T01 is absent (LDIAM = "0"), which is a 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 | |
|
...
Dataset wrap |
---|
|
Rowcaps |
---|
Rows 1-6: | Show the screening identification of the target and non-target lesions. For lymph node target lesions R-T01 and RT02 the TRTESTCD used for the assessments are "LPREP" and "LNSTATE". For non-lymph node target lesions R-T03 and R-T04, TRTESTCD = "LDIAM". | Rows 7-8: | Show the results for the target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs are sum of diameter (TRTESTCD = "SUMDIAM") and sum diameters of non-lymph node tumors (TRTESTCD = "SUMNLNLD"). | Rows 9-10: | Show the results for the non-targets: R-NT01 is a lymph node where the TRTEST used for the assessments is lymph node state (TRTESTCD = "LNSTATE"); R-NT02 is a non-lymph node where the TRTESTCD used for the assessments is tumor state. | Row 16: | Shows a case where TRSTAT = "NOT DONE". TRREASND contains the reason for this result; for TRTEST = "Longest Diameter", the scan was not performed. | Rows 17-21: | Show the week 6 results for the target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". Within row 20, the PCBSD could not be calculated because R-T04 was not measured. TRSTAT = "NOT DONE" and TRREASND contains the reason (in this case, at least 1 target lesion was not measured). | Rows 22-23: | Show that, at week 6, R-NT02 was not evaluable, while providing results for R-NT01 using TRTESTCD as TUMSTATE. | Rows 30-34: | Show the week 12 results for the target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". | Row 70: | Shows the sum diameters of non-lymph node tumors (TRTESTCD = "SUMNLNLD") is "0". This means that the non-lymph node target tumors are all absent. |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TRNAM | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
---|
1 | EX11111 | TR | 90011 | 1 | TARGET | IMG-00001 | R-A1 | R-T01 | LPERP | Longest Perpendicular | 17 | mm | 17 | 17 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TR | 90011 | 2 | TARGET | IMG-00001 | R-A1 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX11111 | TR | 90011 | 3 | TARGET | IMG-00002 | R-A1 | R-T02 | LPERP | Longest Perpendicular | 16 | mm | 16 | 16 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 4 | EX11111 | TR | 90011 | 4 | TARGET | IMG-00002 | R-A1 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX11111 | TR | 90011 | 5 | TARGET | IMG-00001 | R-A1 | R-T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 6 | EX11111 | TR | 90011 | 6 | TARGET | IMG-00003 | R-A1 | R-T04 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 7 | EX11111 | TR | 90011 | 7 | TARGET |
| R-A1 |
| SUMDIAM | Sum of Diameter | 62 | mm | 62 | 62 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
|
| 8 | EX11111 | TR | 90011 | 8 | TARGET |
| R-A1 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 29 | mm | 29 | 29 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
|
| 9 | EX11111 | TR | 90011 | 9 | NON-TARGET | IMG-00002 | R-A1 | R-NT01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 10 | EX11111 | TR | 90011 | 10 | NON-TARGET | IMG-00001 | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 11 | EX11111 | TR | 90011 | 11 | TARGET | IMG-00004 | R-A2 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 12 | EX11111 | TR | 90011 | 12 | TARGET | IMG-00004 | R-A2 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 13 | EX11111 | TR | 90011 | 13 | TARGET | IMG-00005 | R-A2 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 14 | EX11111 | TR | 90011 | 14 | TARGET | IMG-00005 | R-A2 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 15 | EX11111 | TR | 90011 | 15 | TARGET | IMG-00004 | R-A2 | R-T03 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 16 | EX11111 | TR | 90011 | 16 | TARGET |
| R-A2 | R-T04 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 17 | EX11111 | TR | 90011 | 17 | TARGET |
| R-A2 |
| SUMDIAM | Sum of Diameter | 52 | mm | 52 | 52 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 18 | EX11111 | TR | 90011 | 18 | TARGET |
| R-A2 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 28 | mm | 28 | 28 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 19 | EX11111 | TR | 90011 | 19 | TARGET |
| R-R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 20 | EX11111 | TR | 90011 | 20 | TARGET |
| R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter |
|
|
|
|
| NOT DONE | At least one target lesions was not measured |
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 21 | EX11111 | TR | 90011 | 21 | TARGET |
| R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -16 | % | -16 | -16 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 22 | EX11111 | TR | 90011 | 22 | NON-TARGET | IMG-00005 | R-A2 | R-NT01 | LNSTATE | Lymph Node State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 23 | EX11111 | TR | 90011 | 23 | NON-TARGET | IMG-00004 | R-A2 | R-NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 24 | EX11111 | TR | 90011 | 24 | TARGET | IMG-00007 | R-A3 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 25 | EX11111 | TR | 90011 | 25 | TARGET | IMG-00007 | R-A3 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 26 | EX11111 | TR | 90011 | 26 | TARGET | IMG-00008 | R-A3 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 27 | EX11111 | TR | 90011 | 27 | TARGET | IMG-00008 | R-A3 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 28 | EX11111 | TR | 90011 | 28 | TARGET | IMG-00007 | R-A3 | R-T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 29 | EX11111 | TR | 90011 | 29 | TARGET | IMG-00009 | R-A3 | R-T04 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 30 | EX11111 | TR | 90011 | 30 | TARGET |
| R-A3 |
| SUMDIAM | Sum of Diameter | 47 | mm | 47 | 47 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 31 | EX11111 | TR | 90011 | 31 | TARGET |
| R-A3 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 23 | mm | 23 | 23 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 32 | EX11111 | TR | 90011 | 32 | TARGET |
| R-R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -5 | mm | -5 | -5 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 33 | EX11111 | TR | 90011 | 33 | TARGET |
| R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -24 | % | -24 | -24 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 34 | EX11111 | TR | 90011 | 34 | TARGET |
| R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -9 | % | -9 | -9 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 35 | EX11111 | TR | 90011 | 35 | NON-TARGET | IMG-00008 | R-A3 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 36 | EX11111 | TR | 90011 | 36 | NON-TARGET | IMG-00007 | R-A3 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 37 | EX11111 | TR | 90011 | 37 | TARGET | IMG-00010 | R-A4 | R-T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 38 | EX11111 | TR | 90011 | 38 | TARGET | IMG-00010 | R-A4 | R-T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 39 | EX11111 | TR | 90011 | 39 | TARGET | IMG-00011 | R-A4 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 40 | EX11111 | TR | 90011 | 40 | TARGET | IMG-00011 | R-A4 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 41 | EX11111 | TR | 90011 | 41 | TARGET | IMG-00010 | R-A4 | R-T03 | LDIAM | Longest Diameter | 11 | mm | 11 | 11 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 42 | EX11111 | TR | 90011 | 42 | TARGET | IMG-00012 | R-A4 | R-T04 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 43 | EX11111 | TR | 90011 | 43 | TARGET |
| R-A4 |
| SUMDIAM | Sum of Diameter | 37 | mm | 37 | 37 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 44 | EX11111 | TR | 90011 | 44 | TARGET |
| R-A4 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 16 | mm | 16 | 16 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 45 | EX11111 | TR | 90011 | 45 | TARGET |
| R-A4 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 46 | EX11111 | TR | 90011 | 46 | TARGET |
| R-A4 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -40 | % | -40 | -40 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 47 | EX11111 | TR | 90011 | 47 | TARGET |
| R-A4 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -21 | % | -21 | -21 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 48 | EX11111 | TR | 90011 | 48 | NON-TARGET | IMG-00011 | R-A4 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 49 | EX11111 | TR | 90011 | 49 | NON-TARGET | IMG-00010 | R-A4 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 50 | EX11111 | TR | 90011 | 50 | TARGET | IMG-00013 | R-A5 | R-T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 51 | EX11111 | TR | 90011 | 51 | TARGET | IMG-00013 | R-A5 | R-T01 | LPERP | Longest Perpendicular | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 52 | EX11111 | TR | 90011 | 52 | TARGET | IMG-00014 | R-A5 | R-T02 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 53 | EX11111 | TR | 90011 | 53 | TARGET | IMG-00014 | R-A5 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 54 | EX11111 | TR | 90011 | 54 | TARGET | IMG-00013 | R-A5 | R-T03 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 55 | EX11111 | TR | 90011 | 55 | TARGET | IMG-00015 | R-A5 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 56 | EX11111 | TR | 90011 | 56 | TARGET |
| R-A5 |
| SUMDIAM | Sum of Diameter | 23 | mm | 23 | 23 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 57 | EX11111 | TR | 90011 | 57 | TARGET |
| R-A5 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 6 | mm | 6 | 6 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 58 | EX11111 | TR | 90011 | 58 | TARGET |
| R-A5 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -14 | mm | -14 | -14 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 59 | EX11111 | TR | 90011 | 59 | TARGET |
| R-A5 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -62 | % | -62 | -62 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 60 | EX11111 | TR | 90011 | 60 | TARGET |
| R-A5 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -37 | % | -37 | -37 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 61 | EX11111 | TR | 90011 | 61 | NON-TARGET | IMG-00014 | R-A5 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 62 | EX11111 | TR | 90011 | 62 | NON-TARGET | IMG-00013 | R-A5 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 63 | EX11111 | TR | 90011 | 63 | TARGET | IMG-00016 | R-A6 | R-T01 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 64 | EX11111 | TR | 90011 | 64 | TARGET | IMG-00016 | R-A6 | R-T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 65 | EX11111 | TR | 90011 | 65 | TARGET | IMG-00017 | R-A6 | R-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 66 | EX11111 | TR | 90011 | 66 | TARGET | IMG-00017 | R-A6 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 67 | EX11111 | TR | 90011 | 67 | TARGET | IMG-00016 | R-A6 | R-T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 68 | EX11111 | TR | 90011 | 68 | TARGET | IMG-00018 | R-A6 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 69 | EX11111 | TR | 90011 | 69 | TARGET |
| R-A6 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 70 | EX11111 | TR | 90011 | 70 | TARGET |
| R-A6 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 0 | mm | 0 | 0 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 71 | EX11111 | TR | 90011 | 71 | TARGET |
| R-A6 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -6 | mm | -6 | -6 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 72 | EX11111 | TR | 90011 | 72 | TARGET |
| R-A6 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -72 | % | -72 | -72 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 73 | EX11111 | TR | 90011 | 73 | TARGET |
| R-A6 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -26 | % | -26 | -26 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 74 | EX11111 | TR | 90011 | 74 | NON-TARGET | IMG-00017 | R-A6 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 75 | EX11111 | TR | 90011 | 75 | NON-TARGET | IMG-00016 | R-A6 | R-NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 76 | EX11111 | TR | 90011 | 76 | NEW | IMG-00017 | R-A6 | R-NEW01 | TUMSTATE | Tumor State | EQUIVOCAL |
| EQUIVOCAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 77 | EX11111 | TR | 90011 | 77 | TARGET | IMG-00019 | R-A7 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 78 | EX11111 | TR | 90011 | 78 | TARGET | IMG-00019 | R-A7 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 79 | EX11111 | TR | 90011 | 79 | TARGET | IMG-00020 | R-A7 | R-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 80 | EX11111 | TR | 90011 | 80 | TARGET | IMG-00020 | R-A7 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 81 | EX11111 | TR | 90011 | 81 | TARGET | IMG-00019 | R-A7 | R-T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 82 | EX11111 | TR | 90011 | 82 | TARGET | IMG-00021 | R-A7 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 83 | EX11111 | TR | 90011 | 83 | TARGET |
| R-A7 |
| SUMDIAM | Sum of Diameter | 21 | mm | 21 | 21 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 84 | EX11111 | TR | 90011 | 84 | TARGET |
| R-A7 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 0 | mm | 0 | 0 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 85 | EX11111 | TR | 90011 | 85 | TARGET |
| R-A7 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | 4 | mm | 4 | 4 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 86 | EX11111 | TR | 90011 | 86 | TARGET |
| R-A7 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -66 | % | -66 | -66 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 87 | EX11111 | TR | 90011 | 87 | TARGET |
| R-A7 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | 23 | % | 23 | 23 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 88 | EX11111 | TR | 90011 | 88 | NON-TARGET | IMG-00020 | R-A7 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 89 | EX11111 | TR | 90011 | 89 | NON-TARGET | IMG-00019 | R-A7 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 90 | EX11111 | TR | 90011 | 90 | NEW | IMG-00020 | R-A7 | R-NEW01 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 91 | EX11111 | TR | 90011 | 91 | NEW | IMG-00020 | R-A7 | R-NEW01 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 92 | EX11111 | TR | 90011 | 92 | NEW | IMG-00019 | R-A7 | R-NEW02 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 93 | EX11111 | TR | 90011 | 93 | NEW | IMG-00019 | R-A7 | R-NEW02 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 94 | EX11111 | TR | 90011 | 94 | NEW | IMG-00022 | R-A7 | R-NEW03 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| ULTRASOUND | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
|
...