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"NE" (Not Evaluable) is a standard result in the Oncology Response Assessment Result codelist (ONCRSR) which is applicable to RECIST 1.1. Therefore, in RS, "NE" (Not Evaluable) is a valid RSORRES/RSSTRESC for RSTEST = "Overall Response". For RS, a suppqual for "Reason Response Not Evaluable" (RSREASNEREASNE) has been used in some examples. However, in TR, the current modeling for NE (not evaluable) results follows the approach where TRSTAT is populated with "NOT DONE". TRSTAT = "NOT DONE" means that the result was missing and the reason that the result was missing is mapped to TRREASND. The TRREASND values cover reasons such as scan was not performed or the various reason that the tumor was not evaluable. This modelling does not always explicitly or consistently identify the tumors which are not evaluable but some of the examples include "NOT EVALUABLE" in the TRREASND.
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The supprs.xpt table below shows the data on the reason that the response was not evaluable (QNAM = "RSREASNEREASNE") in the case where the reason is collected.
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Row 1: Show that the QVAL for Reason Response Not Evaluable (QNAM = "RSREASNEREASNE"). |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX11111 | RS | 90001 | RSSEQ | 3 | RSREASNEREASNE | Reason Response Not Evaluable | Imaging quality issues and not all scan performed | CRF |
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The supptu.xpt table below shows the data on whether a tumor was previously irradiated (QNAM = "TUPRVIRPRVIR") and whether that tumor was shown to be progressing since it was irradiated (QNAM = "TUPRVIRPPRVIRP").
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Rows 1-3: Show that the target lesions with TUSEQs equal to "1", "2" and "3" where 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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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX11111 | TU | 90001 | TUSEQ | 1 | TUPRVIRPRVIR | Previously Irradiated Indicator | N | CRF | | 2 | EX11111 | TU | 90001 | TUSEQ | 2 | TUPRVIRPRVIR | Previously Irradiated Indicator | N | CRF | | 3 | EX11111 | TU | 90001 | TUSEQ | 3 | TUPRVIRPRVIR | Previously Irradiated Indicator | N | CRF | | 4 | EX11111 | TU | 90001 | TUSEQ | 4 | TUPRVIRPRVIR | Previously Irradiated Indicator | Y | CRF | | 5 | EX11111 | TU | 90001 | TUSEQ | 4 | TUPRVIRPPRVIRP | Previously Irradiated Progression | Y | CRF |
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The supprs.xpt table below shows the data on the reason that the response was Not Evaluable (NE) (QNAM = "RSREASNEREASNE") in the case where it is collected.
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Row 1: Show that the QVAL for Reason Response Not Evaluable (QNAM = "RSREASNEREASNE"). |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX33333 | RS | 90005 | RSSEQ | 12 | RSREASNEREASNE | Reason Response Not Evaluable | Scans of target and non-target tumors were not performed | CRF |
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The supptu.xpt table below shows the textual data on the location detail (QNAM = "TULOCDTLLOCDTL").
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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. |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX44444 | TU | 90004 | TUSEQ | 1 | TULOCDTLLOCDTL | Location Detail | Segment 5 | CRF | | 2 | EX44444 | TU | 90004 | TUSEQ | 3 | TULOCDTLLOCDTL | Location Detail | Back of the abdomen | CRF | | 3 | EX44444 | TU | 90004 | TUSEQ | 5 | TULOCDTLLOCDTL | Location Detail | Lower part of Segment 5 | CRF |
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The supprs.xpt table below shows the data on the reason that the response was Not Evaluable (NE) (QNAM = "RSREASNEREASNE") in the case where it is collected.
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Row 1: Shows that the QVAL for RSSEQ = "6" for Reason Response Not Evaluable (QNAM = "RSREASNEREASNE"). |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX55555 | RS | 90005 | RSSEQ | 6 | RSREASNEREASNE | Reason Response Not Evaluable | Imaging Quality Issues | CRF |
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The supprs.xpt table below shows the data on the reason that the response was Not Evaluable (NE) (QNAM = "RSREASNEREASNE") in the case where the reason is collected.
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Row 1: Shows that the QVAL for RSSEQ = "5" for Reason Response Not Evaluable (QNAM = "RSREASNEREASNE"). |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX77777 | RS | 90005 | RSSEQ | 5 | RSREASNEREASNE | Reason Response Not Evaluable | Imaging Quality Issues | CRF |
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Row 1: Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e., for the non-target site in the brain (TULNKID = "NT01"), the QVAL is "LEPTOMENINGEAL DISEASE". Rows 2-3: Show the plane of measurement (QNAM = "TUPLOMSR") and the slice number (QNAM = "TUSLNUMSLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified. Rows 4-5: Show the plane of measurement (QNAM = "TUPLOMSR") and the slice number (QNAM = "TUSLNUMSLNUM") where the skeletal muscle tissue non-target lesion (TULNKID = "NT02") was identified.
Row 6: Shows that the presentation of the disease in the pericardium is effusion, i.e., for the non-target site in the pericardium (TULNKID = "NT03"), the QVAL is "EFFUSION". |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX77777 | TU | 90007 | TUSEQ | 3 | TUPRTYP | Tumor Presentation Type | LEPTOMENINGEAL DISEASE | CRF | | 2 | EX77777 | TU | 90007 | TUSEQ | 3 | TUPLOMSR | Plane of Measurement | SAGITTAL | CRF | | 3 | EX77777 | TU | 90007 | TUSEQ | 3 | TUSLNUMSLNUM | Slice Number | 55 | CRF | | 4 | EX77777 | TU | 90007 | TUSEQ | 4 | TUPLOMSR | Plane of Measurement | SAGITTAL | CRF | | 5 | EX77777 | TU | 90007 | TUSEQ | 4 | TUSLNUMSLNUM | Slice Number | 88-91 | CRF | | 6 | EX77777 | TU | 90007 | TUSEQ | 4 | TUPRTYP | Tumor Presentation Type | EFFUSION | CRF |
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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 = "PRSLTHKSLTHK") 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 = "PRSLTHKSLTHK") 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 = "PRSLTHKSLTHK") 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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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC1LOC1 | Anatomical Location of Procedure 1 | HEAD | CRF | | 2 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC2LOC2 | Anatomical Location of Procedure 2 | CHEST | CRF | | 3 | EX77777 | PR | 90007 | PRSEQ | 1 | PRSLTHKSLTHK | Slice Thickness | 5 mm | CRF | | 4 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC1LOC1 | Anatomical Location of Procedure 1 | HEAD | CRF | | 5 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC2LOC2 | Anatomical Location of Procedure 2 | CHEST | CRF | | 6 | EX77777 | PR | 90007 | PRSEQ | 3 | PRSLTHKSLTHK | Slice Thickness | 5 mm | CRF | | 7 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC1LOC1 | Anatomical Location of Procedure 1 | HEAD | CRF | | 8 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC2LOC2 | Anatomical Location of Procedure 2 | CHEST | CRF | | 9 | EX77777 | PR | 90007 | PRSEQ | 5 | PRSLTHKSLTHK | 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 | PRLOC1LOC1 | Anatomical Location of Procedure 1 | HEAD | CRF | | 12 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC2LOC2 | Anatomical Location of Procedure 2 | CHEST | CRF | | 13 | EX77777 | PR | 90007 | PRSEQ | 7 | PRSLTHKSLTHK | Slice Thickness | 5 mm | CRF |
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4.8 Example 8: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. This example shows data from a breast cancer study in a metastatic setting.
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| QNAM | RDOMAIN | QLABEL | TYPE | CODELIST | ROLE |
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| RSREASNEREASNE | RS | Reason Response Not Evaluable | text | Free text from CRF | Non-Standard Record Qualifier | TUPRVIRPRVIR | TU | Previously Irradiated Indicator | text | NY | Non-Standard Record Qualifier | | TUPRVIRPPRVIRP | TU | Previously Irradiated Progression | text | NY | Non-Standard Record Qualifier | | TUPRTYP | TU | Tumor Presentation Type | text | DSPRTYP | Non-Standard Record Qualifier | | TULOCDTLLOCDTL | TU | Location Detail | text | Free text from CRF | Non-Standard Record Qualifier | | TUSLNUMSLNUM | TU | Slice Number | text | Free text from CRF | Non-Standard Record Qualifier | | TUPLOMSR | TU | Plane of Measurement | text | Free text from CRF | Non-Standard Record Qualifier | | PRLOC1 | PR | Anatomical Location of Procedure 11 | text | LOC | Non-Standard Record Qualifier | | PRLOC2 | PR | Anatomical Location of Procedure 2 | text | LOC | Non-Standard Record Qualifier | | PRSLTHKSLTHK | PR | Slice Thickness | text | Free text from CRF | Non-Standard Record Qualifier | | PROIQ | PR | Overall Image Quality | text | Free text from CRF | Non-Standard Record Qualifier |
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