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The supppr.xpt table below shows the data to represent the multiple locations covered by the MRI. The Anatomical Location of Procedure 1 and Anatomical Location of Procedure 2 (QNAM = "PRLOC1LOC1" and QNAM = "PRLOC2LOC2") supplemental qualifiers 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 = "PRLOC1LOC1" with QVAL = "HEAD" and QNAM and QNAM = "PRLOC2LOC2" with QVAL = "CHEST". Row 3: Shows the slice thickness (QNAM = "SLTHK") 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 = "PRLOC1LOC1" with QVAL = "HEAD" and QNAM and QNAM = "PRLOC2LOC2" with QVAL = "CHEST". Row 6: Shows the slice thickness (QNAM = "SLTHK") 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 = "PRLOC1LOC1" with QVAL = "HEAD" and QNAM and QNAM = "PRLOC2LOC2" with QVAL = "CHEST". Row 9: Shows the slice thickness (QNAM = "SLTHK") 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 | LOC1 | Anatomical Location 1 | HEAD | CRF | | 2 | EX77777 | PR | 90007 | PRSEQ | 1 | LOC2 | Anatomical Location 2 | CHEST | CRF | | 3 | EX77777 | PR | 90007 | PRSEQ | 1 | SLTHK | Slice Thickness | 5 mm | CRF | | 4 | EX77777 | PR | 90007 | PRSEQ | 3 | LOC1 | Anatomical Location 1 | HEAD | CRF | | 5 | EX77777 | PR | 90007 | PRSEQ | 3 | LOC2 | Anatomical Location 2 | CHEST | CRF | | 6 | EX77777 | PR | 90007 | PRSEQ | 3 | SLTHK | Slice Thickness | 5 mm | CRF | | 7 | EX77777 | PR | 90007 | PRSEQ | 5 | LOC1 | Anatomical Location 1 | HEAD | CRF | | 8 | EX77777 | PR | 90007 | PRSEQ | 5 | LOC2 | Anatomical Location 2 | CHEST | CRF | | 9 | EX77777 | PR | 90007 | PRSEQ | 5 | SLTHK | 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 | LOC1 | Anatomical Location 1 | HEAD | CRF | | 12 | EX77777 | PR | 90007 | PRSEQ | 7 | LOC2 | Anatomical Location 2 | CHEST | CRF | | 13 | EX77777 | PR | 90007 | PRSEQ | 7 | SLTHK | Slice Thickness | 5 mm | CRF |
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The supppr.xpt table below shows the data to represent the multiple locations covered by the CT SCAN. The Anatomical Location of Procedure 1 and Anatomical Location of Procedure 2 (QNAM = "PRLOC1LOC1" and QNAM = "PRLOC2LOC2") supplemental qualifiers are used and controlled terminology is available (LOC).
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| Rowcaps |
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Rows 1-2: Show the 2 locations of the CT SCAN for PRSEQ = "1" where QNAM = "PRLOC1LOC1" with QVAL = "CHEST" and QNAM and QNAM = "PRLOC2LOC2" with QVAL = "ABDOMEN". Rows 3-6: Show the 2 locations of the CT SCAN for PRSEQ 4 and 7. |
| Dataset2 |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX88888 | PR | 90008 | PRSEQ | 1 | PRLOC1LOC1 | Anatomical Location of Procedure 1 | CHEST | eDC | | 2 | EX88888 | PR | 90008 | PRSEQ | 1 | PRLOC2LOC2 | Anatomical Location of Procedure 2 | ABDOMEN | eDC | | 3 | EX88888 | PR | 90008 | PRSEQ | 4 | PRLOC1LOC1 | Anatomical Location of Procedure 1 | CHEST | eDC | | 4 | EX88888 | PR | 90008 | PRSEQ | 4 | PRLOC2LOC2 | Anatomical Location of Procedure 2 | ABDOMEN | eDC | | 5 | EX88888 | PR | 90008 | PRSEQ | 7 | PRLOC1LOC1 | Anatomical Location of Procedure 1 | CHEST | eDC | | 6 | EX88888 | PR | 90008 | PRSEQ | 7 | PRLOC2LOC2 | Anatomical Location of Procedure 2 | ABDOMEN | eDC |
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4.9 Example 9: RECIST 1.1 example to show an assessment where independent radiologist found no evidence of disease at baseline.
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The following table contains additional standard name codes for use in the Supplement Qualifiers for SUPPRS, SUPPTU and SUPPPR datasets.
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| QNAM | RDOMAIN | QLABEL | TYPE | CODELIST | ROLE |
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| REASNE | RS | Reason Response Not Evaluable | text | Free text from CRF | Non-Standard Record Qualifier | PRVIR | TU | Previously Irradiated Indicator | text | NY | Non-Standard Record Qualifier | | PRVIRP | TU | Previously Irradiated Progression | text | NY | Non-Standard Record Qualifier | | TUPRTYP | TU | Tumor Presentation Type | text | DSPRTYP | Non-Standard Record Qualifier | | LOCDTL | TU | Location Detail | text | Free text from CRF | Non-Standard Record Qualifier | | SLNUM | 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| LOC1 | PR | Anatomical Location 1 | text | LOC | Non-Standard Record Qualifier |
PRLOC2| LOC2 | PR | Anatomical Location 2 | text | LOC | Non-Standard Record Qualifier | | SLTHK | 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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