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Row 1: Shows that the subject has no target tumors (TUTESTCD = "TIND"), i.e., the subject does not have measurable disease. Row 2: Shows that the subject has non-target tumors (TUTESTCD = "NTIND"). The subject has non-measurable only disease. Rows 3-5: Show the identification of 3 non-target lesions for a subject with non-target disease only. See below for details on on the Tumor Presentation Type tumor presentation type (QNAM = "TUPRTYPPRTYP") supplemental qualifier. |
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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 |
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| TIND | Target Indicator | N | N |
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| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 2 | EX77777 | TU | 90007 | 2 |
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| NTIND | Non-Target Indicator | Y | Y |
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| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 3 | EX77777 | TU | 90007 | 3 | IMG-00001 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | BRAIN | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 4 | EX77777 | TU | 90007 | 4 | IMG-00002 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | SKELETAL MUSCLE TISSUE | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | | 5 | EX77777 | TU | 90007 | 5 | IMG-00002 | NT03 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | PERICARDIUM | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | |
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The supptu.xpt table below shows the data to describe to describe the disease presentation of a non-target tumor, when needed. The Tumor Presentation Type tumor presentation type (QNAM = "TUPRTYPPRTYP") 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, when needed.
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Row 1: Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e., for the non-target site in the brain (TULNKID = "NT01"), the QVAL is "LEPTOMENINGEAL DISEASE". Rows 2-3: Show the anatomical plane of measurement (QNAM = "TUPLOMSRANTPLN") and the slice number (QNAM = "SLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified. Rows 4-5: Show the anatomical plane of measurement (QNAM = "TUPLOMSRANTPLN") and the slice number (QNAM = "SLNUM") 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 | TUPRTYPPRTYP | Tumor or Lesion Presentation Type | LEPTOMENINGEAL DISEASE | CRF | | 2 | EX77777 | TU | 90007 | TUSEQ | 3 | TUPLOMSRANTPLN | Anatomical Plane of Measurement | SAGITTAL | CRF | | 3 | EX77777 | TU | 90007 | TUSEQ | 3 | SLNUM | Slice Number | 55 | CRF | | 4 | EX77777 | TU | 90007 | TUSEQ | 4 | TUPLOMSRANTPLN | Anatomical Plane of Measurement | SAGITTAL | CRF | | 5 | EX77777 | TU | 90007 | TUSEQ | 4 | SLNUM | Slice Number | 88-91 | CRF | | 6 | EX77777 | TU | 90007 | TUSEQ | 4 | TUPRTYPPRTYP | Tumor or Lesion 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 = "LOC1" with QVAL = "HEAD" and QNAM = "LOC2" 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 = "LOC1" with QVAL = "HEAD" and QNAM = "LOC2" 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 = "LOC1" with QVAL = "HEAD" and QNAM = "LOC2" 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 = "PROIQOIQ") 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 | PROIQOIQ | 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 supptu.xpt table below shows the data to describe to describe the disease presentation of a non-target tumor, when needed. The Tumor Presentation Type tumor presentation type (QNAM = "TUPRTYPPRTYP") supplemental qualifier is used and controlled terminology is available (DSPRTYP).
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Row 1: Shows that the presentation of the disease in the pleural cavity is effusion, i.e., for the non-target site in the pleural cavity (TULOC = "PLEURAL CAVITY" and TULNKID = "NT02"), the QVAL is "EFFUSION". |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| 1 | EX88888 | TU | 900080 | TUSEQ | 3 | TUPRTYPPRTYP | Tumor or Lesion Presentation Type | EFFUSION | CRF |
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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 | | TUPRTYPPRTYP | TU | Tumor or Lesion 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 | | TUPLOMSRANTPLN | TU | Anatomical Plane of Measurement | text | Free text from CRF | Non-Standard Record Qualifier | | LOC1 | PR | Anatomical Location 1 | text | LOC | Non-Standard Record Qualifier | | LOC2 | PR | Anatomical Location 2 | text | LOC | Non-Standard Record Qualifier | | SLTHK | PR | Slice Thickness | text | Free text from CRF | Non-Standard Record Qualifier | | PROIQOIQ | PR | Overall Image Quality | text | Free text from CRF | Non-Standard Record Qualifier |
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