Prior and Current Procedures
Subject 40912 had a previous peripheral artery bypass surgery that took place on 2005-12-16 because a lesion was identified in the left femoral-popliteal artery. The lesion was deemed severe and extensive and the subject was not a good candidate for percutaneous vascular intervention (PVI), hence a bypass graft surgery was performed. Note PRCAT is populated with Prior Intervention. This information is collected during the SCREEN visit on 2007-01-01 (PRDTC).
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRREFID | PRSEQ | PRTRT | PRLOC | PRLAT | PRCAT | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
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| 1 | TUDY01 | PR | 40912 | graft01 | 1 | Peripheral Artery Bypass Graft | Femoral-popliteal Artery | Left | Prior Intervention | 1 | SCREEN | 2007-01-01 | 2005-12-16T06:00 | 2005-12-16T09:00 |
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The findings about procedure dataset below shows several important parameters from the Prior Peripheral Artery Bypass Surgery:
- The native vessel on which the bypass graft was built - row 1.
- The type of the bypass graft (e.g. arterial, venous, synthetic, cadaveric) - row 2
- The locations where the two ends of the bypass vessel graft connect with the native vessel - rows 3-4.
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| Rowcaps |
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| Row 1: | Shows the graft vessel was built on the Left Femoral-popliteal Artery. |
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| Row 2: | Shows the bypass graft type was venous cadaveric graft, which is composed of a vein harvested from a cadaver. |
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| Rows 3-4: | Show the graft anastomoses (connections) to the Left Femoral-popliteal Artery were on the Left Common femoral Artery and Left Popliteal Artery. |
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Row | STUDYID | DOMAIN | USUBJID | FAREFID | FASEQ | FATEST | FAOBJ | FACAT | FAORRES | VISITNUM | VISIT | TUDTC |
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| 2 | TUDY01 | FA | 40912 | graft01 | 2 | Bypass Graft Type | Peripheral Artery Bypass Graft | Prior Intervention | Cadaveric Graft, Venous | 1 | SCREEN | 2007-01-01 |
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| 3 | TUDY01 | FA | 40912 | graft01 | 3 | Proximal Graft Anastomosis (connection) Location | Peripheral Artery Bypass Graft | Prior Intervention | Common femoral Artery | 1 | SCREEN | 2007-01-01 |
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| 4 | TUDY01 | FA | 40912 | graft01 | 4 | Distal Graft Anastomosis (connection) Location | Peripheral Artery Bypass Graft | Prior Intervention | Popliteal Artery | 1 | SCREEN | 2007-01-01 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRTRT | PRCAT | PRLOC | VISITNUM | VISIT | PRDTC | PRSTDTC | PRENDTC |
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| 1 | TUDY01 | PR | 40912 | 1 | CT PERIPHERAL ANGIOGRAPHY | DIAGNOSTIC | LOWER EXTREMITIES | 2 | VISIT 1 | 2007-02-07 | 2007-01-03T08:00 | 2007-01-03T09:00 |
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| TUDY01 | PR | 40912 | 2 | CT PERIPHERAL ANGIOGRAPHY | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
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| 2 | TUDY01 | PR | 40912 | 3 | Cardiac Catheterization | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
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| 3 | TUDY01 | PR | 40912 | 4 | Stent Implantation | PVI |
| 2 | VISIT 1 | 2007-02-07 | 2007-01-05T07:00 | 2007-01-05T09:00 |
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Lesion Type and Location Identification
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| title | Peripheral Artery Lesion CRF |
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| CDASH for Peripheral Arterial Lesion |
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| CDASH for Peripheral Arterial Lesion |
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The below data show Locations of the lesionslesion location identification from the diagnostic CT peripheral angiography procedure.
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| Row 1: | Shows one or more lesions have been identified in the lower limb region. |
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| Row 2: | Shows the location of the lesion in the native vessellesion 1 is identified in the left popliteal artery above the knee. |
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| Row 3: | Shows the location of the graft lesion 1 is located in the FEMORO-POPLITEAL ARTERY the femoro-popliteal artery graft. Note the use of the NSV --RLGFFG, Result location Location is graft flagGraft Flag. Note i I did map PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT to TU result LOCDTL because this variable is not controlled and the flag indicates that we are dealing with a graft location. |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TULOC | TUORRES | TUSTRESC | TU Result LOC | TU Result LAT | TURESLOC | TURESLAT | RLODTLTU Result LOCDTL | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
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| 1 | TUDY01 | TU | 40912 | 1 |
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| LESIONIND | Lesion Indicator | LOWER LIMB REGION | Y | Y |
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| CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 2 | TUDY01 | TU | 40912 | 2 |
| Lesion 1Lesion Location Identification | ABNEXAM | Examination for Abnormality | LOWER LIMB REGION | IDENTIFIEDLESIONIDENTIFIED | LESION | POPLITEAL ARTERY | LEFT | ABOVE KNEE | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| 3 | TUDY01 | TU | 40912 | 3 | graft01 | Graft Lesion 1Lesion Location Identification | ABNEXAM | Examination for Abnormality | LOWER LIMB REGION | IDENTIFIEDLESIONIDENTIFIED | LESION | FEMORO-POPLITEAL ARTERY | LEFT | PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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| Nsvmeta |
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| Variable | Label | Type | Role | Origin |
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| TURLGFFL | Result location is Graft Flag | text | Non-Standard Record Qualifier | CRF |
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Question: Can we use LOC for Graft locations? LOC in most findings domains is supposed to be the location where a test is performed, and RESLOC is where a result is collected. SDTM does not specify that the location needs to be a "naturally occurring" body part, so can we get away with mapping graft locations into LOC/RESLOC?
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Row
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STUDYID
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DOMAIN
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USUBJID
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TUTEST
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TULOC
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TUORRES
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TUMETHOD
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VISITNUM
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VISIT
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TUDTC
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TUDY01
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TUDY01
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TUDY01
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Lesion Role Identification
The below example shows "role" assessment on the lesions that were identified.
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TULOC | TUORRES | TUSTRESC | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC | TUTLGFFL | 1 | TUDY01 | TU | 40912 | 1 | Lesion 1 | Lesion Role Identification | POPLITEAL ARTERY | NON-TARGET | NON-TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | 2 | TUDY01 | TU | 40912 | 2 | Graft Lesion 1 | Lesion Role Identification | LEFT FEMORO-POPLITEAL ARTERY | TARGET | TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 | Y | | Nsvmeta |
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| | Variable | Label | Type | Role | Origin |
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| TUTLGFFL | Test location is Graft Flag | text | Non-Standard Record Qualifier | CRF |
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Mapping graft directly into TULOC.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTEST | TULOC | TUORRES | TUSTRESC | TUMETHOD | TUEVEL | VISITNUM | VISIT | TUDTC |
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| 1 | TUDY01 | TU | 40912 | 1 | Lesion 1 | Lesion Role Identification | POPLITEAL ARTERY | NON-TARGET | NON-TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07 |
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2 | TUDY01 | TU | 40912 | 2 | Graft Lesion 1 | Lesion Role Identification | LEFT FEMORO-POPLITEAL GRAFT | TARGET | TARGET | CT PERIPHERAL ANGIOGRAPHY | INVESTIGATOR | 2 | VISIT 1 | 2007-02-07
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