CV Endpoint TAUG Example 2

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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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Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRLOC	PRLAT	PRCAT	VISITNUM	VISIT	PRDTC	PRSTDTC	PRENDTC
1	TUDY01	PR	40912	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.

These records were originally represented as SUPPTU (in IG3.4 and the CV TAUG), but I think they are better fitted for FAPR? Thoughts?

Row 1:	Shows the graft vessel was built on the Left Femoral-popliteal Artery.
Row 2:	Shows the bypass graft type was venous cadaveric graft, which is composed of a vein harvested from a cadaver.
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	FASEQ	FATEST	FAOBJ	FACAT	FAORRES	VISITNUM	VISIT	TUDTC
2	TUDY01	FA	40912	2	Bypass Graft Type	Peripheral Artery Bypass Graft	Prior Intervention	Cardaveric Graft, Venous	1	SCREEN	2007-01-01
3	TUDY01	FA	40912	3	Proximal Graft Anastomosis (connection) Location	Peripheral Artery Bypass Graft	Prior Intervention	Common femoral Artery	1	SCREEN	2007-01-01
4	TUDY01	FA	40912	4	Distal Graft Anastomosis (connection) Location	Peripheral Artery Bypass Graft	Prior Intervention	Popliteal Artery	1	SCREEN	2007-01-01

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

On 2007-01-03, the subject had undergone lower-extremity CT peripheral angiography during which time two separate lesions were located in the left leg of the subject. One lesion (lesion 1) was in the native left femoral-popliteal artery (this was the lesion that led to the graft bypass surgery back in 2005) the other lesion (graft lesion 1) was located in the left femoral-popliteal graft. While Lesion 1 is considered as non-target, graft lesion 1 is considered as target for the subsequent PVI treatment. On 2007-01-05, a stent was implanted into the left femoral-popliteal graft to correct the stenosis caused by the lesion (graft lesion 1). Note this information is collected on 2007-02-07 during VISIT 1.

Below procedure data show cardiac catheterization and stent implantation.

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Row	STUDYID	DOMAIN	USUBJID	PRSEQ	PRTRT	PRCAT	PRLOC	VISITNUM	VISIT	PRDTC	PRSTDTC	PRENDTC
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
	TUDY01	PR	40912	2	CT PERIPHERAL ANGIOGRAPHY	PVI		2	VISIT 1	2007-02-07	2007-01-05T07:00	2007-01-05T09:00
2	TUDY01	PR	40912	3	Cardiac Catheterization	PVI		2	VISIT 1	2007-02-07	2007-01-05T07:00	2007-01-05T09:00
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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The below data show Locations of the lesions.

Row 1:	Shows one or more lesions have been identified in the lower limb region.
Row 2:	Shows the location of the lesion in the native vessel.
Row 3:	Shows the location of the lesion is in the FEMORO-POPLITEAL ARTERY graft. Note the use of the NSV --RLGFFG, Result location is graft flag. Note 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	TULNKID	TUTEST	TULOC	TUORRES	TUSTRESC	TU Result LOC	TU Result LAT	TU Result LOCDTL	TUMETHOD	TUEVEL	VISITNUM	VISIT	TUDTC	TURLGFFG
1	TUDY01	TU	40912	1		Lesion Indicator	LOWER LIMB REGION	Y	Y				CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
2	TUDY01	TU	40912	2	Lesion 1	Lesion Location Identification	LOWER LIMB REGION	IDENTIFIED	IDENTIFIED	POPLITEAL ARTERY	LEFT	ABOVE KNEE	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
3	TUDY01	TU	40912	3	Graft Lesion 1	Lesion Location Identification	LOWER LIMB REGION	IDENTIFIED	IDENTIFIED	FEMORO-POPLITEAL ARTERY	LEFT	PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07	Y

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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. A reminder that the value in TULOC in this example, is a location made available for viewing via imaging, and you are observing based off of a image, so we are not doing assessments on a naturally occurring, in vitro body part either.

Row 1:	Shows one or more lesions have been identified in the lower limb region.
Row 2:	Shows the location of the lesion in the native vessel.
Row 3:	Shows the location of the lesion is in the FEMORO-POPLITEAL graft.

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTEST	TULOC	TUORRES	TUSTRESC	TU Result LOC	TU Result LAT	TU Result LOCDTL	TUMETHOD	TUEVEL	VISITNUM	VISIT	TUDTC
1	TUDY01	TU	40912	1		Lesion Indicator	LOWER LIMB REGION	Y	Y				CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
2	TUDY01	TU	40912	2	Lesion 1	Lesion Location Identification	LOWER LIMB REGION	IDENTIFIED	IDENTIFIED	POPLITEAL ARTERY	LEFT	ABOVE KNEE	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
3	TUDY01	TU	40912	3	Graft Lesion 1	Lesion Location Identification	LOWER LIMB REGION	IDENTIFIED	IDENTIFIED	LEFT FEMORO-POPLITEAL GRAFT	LEFT	PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07

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Row 1:	Shows one or more lesions have been identified in the lower limb region.
Row 2:	Shows the limb that contains lesion is the left leg. Note TULNKID is created for this record because this limb will undergo "role" assessment and disease response to treatment assessment.
Row 3:	Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery. Note TULNKID is created for this record because this affected vessel will undergo "role" assessment and disease response to treatment assessment.
Row 4:	Shows the lesion is found in the left popliteal artery, in the segment above the knee. Note TULNKID is created for this record because this lesion will undergo "role" assessment and disease response to treatment assessment.
Row 5:	Shows the major vessel that contains a lesion is the femoro-popliteal graft. Note TULNKID is created for this record.
Row 6:	Shows the lesion is located in the proximal anastomosis (connection) of the femoro-popliteal graft. (Note I created two rows here, depending on how you ask the question, whether "graft" is pre-coordinated into TUTEST, TULOC value will change). Note TULNKID is created for this record.
Row 7:	Shows the affected left femoro-popliteal peripheral artery is considered as non-target. In the context of clinical investigation, non-target is any vessel or bypass graft not treated or for which treatment was not attempted with a device or technique being studied. This includes vessels treated with (nonstudy) vascular intervention and vessels managed medically. (ACC/AHA Clinical Data Standards 2014)
Row 8:	Shows the lesion is considered as non-target. In the context of clinical investigation, any lesion not treated or for which treatment was not attempted with the device or technique being studied. This includes lesions treated with (nonstudy) PVI and lesions managed medically. (ACC/AHA Clinical Data Standards 2014)
Row 9:	Shows the affected femoro-popliteal graft vessel is considered as target. In the context of clinical investigation, a target vessel is a blood vessel that contains the target lesion and treated with the study device. (ACC/AHA Clinical Data Standards 2014)
Row 10:	Shows the lesion in the femoro-popliteal graft vessel is considered as target. In the context of clinical investigation, any lesion treated or for which treatment was attempted with a device or technique being studied. (ACC/AHA Clinical Data Standards 2014)
Row 11:	Shows the left leg is considered as target.

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Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTEST	TULOC	TULAT	TULOCDTL	TUORRES	TUSTRESC	TU Result LOC	TU Result LAT	TU Result LOCDTL	TUMETHOD	TUEVEL	VISITNUM	VISIT	TUDTC		LOGFIND
1	TUDY01	TU	40912	8	Lesion 1	Lesion Role Identification	POPLITEAL ARTERY	LEFT	ABOVE KNEE	NON-TARGET	NON-TARGET				CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
2	TUDY01	TU	40912	10	Graft Lesion 1	Lesion Role Identification			See NSV	TARGET	TARGET				CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07		LEFT FEMORO-POPLITEAL GRAFT

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Row 1:	Shows one or more lesions have been identified in the lower limb region.
Row 2:	Shows the location of the lesion in the native vessel.
Row 3:	Shows the location of the lesion is in the FEMORO-POPLITEAL ARTERY graft. Note the use of the NSV --RLGFFG, location is graft flag. Note 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.

tu.xpt

Row	STUDYID	DOMAIN	USUBJID	TUSEQ	TULNKID	TUTEST	TULOC	TUORRES	TUSTRESC	TU Result LOC	TU Result LAT	TU Result LOCDTL	TUMETHOD	TUEVEL	VISITNUM	VISIT	TUDTC	TURLGFFG
1	TUDY01	TU	40912	1		Lesion Indicator	LOWER LIMB REGION	Y	Y				CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
2	TUDY01	TU	40912	2	Lesion 1	Lesion Location Identification	LOWER LIMB REGION	IDENTIFIED	IDENTIFIED	POPLITEAL ARTERY	LEFT	ABOVE KNEE	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07
3	TUDY01	TU	40912	3	Graft Lesion 1	Lesion Location Identification	LOWER LIMB REGION	IDENTIFIED	IDENTIFIED	FEMORO-POPLITEAL ARTERY	LEFT	PROXIMAL ANASTOMOSIS, 5MM FROM THE ORIGIN OF THE GRAFT	CT PERIPHERAL ANGIOGRAPHY	INVESTIGATOR	2	VISIT 1	2007-02-07	Y

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