This example shows how to model complex locations using a combination of location-related TESTs and location variables
This is probably as complicated for modeling anatomy as it goes, most lesion identification may not require this level of detail, i.e. the aneurysm example.
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.
Row 3:
Shows the major vessel that contains a lesion is the left femoro-popliteal peripheral artery.
Row 4:
Shows the lesion is found in the left popliteal artery, in the segment below the knee. Note a TULNKID is created for row 4 where TULNKID = Lesion 1. This --LNKID is used to connect to the lesion severity assessment in CV.
tu.xpt
tu.xpt
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
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
Limb with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
LEG
LEFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
Vessel with Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
FEMORO-POPLITEAL PERIPHERAL ARTERY
LEFT
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
4
TUDY01
TU
40912
4
Lesion 1
Lesion Location Identification
LOWER LIMB REGION
LOCATED
LOCATED
POPLITEAL ARTERY
LEFT
BELOW KNEE
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
cv.xpt
cv.xpt
Row
STUDYID
DOMAIN
USUBJID
RSSEQ
CVLNKID
CVTEST
CVCAT
CVORRES
VISITNUM
VISIT
RSDTC
1
TUDY01
CV
40912
1
Lesion 1
Lesion Severity
Sponsor-defined Criteria
Severe
2
VISIT 1
2007-02-07
$warningHtml
Alternative approach:
tu.xpt
tu.xpt
Row
STUDYID
DOMAIN
USUBJID
TUSEQ
TUGRPID
TUTEST
TULOC
TUORRES
TUMETHOD
TUEVEL
VISITNUM
VISIT
TUDTC
1
TUDY01
TU
40912
1
Lesion Indicator
Lower limb region
Y
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
2
TUDY01
TU
40912
2
1
Limb with Lesion Location Identification
Lower limb region
Leg
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
3
TUDY01
TU
40912
3
1
Limb with Lesion location Laterality Identification
Leg
Left
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
4
TUDY01
TU
40912
4
2
Vessel with Lesion Location Identification
Lower limb region
Femerol-popliteal peripheral artery
CT PERIPHERAL ANGIOGRAPHY
INVESTIGATOR
2
VISIT 1
2007-02-07
5
TUDY01
TU
40912
5
2
Vessel with Lesion Location Laterality Identification