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CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention

Example 1: mapping the entire abnormality identification process in CV, pretending the non-tumor lesion domains don't exisit.

Dataset2

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVLNKGRP	CVGRPID	CVTESTCD	CVTEST	CVLOC	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-123	1		TR	ABNIND	Abnormality Indicator	Thoracic Region	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
2	ABC	CV	ABC-123	2	Target 1	TR-Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic Region	Aneurysm		Aneurysm	Aneurysm		Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	1	BASELINE	2020-04-27
3	ABC	CV	ABC-123	3		AR	ABNIND	Abnormality Indicator	Abdominal region	Y		Y	Y				CT SCAN	1	BASELINE	2020-04-27
4	ABC	CV	ABC-123	4	Non-Target 1	AR-Aneurysm	ABNEXAM	Examination for Abnormality	Abdominal region	Aneurysm		Aneurysm	Aneurysm		Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27
5	ABC	CV	ABC-123	5	Target 1	TR-Aneurysm	ABNROID	Abnormality (Role) Identification		Target for study intervention		Target for study intervention	Target for study intervention				CT SCAN	1	BASELINE	2020-04-27
6	ABC	CV	ABC-123	6	Non-Target 1	AR-Aneurysm	ABNROID	Abnormality (Role) Identification		Non-target for study intervention, monitor		Non-target for study intervention, monitor	Non-target for study intervention, monitor				CT SCAN	1	BASELINE	2020-04-27
7	ABC	CV	ABC-123	7	Target 1	TR-Aneurysm	LENGTH	Length		4	cm	4	4	cm			CT SCAN	1	BASELINE	2020-04-27
8	ABC	CV	ABC-123	8	Target 1	TR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		5	cm	5	5	cm			CT SCAN	1	BASELINE	2020-04-27
9	ABC	CV	ABC-123	9	Non-Target 1	AR-Aneurysm	LENGTH	Length		2	cm	2	2	cm			CT SCAN	1	BASELINE	2020-04-27
10	ABC	CV	ABC-123	10	Non-Target 1	AR-Aneurysm	MAXLDIA	Maximal Luminal Diameter		2.5	cm	2.5	2.5	cm			CT SCAN	1	BASELINE	2020-04-27

Example 1: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is not treated and continuously monitored.

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Dataset wrap

title	cv.xpt
Name	TR

Dataset2

Row	STUDYID	DOMAIN	USUBJID	TRSEQ	TRLNKID	TRTESTCD	TRTEST	TRORRES	TRORRESU	TRSTRESC	TRSTRESN	TRSTRESU	VISITNUM	VISIT	TUDTC
1	ABC	TR	ABC-123	1	TR-Aneurysm	LENGTH	Length	4	cm	4	4	cm	cm	BASELINE	2020-04-27
2	ABC	TR	ABC-123	2	TR-Aneurysm	MAXLDIA	Maximal Luminal Diameter	5	cm	5	5	cm	cm	BASELINE	2020-04-27
3	ABC	TR	ABC-123	3	TR-Aneurysm	LENGTH	Length	2	cm	2	2	cm	cm	VISIT 2	2020-05-27
4	ABC	TR	ABC-123	4	TR-Aneurysm	MAXLDIA	Maximal Luminal Diameter	3	cm	3	3	cm	cm	VISIT 2	2020-05-27

Example 3: what the data should look like if there aren't separate non-tumor lesion domains, whether or not the aneurysm is treated with a study intervention. Pretend there are no TU/TR.

Dataset wrap

title	cv.xpt
Name	cv

Dataset2

2020-04

ROW	STUDYID	DOMAIN	USUBJID	CVSEQ	CVGRPID	CVTESTCD	CVTEST	CVLOC	CVCAT	CVORRES	CVORRESU	CVSTRESC	CVSTRESN	CVSTRESU	CVRESLOC	CVRLODTL	CVMETHOD	VISITNUM	VISIT	CVDTC
1	ABC	CV	ABC-123	1	TR	ABNIND	Abnormality Indicator	Thoracic Region	TARGET FOR STUDY TREATMENT	Y	Y	Y	CT SCAN	1	BASELINE	2020-04-27	2	ABC	CV	ABC-123	2	TR-Aneurysm	ABNEXAM	Examination for Abnormality	Thoracic Region	TARGET FOR STUDY TREATMENT	Aneurysm	Aneurysm	Aneurysm	Thoracic Aorta	Aortic Arch to Descending aorta	CT SCAN	1	BASELINE	2020-04-27	3	ABC	CV	ABC-123	3	AR	ABNIND	Abnormality Indicator	Abdominal region	NON-TARGET FOR STUDY TREATMENT (MONITORING)	Y	Y	Y	CT SCAN	1	BASELINE	2020-04-27	4	ABC	CV	ABC-123	4	AR-Aneurysm	ABNEXAM	Examination for Abnormality	Abdominal region	NON-TARGET FOR STUDY TREATMENT (MONITORING)	Aneurysm	Aneurysm	Aneurysm	Infrarenal aorta	proximal to the iliac bifurcation	CT SCAN	1	BASELINE	2020-04-27	5	ABC	CV	ABC-123	5	TR-Aneurysm	LENGTH	Length	TARGET FOR STUDY TREATMENT	4	cm	4	4	cm	CT SCAN	1	BASELINE	2020-04-27	6	ABC	CV	ABC-123	6	TR-Aneurysm	MAXLDIA	Maximal Luminal Diameter	TARGET FOR STUDY TREATMENT	5	cm	5	5	cm	CT SCAN	1	BASELINE	2020-04-27	7	ABC	CV	ABC-123	7	AR-Aneurysm	LENGTH	Length	NON-TARGET FOR STUDY TREATMENT (MONITORING)	2	cm	2	2	cm	CT SCAN	1	BASELINE	2020-04-27	8	ABC	CV	ABC-123	8	AR-Aneurysm	MAXLDIA	Maximal Luminal Diameter	NON-TARGET FOR STUDY TREATMENT (MONITORING)	2.5	cm	2.5	2.5	cm	CT SCAN	1	BASELINE	-27

The TU/TR/RS domains were created for tumors which in themselves don't belong in any body system domains (tumor can grow and spread to any place), hence they are in their own domains. At some point, non-tumor lesion was added to TU/TR. SDTM now has body-system domains, it then begs the question whether a separate non-tumor lesion domain is needed, when most "lesions" and things that could be considered as lesions, can go into their respective body-system domains. Can the body system domains offer the "unique lesion identifier" through the use of, GRPID, REFID, or other identifier variables?

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CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention

Example 1: mapping the entire abnormality identification process in CV, pretending the non-tumor lesion domains don't exisit.

Example 1: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is not treated and continuously monitored.

Example 3: what the data should look like if there aren't separate non-tumor lesion domains, whether or not the aneurysm is treated with a study intervention. Pretend there are no TU/TR.

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Page History

Versions Compared

Old Version 119

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Include PageCT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study InterventionCT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention

Example 1: mapping the entire abnormality identification process in CV, pretending the non-tumor lesion domains don't exisit.

Example 1: Observed abnormality that's also a lesion, but "non-target" for study intervention, it is not treated and continuously monitored.

Example 3: what the data should look like if there aren't separate non-tumor lesion domains, whether or not the aneurysm is treated with a study intervention. Pretend there are no TU/TR.

Include Page
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention
CT:Decision Tree for Non-tumor Lesion Modeling: Target vs Non-Target for Study Intervention