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The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows a subject that has only Target tumors at screening. The tumor The tumor identifier is in TULNKID and matches TRLNKIDs in the TR TRLNKIDs in the TR Domain.  

Dataset wrap
Nametu
Rowcaps

Row 1: Shows that the subject has at least one target tumor (TUTESTCD = "TIND"), i.e., the subject has measurable disease.   Prior to SDTMIG 3.4, this row would not be included.  However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU.

Row 2: Shows that the subject does not have any non-target tumors (TUTESTCD = "NTIND"). Prior to SDTMIG 3.4, this row would not be included.  However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU.

Row 3: Shows the single target lesion in the breast. The subject only has one target lesion and no non-targets.

Row 4: Shows new bone lesion identified at week 24.

Dataset2
RowSTUDYIDDOMAINUSUBJIDTUSEQTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTULOCTULATTUMETHODTUEVALEPOCHVISITNUMVISITTUDTCTUDY
1EX55555TU900051
TINDTarget IndicatorYY


INVESTIGATORSCREEN1SCREENING2007-01-011
2EX55555TU900052
NTINDNon-Target IndicatorNN


INVESTIGATORSCREEN1SCREENING2007-01-011
3EX55555TU900053T01TUMIDENTTumor IdentificationTARGETTARGETBREASTRIGHTCT SCANINVESTIGATORSCREEN1SCREENING2007-01-011
4EX55555TU900054NEW01TUMIDENTTumor IdentificationNEWNEWBONE
CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168

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Dataset wrap
Nametu
Rowcaps

Rows 1-5: Show the identification of three target lesions "T01", "T02" and "T03", and 2 non-target lesions "NT01" and "NT02" by investigator.

Rows 6-7: Show the identification of two target lesions "R-T01" and "R-T02" by the independent radiologist.

Row 8: Shows the identification of a new tumor "NEW01" by investigator.

Row 9: Shows the identification of a new tumor "R-NEW01" by independent radiologist.

Dataset2
RowSTUDYIDDOMAINUSUBJIDTUSEQTULNKIDTUTESTCDTUTESTTUORRESTUSTRESCTUNAMTULOCTULATTUDIRTUMETHODTUEVALTUEVALIDTUACPTFLEPOCHVISITNUMVISITTUDTCTUDY
1EX66666TU900061T01TUMIDENTTumor IdentificationTARGETTARGET
OCCIPITAL LOBELEFTANTERIORMRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
2EX66666TU900062T02TUMIDENTTumor IdentificationTARGETTARGET
OCCIPITAL LOBERIGHT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
3EX66666TU900063T03TUMIDENTTumor IdentificationTARGETTARGET
TEMPORAL LOBELEFT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
4EX66666TU900064NT01TUMIDENTTumor IdentificationNON-TARGETNON-TARGET
FRONTAL LOBERIGHT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
5EX66666TU900065NT02TUMIDENTTumor IdentificationNON-TARGETNON-TARGET
CEREBELLUMLEFT
MRIINVESTIGATOR

SCREEN1SCREENING2007-01-011
6EX66666TU900066RR1-T01TUMIDENTTumor IdentificationTARGETTARGETACME VENDOROCCIPITAL LOBERIGHTANTERIORMRIINDEPENDENT ASSESSORRADIOLOGIST 1YSCREEN1SCREENING2007-01-011
7EX66666TU900067RR1-T02TUMIDENTTumor IdentificationTARGETTARGETACME VENDORTEMPORAL LOBELEFT
MRIINDEPENDENT ASSESSORRADIOLOGIST 1YSCREEN1SCREENING2007-01-011
8EX66666TU900068NEW01TUMIDENTTumor IdentificationNEWNEW
FRONTAL LOBERIGHT
MRIINVESTIGATOR

TREATMENT4Cycle 3 Day 12007-02-2656
9EX66666TU900069RR1-NEW01TUMIDENTTumor IdentificationNEWNEWACME VENDORFRONTAL LOBERIGHT
MRIINDEPENDENT ASSESSORRADIOLOGIST 1YTREATMENT4Cycle 3 Day 12007-02-2656

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