myCSG © |Area: SDTM| Concept: TR : Tumor/Lesion Results | Lesson: LONCEX06 : Tumor/Lesion Results - Investigator tumor identification, tumor results and response data using RECIST 1.1 |

  • Consists of data and programming for one of the oncology specific SDTM domains, TR:
  • Non-target lesion identification at screening
  • Target lesion identification at screening
  • Non-target lesion assessment during postbaseline period
  • Target lesion assessment during postbaseline period
  • Evaluation for new lesions during postbaseline period
  • Target, non-target and overall response assessment during postbaseline period
  • Related lessons are :
    • SDTM_TU_LONCEX06
    • SDTM_TR_LONCEX06
    • SDTM_RS_LONCEX06

TUTGSC : Tumor Assessment - Target - Screening (RECIST v1.1)
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]

T01
T02
T03
T04
T05
Location
[TULOC]
Laterality
[TULAT]
Method of Evaluation
[TUMETHOD]
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]

INVESTIGATOR
Longest Diameter
[LDIAM_TRORRES]
Longest Diameter Unit
[LDIAM_TRORRESU]

mm




TUTG : Tumor Assessment - Target (RECIST v1.1)
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]

T01
T02
T03
T04
T05
Select if changes to tumor were identified
[TUCHANGE]
Method of Evaluation
[TUMETHOD]
Method of Evaluation
[TUMETHOD]
Date of Procedure
[TUDAT]
Tumor Identification Evaluator
[TUEVAL]

INVESTIGATOR
Longest Diameter
[LDIAM_TRORRES]
Longest Diameter Unit
[LDIAM_TRORRESU]

mm
Check if the diameter was too small to measure
[LDIAM_TRTOOSM]
Check if the tumor was inevaluable
[TRINEVAL]
If the tumor was inevaluable, what was the reason?
[TRREASND]




TUNT : Tumor Assessment - Non-Target (RECIST v1.1)
NOT DONE
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]

NT01
NT02
NT03
NT04
NT05
Method of Evaluation
[TUMETHOD]
CT SCAN
MRI
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]

INVESTIGATOR
Tumor State
[TUMSTATE_TRORRES]

Present
Absent
For previously identified new lesions,
Check if the tumor was inevaluable
[TRINEVAL]

Inevaluable
Check if the tumor was inevaluable
[TRINEVAL]

Inevaluable
NOT DONE
If the tumor was inevaluable, what was the reason?
[TRREASND]


If the tumor was inevaluable, what was the reason?
[TRREASND]






TUNTSC : Tumor Assessment - Non-Target - Screening (RECIST v1.1)
Question Response
Line Number
[TUSPID]
Tumor ID
[TULNKID]
Location
[TULOC]
Laterality
[TULAT]
Method of Evaluation
[TUMETHOD]
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]




TUNW : Tumor Assessment - New (RECIST v1.1)
NEW02
NEW03
NEW04
NEW05
Question Response
Line Number
[TUSPID]
Is this an assessment on previously identified lesion?
[TUPLEYN]
State of the tumor
[TUMSTATE_TRORRES]
Tumor ID
[TULNKID]

NEW01
Is this an assessment on previously identified lesion?
[TUPLEYN]
State of the tumor
[TUMSTATE_TRORRES]
Location
[TULOC]
Laterality
[TULAT]
Method of Evaluation
[TUMETHOD]

CT SCAN
MRI
Date of Procedure
[TUDAT]
Evaluator
[TUEVAL]




RS_REC : Disease Response (RECIST 1.1)
Question Response
Response Date
[RSDAT]
Target Response
[TRGRESP_RSORRES]

CR
PR
SD
PD
Non-target Response
[NTRGRESP_RSORRES]

CR
Non-CR/Non-PD/PD
Overall Response
[OVRLRESP_RSORRES]

CR
PR
SD
PD
NE
Response Evaluator
[RSEVAL]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_TUNTSCFORM_TUNTFORM_TUTGSCFORM_TUTGFORM_TUNW
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'TR'
_ USUBJID Unique Subject Identifier Char Populate by concatenating the text "statschoice-" as prefix to the value in SUBJECT variable.
_ TRSEQ Sequence Number Num Sort the records using USUBJID, TRTESTCD, TRMETHOD, TRDTC, TRLNKID and set to 1 on the first record of subject and increment by 1 on subsequent records.
_ TRGRPID Group ID Char Populate as 'NON-TARGET' Populate as 'NON-TARGET' Populate as 'TARGET' Populate as 'TARGET' Populate as 'NEW'
_ TRSPID Sponsor-Defined Identifier Char Populate using TUSPID Populate using TUSPID Populate using TUSPID Populate using TUSPID Populate using TUSPID
_ TRLNKID Link ID Char Populate using TULNKID Populate using TULNKID Populate using TULNKID Populate using TULNKID Populate using TULNKID
_ TRLNKGRP Link Group Char Populate with the values from FOLDERNAME variable
_ TRTESTCD Tumor/Lesion Assessment Short Name Char Create a record with TRTESTCD=TUMSTATE for each record present in the input dataset. Create a record with TRTESTCD=TUMSTATE to capture the result from TUMSTATE_TRORRES. Create a record with TRTESTCD=DIAMETER to capture the result from LDIAM. Create a record with TRTESTCD=DIAMETER to capture the result from LDIAM. Create a record with TRTESTCD=TUMSTATE to capture the result from TUMSTATE_TRORRES.
_ TRTEST Tumor/Lesion Assessment Test Name Char Populate as 'Tumor State' when TRTESTCD=TUMSTATE. Populate as 'Tumor State' when TRTESTCD=TUMSTATE. Populate as 'Diameter' when TRTESTCD=DIAMETER. Populate as 'Diameter' when TRTESTCD=DIAMETER. Populate as 'Tumor State' when TRTESTCD=TUMSTATE.
_ TRORRES Result or Finding in Original Units Char Populate as "PRESENT". Populate using TUMSTATE_TRORRES on the record with TRTESTCD=TUMSTATE. Populate with the value from LDIAM variable. 1) Populate as "TOO SMALL TO MEASURE" when TRTOOSM="Y". 2) Populate with the value from LDIAM variable. Populate using TUMSTATE_TRORRES on the record with TRTESTCD=TUMSTATE.
_ TRORRESU Original Units Char Populate with the value from LDIAM_TRORRESU variable when TU.TUORRES is not null. Populate with the value from LDIAM_TRORRESU variable when TU.TUORRES is not null.
_ TRSTRESC Character Result/Finding in Std Format Char Populate with the value from TU.TRORRES 1) Populate as "5" when TU.TUORRES is "TOO SMALL TO MEASURE". 2) Else populate with the value from TU.TUORRES.
_ TRSTRESN Numeric Result/Finding in Standard Units Num Populate using TR.TRSTRESC after converting to numeric value where applicable.
_ TRSTRESU Standard Units Char Populate using TR.TRORRESU
_ TRSTAT Completion Status Char Populate as 'NOT DONE' when TRINEVAL is not null. Populate as 'NOT DONE' when TRINEVAL is not null. Populate as 'NOT DONE' when TRINEVAL is not null.
_ TRREASND Reason Not Done Char Populate using TRREASND when TRSTAT=NOT DONE Populate using TRREASND when TRSTAT=NOT DONE Populate using TRREASND when TRSTAT=NOT DONE
_ TRMETHOD Method Used to Identify the Tumor/Lesion Char Populate with the values from TUMETHOD varaible Populate with the values from TUMETHOD varaible Populate with the values from TUMETHOD varaible Populate with the values from TUMETHOD varaible Populate with the values from TUMETHOD varaible
_ TREVAL Evaluator Char Populate with the values from TUEVAL varaible Populate with the values from TUEVAL varaible Populate with the values from TUEVAL varaible Populate with the values from TUEVAL varaible Populate with the values from TUEVAL varaible
_ VISITNUM Visit Number Num Populate using FOLDERSEQ
_ VISIT Visit Name Char Populate using FOLDERNAME
_ TRDTC Date/Time of Tumor/Lesion Measurement Char Populate using TUDAT after converting it to ISO 8601 format.
_ TRDY Study Day of Tumor/Lesion Measurement Num Derive using SDTM.DM.RFSTDTC and SDTM.TR.TRDTC. When TRDTC is before RFSTDTC, populate using the difference between TRDTC and RFSTDTC. When TRDTC is on or after RFSTDTC, add 1 to the difference between TRDTC and RFSTDTC.
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