myCSG © |Area: SDTM| Concept: RS : Disease Response and Clin Classification | Lesson: LONCEX06 : Disease Response - 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, RS:
    • 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_RS_REC
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'RS'
_ USUBJID Unique Subject Identifier Char Concatenate the value of STUDYID variable to SUBJECT variable with a hyphen in between.
_ RSSEQ Sequence Number Num Sort the records by USUBJID, RSCAT, RSTESTCD, RSDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject
_ RSTESTCD Assessment Short Name Char Create a record with RSTESTCD=TRGRESP to store the result from TRGRESP_RSORRES.
Create a record with RSTESTCD=NTRGRESP to store the result from TRGRESP_RSORRES.
Create a record with RSTESTCD=OVRLRESP to store the result from OVRLRESP_RSORRES.
_ RSTEST Assessment Name Char Populate as 'Target Response' when RSTESTCD=TRGRESP.
Populate as 'Non-target Response' when RSTESTCD=NTRGRESP.
Populate as 'Overall Response' when RSTESTCD=OVRLRESP.
_ RSORRES Result or Finding in Original Units Char Populate using TRGRESP_RSORRES when creating row for RSTESTCD=TRGRESP.
Populate using NTRGRESP_RSORRES when creating row for RSTESTCD=NTRGRESP.
Populate using OVRLRESP_RSORRES when creating row for RSTESTCD=OVRLRESP.
_ RSSTRESC Character Result/Finding in Std Format Char Populate with the values from RS.RSORRES
_ RSEVAL Evaluator Char Populate with the values from RSEVAL variable.
_ VISITNUM Visit Number Num Populate with the value from FOLDERSEQ
_ VISIT Visit Name Char Populate with the value from FOLDERNAME
_ RSDTC Date/Time of Assessment Char Populate using RSDAT_RAW after converting to ISO8601 format.
_ RSDY Study Day of Assessment Num Populate using RS.RSDTC and DM.RFSTDTC. If RSDTC is on or after RFSTDTC then populate with the resulting value of RSDTC-RFSTDTC+1. Else if RSDTC is before RFSTDTC then populate with the resulting value of RSDTC-RFSTDTC.
Complete SAS code to generate the output is available for registered users!

Already registered! Login
Not registered, you can signup here! Signup

Dont want to register?
You can directly purchase this lesson (code+input data) here


You can purchase this lesson (code+input data) here

If you are looking to purchase subscription for full access to data and programs for all lessons (TASKS+SDTM+ADaM+TFLs), you can send us a message on +91-7330--77--66--49-- on Whatsapp.
R data is available only for R subscribers.
You can contact us on +91-7330--77--66---49 for purchasing subscription to R programs and data
R codes are available only for R subscribers.
You can contact us on +91-7330--77--66---49 for purchasing subscription to R programs and data