New Lesion
Sources: DB1, SDTM | Forms loaded: 8
TU (Tumor Identification)
RS (Disease Response and Clin Classification)
Show domain info
Primary Domain
TU
All Domains
TU, RS
# Question Response / annotation
1
Lesion Number
field_001
TULNKID
RSLNKID
2
Date of Assessment
field_002
TUDTC
RSDTC
3
Anatomical Location
field_003
TULOC
4
Anatomical Location Other Specify
field_004
TULOCOTH in SUPPTU
5
Laterality
field_005
TULAT
6
Directionality
field_006
TUDIR
7
Method of Evaluation
field_007
TUMETHOD
8
Status
field_008
RSORRES
Non-target Lesion
Sources: DB1, SDTM | Forms loaded: 8
TU (Tumor Identification)
RS (Disease Response and Clin Classification)
Show domain info
Primary Domain
TU
All Domains
TU, RS
# Question Response / annotation
1
Lesion Number
field_001
TULNKID
RSLNKID
2
Date of Assessment
field_002
TUDTC
RSDTC
3
Anatomical Location
field_003
TULOC
4
Anatomical Location Other Specify
field_004
TULOCOTH in SUPPTU
5
Laterality
field_005
TULAT
6
Directionality
field_006
TUDIR
7
Method of Evaluation
field_007
TUMETHOD
8
Status
field_008
RSORRES
Tumor Assessment - Non-Target (RECIST v1.1)
Sources: DB1, SDTM | Forms loaded: 8
TR (Tumor/Lesion Results)
TU (Tumor/Lesion Identification)
Show domain info
Primary Domain
TR
All Domains
TR, TU
# Question Response / annotation
6
Line Number
TUSPID
TRSPID
7
Tumor ID
TULNKID
TRLNKID
12
Method of Evaluation
TUMETHOD
TRMETHOD
14
Date of Procedure
TUDAT
TRDTC
15
Evaluator
TUEVAL
TREVAL
16
Tumor State
TUMSTATE_TRORRES
TRORRES when TRTESTCD = TUMSTATE
17
Check if the tumor was inevaluable
TRINEVAL
TRSTAT = NOT DONE when TRTESTCD = TUMSTATE
17
For previously identified new lesions, check if the tumor was inevaluable
TRINEVAL_2
TRSTAT = NOT DONE when TRTESTCD = TUMSTATE
18
If the tumor was inevaluable, what was the reason?
TRREASND
No options
TRREASND when TRTESTCD = TUMSTATE
18
If the tumor was inevaluable, what was the reason?
TRREASND_2
No options
TRREASND when TRTESTCD = TUMSTATE
Tumor Assessment - Non-Target - Screening (RECIST v1.1)
Sources: DB1, SDTM | Forms loaded: 8
TU (Tumor/Lesion Identification)
TR (Tumor/Lesion Results)
Show domain info
Primary Domain
TU
All Domains
TU, TR
# Question Response / annotation
6
Line Number
TUSPID
TUSPID
TRSPID
7
Tumor ID
TULNKID
TULNKID
TRLNKID
8
Location
TULOC
TULOC
9
Laterality
TULAT
TULAT
11
Method of Evaluation
TUMETHOD
TUMETHOD
13
Date of Procedure
TUDAT
TUDTC
TRDTC
14
Evaluator
TUEVAL
TUEVAL
TREVAL
Tumor Assessment - New (RECIST v1.1)
Sources: DB1, SDTM | Forms loaded: 8
TU (Tumor/Lesion Identification)
TR (Tumor/Lesion Results)
Show domain info
Primary Domain
TU
All Domains
TU, TR
# Question Response / annotation
6
Line Number
TUSPID
TUSPID
TRSPID
7
Tumor ID
TULNKID
TULNKID
TRLNKID
7
Is this an assessment on previously identified lesion?
TUPLEYN
[NOT SUBMITTED]
7
State of the tumor
TUMSTATE_TRORRES
TRORRES when TRTESTCD = TUMSTATE
8
Location
TULOC
TULOC
9
Laterality
TULAT
TULAT
11
Method of Evaluation
TUMETHOD
TUMETHOD
TRMETHOD
13
Date of Procedure
TUDAT
TUDTC
TRDTC
14
Evaluator
TUEVAL
TUEVAL
TREVAL
Tumor Assessment - Target - Screening (RECIST v1.1)
Sources: DB1, SDTM | Forms loaded: 8
TU (Tumor/Lesion Identification)
TR (Tumor/Lesion Results)
Show domain info
Primary Domain
TU
All Domains
TU, TR
# Question Response / annotation
6
Line Number
TUSPID
TUSPID
7
Tumor ID
TULNKID
TULNKID
TRLNKID
8
Location
TULOC
TULOC
9
Laterality
TULAT
TULAT
11
Method of Evaluation
TUMETHOD
TUMETHOD
13
Date of Procedure
TUDAT
TUDTC
14
Evaluator
TUEVAL
TUEVAL
15
Longest Diameter
LDIAM_TRORRES
TRORRES when TRTESTCD = LDIAM
16
Longest Diameter Unit
LDIAM_TRORRESU
TRORRESU when TRTESTCD = LDIAM
Tumor Assessment YN?
Sources: DB1, SDTM | Forms loaded: 8
TU (Tumor/Lesion Identification)
Show domain info
Primary Domain
TU
All Domains
TU
# Question Response / annotation
Target Lesion
Sources: DB1, SDTM | Forms loaded: 8
TU (Tumor Identification)
TR (Tumor/Lesion Results)
Show domain info
Primary Domain
TU
All Domains
TU, TR
# Question Response / annotation
1
Lesion Number
field_001
TULNKID
TRLNKID
2
Date of Assessment
field_002
TUDTC
TRDTC
3
Anatomical Location
field_003
TULOC
4
Anatomical Location Other Specify
field_004
TULOCOTH in SUPPTU
5
Laterality
field_005
TULAT
6
Directionality
field_006
TUDIR
7
Method of Evaluation
field_007
TUMETHOD
TRMETHOD
8
What was the Diameter of the Tumor?
field_008
TRORRES when TRTESTCD = DIAMETER
9
What were the units for the Diameter?
field_009
TRORRESU when TRTESTCD = DIAMETER
10
Reason not measured
field_010
TRORRES / TRREASND
11
If Not Evaluable (NE), select
field_011
TRREASND when TRTESTCD = DIAMETER
12
Sum of Target Lesion Diameters
field_012
TRORRES