Tumor Assessment - Non-Target (RECIST v1.1)
Sources: DB1, SDTM | Forms loaded: 6
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: 6
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: 6
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 (RECIST v1.1)
Sources: DB1, SDTM | Forms loaded: 6
TR (Tumor/Lesion Results)
Show domain info
Primary Domain
TR
All Domains
TR
# Question Response / annotation
6
Line Number
TUSPID
TRSPID
7
Tumor ID
TULNKID
TRLNKID
11
Select if changes to tumor were identified
TUCHANGE
12
Method of Evaluation
TUMETHOD
TRMETHOD
14
Date of Procedure
TUDAT
TRDTC
15
Tumor Identification Evaluator
TUEVAL
TREVAL
16
Longest Diameter
LDIAM_TRORRES
TRORRES when TRTESTCD = LDIAM
17
Longest Diameter Unit
LDIAM_TRORRESU
TRORRESU when TRTESTCD = LDIAM
18
Check if the diameter was too small to measure
LDIAM_TRTOOSM
TRORRES = TOO SMALL TO MEASURE when TRTESTCD = LDIAM
19
Check if the tumor was inevaluable
TRINEVAL
TRSTAT = NOT DONE when TRTESTCD = LDIAM
20
If the tumor was inevaluable, what was the reason?
TRREASND
TRREASND when TRTESTCD = LDIAM
Tumor Assessment - Target - Screening (RECIST v1.1)
Sources: DB1, SDTM | Forms loaded: 6
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
Target Lesion
Sources: DB1, SDTM | Forms loaded: 6
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