Page History

Rows 1-6: Show the screening assessments of the target lesions. For lymph node target lesions "T01" and "T02" the TRTESTCD used for the assessments are "LPREP" and "LNSTATE".  For non-lymph node target lesions,"T03" and "T04", the TRTESTCD used for the assessments is "LDIAM".

Rows 7-8: Show the results for the non-targets. "NT01" is a lymph node where the TRTEST used for the assessments is "Lymph Node State" (TRTESTCD = "LNSTATE"). "NT02" is a non-lymph node where the TRTEST used for the assessments is "Tumor State" (TRTESTCD = "TUMSTATE").

Row 14: Shows a case where the scan was not performed at week 6 (for TRTEST = "Longest Diameter", TRSTAT = "NOT DONE" with TRREASND = "SCAN NOT PERFORMED").

Row 15: Shows a case where the non-target "NT01" was not evaluable (for TRTEST = "Lymph Node State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE"). 

Row 16: Shows a case where the non-target "NT02" was not evaluable (for TRTEST = "Tumor State", TRSTAT = "NOT DONE" with TRREASND = "NOT ASSESSABLE: Image obscuredEVALUABLE").

Row 30: Shows a target lesion "T04" which is too small to measure. The TRORRES = "TOO SMALL TO MEASURE", and the TRSTRESC and TRSTRESN are standardized to "5" with TRSTRESU as "mm".  The standardized value of "5" ensures that the sum of diameters includes a value for that lesion because it has not disappeared. The method of standardization of the TRSTRESC and TRSTRESN values is sponsor specific.  

Row 58: Shows a new lesion "NEW01" which has a measurement of 4 mm.  Note that this value is less than 5 mm and has not been reported as "TOO SMALL TO MEASURE".

Row 11: Shows the longest diameter of "T04" at the assessment before it splits.

Rows 18-19: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 16.

Rows 24-25: Show that tumors "T02" and "T03" are no longer measured individually. The TRSTAT = "NOT DONE" and the TRREASND = "TUMOR MERGED". These rows are optional and can be included if part of the collection. In the case where a sponsor includes TUMSTATE for target lesions, TUMSTATE may be assigned to "TUMOR MERGED".

Row 26: Shows the longest diameter of the newly merged "T02/T03" tumor at week 24.

Rows 27-28: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 24.

Row 33: Shows the longest diameter of the newly merged "T02/T03" tumor at week 32. Sponsors can continue to include individual tumors as not done as in rows 24-25.

Rows 34-35: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 32.

Row 37: Shows the Tumor State of the non-target "NT01" as enlargement from nadir (TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). This Tumor State indicates that the non-Target tumors in the "LUNG" have shown enlargement from their previous smallest state.

Rows 39-40: Shows the Tumor State of the a new tumor "NEW01" and the longest diameter of the new tumor.

Rows 1-32: Show RECIST 1.1 assessments of target and non-target lesions at screening, week 8, week 16 and week 24.

Rows 33-39: Show that the scans of target and non-target lesions were not done at week 32.

Rows 1-14: Show the longest diameter and sum of longest diameter for the target lesion. The subject only has one target lesion and no non-targets.

Rows 3-6: Show assessment where the target lesion is absent. The longest diameter is shown as "0". If a sponsor collects that the tumor is absent rather than entering the longest diameter as "0", then the sponsor may optionally derive the longest diameter as "0" and represent the tumor state as ABSENT, if desired. 

Row 15: Shows a new lesion state at week 24.

Rows 1-6: Show the qualitative assessments of the tumor state of the 3 non-target lesions "NT01", "NT02", and "NT03" at screening and week 6.

Rows 7-9: Show the week 12 assessments. Row 7 shows the assessment of "NT01" non-target lesion in the brain whereas rows 8 and 9 illustrate the assessments of the non-target lesions "NT02" and "NT03" in the skeletal muscle tissue and pericardium, respectively, were not done.  This is because the non-target lesions were obscured on the MRI and not assessable (TRSTAT = "NOT DONE" and TRREASND = "NOT EVALUABLE: Lesion obscured").

Rows 10-11: Show that at the week 20 assessment, the "NT01" and "NT02" were enlarged from a previous smallest size, i.e., TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR".

Rows 1-6: Show the screening identification of the target and non-target lesions.  For lymph node target lesions "R-T01" and "RT02" the TRTESTCD used for the assessments are "LPREP" and "LNSTATE".  For non-lymph node target lesions "R-T03" and "R-T04" the TRTESTCD used for the assessments is "LDIAM".

Rows 7-8: Show the results for the Target lesions as a group (TRGRPID = "TARGET").  The TRTESTCDs are Sum of Diameter (TRTESTCD = "SUMDIAM") and Sum Diameters of Non Lymph Node Tumors (TRTESTCD = "SUMNLNLD").

Rows 9-10: Show the results for the non-targets.  "R-NT01" is a lymph node where the TRTEST used for the assessments is "Lymph Node State" (TRTESTCD = "LNSTATE").  "R-NT02" is a non-lymph node where the TRTESTCD used for the assessments is Tumor State (TRTESTCD = "TUMSTATE").

Row 16: Shows a case where TRSTAT is "NOT DONE" with the reason for the result being not done as TRTEST of Longest Diameter with TRREASND as "SCAN NOT PERFORMED". 

Rows 17-21: Show the week 6 results for the Target lesions as a group (TRGRPID = "TARGET").  The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD". Within Row 20, the PCBSD could not be calculated because "R-T04" was not measured.  TRSTAT is assigned "NOT DONE" and TRREASND contains the reason, in this case at least one target lesion was not measured.

Rows 22-23: Show the week 6 that "R-NT02" was not not evaluable and the results the "R-NT01" non-target lesion using TRTESTCD as TUMSTATE. 

Rows 30-34: Show the week 12 results for the Target lesions as a group (TRGRPID = "TARGET").  The TRTESTCDs used for the assessments are: "SUMDIAM", "SUMNLNLD", "ACNSD", "PCBSD" and "PCNSD".

Row 70: Shows the Sum Diameters of Non Lymph node Tumors (TRTESTCD = "SUMNLNLD") is "0".  This means that the non-lymph node target tumors are all absent.