Page History

Rows 1-6: Show the screening identification of the target and non-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 for the non-targets. "NT01" is a lymph node where the TRTESTCD TRTEST used for the assessments is "Lymph Note Node State" (TRTESTCD = "LNSTATE"). "NT02" is a non-lymph node where the TRTESTCD 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 obscured").

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. Providing this The method of standardization of the TRSTRESC 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 1: Shows a case where scans the an independent radiologist found no evidence of disease (RSSTRESC = "NED") at baseline. This a rare case where a response assessment would be recorded based on the screening assessment.

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

Rows 9-10: Show the results for the for the non-targets.  "R-NT01" is a lymph node where the TRTESTCD TRTEST used for the assessments is "Lymph Note 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 Note node Tumors (TRTESTCD = "SUMNLNLD") is "0".  This means that the non-lymph node target tumors are all absent.