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 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. 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.

Row 12: Shows RSCAT = "RECIST 1.1". The Overall Response (RSTESTCD = "OVRLRESP") has RSORRES = "NE" because the scans of the target and non-target lesions were not done. 

Row 13: Shows a protocol defined response which is outside of RECIST 1.1. In this case, it is symptomatic deterioration. This is represented with RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA" and Symptomatic Deterioration (RSTESTCD = "SYMPTDTR") with RSORRES = "Increased weakness and weight loss". The RSORRES contains the actual symptomatic deterioration results. The RSSTRESC = "PD" is a standardized representation of the symptomatic deterioration response.    

Row 14: Shows RSCAT= "PROTOCOL DEFINED RESPONSE CRITERIA and the Overall Response (RSTESTCD = "OVRLRESP") with RSORRES = "PD".

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 1-32: Show that two radiologists independently reviewed the scans. TRLNKGRP has values "R1-A2" and "R1-A3" to indicate the assessments by "RADIOLOGIST 1" which are linked to the results determine by "RADIOLOGIST 1" in RS. Likewise, the values "R2-A2" and "R2-A3" to indicate the assessments by "RADIOLOGIST 2" which are linked to the results determine by "RADIOLOGIST 2" in RS.
Rows 17-32: Show that the results provided by "RADIOLOGIST 2" are the accepted records (TRACPTFL). The accepted record flags are per the data transfer from the independent reviewer.

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, 18-23 and 38-39: Show Longest Diameter, Sum of Longest Diameter, and Tumor State for assessments at screening, cycle 2 and cycle 3 from the investigator. 

Rows 7-17, 24-37 and 40-44: Show the volumetric measurements at screening, cycle 2 and cycle 3 from the independent radiologist.