Page History

Rows 1-11: 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 12: Shows a new lesion state at week 24.

Row 1: Shows that the presentation of the disease in the brain is leptomeningeal carcinomatosis, i.e., for the non-target site in the brain (TULNKID = "NT01"), the QVAL is "LEPTOMENINGEAL DISEASE".

Rows 2-3: Show the plane of measurement (QNAM = "TUPLOMSR") and the slice number (QNAM = "TUSLNUM") where the brain non-target lesion (TULNKID = "NT01") was identified.

Rows 4-5: Show the plane of measurement (QNAM = "TUPLOMSR") and the slice number (QNAM = "TUSLNUM") where the skeletal muscle tissue non-target lesion (TULNKID = "NT02") was identified.
Row 6: Shows that the presentation of the disease in the pericardium is effusion, i.e., for the non-target site in the pericardium (TULNKID = "NT03"), the QVAL is "EFFUSION".

Rows 1-3: Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 12. The Target Response of partial response (PR)  is is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. The Non-Target Response of stable disease (SD) is based on the judgement of the non-target lesions/tumors taken collectively. In this case at week 12, one of the non-targets is absent and one of the non-targets has enlarged from nadir. The Overall Response is partial response (PR).

Rows 4-6: Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 24. The Target Response of complete response (CR) is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. The Non-Target Response of stable disease (SD) is based on the judgement of the non-target lesions/tumors taken collectively. In this case at week 24, one of the non-targets is absent and one of the non-targets is still present. The Overall Response is partial response (PR).

Rows 1-3: Shows Show a subject with 1 target lesion with TULNKID "R-T01" and 2 non-target lesions/sites with TULNKID "R-NT01" and "R-NT02" identified at screening. "T01" is located in the "LIVER", "R-NT01" is also located in the liver and "R-NT02" is located in the "CHEST WALL".

Rows 1-4: Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-Target lesions/sites "R-NT01" and "R-NT02" in the "LIVER" and "CHEST WALL" at screening.

Rows 5-11: Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 12. "R-T01" showed a  show a decrease from 17mm at baseline to 7mm which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. "R-NT01" has a TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "ENLARGEMENT FROM NADIR". 

Rows 12-18: Show the measurement of the "R-T01" target tumor and the tumor states of "R-NT01" and "R-NT02" non-targets at week 24. "R-T01"  was absent is absent (LDIAM = "0") which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. "R-NT01" remained TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "PRESENT".