Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

The supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.

Dataset wrap
Namesupprssupptr
Rowcaps

Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE").  

Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX22222TR90002TRSEQ30TRREASNEReason Tumor/Lesion Not EvaluableImage obscuredCRF

...

The supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.

Dataset wrap
Namesupprssupptr
Rowcaps

Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE").  

Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX33333TR90003TRSEQ30TRREASNEReason Tumor/Lesion Not EvaluableImage obscuredCRF

...

Dataset wrap
Nametr
Rowcaps

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.

Dataset2
RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRSTATTRREASNDTRMETHODTREVALEPOCHVISITNUMVISITTRDTCTRDY
1EX55555TR900051TARGETA1T01LDIAMLongest Diameter10mm1010mm

CT SCANINVESTIGATORSCREEN1SCREENING2007-01-021
2EX55555TR900052TARGETA1
SUMDIAMSum of  Diameter10mm1010mm


INVESTIGATORSCREEN1SCREENING

3EX55555TR900053TARGETA2T01LDIAMLongest Diameter0mm00mm

CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
4EX55555TR900054TARGETA2T01TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT3WEEK 82007-02-2756
5EX55555TR900055TARGETA2
SUMDIAMSum of Diameter0mm00mm


INVESTIGATORTREATMENT3WEEK 8

6EX55555TR900056TARGETA3T01LDIAMLongest Diameter0mm00mm

CT SCANINVESTIGATORTREATMENT4.1UNCHEDULED WEEK 132007-04-0391
7EX55555TR900057TARGETA3T01TUMSTATETumor StateABSENT
ABSENT



CT SCANINVESTIGATORTREATMENT4.1UNCHEDULED WEEK 132007-04-0391
8EX55555TR900058TARGETA3
SUMDIAMSum of Diameter0mm00mm


INVESTIGATORTREATMENT4.1UNCHEDULED WEEK 13

9EX55555TR900059TARGETA4T01LDIAMLongest Diameter




NOT DONENOT EVALUABLECT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
10EX55555TR9000510TARGETA4T01TUMSTATETumor State




NOT DONENOT EVALUABLECT SCANINVESTIGATORTREATMENT5WEEK 162007-04-24112
11EX55555TR9000511TARGETA4
SUMDIAMSum of Diameter




NOT DONEMISSING DIAMETERS
INVESTIGATORTREATMENT5WEEK 16

12EX55555TR9000512TARGETA5T01LDIAMLongest Diameter5mm55mm

CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
13EX55555TR9000513TARGETA5T01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
14EX55555TR9000514TARGETA5
SUMDIAMSum of Diameter5mm55mm


INVESTIGATORTREATMENT7WEEK 24

15EX55555TR9000515NEWA5NEW01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168

The supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.

Dataset wrap
Namesupprssupptr
Rowcaps

Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE").  

Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX55555TR90005TRSEQ9TRREASNEReason Tumor/Lesion Not EvaluableMotion issueCRF
2EX55555TR90005TRSEQ10TRREASNEReason Tumor/Lesion Not EvaluableMotion issueCRF

...

The supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.

Dataset wrap
Namesupprssupptr
Rowcaps

Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE").  

Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX77777TR90007TRSEQ8TRREASNEReason Tumor/Lesion Not EvaluableScan blurryCRF
2EX77777TR90007TRSEQ9TRREASNEReason Tumor/Lesion Not EvaluableScan blurryCRF

...

The supptr.xpt table below shows the data on the reason that the tumor was not evaluable (QNAM = "TRREASNE") in the case where the reason is collected.

Dataset wrap
Namesupprssupptr
Rowcaps

Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE").  

Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX11111TR90011TRSEQ22TRREASNEReason Tumor/Lesion Not EvaluableMotion issueCRF
2EX11111TR90011TRSEQ23TRREASNEReason Tumor/Lesion Not EvaluableMotion issueCRF

...