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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.

Dataset2
RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRNAMTRMETHODTREVALTREVALIDTRACPTFLEPOCHVISITNUMVISITTRDTCTRDY
1EX44444TR900041TARGETR1-A1R1-T01LDIAMLongest Diameter15mm1515mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
2EX44444TR900042TARGETR1-A1R1-T02LDIAMLongest Diameter25mm2525mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
3EX44444TR900043TARGETR1-A1
SUMDIAMSum
of 
of Diameter40mm4040mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
4EX44444TR900044NON-TARGETR1-A1R1-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
SCREEN1SCREENING2007-01-021
5EX44444TR900045TARGETR1-A2R1-T01LDIAMLongest Diameter10mm1010mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
6EX44444TR900046TARGETR1-A2R1-T02LDIAMLongest Diameter25mm2525mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
7EX44444TR900047TARGETR1-A2
SUMDIAMSum
of 
of Diameter35mm3535mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 8

8EX44444TR900048TARGETR1-A2
PCBSDPercent Change From Baseline in Sum
of 
of Diameter-13%-13-13%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 8

9EX44444TR900049TARGETR1-A2
PCNSDPercent Change From Nadir in Sum
of 
of Diameter-13%-13-13%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 8

10EX44444TR9000410NON-TARGETR1-A2R1-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT3WEEK 82007-02-2756
11EX44444TR9000411TARGETR1-A3R1-T01LDIAMLongest Diameter5mm55mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
12EX44444TR9000412TARGETR1-A3R1-T02LDIAMLongest Diameter10mm1010mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
13EX44444TR9000413TARGETR1-A3
SUMDIAMSum
of 
of Diameter15mm1515mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 16

14EX44444TR9000414TARGETR1-A3
PCBSDPercent Change From Baseline in Sum
of 
of Diameter-63%-63-63%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 16

15EX44444TR9000415TARGETR1-A3
PCNSDPercent Change From Nadir in Sum
of 
of Diameter-57%-57-57%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 16

16EX44444TR9000416NON-TARGETR1-A3R1-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 1
TREATMENT5WEEK 162007-04-24112
17EX44444TR9000417TARGETR2-A1R2-T01LDIAMLongest Diameter25mm2525mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
18EX44444TR9000418TARGETR2-A1R2-T02LDIAMLongest Diameter20mm2020mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
19EX44444TR9000419TARGETR2-A1
SUMDIAMSum of  Diameter45mm4545mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING

20EX44444TR9000420NON-TARGETR2-A1R2-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YSCREEN1SCREENING2007-01-021
21EX44444TR9000421TARGETR2-A2R2-T01LDIAMLongest Diameter10mm1010mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
22EX44444TR9000422TARGETR2-A2R2-T02LDIAMLongest Diameter8mm88mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
23EX44444TR9000423TARGETR2-A2
SUMDIAMSum of  Diameter18mm1818mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 8

24EX44444TR9000424TARGETR2-A2
PCBSDPercent Change From Baseline in Sum
of 
of Diameter-60%-60-60%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 8

25EX44444TR9000425TARGETR2-A2
PCNSDPercent Change From Nadir in Sum of Diameter-60%-60-60%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 8

26EX44444TR9000426NON-TARGETR2-A2R2-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT3WEEK 82007-02-2756
27EX44444TR9000427TARGETR2-A3R2-T01LDIAMLongest Diameter15mm1515mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112
28EX44444TR9000428TARGETR2-A3R2-T02LDIAMLongest DiameterTOO SMALL TO MEASUREmm55mmRADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112
29EX44444TR9000429TARGETR2-A3
SUMDIAMSum
of 
of Diameter20mm2020mmRADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 16

30EX44444TR9000430TARGETR2-A3
PCBSDPercent Change From Baseline in Sum of Longest Diameter-56%-56-56%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 16

31EX44444TR9000431TARGETR2-A3
PCNSLDPercent Change From Nadir in Sum of Longest Diameter11%1111%RADIOL INC.
INDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 16

32EX44444TR9000432NON-TARGETR2-A3R2-NT01TUMSTATETumor StatePRESENT
PRESENT

RADIOL INC.CT SCANINDEPENDENT ASSESSORRADIOLOGIST 2YTREATMENT5WEEK 162007-04-24112

4.5 Example 5: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the data for a subject that has only Target tumors at screening.  This example includes an unscheduled assessment.

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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  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  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  of Diameter




NOT DONE

INVESTIGATORTREATMENT5WEEK 16

12EX55555TR9000512TARGETA5T01LDIAMLongest Diameter5mm55mm

CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168
13EX55555TR9000513TARGETA5T01TUMSTATETumor StatePRESENT
PRESENT



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


INVESTIGATORTREATMENT7WEEK 24

15EX55555TR9000515NEWA5NEW01TUMSTATETumor StatePRESENT
PRESENT



CT SCANINVESTIGATORTREATMENT7WEEK 242009-06-19168

...

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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.

Dataset2
RowSTUDYIDDOMAINUSUBJIDTRSEQTRGRPIDTRLNKGRPTRLNKIDTRTESTCDTRTESTTRORRESTRORRESUTRSTRESCTRSTRESNTRSTRESUTRNAMTRMETHODTREVALTREVALIDEPOCHVISITNUMVISITTRDTCTRDY
1EX66666TR900061TARGETA1T01LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
2EX66666TR900062TARGETA1T02LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
3EX66666TR900063TARGETA1T03LDIAMLongest Diameter5mm55mm
MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
4EX66666TR900064TARGETA1
SUMDIAMSum of  of Diameter25mm2525mm

INVESTIGATOR
SCREEN1SCREENING

5EX66666TR900065NON-TARGETA1NT01TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
6EX66666TR900066NON-TARGETA1NT02TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
SCREEN1SCREENING2007-01-011
7EX66666TR900067TARGETR1-A1R1-T01LDIAMLongest Diameter10mm1010mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
8EX66666TR900068TARGETR1-A1R1-T01LPERPLongest Perpendicular5mm55mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
9EX66666TR900069TARGETR1-A1R1-T01PPDProduct of Perpendicular Diameters50mm25050mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

10EX66666TR9000610TARGETR1-A1R1-T01VOLUMEVolume250uL250250uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
11EX66666TR9000611TARGETR1-A1R1-T02LDIAMLongest Diameter7mm77mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
12EX66666TR9000612TARGETR1-A1R1-T02LPERPLongest Perpendicular10mm1010mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
13EX66666TR9000613TARGETR1-A1R1-T02PPDProduct of Perpendicular Diameters70mm27070mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

14EX66666TR9000614TARGETR1-A1R1-T02VOLUMEVolume350uL350350uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING2007-01-011
15EX66666TR9000615TARGETR1-A1
SUMDIAMSum of  of Diameter17mm1717mmACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

16EX66666TR9000616TARGETR1-A1
SUMPPDSum of Products of Perpendicular Diameters120mm2120120mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

17EX66666TR9000617TARGETR1-A1
SUMVOLSum of Volume600uL600600uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1SCREEN1SCREENING

18EX66666TR9000618TARGETA2T01LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
19EX66666TR9000619TARGETA2T02LDIAMLongest Diameter10mm1010mm
MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
20EX66666TR9000620TARGETA2T03LDIAMLongest Diameter5mm55mm
MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
21EX66666TR9000621TARGETA2
SUMDIAMSum of  of Diameter25mm2525mm

INVESTIGATOR
TREATMENT3Cycle 2 Day 1

22EX66666TR9000622NON-TARGETA2NT01TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
23EX66666TR9000623NON-TARGETA2NT02TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
TREATMENT3Cycle 2 Day 12007-01-2828
24EX66666TR9000624TARGETR1-A2R1-T01LDIAMLongest Diameter12mm1212mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
25EX66666TR9000625TARGETR1-A2R1-T01LPERPLongest Perpendicular7mm77mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
26EX66666TR9000626TARGETR1-A2R1-T01PPDProduct of Perpendicular Diameters84mm28484mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

27EX66666TR9000627TARGETR1-A2R1-T01VOLUMEVolume420uL420420uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
28EX66666TR9000628TARGETR1-A2R1-T02LDIAMLongest Diameter6mm66mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
29EX66666TR9000629TARGETR1-A2R1-T02LPERPLongest Perpendicular9mm99mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
30EX66666TR9000630TARGETR1-A2R1-T02PPDProduct of Perpendicular Diameters54mm25454mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

31EX66666TR9000631TARGETR1-A2R1-T02VOLUMEVolume315uL315315uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 12007-01-2828
32EX66666TR9000632TARGETR1-A2
SUMDIAMSum of  of Diameter18mm1818mmACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

33EX66666TR9000633TARGETR1-A2
SUMPPDSum of Products of Perpendicular Diameters138mm2138138mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

34EX66666TR9000634TARGETR1-A2
SUMVOLSum of Volume735uL735735uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

35EX66666TR9000635TARGETR1-A2
PCBSDPercent Change From Baseline in Sum of  Diameter6%66%ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

36EX66666TR9000636TARGETR1-A2
PCBSPPDPercent Change Baseline in Sum of PPD23%2323%ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

37EX66666TR9000637TARGETR1-A2
PCBSVPercent Change From Baseline in Sum of Volume23%2323%ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT3Cycle 2 Day 1

38EX66666TR9000638NEWA3NEW01TUMSTATETumor StatePRESENT
PRESENT


MRIINVESTIGATOR
TREATMENT4Cycle 3 Day 12007-02-2656
39EX66666TR9000639NEWA3NEW01LDIAMLongest Diameter9mm99mm
MRIINVESTIGATOR
TREATMENT4Cycle 3 Day 12007-02-2656
40EX66666TR9000640NEWR1-A3R1-NEW01TUMSTATETumor StatePRESENT
PRESENT

ACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656
41EX66666TR9000641NEWR1-A3R1-NEW01LDIAMLongest Diameter9mm99mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656
42EX66666TR9000642NEWR1-A3R1-NEW01LPERPLongest Perpendicular5mm55mmACME VENDORMRIINDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656
43EX66666TR9000643NEWR1-A3R1-NEW01PPDProduct of Perpendicular Diameters45mm24545mm2ACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 1

44EX66666TR9000644NEWR1-A3R1-NEW01VOLUMEVolume270uL270270uLACME VENDOR
INDEPENDENT ASSESSORRADIOLOGIST 1TREATMENT4Cycle 3 Day 12007-02-2656

...

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Rows 1-2: Show the 2 locations of the CT SCAN for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "CHEST" and QNAM = "PRLOC2" with QVAL = "ABDOMEN".

Rows 3-6: Show the 2 locations of the CT SCAN for PRSEQ 4 and 7.

Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
1EX88888PR90008PRSEQ1PRLOC1Anatomical Location 1CHESTeDC
2EX88888PR90008PRSEQ1PRLOC2

Anatomical Location 2

ABDOMENeDC
3EX88888PR90008PRSEQ4PRLOC1

Anatomical Location 1

CHESTeDC
4EX88888PR90008PRSEQ4PRLOC2

Anatomical Location 2

ABDOMENeDC
5EX88888PR90008PRSEQ7PRLOC1

Anatomical Location 1

CHESTeDC
6EX88888PR90008PRSEQ7PRLOC2

Anatomical Location 2

ABDOMENeDC

4.9 Example 9: RECIST 1.1 example to show an assessment where independent radiologist found no evidence of disease at baseline. 

...