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Revision History
Date | Version |
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20222023-09XX-13XX | 1.0 Draft |
© 2022 Clinical 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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Rows 1-3: Show the Target Response (RSTESTCD = "TRGRESP") and Non-Target Response (RSTESTCD = "NTRGRESP") tests and corresponding Overall Response (RSTESTCD = "OVRLRESP") at the week 6 assessment. The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP is used to associate the Overall Response to underlying data in other domains (e.g., TR). Note that "NE" (Not evaluable) is a valid Overall Response value per the RECIST 1.1 criteria which means that RSORRES is "NE" rather than represented in RSSTAT. Rows 4-12: Show the week 12, week 20 and week 28 responses. Rows 13-20: At week 36, the New Lesion Progression test is used to represent an equivocal new lesion (RSTESTCD = "NEWLPROG" and RSORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (RSTESTCD = "NEWLPROG" and RSORRES = "UNEQUIVOCAL"). There are different methods of collecting data when there is an equivocal new lesion. Some sponsors update the Overall Response when equivocal evidence of a new lesion has been confirmed at a later assessment (i.e., documented as unequivocal). Other sponsors derive (in ADaM) the new progression date as the date when the new lesion was first identified. Note: Sponsor may include the New Lesion Indicator test (RSTESTCD = "NEWLIND") at every timepoint if the new lesion yes or no question is part of the data collection. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX11111 | RS | 90001 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 46 | 2 | EX11111 | RS | 90001 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 46 | 3 | EX11111 | RS | 90001 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 46 | 4 | EX11111 | RS | 90001 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-39 | 88 | 5 | EX11111 | RS | 90001 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 88 | 6 | EX11111 | RS | 90001 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 88 | 7 | EX11111 | RS | 90001 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 8 | EX11111 | RS | 90001 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 9 | EX11111 | RS | 90001 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 10 | EX11111 | RS | 90001 | 10 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 204 | 11 | EX11111 | RS | 90001 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 204 | 12 | EX11111 | RS | 90001 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 204 | 13 | EX11111 | RS | 90001 | 13 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 14 | EX11111 | RS | 90001 | 14 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 15 | EX11111 | RS | 90001 | 15 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | EQUIVOCAL | EQUIVOCAL | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 16 | EX11111 | RS | 90001 | 16 | A6 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 17 | EX11111 | RS | 90001 | 17 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 18 | EX11111 | RS | 90001 | 18 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 19 | EX11111 | RS | 90001 | 19 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | UNEQUIVOCAL | UNEQUIVOCAL | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 20 | EX11111 | RS | 90001 | 20 | A7 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 |
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Rows 1-6: Show a subject with 4 target lesions with TULNKIDs "T01"-"T04" and 2 non-target lesions with TULNKIDs "NT01" and "NT02" identified at screening. "T01" and "T02" target lesions are lymph nodes. "T01" is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). The TULOC contains the location from the anatomical location terminology. Note that some locations in controlled terminology contain laterality and/or directionality (as shown in row 7). The laterality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality. Row 7: Shows at week 36, an equivocal new lesion (TULNKID = "NEW01") was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location. Row 8-9: Show at week 44, new unequivocal new lesions (TULNKID = "NEW02" and TULNKID = "NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE"). |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUDIR | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
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1 | EX11111 | TU | 90001 | 1 | IMG-00001 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | SUPRACLAVICULAR LYMPH NODE | RIGHT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TU | 90001 | 2 | IMG-00002 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | THORACIC LYMPH NODE |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX11111 | TU | 90001 | 3 | IMG-00001 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | THYROID GLAND | LEFT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 4 | EX11111 | TU | 90001 | 4 | IMG-00003 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | SKIN OF THE TRUNK |
| UPPER | PHOTOGRAPHY | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 5 | EX11111 | TU | 90001 | 5 | IMG-00002 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | MEDIASTINAL LYMPH NODE | RIGHT |
| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 6 | EX11111 | TU | 90001 | 6 | IMG-00001 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | CEREBELLUM | RIGHT |
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | 1 | 7 | EX11111 | TU | 90001 | 7 | IMG-00020 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LUNG, LEFT LOWER LOBE |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 8 | EX11111 | TU | 90001 | 8 | IMG-00019 | NEW02 | TUMIDENT | Tumor Identification | NEW | NEW | CEREBELLUM | LEFT |
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 9 | EX11111 | TU | 90001 | 9 | IMG-00022 | NEW03 | TUMIDENT | Tumor Identification | NEW | NEW | FEMORAL LYMPH NODE | LEFT |
| ULTRASOUND | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 |
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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 EVALUABLE"). 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". |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX11111 | TR | 90001 | 1 | TARGET | IMG-00001 | A1 | T01 | LPERP | Longest Perpendicular | 17 | mm | 17 | 17 | mm |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TR | 90001 | 2 | TARGET | IMG-00001 | A1 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX11111 | TR | 90001 | 3 | TARGET | IMG-00002 | A1 | T02 | LPERP | Longest Perpendicular | 16 | mm | 16 | 16 | mm |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 4 | EX11111 | TR | 90001 | 4 | TARGET | IMG-00002 | A1 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX11111 | TR | 90001 | 5 | TARGET | IMG-00001 | A1 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 6 | EX11111 | TR | 90001 | 6 | TARGET | IMG-00003 | A1 | T04 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 7 | EX11111 | TR | 90001 | 7 | NON-TARGET | IMG-00002 | A1 | NT01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 8 | EX11111 | TR | 90001 | 8 | NON-TARGET | IMG-00001 | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 9 | EX11111 | TR | 90001 | 9 | TARGET | IMG-00004 | A2 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 10 | EX11111 | TR | 90001 | 10 | TARGET | IMG-00004 | A2 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 11 | EX11111 | TR | 90001 | 11 | TARGET | IMG-00005 | A2 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 12 | EX11111 | TR | 90001 | 12 | TARGET | IMG-00005 | A2 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 13 | EX11111 | TR | 90001 | 13 | TARGET | IMG-00004 | A2 | T03 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 14 | EX11111 | TR | 90001 | 14 | TARGET |
| A2 | T04 | LDIAM | Longest Diameter |
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| NOT DONE | SCAN NOT PERFORMED | PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 40 | WEEK 6 |
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| 15 | EX11111 | TR | 90001 | 15 | NON-TARGET | IMG-00005 | A2 | NT01 | LNSTATE | Lymph Node State |
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| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 16 | EX11111 | TR | 90001 | 16 | NON-TARGET | IMG-00004 | A2 | NT02 | TUMSTATE | Tumor State |
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| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 17 | EX11111 | TR | 90001 | 17 | TARGET | IMG-00007 | A3 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 18 | EX11111 | TR | 90001 | 18 | TARGET | IMG-00007 | A3 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 19 | EX11111 | TR | 90001 | 19 | TARGET | IMG-00008 | A3 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 20 | EX11111 | TR | 90001 | 20 | TARGET | IMG-00008 | A3 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 21 | EX11111 | TR | 90001 | 21 | TARGET | IMG-00007 | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 22 | EX11111 | TR | 90001 | 22 | TARGET | IMG-00009 | A3 | T04 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 23 | EX11111 | TR | 90001 | 23 | NON-TARGET | IMG-00008 | A3 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 24 | EX11111 | TR | 90001 | 24 | NON-TARGET | IMG-00007 | A3 | NT02 | TUMSTATE | Tumor State |
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| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 25 | EX11111 | TR | 90001 | 25 | TARGET | IMG-00010 | A4 | T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 26 | EX11111 | TR | 90001 | 26 | TARGET | IMG-00010 | A4 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 27 | EX11111 | TR | 90001 | 27 | TARGET | IMG-00011 | A4 | T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 28 | EX11111 | TR | 90001 | 28 | TARGET | IMG-00011 | A4 | T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 29 | EX11111 | TR | 90001 | 29 | TARGET | IMG-00010 | A4 | T03 | LDIAM | Longest Diameter | 11 | mm | 11 | 11 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 30 | EX11111 | TR | 90001 | 30 | TARGET | IMG-00012 | A4 | T04 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 31 | EX11111 | TR | 90001 | 31 | NON-TARGET | IMG-00011 | A4 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 32 | EX11111 | TR | 90001 | 32 | NON-TARGET | IMG-00010 | A4 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 33 | EX11111 | TR | 90001 | 33 | TARGET | IMG-00013 | A5 | T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 34 | EX11111 | TR | 90001 | 34 | TARGET | IMG-00013 | A5 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 35 | EX11111 | TR | 90001 | 35 | TARGET | IMG-00014 | A5 | T02 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 36 | EX11111 | TR | 90001 | 36 | TARGET | IMG-00014 | A5 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 37 | EX11111 | TR | 90001 | 37 | TARGET | IMG-00013 | A5 | T03 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 38 | EX11111 | TR | 90001 | 38 | TARGET | IMG-00015 | A5 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 39 | EX11111 | TR | 90001 | 39 | NON-TARGET | IMG-00014 | A5 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 40 | EX11111 | TR | 90001 | 40 | NON-TARGET | IMG-00013 | A5 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
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| MRI | INVESTIGATOR | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 41 | EX11111 | TR | 90001 | 41 | TARGET | IMG-00016 | A6 | T01 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 42 | EX11111 | TR | 90001 | 42 | TARGET | IMG-00016 | A6 | T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 43 | EX11111 | TR | 90001 | 43 | TARGET | IMG-00017 | A6 | T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 44 | EX11111 | TR | 90001 | 44 | TARGET | IMG-00017 | A6 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 45 | EX11111 | TR | 90001 | 45 | TARGET | IMG-00016 | A6 | T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 46 | EX11111 | TR | 90001 | 46 | TARGET | IMG-00018 | A6 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
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| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 47 | EX11111 | TR | 90001 | 47 | NON-TARGET | IMG-00017 | A6 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 48 | EX11111 | TR | 90001 | 48 | NON-TARGET | IMG-00016 | A6 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
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| MRI | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 49 | EX11111 | TR | 90001 | 49 | NEW | IMG-00017 | A6 | NEW01 | TUMSTATE | Tumor State | EQUIVOCAL |
| EQUIVOCAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 50 | EX11111 | TR | 90001 | 50 | TARGET | IMG-00019 | A7 | T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
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| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 51 | EX11111 | TR | 90001 | 51 | TARGET | IMG-00019 | A7 | T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
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| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 52 | EX11111 | TR | 90001 | 52 | TARGET | IMG-00020 | A7 | T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
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| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 53 | EX11111 | TR | 90001 | 53 | TARGET | IMG-00020 | A7 | T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
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| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 54 | EX11111 | TR | 90001 | 54 | TARGET | IMG-00019 | A7 | T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 55 | EX11111 | TR | 90001 | 55 | TARGET | IMG-00021 | A7 | T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 56 | EX11111 | TR | 90001 | 56 | NON-TARGET | IMG-00020 | A7 | NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 57 | EX11111 | TR | 90001 | 57 | NON-TARGET | IMG-00019 | A7 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 58 | EX11111 | TR | 90001 | 58 | NEW | IMG-00020 | A7 | NEW01 | LDIAM | Longest Diameter | 4 | mm | 4 | 4 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 59 | EX11111 | TR | 90001 | 59 | NEW | IMG-00020 | A7 | NEW01 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 60 | EX11111 | TR | 90001 | 60 | NEW | IMG-00019 | A7 | NEW02 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm |
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 61 | EX11111 | TR | 90001 | 61 | NEW | IMG-00019 | A7 | NEW02 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 62 | EX11111 | TR | 90001 | 62 | NEW | IMG-00022 | A7 | NEW03 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| ULTRASOUND | INVESTIGATOR | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 315 | |
|
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Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE"). |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX11111 | TR | 90001 | TRSEQ | 15 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Imaging quality issues | CRF | 2 | EX11111 | TR | 90001 | TRSEQ | 16 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF | 3 | EX11111 | TR | 90001 | TRSEQ | 24 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Imaging quality issues | CRF |
|
|
4.1.4 PR Domain Model
The pr.xpt table below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at screening, week 6, week 12 and subsequent 8-week follow-up visits. The example shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin of the trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN OF THE TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.
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Rows 1-12: Show the Target Response (RSTESTCD = "TRGRESP"), Non-Target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") at week 8, 16, 24 and 32. RSLNKGRP is used to link the Overall Response to the underlying assessments in the TR domain which support the Overall Response at the assessment. |
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX22222 | RS | 90002 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX22222 | RS | 90002 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX22222 | RS | 90002 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX22222 | RS | 90002 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 5 | EX22222 | RS | 90002 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX22222 | RS | 90002 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX22222 | RS | 90002 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 8 | EX22222 | RS | 90002 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 9 | EX22222 | RS | 90002 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 10 | EX22222 | RS | 90002 | 10 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | 11 | EX22222 | RS | 90002 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | 12 | EX22222 | RS | 90002 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 |
|
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Rows 7-8: Show the identification of a split tumor when it was first identified as split (fragmented). In this example, TULNKID = "T04" splits into two tumors TULNKID = "T04.1" and TULNKID = "T04.2" with TUGRPID = "T04". TUGRPID = "T04" provides traceability and links the split tumor to its parent records. Row 9: Shows the identification of a merged tumor when it was first identified as merged (coalesced). In this example, TULNKID = "T02" and TULNKID = "T03" merged into tumor TULNKID = "T02/T03". The TULNKID is a combination of the child tumors and therefore provides the traceability back to the child tumors. |
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TUREFID | TUSPID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX22222 | TU | 90002 | 1 |
| IMG-00001 | TRG-SCR-01 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, RIGHT MIDDLE LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX22222 | TU | 90002 | 2 |
| IMG-00001 | TRG-SCR-02 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX22222 | TU | 90002 | 3 |
| IMG-00001 | TRG-SCR-03 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX22222 | TU | 90002 | 4 |
| IMG-00001 | TRG-SCR-04 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX22222 | TU | 90002 | 5 |
| IMG-00001 | NTG-SCR-01 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | LUNG | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX22222 | TU | 90002 | 6 |
| IMG-00001 | NTG-SCR-02 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | LIVER | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX22222 | TU | 90002 | 7 | T04 | IMG-00002 | TRG-W16-07 | T04.1 | TUSPLIT | Tumor Split | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 8 | EX22222 | TU | 90002 | 8 | T04 | IMG-00002 | TRG-W16-08 | T04.2 | TUSPLIT | Tumor Split | TARGET | TARGET | KIDNEY, UPPER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 9 | EX22222 | TU | 90002 | 9 |
| IMG-00003 | TRG-W28-07 | T02/T03 | TUMERGE | Tumor Merged | TARGET | TARGET | LUNG, LEFT LOWER LOBE | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 10 | EX22222 | TU | 90002 | 10 |
| IMG-00004 | NWT-W32-01 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LIVER | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-14 | 224 | |
|
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Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE"). |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX22222 | TR | 90002 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
|
|
4.3 Example 3: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data.
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Rows 1-7: Show a subject with 4 target lesions with TULNKID "T01"-"T04" and 3 non-target lesions with TULNKID "NT01"-"NT03" identified at screening. The subject did not have any new lesions. |
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUMETHOD | TUEVAL | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX33333 | TU | 90003 | 1 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LUNG, RIGHT MIDDLE LOBE |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX33333 | TU | 90003 | 2 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LIVER |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX33333 | TU | 90003 | 3 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| LIVER |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX33333 | TU | 90003 | 4 | T04 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| KIDNEY, UPPER LOBE | RIGHT | CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX33333 | TU | 90003 | 5 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| LUNG |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX33333 | TU | 90003 | 6 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| ABDOMINAL CAVITY |
| CT SCAN | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX33333 | TU | 90003 | 7 | NT03 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| CLAVICLE | RIGHT | SCINTIGRAPHY | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | |
|
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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. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
---|
1 | EX33333 | TR | 90003 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 16 | mm | 16 | 16 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX33333 | TR | 90003 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 28 | mm | 28 | 28 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX33333 | TR | 90003 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 41 | mm | 41 | 41 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX33333 | TR | 90003 | 4 | TARGET | A1 | T04 | LDIAM | Longest Diameter | 82 | mm | 83 | 83 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX33333 | TR | 90003 | 5 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 167 | mm | 168 | 168 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| 6 | EX33333 | TR | 90003 | 6 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 7 | EX33333 | TR | 90003 | 7 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 8 | EX33333 | TR | 90003 | 8 | NON-TARGET | A1 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| SCINTIGRAPHY | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 9 | EX33333 | TR | 90003 | 9 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 10 | EX33333 | TR | 90003 | 10 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX33333 | TR | 90003 | 11 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 12 | EX33333 | TR | 90003 | 12 | TARGET | A2 | T04 | LDIAM | Longest Diameter | 65 | mm | 65 | 65 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 13 | EX33333 | TR | 90003 | 13 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 125 | mm | 125 | 125 | mm |
|
|
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 14 | EX33333 | TR | 90003 | 14 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 15 | EX33333 | TR | 90003 | 15 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 16 | EX33333 | TR | 90003 | 16 | NON-TARGET | A2 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 17 | EX33333 | TR | 90003 | 17 | TARGET | A3 | T01 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 18 | EX33333 | TR | 90003 | 18 | TARGET | A3 | T02 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 19 | EX33333 | TR | 90003 | 19 | TARGET | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 20 | EX33333 | TR | 90003 | 20 | TARGET | A3 | T04 | LDIAM | Longest Diameter | 40 | mm | 40 | 40 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 21 | EX33333 | TR | 90003 | 21 | TARGET | A3 |
| SUMDIAM | Sum of Diameter | 72 | mm | 72 | 72 | mm |
|
|
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| 22 | EX33333 | TR | 90003 | 22 | NON-TARGET | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 23 | EX33333 | TR | 90003 | 23 | NON-TARGET | A3 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 24 | EX33333 | TR | 90003 | 24 | NON-TARGET | A3 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| 25 | EX33333 | TR | 90003 | 25 | TARGET | A4 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 26 | EX33333 | TR | 90003 | 26 | TARGET | A4 | T02 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 27 | EX33333 | TR | 90003 | 27 | TARGET | A4 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 28 | EX33333 | TR | 90003 | 28 | TARGET | A4 | T04 | LDIAM | Longest Diameter | 36 | mm | 36 | 36 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 29 | EX33333 | TR | 90003 | 29 | TARGET | A4 |
| SUMDIAM | Sum of Diameter | 56 | mm | 56 | 56 | mm |
|
|
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 |
|
| 30 | EX33333 | TR | 90003 | 30 | NON-TARGET | A4 | NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 31 | EX33333 | TR | 90003 | 31 | NON-TARGET | A4 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 32 | EX33333 | TR | 90003 | 32 | NON-TARGET | A4 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | 33 | EX33333 | TR | 90003 | 33 | TARGET | A5 | T01 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 34 | EX33333 | TR | 90003 | 34 | TARGET | A5 | T02 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 35 | EX33333 | TR | 90003 | 35 | TARGET | A5 | T03 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 36 | EX33333 | TR | 90003 | 36 | TARGET | A5 | T04 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 37 | EX33333 | TR | 90003 | 37 | NON-TARGET | A5 | NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 38 | EX33333 | TR | 90003 | 38 | NON-TARGET | A5 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| 39 | EX33333 | TR | 90003 | 39 | NON-TARGET | A5 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | SCINTIGRAPHY | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
|
|
|
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Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE"). |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX33333 | TR | 90003 | TRSEQ | 30 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Image obscured | CRF |
|
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4.4 Example 4: RECIST 1.1 example to show independent assessor response (RS) data and the underlying tumor identification (TU), and tumor results (TR) data. This example shows the use of the acceptance flag to identify records when multiple assessments are performed by independent assessors (Radiologist 1 and Radiologist 2) for the same timepoint.
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Rows 1-16: Show data from an independent review where the RSNAM, RSEVAL and RSEVALID are used. The RSNAM contains the name of the vendor, the RSEVAL contains role of the person who provided the assessment, in this case, RSEVAL = "INDEPENDENT ASSESSOR" and the RSEVALID contains the specific type of medical reviewer who performed the independent assessment. In this case, two radiologists independently reviewed the scans. The RSEVALID indicates the assessments by 'RADIOLOGIST 1" and "RADIOLOGIST 2". The acceptance flag (RSACPTFL) indicates that the "RADIOLOGIST 2" records are the accepted records in rows 9-16. The Best Overall Response (RSTESTCD = "BESTRESP") is provided by the vendor in the data transfer in rows 4, 8, 12 and 16. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | RSACPTFL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX44444 | RS | 90004 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX44444 | RS | 90004 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX44444 | RS | 90004 | 3 | R1-A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX44444 | RS | 90004 | 4 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 5 | EX44444 | RS | 90004 | 5 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX44444 | RS | 90004 | 6 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX44444 | RS | 90004 | 7 | R1-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 8 | EX44444 | RS | 90004 | 8 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 9 | EX44444 | RS | 90004 | 9 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 10 | EX44444 | RS | 90004 | 10 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX44444 | RS | 90004 | 11 | R2-A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 12 | EX44444 | RS | 90004 | 12 |
| BESTRESP | Best Overall Response | RECIST 1.1 | SD | SD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 13 | EX44444 | RS | 90004 | 13 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 14 | EX44444 | RS | 90004 | 14 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 15 | EX44444 | RS | 90004 | 15 | R2-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 16 | EX44444 | RS | 90004 | 16 |
| BESTRESP | Best Overall Response | RECIST 1.1 | PR | PR | RADIOL INC. | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | |
|
...
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Rows 1-3: Show the identification of two target lesions "R1-T01" and "R1-T02"and one non-target lesion "R1-NT01" by independent radiologist (TUEVALID = "RADIOLOGIST 1"). Rows 4-6: Show the identification of two target lesions "R2-T01" and "R2-T02"and one non-target lesion "R2-NT01" by another independent radiologist (TUEVALID = "RADIOLOGIST 2"). |
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUMETHOD | TUEVAL | TUEVALID | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX44444 | TU | 90004 | 1 | R1-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | LIVER |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX44444 | TU | 90004 | 2 | R1-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | KIDNEY, UPPER LOBE | LEFT | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX44444 | TU | 90004 | 3 | R1-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL INC. | ABDOMINAL CAVITY |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX44444 | TU | 90004 | 4 | R2-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | KIDNEY, UPPER LOBE | LEFT | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX44444 | TU | 90004 | 5 | R2-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL INC. | LIVER |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 6 | EX44444 | TU | 90004 | 6 | R2-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL INC. | ABDOMINAL CAVITY |
| CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | |
|
...
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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 |
---|
Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | TRACPTFL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
---|
1 | EX44444 | TR | 90004 | 1 | TARGET | R1-A1 | R1-T01 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX44444 | TR | 90004 | 2 | TARGET | R1-A1 | R1-T02 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 3 | EX44444 | TR | 90004 | 3 | TARGET | R1-A1 |
| SUMDIAM | Sum of Diameter | 40 | mm | 40 | 40 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 4 | EX44444 | TR | 90004 | 4 | NON-TARGET | R1-A1 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 5 | EX44444 | TR | 90004 | 5 | TARGET | R1-A2 | R1-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 6 | EX44444 | TR | 90004 | 6 | TARGET | R1-A2 | R1-T02 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 7 | EX44444 | TR | 90004 | 7 | TARGET | R1-A2 |
| SUMDIAM | Sum of Diameter | 35 | mm | 35 | 35 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
|
| 8 | EX44444 | TR | 90004 | 8 | TARGET | R1-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -13 | % | -13 | -13 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
|
| 9 | EX44444 | TR | 90004 | 9 | TARGET | R1-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -13 | % | -13 | -13 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 |
|
| 10 | EX44444 | TR | 90004 | 10 | NON-TARGET | R1-A2 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 11 | EX44444 | TR | 90004 | 11 | TARGET | R1-A3 | R1-T01 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 12 | EX44444 | TR | 90004 | 12 | TARGET | R1-A3 | R1-T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 13 | EX44444 | TR | 90004 | 13 | TARGET | R1-A3 |
| SUMDIAM | Sum of Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
|
| 14 | EX44444 | TR | 90004 | 14 | TARGET | R1-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -63 | % | -63 | -63 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
|
| 15 | EX44444 | TR | 90004 | 15 | TARGET | R1-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -57 | % | -57 | -57 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 |
|
| 16 | EX44444 | TR | 90004 | 16 | NON-TARGET | R1-A3 | R1-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 1 |
| TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 17 | EX44444 | TR | 90004 | 17 | TARGET | R2-A1 | R2-T01 | LDIAM | Longest Diameter | 25 | mm | 25 | 25 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 18 | EX44444 | TR | 90004 | 18 | TARGET | R2-A1 | R2-T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 19 | EX44444 | TR | 90004 | 19 | TARGET | R2-A1 |
| SUMDIAM | Sum of Diameter | 45 | mm | 45 | 45 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING |
|
| 20 | EX44444 | TR | 90004 | 20 | NON-TARGET | R2-A1 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 21 | EX44444 | TR | 90004 | 21 | TARGET | R2-A2 | R2-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 22 | EX44444 | TR | 90004 | 22 | TARGET | R2-A2 | R2-T02 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 23 | EX44444 | TR | 90004 | 23 | TARGET | R2-A2 |
| SUMDIAM | Sum of Diameter | 18 | mm | 18 | 18 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
|
| 24 | EX44444 | TR | 90004 | 24 | TARGET | R2-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -60 | % | -60 | -60 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
|
| 25 | EX44444 | TR | 90004 | 25 | TARGET | R2-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -60 | % | -60 | -60 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 |
|
| 26 | EX44444 | TR | 90004 | 26 | NON-TARGET | R2-A2 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 27 | EX44444 | TR | 90004 | 27 | TARGET | R2-A3 | R2-T01 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 28 | EX44444 | TR | 90004 | 28 | TARGET | R2-A3 | R2-T02 | LDIAM | Longest Diameter | TOO SMALL TO MEASURE | mm | 5 | 5 | mm | RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 29 | EX44444 | TR | 90004 | 29 | TARGET | R2-A3 |
| SUMDIAM | Sum of Diameter | 20 | mm | 20 | 20 | mm | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
|
| 30 | EX44444 | TR | 90004 | 30 | TARGET | R2-A3 |
| PCBSD | Percent Change From Baseline in Sum of Longest Diameter | -56 | % | -56 | -56 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
|
| 31 | EX44444 | TR | 90004 | 31 | TARGET | R2-A3 |
| PCNSLD | Percent Change From Nadir in Sum of Longest Diameter | 11 | % | 11 | 11 | % | RADIOL INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 |
|
| 32 | EX44444 | TR | 90004 | 32 | NON-TARGET | R2-A3 | R2-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST 2 | Y | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 |
|
|
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Rows 1-2: Show the Target Response (RSTESTCD = "TRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") of CR (Complete Response) at week 8. The subject only has one target lesion and no non-targets. The Non-target Response (RSTESTCD = "NTRGRESP") is not applicable and a record may be included to represent this, if desired. Rows 3-4: Show an unscheduled response assessment which was done to confirm the complete response ("CR"). The RSLNKGRP differentiates the assessment and the VISIT is "UNSCHEDULED WEEK 13". Rows 5-6: Show Target Response (RSTESTCD = "TRGRESP") of not evaluable ("NE") and Overall Response (RSTESTCD = "OVRLRESP") of not evaluable ("NE") due to an unreadable image. |
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX55555 | RS | 90005 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 2 | EX55555 | RS | 90005 | 2 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 3 | EX55555 | RS | 90005 | 3 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 4 | EX55555 | RS | 90005 | 4 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 5 | EX55555 | RS | 90005 | 5 |
| TRGRESP | Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 6 | EX55555 | RS | 90005 | 6 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 7 | EX55555 | RS | 90005 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 8 | EX55555 | RS | 90005 | 8 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | |
|
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Row 1: Shows that the subject has at least one target tumor (TUTESTCD = "TIND"), i.e., the subject has measurable disease. Prior to SDTMIG 3.4, this row would not be included. However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU. Row 2: Shows that the subject does not have any non-target tumors (TUTESTCD = "NTIND"). Prior to SDTMIG 3.4, this row would not be included. However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU. Row 3: Shows the single target lesion in the breast. The subject only has one target lesion and no non-targets. Row 4: Shows new bone lesion identified at week 24. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX55555 | TU | 90005 | 1 |
| TIND | Target Indicator | Y | Y |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX55555 | TU | 90005 | 2 |
| NTIND | Non-Target Indicator | N | N |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX55555 | TU | 90005 | 3 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | BREAST | RIGHT | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX55555 | TU | 90005 | 4 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | BONE |
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | |
|
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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 |
---|
Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
---|
1 | EX55555 | TR | 90005 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | 2 | EX55555 | TR | 90005 | 2 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 10 | mm | 10 | 10 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| 3 | EX55555 | TR | 90005 | 3 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 4 | EX55555 | TR | 90005 | 4 | TARGET | A2 | T01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | 5 | EX55555 | TR | 90005 | 5 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm |
|
|
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| 6 | EX55555 | TR | 90005 | 6 | TARGET | A3 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 7 | EX55555 | TR | 90005 | 7 | TARGET | A3 | T01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 | 2007-04-03 | 91 | 8 | EX55555 | TR | 90005 | 8 | TARGET | A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm |
|
|
| INVESTIGATOR | TREATMENT | 4.1 | UNCHEDULED WEEK 13 |
|
| 9 | EX55555 | TR | 90005 | 9 | TARGET | A4 | T01 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 10 | EX55555 | TR | 90005 | 10 | TARGET | A4 | T01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | 11 | EX55555 | TR | 90005 | 11 | TARGET | A4 |
| SUMDIAM | Sum of Diameter |
|
|
|
|
| NOT DONE | MISSING DIAMETERS |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| 12 | EX55555 | TR | 90005 | 12 | TARGET | A5 | T01 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 13 | EX55555 | TR | 90005 | 13 | TARGET | A5 | T01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | 14 | EX55555 | TR | 90005 | 14 | TARGET | A5 |
| SUMDIAM | Sum of Diameter | 5 | mm | 5 | 5 | mm |
|
|
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 |
|
| 15 | EX55555 | TR | 90005 | 15 | NEW | A5 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 |
|
|
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Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE"). |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX55555 | TR | 90005 | TRSEQ | 9 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF | 2 | EX55555 | TR | 90005 | TRSEQ | 10 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF |
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4.6 Example 6: RECIST 1.1 example to show investigator and independent assessor response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data. This example shows the investigator tumor identification, tumor results, and response data using RECIST 1.1 along with the independent radiologist's tumor identification, tumor results, and response data using volumetric measurements.
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Rows 1-6: Show response assessments at cycle 2 and cycle 3 from the investigator following RECIST 1.1. Rows 7-8: Show response assessments at cycle 2 and cycle 3 from the independent radiologist using protocol specified response criteria based on volumetric measurements (RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA"). |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | RSACPTFL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX66666 | RS | 90006 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
|
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 2 | EX66666 | RS | 90006 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR |
|
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 3 | EX66666 | RS | 90006 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
|
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 4 | EX66666 | RS | 90006 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 5 | EX66666 | RS | 90006 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 6 | EX66666 | RS | 90006 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD |
| INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 7 | EX66666 | RS | 90006 | 7 | R1-A2 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | SD | SD | ACME VENDOR | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 8 | EX66666 | RS | 90006 | 8 | R1-A3 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | PD | PD | ACME VENDOR | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
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Rows 1-5: Show the identification of three target lesions "T01", "T02" and "T03", and 2 non-target lesions "NT01" and "NT02" by investigator. Rows 6-7: Show the identification of two target lesions "R-T01" and "R-T02" by the independent radiologist. Row 8: Shows the identification of a new tumor "NEW01" by investigator. Row 9: Shows the identification of a new tumor "R-NEW01" by independent radiologist. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TULAT | TUDIR | TUMETHOD | TUEVAL | TUEVALID | TUACPTFL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX66666 | TU | 90006 | 1 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| OCCIPITAL LOBE | LEFT | ANTERIOR | MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX66666 | TU | 90006 | 2 | T02 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| OCCIPITAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX66666 | TU | 90006 | 3 | T03 | TUMIDENT | Tumor Identification | TARGET | TARGET |
| TEMPORAL LOBE | LEFT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX66666 | TU | 90006 | 4 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| FRONTAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 5 | EX66666 | TU | 90006 | 5 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET |
| CEREBELLUM | LEFT |
| MRI | INVESTIGATOR |
|
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX66666 | TU | 90006 | 6 | R1-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | OCCIPITAL LOBE | RIGHT | ANTERIOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX66666 | TU | 90006 | 7 | R1-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | TEMPORAL LOBE | LEFT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 8 | EX66666 | TU | 90006 | 8 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW |
| FRONTAL LOBE | RIGHT |
| MRI | INVESTIGATOR |
|
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 9 | EX66666 | TU | 90006 | 9 | R1-NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | ACME VENDOR | FRONTAL LOBE | RIGHT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
|
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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 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
---|
1 | EX66666 | TR | 90006 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX66666 | TR | 90006 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX66666 | TR | 90006 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX66666 | TR | 90006 | 4 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 25 | mm | 25 | 25 | mm |
|
| INVESTIGATOR |
| SCREEN | 1 | SCREENING |
|
| 5 | EX66666 | TR | 90006 | 5 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 6 | EX66666 | TR | 90006 | 6 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 7 | EX66666 | TR | 90006 | 7 | TARGET | R1-A1 | R1-T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 8 | EX66666 | TR | 90006 | 8 | TARGET | R1-A1 | R1-T01 | LPERP | Longest Perpendicular | 5 | mm | 5 | 5 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 9 | EX66666 | TR | 90006 | 9 | TARGET | R1-A1 | R1-T01 | PPD | Product of Perpendicular Diameters | 50 | mm2 | 50 | 50 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 10 | EX66666 | TR | 90006 | 10 | TARGET | R1-A1 | R1-T01 | VOLUME | Volume | 250 | uL | 250 | 250 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 11 | EX66666 | TR | 90006 | 11 | TARGET | R1-A1 | R1-T02 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 12 | EX66666 | TR | 90006 | 12 | TARGET | R1-A1 | R1-T02 | LPERP | Longest Perpendicular | 10 | mm | 10 | 10 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 13 | EX66666 | TR | 90006 | 13 | TARGET | R1-A1 | R1-T02 | PPD | Product of Perpendicular Diameters | 70 | mm2 | 70 | 70 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 14 | EX66666 | TR | 90006 | 14 | TARGET | R1-A1 | R1-T02 | VOLUME | Volume | 350 | uL | 350 | 350 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 15 | EX66666 | TR | 90006 | 15 | TARGET | R1-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 16 | EX66666 | TR | 90006 | 16 | TARGET | R1-A1 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 120 | mm2 | 120 | 120 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 17 | EX66666 | TR | 90006 | 17 | TARGET | R1-A1 |
| SUMVOL | Sum of Volume | 600 | uL | 600 | 600 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | SCREEN | 1 | SCREENING |
|
| 18 | EX66666 | TR | 90006 | 18 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 19 | EX66666 | TR | 90006 | 19 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 20 | EX66666 | TR | 90006 | 20 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 21 | EX66666 | TR | 90006 | 21 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 25 | mm | 25 | 25 | mm |
|
| INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 |
|
| 22 | EX66666 | TR | 90006 | 22 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 23 | EX66666 | TR | 90006 | 23 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 24 | EX66666 | TR | 90006 | 24 | TARGET | R1-A2 | R1-T01 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 25 | EX66666 | TR | 90006 | 25 | TARGET | R1-A2 | R1-T01 | LPERP | Longest Perpendicular | 7 | mm | 7 | 7 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 26 | EX66666 | TR | 90006 | 26 | TARGET | R1-A2 | R1-T01 | PPD | Product of Perpendicular Diameters | 84 | mm2 | 84 | 84 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 27 | EX66666 | TR | 90006 | 27 | TARGET | R1-A2 | R1-T01 | VOLUME | Volume | 420 | uL | 420 | 420 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 28 | EX66666 | TR | 90006 | 28 | TARGET | R1-A2 | R1-T02 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 29 | EX66666 | TR | 90006 | 29 | TARGET | R1-A2 | R1-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 30 | EX66666 | TR | 90006 | 30 | TARGET | R1-A2 | R1-T02 | PPD | Product of Perpendicular Diameters | 54 | mm2 | 54 | 54 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 31 | EX66666 | TR | 90006 | 31 | TARGET | R1-A2 | R1-T02 | VOLUME | Volume | 315 | uL | 315 | 315 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 | 2007-01-28 | 28 | 32 | EX66666 | TR | 90006 | 32 | TARGET | R1-A2 |
| SUMDIAM | Sum of Diameter | 18 | mm | 18 | 18 | mm | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 33 | EX66666 | TR | 90006 | 33 | TARGET | R1-A2 |
| SUMPPD | Sum of Products of Perpendicular Diameters | 138 | mm2 | 138 | 138 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 34 | EX66666 | TR | 90006 | 34 | TARGET | R1-A2 |
| SUMVOL | Sum of Volume | 735 | uL | 735 | 735 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 35 | EX66666 | TR | 90006 | 35 | TARGET | R1-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | 6 | % | 6 | 6 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 36 | EX66666 | TR | 90006 | 36 | TARGET | R1-A2 |
| PCBSPPD | Percent Change Baseline in Sum of PPD | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 37 | EX66666 | TR | 90006 | 37 | TARGET | R1-A2 |
| PCBSV | Percent Change From Baseline in Sum of Volume | 23 | % | 23 | 23 | % | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 3 | Cycle 2 Day 1 |
|
| 38 | EX66666 | TR | 90006 | 38 | NEW | A3 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 39 | EX66666 | TR | 90006 | 39 | NEW | A3 | NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm |
| MRI | INVESTIGATOR |
| TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 40 | EX66666 | TR | 90006 | 40 | NEW | R1-A3 | R1-NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 41 | EX66666 | TR | 90006 | 41 | NEW | R1-A3 | R1-NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 42 | EX66666 | TR | 90006 | 42 | NEW | R1-A3 | R1-NEW01 | LPERP | Longest Perpendicular | 5 | mm | 5 | 5 | mm | ACME VENDOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | 43 | EX66666 | TR | 90006 | 43 | NEW | R1-A3 | R1-NEW01 | PPD | Product of Perpendicular Diameters | 45 | mm2 | 45 | 45 | mm2 | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 |
|
| 44 | EX66666 | TR | 90006 | 44 | NEW | R1-A3 | R1-NEW01 | VOLUME | Volume | 270 | uL | 270 | 270 | uL | ACME VENDOR |
| INDEPENDENT ASSESSOR | RADIOLOGIST 1 | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 |
|
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Rows 1-3: Show the week 6 response assessment for a subject with non-target disease only. The Target Response (RSTESTCD = "TRGRESP") is not applicable for subjects with non-target disease only. This can be represented as RSSTAT = "NOT DONE" and RSREASND = "Subject does not have target lesions". The Non-Target Response (RSTESTCD = "NTRGRESP") is non complete response/non progressive disease (NON-CR/NON-PD). The Overall Response (RSTESTCD = "OVRLRESP") is non complete response/non progressive disease (NON-CR/NON-PD) which is a valid Overall Response in RECIST 1.1 for subjects with non-target disease only. Rows 4-6: Show the week 12 response assessment for a subject with non-target disease only. The Non-Target Response (RSTESTCD = "NTRGRESP") is NE (Not Evaluable) because not all non-target lesions were evaluated and none of the evaluated non-targets showed progression. The brain did not show progression and the assessments of the non-target lesions in the skeletal muscle tissue and pericardium were not done because the non-target lesions were obscured on the MRI and not assessable. Therefore, the Overall Response (RSTESTCD = "OVRLRESP") is "NE" (not evaluable). Note that "NE" is a valid Overall Response value per the RECIST 1.1 criteria which means it that RSORRES is "NE" rather than represented in RSSTAT. Rows 7-9: Show the week 20 assessment where the non-targets were enlarged from a previous smallest size. The Non-Target Response (RSTESTCD = "NTRGRESP") is "PD" (progressive disease) which results in an Overall Response (RSTESTCD = "OVRLRESP") of "PD". |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY | RSSTAT | RSREASND |
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1 | EX77777 | RS | 90007 | 1 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | NOT DONE | Subject does not have target lesions | 2 | EX77777 | RS | 90007 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 |
|
| 3 | EX77777 | RS | 90007 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 |
|
| 4 | EX77777 | RS | 90007 | 4 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | NOT DONE | Subject does not have target lesions | 5 | EX77777 | RS | 90007 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 |
|
| 6 | EX77777 | RS | 90007 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 |
|
| 7 | EX77777 | RS | 90007 | 7 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | NOT DONE | Subject does not have target lesions | 8 | EX77777 | RS | 90007 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 |
|
| 9 | EX77777 | RS | 90007 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 |
|
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Row 1: Shows that the subject has no target tumors (TUTESTCD = "TIND"), i.e., the subject does not have measurable disease. Row 2: Shows that the subject has non-target tumors (TUTESTCD = "NTIND"). The subject has non-measurable only disease. Rows 3-5: Show the identification of 3 non-target lesions for a subject with non-target disease only. See below for details on on the tumor presentation type (QNAM = "TUPRTYP") supplemental qualifier. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX77777 | TU | 90007 | 1 |
|
| TIND | Target Indicator | N | N |
|
| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 2 | EX77777 | TU | 90007 | 2 |
|
| NTIND | Non-Target Indicator | Y | Y |
|
| INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 3 | EX77777 | TU | 90007 | 3 | IMG-00001 | NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | BRAIN | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 4 | EX77777 | TU | 90007 | 4 | IMG-00002 | NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | SKELETAL MUSCLE TISSUE | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 5 | EX77777 | TU | 90007 | 5 | IMG-00002 | NT03 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | PERICARDIUM | MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | |
|
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Rows 1-6: Show the qualitative assessments of the tumor state of the 3 non-target lesions "NT01", "NT02", and "NT03" at screening and week 6. Rows 7-9: Show the week 12 assessments. Row 7 shows the assessment of "NT01" non-target lesion in the brain whereas rows 8 and 9 illustrate the assessments of the non-target lesions "NT02" and "NT03" in the skeletal muscle tissue and pericardium, respectively, were not done. This is because the non-target lesions were obscured on the MRI and not assessable (TRSTAT = "NOT DONE" and TRREASND = "NOT EVALUABLE: Lesion obscured"). Rows 10-11: Show that at the week 20 assessment, the "NT01" and "NT02" were enlarged from a previous smallest size, i.e., TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR". |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TREVAL | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
---|
1 | EX77777 | TR | 90007 | 1 | NON-TARGET | IMG-00001 | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 2 | EX77777 | TR | 90007 | 2 | NON-TARGET | IMG-00001 | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 3 | EX77777 | TR | 90007 | 3 | NON-TARGET | IMG-00001 | A1 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | SCREEN | 10 | SCREENING | 2010-01-04 | 1 | 4 | EX77777 | TR | 90007 | 4 | NON-TARGET | IMG-00003 | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | 5 | EX77777 | TR | 90007 | 5 | NON-TARGET | IMG-00003 | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | 6 | EX77777 | TR | 90007 | 6 | NON-TARGET | IMG-00003 | A2 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 40 | WEEK 6 | 2010-02-18 | 46 | 7 | EX77777 | TR | 90007 | 7 | NON-TARGET | IMG-00005 | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | 8 | EX77777 | TR | 90007 | 8 | NON-TARGET | IMG-00005 | A3 | NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | 9 | EX77777 | TR | 90007 | 9 | NON-TARGET | IMG-00005 | A3 | NT03 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | INVESTIGATOR | TREATMENT | 60 | WEEK 12 | 2010-04-02 | 88 | 10 | EX77777 | TR | 90007 | 10 | NON-TARGET | IMG-00007 | A4 | NT01 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 11 | EX77777 | TR | 90007 | 11 | NON-TARGET | IMG-00007 | A4 | NT02 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 12 | EX77777 | TR | 90007 | 12 | NON-TARGET | IMG-00007 | A4 | NT03 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | INVESTIGATOR | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | |
|
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Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE"). |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX77777 | TR | 90007 | TRSEQ | 8 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Scan blurry | CRF | 2 | EX77777 | TR | 90007 | TRSEQ | 9 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Scan blurry | CRF |
|
|
4.7.4 PR Domain Model
The pr.xpt table below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at the screening, week 6, week 12 and subsequent 8-week follow-up visits. The example shows an MRI of the head and chest (PRTRT = "MRI" and PRLOC = "MULTIPLE") at each disease assessment timepoint. Pre protocol, non-target lesions in the "BRAIN" are assessed using "MRI" as the primary method of assessment for RECIST 1.1. Correlative imaging is used in addition to the primary method for the RECIST 1.1 evaluation in order to assess the brain lesion(s). The primary method of assessment (i.e., MRI) in represented in TU and TR domains along with assessment results. Correlative imaging (e.g., CT SCAN of the HEAD) is represented only in the PR domain. The image identifier is in PRREFID.
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Rows 1-2: Show the scans preformed at the screening disease assessment. The MRI is the primary method used to assess the lesions for RECIST 1.1 and the results are in TU and TR. Row 2 shows the correlative imaging of the brain (i.e., CT SCAN of the HEAD). Rows 3-8: Show the scans preformed at the disease assessments at weeks 6, 12 and 20.
|
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRPRESP | PROCCUR | PRLOC | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
---|
1 | EX77777 | PR | 90007 | 1 | IMG-00001 | A1 | MRI | Y | Y | MULTIPLE | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX77777 | PR | 90007 | 2 | IMG-00002 | A1 | CT SCAN | Y | Y | HEAD | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX77777 | PR | 90007 | 3 | IMG-00003 | A2 | MRI | Y | Y | MULTIPLE | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 4 | EX77777 | PR | 90007 | 4 | IMG-00004 | A2 | CT SCAN | Y | Y | HEAD | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 5 | EX77777 | PR | 90007 | 5 | IMG-00005 | A3 | MRI | Y | Y | MULTIPLE | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 6 | EX77777 | PR | 90007 | 6 | IMG-00006 | A3 | CT SCAN | Y | Y | HEAD | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 7 | EX77777 | PR | 90007 | 7 | IMG-00007 | A4 | MRI | Y | Y | MULTIPLE | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 8 | EX77777 | PR | 90007 | 8 | IMG-00008 | A4 | CTSCAN | Y | Y | HEAD | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | |
|
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Rows 1-2: Show the 2 locations of the MRI at screening for PRSEQ = "1" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 3: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at screening for PRSEQ = "1". Rows 4-5: Show the 2 locations of the MRI at week 6 for PRSEQ = "3" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 6: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 6 for PRSEQ = "3". Rows 7-8: Show the 2 locations of the MRI at week 12 for PRSEQ = "5" where QNAM = "PRLOC1" with QVAL = "HEAD" and QNAM = "PRLOC2" with QVAL = "CHEST". Row 9: Shows the slice thickness (QNAM = "PRSLTHK") of the MRI at week 12 for PRSEQ = "5". Row 10: Shows the overall image quality issue (QNAM = "PROIQ") of the MRI at week 12 for PRSEQ = "5". |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 2 | EX77777 | PR | 90007 | PRSEQ | 1 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 3 | EX77777 | PR | 90007 | PRSEQ | 1 | PRSLTHK | Slice Thickness | 5 mm | CRF | 4 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 5 | EX77777 | PR | 90007 | PRSEQ | 3 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 6 | EX77777 | PR | 90007 | PRSEQ | 3 | PRSLTHK | Slice Thickness | 5 mm | CRF | 7 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 8 | EX77777 | PR | 90007 | PRSEQ | 5 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 9 | EX77777 | PR | 90007 | PRSEQ | 5 | PRSLTHK | Slice Thickness | 5 mm | CRF | 10 | EX77777 | PR | 90007 | PRSEQ | 5 | PROIQ | Overall Image Quality | Motion issues and lesions where obscured | CRF | 11 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC1 | Anatomical Location 1 | HEAD | CRF | 12 | EX77777 | PR | 90007 | PRSEQ | 7 | PRLOC2 | Anatomical Location 2 | CHEST | CRF | 13 | EX77777 | PR | 90007 | PRSEQ | 7 | PRSLTHK | Slice Thickness | 5 mm | CRF |
|
|
4.8 Example 8: RECIST 1.1 example to show response (RS) data and the underlying tumor identification (TU) and tumor results (TR) data based on an independent assessment. This example shows data from a breast cancer study in a metastatic setting.
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Rows 1-3: Show the response assessments at week 12. The target lesion showed 59% decrease from screening so the Target Response (RSTESTCD = "TRGRESP") is a partial response (RSSTRESC = "PR"). In the protocol, scintigraphy is only to be performed every 6 months or in order to verify CR (Complete Response). Therefore, the Non-target Response (RSTESTCD = "NTRGRESP") is not evaluable (RSSTRESC = "NE") because scintigraphy of the bone was not performed at week 12, i.e., not all non-target lesions were evaluated. The Overall Response (RSTESTCD = "OVRLRESP") is a partial response (RSSTRESC = "PR") based on the target lesions and protocol requirements. Rows 4-6: Show the response assessments at week 24 where the target lesion and the non-target lesions were absent. The Target Response (RSTESTCD = "TRGRESP"), Non-target Response (RSTESTCD = "NTRGRESP") and Overall Response (RSTESTCD = "OVRLRESP") are CR (Complete Response). |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
---|
1 | EX88888 | RS | 90008 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 2 | EX88888 | RS | 90008 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 3 | EX88888 | RS | 90008 | 3 | R-A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 4 | EX88888 | RS | 90008 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | 5 | EX88888 | RS | 90008 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | 6 | EX88888 | RS | 90008 | 6 | R-A3 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | VENDOR1 | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | |
|
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Rows 1-3: Show the identification of a "R-T01" target tumor in the "LIVER" and the assessment of the 2 non-target tumors "R-NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" at screening. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TUMETHOD | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX88888 | TU | 90008 | 1 | IMG-00001 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | VENDOR1 | LIVER | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 2 | EX88888 | TU | 90008 | 2 | IMG-00002 | R-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | VENDOR1 | BONE | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX88888 | TU | 90008 | 3 | IMG-00001 | R-NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | VENDOR1 | PLEURAL CAVITY | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | |
|
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Rows 1-4: Show the measurements of the "R-T01" target tumor in the "LIVER" and the assessments of the 2 non-target lesions "R-NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" at screening. Rows 5-11: Show the measurement of the "R-T01" target tumor and the tumor state of the "R-NT02" non-target in the "PLEURAL CAVITY" at week 12. In the protocol, "SCINTIGRAPHY" is only to be performed every 6 months or in order to verify a CR (Complete Response). Therefore, the "SCINTIGRAPHY" of "R-NT01" non-target in the "BONE" was not performed at week 12 (TRSTAT = "NOT DONE" and TRREASND = "SCAN NOT PERFORMED"). Rows 12-18: Show at week 24, the "R-T01" target lesion was absent (i.e., DIAMETER = "0") and the non-targets R-"NT01" and "R-NT02" in the "BONE" and "PLEURAL CAVITY" were absent (TRTESTCD = "TUMSTATE" with TRORRES = "ABSENT"). The "SCINTIGRAPHY" was performed in order to verify the Overall Response of CR (Complete Response). |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRNAM | TRMETHOD | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX88888 | TR | 90008 | 1 | TARGET | IMG-00001 | R-A1 | R-T01 | LDIAM | Longest Diameter | 17 | mm | 17 | 17 | mm |
|
| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 2 | EX88888 | TR | 90008 | 2 | TARGET |
| R-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX88888 | TR | 90008 | 3 | NON-TARGET | IMG-00002 | R-A1 | R-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| VENDOR1 | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 4 | EX88888 | TR | 90008 | 4 | NON-TARGET | IMG-00001 | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX88888 | TR | 90008 | 5 | TARGET | IMG-00004 | R-A2 | R-T01 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm |
|
| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 6 | EX88888 | TR | 90008 | 6 | TARGET |
| R-A2 |
| SUMDIAM | Sum of Diameter | 7 | mm | 7 | 7 | mm |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 7 | EX88888 | TR | 90008 | 7 | TARGET |
| R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 8 | EX88888 | TR | 90008 | 8 | TARGET |
| R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -59 | % | -59 | -59 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 9 | EX88888 | TR | 90008 | 9 | TARGET |
| R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -59 | % | -59 | -59 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 10 | EX88888 | TR | 90008 | 10 | NON-TARGET |
| R-A2 | R-NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 11 | EX88888 | TR | 90008 | 11 | NON-TARGET | IMG-00004 | R-A2 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 12 | EX88888 | TR | 90008 | 12 | TARGET | IMG-00005 | R-A3 | R-T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | 13 | EX88888 | TR | 90008 | 13 | TARGET |
| R-A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 14 | EX88888 | TR | 90008 | 14 | TARGET |
| R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -17 | mm | -17 | -17 | mm |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 15 | EX88888 | TR | 90008 | 15 | TARGET |
| R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -100 | % | -100 | -100 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 16 | EX88888 | TR | 90008 | 16 | TARGET |
| R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -100 | % | -100 | -100 | % |
|
| VENDOR1 |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 17 | EX88888 | TR | 90008 | 17 | NON-TARGET | IMG-00006 | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| VENDOR1 | SCINTIGRAPHY | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | 18 | EX88888 | TR | 90008 | 18 | NON-TARGET | IMG-00005 | R-A3 | R-NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| VENDOR1 | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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Rows 1-3: Show the scans performed at screening. The CT SCAN and SCINTIGRAPHY are the primary methods used to assess the target and non-target lesion for RECIST 1.1 and the results are in TU and TR. Row 3 shows the correlative imaging (i.e., MRI) of the bone lesion in the FEMUR. Rows 4-6: Show that the CT scan was performed (PROCCUR = "Y") and that the scintigraphy and MRI were not performed (PROCCUR = "N") at week 12. Rows 7-9: Show the scans performed at week 24.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRLOC | PRPRESP | PROCCUR | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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1 | EX88888 | PR | 90008 | 1 | IMG-00001 | A1 | CT SCAN | MULTIPLE | Y | Y | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX88888 | PR | 90008 | 2 | IMG-00002 | A1 | SCINTIGRAPHY | BONE | Y | Y | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX88888 | PR | 90008 | 3 | IMG-00003 | A1 | MRI | FEMUR | Y | Y | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 4 | EX88888 | PR | 90008 | 4 | IMG-00004 | A2 | CT SCAN | MULTIPLE | Y | Y | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 5 | EX88888 | PR | 90008 | 5 |
| A2 | SCINTIGRAPHY | BONE | Y | N | TREATMENT | 20 | WEEK 12 |
|
| 6 | EX88888 | PR | 90008 | 6 |
| A2 | MRI | FEMUR | Y | N | TREATMENT | 20 | WEEK 12 |
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| 7 | EX88888 | PR | 90008 | 7 | IMG-00005 | A3 | CT SCAN | MULTIPLE | Y | Y | TREATMENT | 30 | WEEK 24 | 2010-06-24 | 172 | 8 | EX88888 | PR | 90008 | 8 | IMG-00006 | A3 | SCINTIGRAPHY | BONE | Y | Y | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | 9 | EX88888 | PR | 90008 | 9 | IMG-00007 | A3 | MRI | FEMUR | Y | Y | TREATMENT | 30 | WEEK 24 | 2010-06-25 | 173 | |
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Row 1: Shows a case where the 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. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX99999 | RS | 90009 | 1 | A1 | OVRLRESP | Overall Response | RECIST 1.1 | NED | NED | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-03-29 | 1 | |
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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 PR (Partial Response) is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -59%. The Non-Target Response of SD (Stable Disease) 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 PR (Partial Response). 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 CR (Complete Response) is based on the Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. The Non-Target Response of SD (Stable Disease) 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 PR (Partial Response). |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX01010 | RS | 90010 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 2 | EX01010 | RS | 90010 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | SD | SD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 3 | EX01010 | RS | 90010 | 3 | R-A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 4 | EX01010 | RS | 90010 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | 5 | EX01010 | RS | 90010 | 5 |
| NRGRESP | Non-Target Response | RECIST 1.1 | SD | SD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | 6 | EX01010 | RS | 90010 | 6 | R-A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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Rows 1-3: 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". |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TUNAM | TULOC | TUMETHOD | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX01010 | TU | 90010 | 1 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | RADIOL. INC. | LIVER | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 2 | EX01010 | TU | 90010 | 2 | R-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL. INC. | LIVER | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX01010 | TU | 90010 | 3 | R-NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | RADIOL. INC. | CHEST WALL | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | |
|
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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" shows 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" is absent (LDIAM = "0") which is a Percent Change From Baseline in Sum of Diameter (PCBSD) of -100%. "R-NT01" remains TUMSTATE = "ABSENT" and "R-NT02" has a TUMSTATE = "PRESENT". |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRNAM | TRMETHOD | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX01010 | TR | 90010 | 1 | TARGET | R-A1 | R-T01 | LDIAM | Longest Diameter | 17 | mm | 17 | 17 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 2 | EX01010 | TR | 90010 | 2 | TARGET | R-A1 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
|
| 3 | EX01010 | TR | 90010 | 3 | NON-TARGET | R-A1 | R-NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 4 | EX01010 | TR | 90010 | 4 | NON-TARGET | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX01010 | TR | 90010 | 5 | TARGET | R-R-A2 | R-T01 | LDIAM | Longest Diameter | 7 | mm | 7 | 7 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 6 | EX01010 | TR | 90010 | 6 | TARGET | R-A2 |
| SUMDIAM | Sum of Diameter | 7 | mm | 7 | 7 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 7 | EX01010 | TR | 90010 | 7 | TARGET | R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 8 | EX01010 | TR | 90010 | 8 | TARGET | R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -59 | % | -59 | -59 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 9 | EX01010 | TR | 90010 | 9 | TARGET | R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -59 | % | -59 | -59 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 |
|
| 10 | EX01010 | TR | 90010 | 10 | NON-TARGET | R-A2 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 11 | EX01010 | TR | 90010 | 11 | NON-TARGET | R-A2 | R-NT02 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 20 | WEEK 12 | 2010-03-29 | 85 | 12 | EX01010 | TR | 90010 | 12 | TARGET | R-A3 | R-T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm | RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | 13 | EX01010 | TR | 90010 | 13 | TARGET | R-A3 |
| SUMDIAM | Sum of Diameter | 0 | mm | 0 | 0 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 14 | EX01010 | TR | 90010 | 14 | TARGET | R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -17 | mm | -17 | -17 | mm | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 15 | EX01010 | TR | 90010 | 15 | TARGET | R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -100 | % | -100 | -100 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 16 | EX01010 | TR | 90010 | 16 | TARGET | R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -100 | % | -100 | -100 | % | RADIOL. INC. |
| INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 |
|
| 17 | EX01010 | TR | 90010 | 17 | NON-TARGET | R-A3 | R-NT01 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | 18 | EX01010 | TR | 90010 | 18 | NON-TARGET | R-A3 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
| RADIOL. INC. | CT SCAN | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 30 | WEEK 24 | 2010-06-23 | 171 | |
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Rows 1-3: Show the Target Response (RSTESTCD = "TRGRESP") and Non-Target Response (RSTESTCD = "NTRGRESP") tests and corresponding Overall Response (RSTESTCD = "OVRLRESP") at the week 6 assessment. The RSLNKGRP is populated on the Overall Response record only. The RSLNKGRP is used to associate underlying data in other domains to the Overall Response. Rows 4-12: Show the week 12, week 20 and week 28 responses. Row 13-20: At week 36, the New Lesion Progression (RSTESTCD = "NEWLPROG") test is used to represent an equivocal new lesion (RSORRES = "EQUIVOCAL") and to represent at week 44 that there are unequivocal new lesions (RSORRES = "UNEQUIVOCAL"). |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | EPOCH | VISITNUM | VISIT | RSDTC | RSDY |
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1 | EX11111 | RS | 90011 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | NE | NE | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 2 | EX11111 | RS | 90011 | 2 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NE | NE | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 3 | EX11111 | RS | 90011 | 3 | R-A2 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 4 | EX11111 | RS | 90011 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 5 | EX11111 | RS | 90011 | 5 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 6 | EX11111 | RS | 90011 | 6 | R-A3 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 7 | EX11111 | RS | 90011 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 8 | EX11111 | RS | 90011 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 9 | EX11111 | RS | 90011 | 9 | R-A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 10 | EX11111 | RS | 90011 | 10 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 11 | EX11111 | RS | 90011 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 12 | EX11111 | RS | 90011 | 12 | R-A5 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 13 | EX11111 | RS | 90011 | 13 |
| TRGRESP | Target Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 14 | EX11111 | RS | 90011 | 14 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 15 | EX11111 | RS | 90011 | 15 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | EQUIVOCAL | EQUIVOCAL | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 16 | EX11111 | RS | 90011 | 16 | R-A6 | OVRLRESP | Overall Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 17 | EX11111 | RS | 90011 | 17 |
| TRGRESP | Target Response | RECIST 1.1 | PD | PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 18 | EX11111 | RS | 90011 | 18 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | CR | CR | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 19 | EX11111 | RS | 90011 | 19 |
| NEWLPROG | New Lesion Progression | RECIST 1.1 | UNEQUIVOCAL | UNEQUIVOCAL | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 20 | EX11111 | RS | 90011 | 20 | R-A7 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 |
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Rows 1-6: Show a subject with 4 target lesions with TULNKID "R-T01"-"R-T04" and 2 non-target lesions with TULNKID "R-NT01" and "R-NT02" identified at screening. "R-T01" and "R-T02" target lesions are lymph nodes. "R-T01" is located in the supraclavicular lymph node (TULOC = "SUPRACLAVICULAR LYMPH NODE") on the right side (TULAT = "RIGHT"). The TULOC contains the location from the anatomical location terminology. Note that some locations contain in the anatomical location controlled terminology contain laterality and/or directionality. The laterality should not generally be added to TULOC unless in the controlled terminology, likewise for directionality. Row 7: Shows at week 36, an equivocal new lesion (TULNKID = "R-NEW01") was identified in the left lower lobe of the lung (TULOC = "LUNG, LEFT LOWER LOBE"). In this instance, "LUNG, LEFT LOWER LOBE" is a published controlled term for anatomical location. Row 8-9: Show at week 44, new unequivocal new lesions (TULNKID = "R-NEW02" and "R-NEW03") were identified in the cerebellum (TULOC = "CEREBELLUM") and the femoral lymph node (TULOC = "FEMORAL LYMPH NODE"). |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUREFID | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUDIR | TUMETHOD | TUNUM | TUEVAL | TUEVALID | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX11111 | TU | 90011 | 1 | IMG-00001 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | SUPRACLAVICULAR LYMPH NODE | RIGHT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TU | 90011 | 2 | IMG-00002 | R-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | THORACIC LYMPH NODE |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX11111 | TU | 90011 | 3 | IMG-00001 | R-T03 | TUMIDENT | Tumor Identification | TARGET | TARGET | THYROID GLAND | LEFT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 4 | EX11111 | TU | 90011 | 4 | IMG-00003 | R-T04 | TUMIDENT | Tumor Identification | TARGET | TARGET | SKIN OF THE TRUNK |
| UPPER | PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 5 | EX11111 | TU | 90011 | 5 | IMG-00002 | R-NT01 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | MEDIASTINAL LYMPH NODE | RIGHT |
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 6 | EX11111 | TU | 90011 | 6 | IMG-00001 | R-NT02 | TUMIDENT | Tumor Identification | NON-TARGET | NON-TARGET | CEREBELLUM | RIGHT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | 1 | 7 | EX11111 | TU | 90011 | 7 | IMG-00020 | R-NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | LUNG, LEFT LOWER LOBE |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 8 | EX11111 | TU | 90011 | 8 | IMG-00019 | R-NEW02 | TUMIDENT | Tumor Identification | NEW | NEW | CEREBELLUM | LEFT |
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-18 | 317 | 9 | EX11111 | TU | 90011 | 9 | IMG-00022 | R-NEW03 | TUMIDENT | Tumor Identification | NEW | NEW | FEMORAL LYMPH NODE | LEFT |
| ULTRASOUND | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-18 | 317 |
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Rows 1-6: Show the screening identification 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 Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCDs are Sum of Diameter (TRTESTCD = "SUMDIAM") and Sum Diameters of Non Lymph Node Tumors (TRTESTCD = "SUMNLNLD"). Rows 9-10: Show the results for the non-targets. "R-NT01" is a lymph node where the TRTEST used for the assessments is "Lymph 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 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 the PCBSD could not be calculated because "R-T04" was not measured. TRSTAT is assigned "NOT DONE" and TRREASND 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 the Sum Diameters of Non Lymph node Tumors (TRTESTCD = "SUMNLNLD") is "0". This means that the non-lymph node target tumors are all absent. |
Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TRSEQ | TRGRPID | TRREFID | TRLNKGRP | TRLNKID | TRTESTCD | TRTEST | TRORRES | TRORRESU | TRSTRESC | TRSTRESN | TRSTRESU | TRSTAT | TRREASND | TRMETHOD | TRNAM | TREVAL | TREVALID | EPOCH | VISITNUM | VISIT | TRDTC | TRDY |
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1 | EX11111 | TR | 90011 | 1 | TARGET | IMG-00001 | R-A1 | R-T01 | LPERP | Longest Perpendicular | 17 | mm | 17 | 17 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | TR | 90011 | 2 | TARGET | IMG-00001 | R-A1 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 3 | EX11111 | TR | 90011 | 3 | TARGET | IMG-00002 | R-A1 | R-T02 | LPERP | Longest Perpendicular | 16 | mm | 16 | 16 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 4 | EX11111 | TR | 90011 | 4 | TARGET | IMG-00002 | R-A1 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 5 | EX11111 | TR | 90011 | 5 | TARGET | IMG-00001 | R-A1 | R-T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 6 | EX11111 | TR | 90011 | 6 | TARGET | IMG-00003 | R-A1 | R-T04 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 7 | EX11111 | TR | 90011 | 7 | TARGET |
| R-A1 |
| SUMDIAM | Sum of Diameter | 62 | mm | 62 | 62 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
|
| 8 | EX11111 | TR | 90011 | 8 | TARGET |
| R-A1 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 29 | mm | 29 | 29 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING |
|
| 9 | EX11111 | TR | 90011 | 9 | NON-TARGET | IMG-00002 | R-A1 | R-NT01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 10 | EX11111 | TR | 90011 | 10 | NON-TARGET | IMG-00001 | R-A1 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 11 | EX11111 | TR | 90011 | 11 | TARGET | IMG-00004 | R-A2 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 12 | EX11111 | TR | 90011 | 12 | TARGET | IMG-00004 | R-A2 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 13 | EX11111 | TR | 90011 | 13 | TARGET | IMG-00005 | R-A2 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 14 | EX11111 | TR | 90011 | 14 | TARGET | IMG-00005 | R-A2 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 15 | EX11111 | TR | 90011 | 15 | TARGET | IMG-00004 | R-A2 | R-T03 | LDIAM | Longest Diameter | 14 | mm | 14 | 14 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 16 | EX11111 | TR | 90011 | 16 | TARGET |
| R-A2 | R-T04 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | SCAN NOT PERFORMED | PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 17 | EX11111 | TR | 90011 | 17 | TARGET |
| R-A2 |
| SUMDIAM | Sum of Diameter | 52 | mm | 52 | 52 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 18 | EX11111 | TR | 90011 | 18 | TARGET |
| R-A2 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 28 | mm | 28 | 28 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 19 | EX11111 | TR | 90011 | 19 | TARGET |
| R-R-A2 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 20 | EX11111 | TR | 90011 | 20 | TARGET |
| R-A2 |
| PCBSD | Percent Change From Baseline in Sum of Diameter |
|
|
|
|
| NOT DONE | At least one target lesions was not measured |
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 21 | EX11111 | TR | 90011 | 21 | TARGET |
| R-A2 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -16 | % | -16 | -16 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 |
|
| 22 | EX11111 | TR | 90011 | 22 | NON-TARGET | IMG-00005 | R-A2 | R-NT01 | LNSTATE | Lymph Node State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 23 | EX11111 | TR | 90011 | 23 | NON-TARGET | IMG-00004 | R-A2 | R-NT02 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE | MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 24 | EX11111 | TR | 90011 | 24 | TARGET | IMG-00007 | R-A3 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 25 | EX11111 | TR | 90011 | 25 | TARGET | IMG-00007 | R-A3 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 26 | EX11111 | TR | 90011 | 26 | TARGET | IMG-00008 | R-A3 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 27 | EX11111 | TR | 90011 | 27 | TARGET | IMG-00008 | R-A3 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 28 | EX11111 | TR | 90011 | 28 | TARGET | IMG-00007 | R-A3 | R-T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 29 | EX11111 | TR | 90011 | 29 | TARGET | IMG-00009 | R-A3 | R-T04 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 30 | EX11111 | TR | 90011 | 30 | TARGET |
| R-A3 |
| SUMDIAM | Sum of Diameter | 47 | mm | 47 | 47 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 31 | EX11111 | TR | 90011 | 31 | TARGET |
| R-A3 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 23 | mm | 23 | 23 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 32 | EX11111 | TR | 90011 | 32 | TARGET |
| R-R-A3 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -5 | mm | -5 | -5 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 33 | EX11111 | TR | 90011 | 33 | TARGET |
| R-A3 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -24 | % | -24 | -24 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 34 | EX11111 | TR | 90011 | 34 | TARGET |
| R-A3 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -9 | % | -9 | -9 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 |
|
| 35 | EX11111 | TR | 90011 | 35 | NON-TARGET | IMG-00008 | R-A3 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 36 | EX11111 | TR | 90011 | 36 | NON-TARGET | IMG-00007 | R-A3 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 37 | EX11111 | TR | 90011 | 37 | TARGET | IMG-00010 | R-A4 | R-T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 38 | EX11111 | TR | 90011 | 38 | TARGET | IMG-00010 | R-A4 | R-T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 39 | EX11111 | TR | 90011 | 39 | TARGET | IMG-00011 | R-A4 | R-T02 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 40 | EX11111 | TR | 90011 | 40 | TARGET | IMG-00011 | R-A4 | R-T02 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 41 | EX11111 | TR | 90011 | 41 | TARGET | IMG-00010 | R-A4 | R-T03 | LDIAM | Longest Diameter | 11 | mm | 11 | 11 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 42 | EX11111 | TR | 90011 | 42 | TARGET | IMG-00012 | R-A4 | R-T04 | LDIAM | Longest Diameter | 5 | mm | 5 | 5 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 43 | EX11111 | TR | 90011 | 43 | TARGET |
| R-A4 |
| SUMDIAM | Sum of Diameter | 37 | mm | 37 | 37 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 44 | EX11111 | TR | 90011 | 44 | TARGET |
| R-A4 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 16 | mm | 16 | 16 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 45 | EX11111 | TR | 90011 | 45 | TARGET |
| R-A4 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -10 | mm | -10 | -10 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 46 | EX11111 | TR | 90011 | 46 | TARGET |
| R-A4 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -40 | % | -40 | -40 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 47 | EX11111 | TR | 90011 | 47 | TARGET |
| R-A4 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -21 | % | -21 | -21 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 |
|
| 48 | EX11111 | TR | 90011 | 48 | NON-TARGET | IMG-00011 | R-A4 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 49 | EX11111 | TR | 90011 | 49 | NON-TARGET | IMG-00010 | R-A4 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 50 | EX11111 | TR | 90011 | 50 | TARGET | IMG-00013 | R-A5 | R-T01 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 51 | EX11111 | TR | 90011 | 51 | TARGET | IMG-00013 | R-A5 | R-T01 | LPERP | Longest Perpendicular | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 52 | EX11111 | TR | 90011 | 52 | TARGET | IMG-00014 | R-A5 | R-T02 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 53 | EX11111 | TR | 90011 | 53 | TARGET | IMG-00014 | R-A5 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 54 | EX11111 | TR | 90011 | 54 | TARGET | IMG-00013 | R-A5 | R-T03 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 55 | EX11111 | TR | 90011 | 55 | TARGET | IMG-00015 | R-A5 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 56 | EX11111 | TR | 90011 | 56 | TARGET |
| R-A5 |
| SUMDIAM | Sum of Diameter | 23 | mm | 23 | 23 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 57 | EX11111 | TR | 90011 | 57 | TARGET |
| R-A5 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 6 | mm | 6 | 6 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 58 | EX11111 | TR | 90011 | 58 | TARGET |
| R-A5 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -14 | mm | -14 | -14 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 59 | EX11111 | TR | 90011 | 59 | TARGET |
| R-A5 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -62 | % | -62 | -62 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 60 | EX11111 | TR | 90011 | 60 | TARGET |
| R-A5 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -37 | % | -37 | -37 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 |
|
| 61 | EX11111 | TR | 90011 | 61 | NON-TARGET | IMG-00014 | R-A5 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 62 | EX11111 | TR | 90011 | 62 | NON-TARGET | IMG-00013 | R-A5 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 63 | EX11111 | TR | 90011 | 63 | TARGET | IMG-00016 | R-A6 | R-T01 | LPERP | Longest Perpendicular | 8 | mm | 8 | 8 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 64 | EX11111 | TR | 90011 | 64 | TARGET | IMG-00016 | R-A6 | R-T01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 65 | EX11111 | TR | 90011 | 65 | TARGET | IMG-00017 | R-A6 | R-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 66 | EX11111 | TR | 90011 | 66 | TARGET | IMG-00017 | R-A6 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 67 | EX11111 | TR | 90011 | 67 | TARGET | IMG-00016 | R-A6 | R-T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 68 | EX11111 | TR | 90011 | 68 | TARGET | IMG-00018 | R-A6 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 69 | EX11111 | TR | 90011 | 69 | TARGET |
| R-A6 |
| SUMDIAM | Sum of Diameter | 17 | mm | 17 | 17 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 70 | EX11111 | TR | 90011 | 70 | TARGET |
| R-A6 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 0 | mm | 0 | 0 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 71 | EX11111 | TR | 90011 | 71 | TARGET |
| R-A6 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | -6 | mm | -6 | -6 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 72 | EX11111 | TR | 90011 | 72 | TARGET |
| R-A6 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -72 | % | -72 | -72 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 73 | EX11111 | TR | 90011 | 73 | TARGET |
| R-A6 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | -26 | % | -26 | -26 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 |
|
| 74 | EX11111 | TR | 90011 | 74 | NON-TARGET | IMG-00017 | R-A6 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 75 | EX11111 | TR | 90011 | 75 | NON-TARGET | IMG-00016 | R-A6 | R-NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 76 | EX11111 | TR | 90011 | 76 | NEW | IMG-00017 | R-A6 | R-NEW01 | TUMSTATE | Tumor State | EQUIVOCAL |
| EQUIVOCAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 77 | EX11111 | TR | 90011 | 77 | TARGET | IMG-00019 | R-A7 | R-T01 | LPERP | Longest Perpendicular | 12 | mm | 12 | 12 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 78 | EX11111 | TR | 90011 | 78 | TARGET | IMG-00019 | R-A7 | R-T01 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 79 | EX11111 | TR | 90011 | 79 | TARGET | IMG-00020 | R-A7 | R-T02 | LPERP | Longest Perpendicular | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 80 | EX11111 | TR | 90011 | 80 | TARGET | IMG-00020 | R-A7 | R-T02 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 81 | EX11111 | TR | 90011 | 81 | TARGET | IMG-00019 | R-A7 | R-T03 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 82 | EX11111 | TR | 90011 | 82 | TARGET | IMG-00021 | R-A7 | R-T04 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| PHOTOGRAPHY | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 83 | EX11111 | TR | 90011 | 83 | TARGET |
| R-A7 |
| SUMDIAM | Sum of Diameter | 21 | mm | 21 | 21 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 84 | EX11111 | TR | 90011 | 84 | TARGET |
| R-A7 |
| SUMNLNLD | Sum Diameters of Non Lymph Node Tumors | 0 | mm | 0 | 0 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 85 | EX11111 | TR | 90011 | 85 | TARGET |
| R-A7 |
| ACNSD | Absolute Change From Nadir in Sum of Diameter | 4 | mm | 4 | 4 | mm |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 86 | EX11111 | TR | 90011 | 86 | TARGET |
| R-A7 |
| PCBSD | Percent Change From Baseline in Sum of Diameter | -66 | % | -66 | -66 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 87 | EX11111 | TR | 90011 | 87 | TARGET |
| R-A7 |
| PCNSD | Percent Change From Nadir in Sum of Diameter | 23 | % | 23 | 23 | % |
|
|
| RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 |
|
| 88 | EX11111 | TR | 90011 | 88 | NON-TARGET | IMG-00020 | R-A7 | R-NT01 | LNSTATE | Lymph Node State | NON-PATHOLOGICAL |
| NON-PATHOLOGICAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 89 | EX11111 | TR | 90011 | 89 | NON-TARGET | IMG-00019 | R-A7 | R-NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 90 | EX11111 | TR | 90011 | 90 | NEW | IMG-00020 | R-A7 | R-NEW01 | LDIAM | Longest Diameter | 8 | mm | 8 | 8 | mm |
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 91 | EX11111 | TR | 90011 | 91 | NEW | IMG-00020 | R-A7 | R-NEW01 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| CT SCAN | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 92 | EX11111 | TR | 90011 | 92 | NEW | IMG-00019 | R-A7 | R-NEW02 | LDIAM | Longest Diameter | 6 | mm | 6 | 6 | mm |
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 93 | EX11111 | TR | 90011 | 93 | NEW | IMG-00019 | R-A7 | R-NEW02 | TUMSTATE | Tumor State | UNEQUIVOCAL |
| UNEQUIVOCAL |
|
|
|
| MRI | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 94 | EX11111 | TR | 90011 | 94 | NEW | IMG-00022 | R-A7 | R-NEW03 | LNSTATE | Lymph Node State | PATHOLOGICAL |
| PATHOLOGICAL |
|
|
|
| ULTRASOUND | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
|
...
Dataset wrap |
---|
|
Rowcaps |
---|
Row 1: Show that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE"). |
Dataset2 |
---|
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
---|
1 | EX11111 | TR | 90011 | TRSEQ | 22 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF | 2 | EX11111 | TR | 90011 | TRSEQ | 23 | TRREASNE | Reason Tumor/Lesion Not Evaluable | Motion issue | CRF |
|
|
4.11.4 PR Domain Model
The pr.xpt table below shows the terminology used to implement RECIST 1.1 in the PR domain. This example shows the data for one subject collected at the week 6, week 12, and subsequent 8-week follow-up visits. The example shows an MRI of the head and neck (PRTRT = "MRI" and PRLOC = "HEAD AND NECK"), a CT scan of the chest (PRTRT = "CT SCAN" and PRLOC = "CHEST"), and medical photography of the skin and trunk (PRTRT = "PHOTOGRAPHY" and PRLOC = "SKIN AND TRUNK") at each disease assessment timepoint. The image identifier is in PRREFID.
Dataset wrap |
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Rowcaps |
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Rows 1-3: Show the scans preformed at screening. The results of the scans are record in TU and TR. Rows 4-21: Show the scans preformed at weeks 6, 12, 20, 28, 36 and 44. The results of the scans are record in TU and TR.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | PRSEQ | PRREFID | PRLNKGRP | PRTRT | PRLOC | PRNAM | PREVAL | PREVALID | EPOCH | VISITNUM | VISIT | PRSTDTC | PRSTDY |
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1 | EX11111 | PR | 90011 | 1 | IMG-00001 | R-A1 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-01 | -3 | 2 | EX11111 | PR | 90011 | 2 | IMG-00002 | R-A1 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-02 | -2 | 3 | EX11111 | PR | 90011 | 3 | IMG-00003 | R-A1 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | SCREEN | 10 | SCREENING | 2010-01-03 | -1 | 4 | EX11111 | PR | 90011 | 4 | IMG-00004 | R-A2 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-15 | 43 | 5 | EX11111 | PR | 90011 | 5 | IMG-00005 | R-A2 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 40 | WEEK 6 | 2010-02-16 | 44 | 6 | EX11111 | PR | 90011 | 6 | IMG-00007 | R-A3 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-29 | 85 | 7 | EX11111 | PR | 90011 | 7 | IMG-00008 | R-A3 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-03-30 | 86 | 8 | EX11111 | PR | 90011 | 8 | IMG-00009 | R-A3 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 60 | WEEK 12 | 2010-04-01 | 87 | 9 | EX11111 | PR | 90011 | 9 | IMG-00010 | R-A4 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-27 | 144 | 10 | EX11111 | PR | 90011 | 10 | IMG-00011 | R-A4 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-28 | 145 | 11 | EX11111 | PR | 90011 | 11 | IMG-00012 | R-A4 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 80 | WEEK 20 | 2010-05-30 | 147 | 12 | EX11111 | PR | 90011 | 12 | IMG-00013 | R-A5 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-23 | 201 | 13 | EX11111 | PR | 90011 | 13 | IMG-00014 | R-A5 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-24 | 202 | 14 | EX11111 | PR | 90011 | 14 | IMG-00015 | R-A5 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 100 | WEEK 28 | 2010-07-25 | 203 | 15 | EX11111 | PR | 90011 | 15 | IMG-00016 | R-A6 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 16 | EX11111 | PR | 90011 | 16 | IMG-00017 | R-A6 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 17 | EX11111 | PR | 90011 | 17 | IMG-00018 | R-A6 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 120 | WEEK 36 | 2010-09-17 | 257 | 18 | EX11111 | PR | 90011 | 18 | IMG-00019 | R-A7 | MRI | HEAD AND NECK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-14 | 313 | 19 | EX11111 | PR | 90011 | 19 | IMG-00020 | R-A7 | CT SCAN | CHEST | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-15 | 314 | 20 | EX11111 | PR | 90011 | 20 | IMG-00021 | R-A7 | PHOTOGRAPHY | SKIN OF THE TRUNK | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | 21 | EX11111 | PR | 90011 | 21 | IMG-00022 | R-A7 | ULTRASOUND | PELVIS | RADIOL. INC. | INDEPENDENT ASSESSOR | RADIOLOGIST | TREATMENT | 140 | WEEK 44 | 2010-11-16 | 315 | |
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Dataset wrap |
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Rowcaps |
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Rows 1-2: Show the one-to-many relationship between TU and TR using --LNKID. --LNKID is the tumor identifier. The matching RELID value indicates that the two rows form the relationship. Rows 3-4: Show the many-to-one relationship between TR and RS using --LNKGRP. --LNKGRP is the identifier used to group and link all of the measurement/assessment records used in the assessment of the overall response record in the RS domain. The matching RELID value indicates that the two rows form the relationship. Rows 5-6: Show the one-to-many relationship between TU and PR using --REFID. --REFID contains the image identifier. The matching RELID value indicates that the two rows form the relationship. |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | ABC12345 | TU |
| TULNKID |
| One | TUTR1 | 2 | ABC12345 | TR |
| TRLNKID |
| Many | TUTR1 | 3 | ABC12345 | TR |
| TRLNKGRP |
| Many | TRRS1 | 4 | ABC12345 | RS |
| RSLNKGRP |
| One | TRRS1 | 5 | ABC12345 | PR |
| PRREFID |
| One | PRTU1 | 6 | ABC12345 | TU |
| TUREFID |
| Many | PRTU1 |
|
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The following table contains additional standard name codes for use in the Supplemental Qualifiers for SUPPRS, SUPPTU and SUPPPR datasets.
Dataset wrap |
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Variable | Label | Type | Codelist | Role |
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RSREASNE | Reason Response Not Evaluable | Char |
| Non-Standard Qualifier | TUPRVIR | Previously Irradiated Indicator | Char | (NY) | Non-Standard Qualifier | TUPRVIRP | Previously Irradiated Progression | Char | (NY) | Non-Standard Qualifier | TUPRTYP | Tumor or Lesion Presentation Type | Char | (DSPRTYP) | Non-Standard Qualifier | TULOCDTL | Location Detail | Char |
| Non-Standard Qualifier | TUSLNUM | Slice Number | Char |
| Non-Standard Qualifier | TUANTPLN | Anatomical Plane | Char |
| Non-Standard Qualifier | TRREASNE | Reason Tumor/Lesion Not Evaluable | Char |
| Non-Standard Qualifier | PRLOC1 | Anatomical Location 1 | Char | (LOC) | Non-Standard Qualifier | PRLOC2 | Anatomical Location 2 | Char | (LOC) | Non-Standard Qualifier | PRSLTHK | Slice Thickness | Char |
| Non-Standard Qualifier | PROIQ | Overall Image Quality | Char |
| Non-Standard Qualifier |
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End of Document
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Info |
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title | Information for Reviewers |
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Text in black is part of the template used to create this document and is not under review. Please review the blue text and all examples; this text represents the changes made to the template that are specific to this disease response criteria. |