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Title | Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
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CDISC Reference | Disease Response Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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Criteria Short Name | |
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Criteria Permission Status | Exempt from Copyright |
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Team | CDISC Oncology Subteam |
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Supplement Version | 1.0 |
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Status | DRAFT |
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Date | 20222023-09XX-13XX |
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Notes | - This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
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4.1 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR), and procedure (PR) data.
The example shows the case where lymph nodes are selected as target lesions. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.
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Rows 1-3: | Show the Target Response (RSTESTCD = "TRGRESP") |
and Nonand Non-Target Response (RSTESTCD = "NTRGRESP") tests and |
corresponding Overall 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 used to represent an equivocal new lesion (RSTESTCD = "NEWLPROG" and RSORRES = "EQUIVOCAL") and to represent |
at week that there 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 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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Show | Shows that the QVAL for Reason Response Not Evaluable (QNAM = "RSREASNE"). |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX11111 | RS | 90001 | RSSEQ | 3 | RSREASNE | Reason Response Not Evaluable | Imaging quality issues and not all scan performed | CRF |
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The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This This example shows the data for one subject at screening and screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph lymph nodes are selected as target tumors. In In RECIST 1.1, target lymph node tumors are measured in the longest perpendicular (TRTESTCD = "LPERP") in the TR domain. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.
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Show a | 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 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 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"). |
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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 1-3: | Show that the target lesions with TUSEQs equal to "1", "2" and "3" where not previously irradiated. | Rows 4-5: | Show that that target lesion with TUSEQ = "4" was previously irradiated and shown to be progressing |
since it was irradiated |
Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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1 | EX11111 | TU | 90001 | TUSEQ | 1 | TUPRVIR | Previously Irradiated Indicator | N | CRF | 2 | EX11111 | TU | 90001 | TUSEQ | 2 | TUPRVIR | Previously Irradiated Indicator | N | CRF | 3 | EX11111 | TU | 90001 | TUSEQ | 3 | TUPRVIR | Previously Irradiated Indicator | N | CRF | 4 | EX11111 | TU | 90001 | TUSEQ | 4 | TUPRVIR | Previously Irradiated Indicator | Y | CRF | 5 | EX11111 | TU | 90001 | TUSEQ | 4 | TUPRVIRP | Previously Irradiated Progression | Y | CRF |
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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 | Shows a case where the non-target "NT01" was not evaluable (for TRTEST = "Lymph Node State", TRSTAT = "NOT DONE" with TRREASND = "NOT EVALUABLE"). |
Shows | 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". |
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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 |
|
| 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 |
|
|
|
| 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 |
|
| 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 |
|
| 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 |
|
|
|
| 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 |
|
|
|
| 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 |
|
|
|
| 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 |
|
| 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 |
|
|
|
| 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 |
|
| 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 |
|
|
|
| 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 | |
|
...
Dataset wrap |
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Rowcaps |
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Show | Shows that the QVAL for Reason Tumor/Lesion Not Evaluable (QNAM = "TRREASNE"). |
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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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 |
|
|
...