...
In TR, the TRDTC is populated with the date of tumor/lesion assessment/measurement, i.e., the date of the scan, image, or physical exam. In the examples, the summary results (e.g., Sum of Diameter) do not have TRMETHOD and TRDTC associated with them. However, if an appropriate TRDTC is available, it can be populated. In TR, scans which are not performed do not have a TRDTC populated.
Symptomatic deterioration may be collected in studies using RECIST 1.1 but it is not part of an objective RECIST 1.1 response. See example 4.3 for a detailed example for representing these data.
Note that examples in this disease response supplement are based on assumptions about the data collection forms. For example, the collection of split and merged tumors may be collected in different ways depending on the form design and system limitations. The preferred SDTM data representation is shown in the examples.
...
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
Row 11: Shows the longest diameter of "T04" at the assessment before it splits. Rows 18-19: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 16. Rows 24-25: Show that tumors "T02" and "T03" are no longer measured individually. The TRSTAT = "NOT DONE" and the TRREASND = "TUMOR MERGED". These rows are optional and can be included if part of the collection. In the case where a sponsor includes TUMSTATE for target lesions, TUMSTATE may be assigned to "TUMOR MERGED". Row 26: Shows the longest diameter of the newly merged "T02/T03" tumor at week 24. Rows 27-28: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 24. Row 33: Shows the longest diameter of the newly merged "T02/T03" tumor at week 32. Sponsors can continue to include individual tumors as not done as in rows 24-25. Rows 34-35: Show the longest diameters of the split lesions "T04.1" and "T04.2" at week 32. Row 37: Shows the Tumor State of the non-target "NT01" as enlargement from nadir (TRTESTCD = "TUMSTATE" and TRORRES = "ENLARGEMENT FROM NADIR"). This Tumor State indicates that the non-Target tumors in the "LUNG" have shown enlargement from their previous smallest state. Rows 39-40: Shows the Tumor State of the a new tumor "NEW01" and the longest diameter of the new tumor. |
| 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 | EX22222 | TR | 90002 | 1 | TARGET | A1 | T01 | LDIAM | Longest Diameter | 16 | mm | 16 | 16 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 2 | EX22222 | TR | 90002 | 2 | TARGET | A1 | T02 | LDIAM | Longest Diameter | 28 | mm | 28 | 28 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 3 | EX22222 | TR | 90002 | 3 | TARGET | A1 | T03 | LDIAM | Longest Diameter | 41 | mm | 41 | 41 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 4 | EX22222 | TR | 90002 | 4 | TARGET | A1 | T04 | LDIAM | Longest Diameter | 83 | mm | 83 | 83 | mm |
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 5 | EX22222 | TR | 90002 | 5 | TARGET | A1 |
| SUMDIAM | Sum of Diameter | 168 | mm | 168 | 168 | mm |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING |
|
| | 6 | EX22222 | TR | 90002 | 6 | NON-TARGET | A1 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 7 | EX22222 | TR | 90002 | 7 | NON-TARGET | A1 | NT02 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-02 | 1 | | 8 | EX22222 | TR | 90002 | 8 | TARGET | A2 | T01 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 9 | EX22222 | TR | 90002 | 9 | TARGET | A2 | T02 | LDIAM | Longest Diameter | 20 | mm | 20 | 20 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 10 | EX22222 | TR | 90002 | 10 | TARGET | A2 | T03 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 11 | EX22222 | TR | 90002 | 11 | TARGET | A2 | T04 | LDIAM | Longest Diameter | 65 | mm | 65 | 65 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 12 | EX22222 | TR | 90002 | 12 | TARGET | A2 |
| SUMDIAM | Sum of Diameter | 125 | mm | 125 | 125 | mm |
|
|
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 |
|
| | 13 | EX22222 | TR | 90002 | 13 | NON-TARGET | A2 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 14 | EX22222 | TR | 90002 | 14 | NON-TARGET | A2 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 15 | EX22222 | TR | 90002 | 15 | 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 | | 16 | EX22222 | TR | 90002 | 16 | TARGET | A3 | T02 | LDIAM | Longest Diameter | 12 | mm | 12 | 12 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 17 | EX22222 | TR | 90002 | 17 | TARGET | A3 | T03 | LDIAM | Longest Diameter | 15 | mm | 15 | 15 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 18 | EX22222 | TR | 90002 | 18 | TARGET | A3 | T04.1 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 19 | EX22222 | TR | 90002 | 19 | TARGET | A3 | T04.2 | LDIAM | Longest Diameter | 10 | mm | 10 | 10 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 20 | EX22222 | TR | 90002 | 20 | TARGET | A3 |
| SUMDIAM | Sum of Diameter | 72 | mm | 72 | 72 | mm |
|
|
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 |
|
| | 21 | EX22222 | TR | 90002 | 21 | NON-TARGET | A3 | NT01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 22 | EX22222 | TR | 90002 | 22 | NON-TARGET | A3 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 23 | EX22222 | TR | 90002 | 23 | TARGET | A4 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 24 | EX22222 | TR | 90002 | 24 | TARGET | A4 | T02 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | TUMOR MERGED | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 25 | EX22222 | TR | 90002 | 25 | TARGET | A4 | T03 | LDIAM | Longest Diameter |
|
|
|
|
| NOT DONE | TUMOR MERGED | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 26 | EX22222 | TR | 90002 | 26 | TARGET | A4 | T02/T03 | LDIAM | Longest Diameter | 35 | mm | 35 | 35 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 27 | EX22222 | TR | 90002 | 27 | TARGET | A4 | T04.1 | LDIAM | Longest Diameter | 30 | mm | 30 | 30 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 28 | EX22222 | TR | 90002 | 28 | TARGET | A4 | T04.2 | LDIAM | Longest Diameter | 19 | mm | 19 | 19 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 29 | EX22222 | TR | 90002 | 29 | TARGET | A4 |
| SUMDIAM | Sum of Diameter | 84 | mm | 84 | 84 | mm |
|
|
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 |
|
| | 30 | EX22222 | TR | 90002 | 30 | NON-TARGET | A4 | NT01 | TUMSTATE | Tumor State |
|
|
|
|
| NOT DONE | NOT EVALUABLE: Image obscured | CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 31 | EX22222 | TR | 90002 | 31 | NON-TARGET | A4 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2007-06-19 | 168 | | 32 | EX22222 | TR | 90002 | 32 | TARGET | A5 | T01 | LDIAM | Longest Diameter | 0 | mm | 0 | 0 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | | 33 | EX22222 | TR | 90002 | 33 | TARGET | A5 | T02/T03 | LDIAM | Longest Diameter | 80 | mm | 80 | 80 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | | 34 | EX22222 | TR | 90002 | 34 | TARGET | A5 | T04.1 | LDIAM | Longest Diameter | 49 | mm | 49 | 49 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | | 35 | EX22222 | TR | 90002 | 35 | TARGET | A5 | T04.2 | LDIAM | Longest Diameter | 26 | mm | 26 | 26 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | | 36 | EX22222 | TR | 90002 | 36 | TARGET | A5 |
| SUMDIAM | Sum of Diameter | 155 | mm | 155 | 155 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 37 | EX22222 | TR | 90002 | 37 | NON-TARGET | A5 | NT01 | TUMSTATE | Tumor State | ENLARGEMENT FROM NADIR |
| ENLARGEMENT FROM NADIR |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | | 38 | EX22222 | TR | 90002 | 38 | NON-TARGET | A5 | NT02 | TUMSTATE | Tumor State | ABSENT |
| ABSENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | | 39 | EX22222 | TR | 90002 | 39 | NEW | A5 | NEW01 | TUMSTATE | Tumor State | PRESENT |
| PRESENT |
|
|
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 | | 40 | EX22222 | TR | 90002 | 40 | NEW | A5 | NEW01 | LDIAM | Longest Diameter | 9 | mm | 9 | 9 | mm |
|
| CT SCAN | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2007-08-14 | 224 |
|
|
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
...
.
...
4.3.1 RS Domain Model
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at week 8 and subsequent 8-week follow-up visits. The investigator also indicated that there was symptomatic deterioration indicating progression based on a clinical assessment that is not part of the response criteria (RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA"). The actual symptomatic deterioration is represented in the RSORRES value and the standardize representation (RSSTRESC) is "PD" (progressive disease). The Symptomatic Deterioration test (RSTESTCD = "SYMPTDTR") should only be used when this information is collected as part of the response forms. Normally, it is expected that the subject continues having disease assessments until objective evidence of progression is documented.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
Row 12: Shows RSCAT = "RECIST 1.1". The Overall Response (RSTESTCD = "OVRLRESP") has RSORRES = "NE" because the scans of the target and non-target lesions were not done. Row 13: Shows a protocol defined response which is outside of RECIST 1.1. In this case, it is symptomatic deterioration. This is represented with RSCAT = "PROTOCOL DEFINED RESPONSE CRITERIA" and Symptomatic Deterioration (RSTESTCD = "SYMPTDTR") with RSORRES = "Increased weakness and weight loss". The RSORRES contains the actual symptomatic deterioration results. The RSSTRESC = "PD" is a standardized representation of the symptomatic deterioration response. Row 14: Shows RSCAT= "PROTOCOL DEFINED RESPONSE CRITERIA and the Overall Response (RSTESTCD = "OVRLRESP") with RSORRES = "PD". |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTAT | RSEVAL | EPOCH | VISITNUM | VISIT | RSDTC | RSDY | | 1 | EX33333 | RS | 90003 | 1 |
| TRGRESP | Target Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 2 | EX33333 | RS | 90003 | 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 | EX33333 | RS | 90003 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | SD | SD |
| INVESTIGATOR | TREATMENT | 3 | WEEK 8 | 2007-02-27 | 56 | | 4 | EX33333 | RS | 90003 | 4 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 5 | EX33333 | RS | 90003 | 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 | EX33333 | RS | 90003 | 6 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 5 | WEEK 16 | 2007-04-24 | 112 | | 7 | EX33333 | RS | 90003 | 7 |
| TRGRESP | Target Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | | 8 | EX33333 | RS | 90003 | 8 |
| NTRGRESP | Non-Target Response | RECIST 1.1 | NON-CR/NON-PD | NON-CR/NON-PD |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | | 9 | EX33333 | RS | 90003 | 9 | A4 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR |
| INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-26 | 175 | | 10 | EX33333 | RS | 90003 | 10 |
| TRGRESP | Target Response | RECIST 1.1 |
|
| NOT DONE | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 11 | EX33333 | RS | 90003 | 11 |
| NTRGRESP | Non-Target Response | RECIST 1.1 |
|
| NOT DONE | INVESTIGATOR | TREATMENT | 9 | WEEK 32 |
|
| | 12 | EX33333 | RS | 90003 | 12 | A5 | OVRLRESP | Overall Response | RECIST 1.1 | NE | NE | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 13 | EX33333 | RS | 90003 | 13 | SYMPTDTR | Symptomatic Deterioration | PROTOCOL DEFINED RESPONSE CRITERIA | Increased weakness and weight loss | PD | INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-12 | 226 | 14 | EX33333 | RS | 90003 | 14 | A5 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | PD | PD |
| INVESTIGATOR | TREATMENT | 9 | WEEK 32 | 2009-08-12 | 226 |
|
|
|
|
The supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable) (QNAM = "REASNE") in the case where it is collected.
...
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example also shows a case were progressive disease due to symptomatic deterioration was determined based on a clinical assessment by the investigator. In addition, the example represents a situation where a result was not provided because the scan was not performed.
...