...
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the response data for one subject collected at the at the week 8 and subsequent 8-week follow-up visits.
...
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example to show 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 using RECIST 1.1. It is not expected that the TUACPTFL flag would be populated by the sponsor. That type of record selection or censoring would by part of the analysis dataset.
...
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator response data using RECIST 1.1 for a subject that has only target tumors at screening. This includes an unscheduled assessment.
...
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows investigator response data using RECIST 1.1 and the independent radiologist's response data using bi-dimensional and volumetric measurements.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
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 |
|---|
| 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 | |
|
...
The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. The example shows investigator tumor identification, tumor results, and response data using RECIST 1.1 and the independent radiologist's tumor identification, tumor results, and response data using bi-dimensional and volumetric measurements. The example shows example shows the identification of a new tumor where the investigator identified the new tumor only and the independent assessor identified and measured it. The tumor The tumor identifier is in TULNKID and matches TRLNKIDs in the TR TRLNKIDs in the TR Domain.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
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 |
|---|
| 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 | R-T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | OCCIPITAL LOBE | RIGHT | ANTERIOR | MRI | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | | 7 | EX66666 | TU | 90006 | 7 | R-T02 | TUMIDENT | Tumor Identification | TARGET | TARGET | ACME VENDOR | TEMPORAL LOBE | LEFT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST | 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 | R-NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | ACME VENDOR | FRONTAL LOBE | RIGHT |
| MRI | INDEPENDENT ASSESSOR | RADIOLOGIST | Y | TREATMENT | 4 | Cycle 3 Day 1 | 2007-02-26 | 56 | |
|
...
The tr.xpt table below shows the terminology used to implement RECIST 1.1 in the TR domain. This example shows investigator and independent radiologist's tumor results and the . The independent radiologist's tumor results using are based on bi-dimensional and volumetric measurements. The example also includes the situation where new tumors are measured by the independent radiologist.
...
The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example to shows RECIST 1.1 non-target and overall responses for a subject who did not have target lesions at baseline (target response is not applicable). This example also shows a "NE" overall response due to an unreadable image.
...