...
Two aneurysms are identified in the thoracic and abdominal regions.
CVLNKGRP CVLNKID provides the unique identifier for each identified aneurysm.
LNKGRP will link the CV records to other domain datasets, such as RS and CC for disease response to treatment and clinical classfication data.
| Dataset2 |
|---|
ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVGRPID | CVLNKGRP | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
|---|
| 1 | ABC | CV | ABC-123 | 1 |
|
| TR | ABNIND | Abnormality Indicator | Thoracic Region | Y |
| Y | Y |
|
|
| CT SCAN | 1 | BASELINE | 2020-04-27 | | 2 | ABC | CV | ABC-123 | 2 | Target | A1 | TR- Aneurysm | ABNEXAM | Examination for Abnormality | Thoracic Region | Aneurysm |
| Aneurysm | Aneurysm |
| Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 | | 3 | ABC | CV | ABC-123 | 3 |
|
| AR | ABNIND | Abnormality Indicator | Abdominal region | Y |
| Y | Y |
|
|
| CT SCAN | 1 | BASELINE | 2020-04-27 | | 4 | ABC | CV | ABC-123 | 4 | Non-Target |
| AR-Aneurysm | ABNEXAM | Examination for Abnormality | Abdominal region | Aneurysm |
| Aneurysm | Aneurysm |
| Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 | | 5 | ABC | CV | ABC-123 | 5 | Target | A1 | TR- Aneurysm | ABNROID | Abnormality (Role) Identification |
| Target for study intervention |
| Target for study intervention | Target for study intervention |
|
|
| CT SCAN | 1 | BASELINE | 2020-04-27 | | 6 | ABC | CV | ABC-123 | 6 | Non-Target |
| AR-Aneurysm | ABNROID | Abnormality (Role) Identification |
| Non-target for study intervention, monitor progression |
| Non-target for study intervention, monitor progression | Non-target for study intervention, monitor progression |
|
|
| CT SCAN | 1 | BASELINE | 2020-04-27 | | 7 | ABC | CV | ABC-123 | 7 | Target | A1 | TR- Aneurysm | LENGTH | Length |
| 4 | cm | 4 | 4 | cm |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 | | 8 | ABC | CV | ABC-123 | 8 | Target | A1 | TR- Aneurysm | MAXLDIA | Maximal Luminal Diameter |
| 5 | cm | 5 | 5 | cm |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 | | 9 | ABC | CV | ABC-123 | 9 | Non-Target |
| AR-Aneurysm | LENGTH | Length |
| 2 | cm | 2 | 2 | cm |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 | | 10 | ABC | CV | ABC-123 | 10 | Non-Target |
| AR-Aneurysm | MAXLDIA | Maximal Luminal Diameter |
| 2.5 | cm | 2.5 | 2.5 | cm |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
...
TU/TR/RS were originally built to assess tumor response to "study" treatment. Both "target" and "non-target" tumors receive the same study treatment, are then tracked and evaluated. "Target" and "non-target" tumor properties are mapped to TR and their responses to treatment are mapped to RS. Depending on the criteria used, "Target" and "non-target" tumor responses to treatment are evaluated a little differently. "Non-target" in the tumor context, does NOT mean, "not treated by study intervention".
In the CV data element projects, non-target is used to describe a lesion that will NOT be treated by a study intervention. Such a lesion may be untreated, managed by a non-study drug, or treated with a non-study device or procedure. This type of data has also been mapped into TU and TR, is this correct? If TU/TR are built to house lesion response to study treatment type of data, then I think the CV modeling is incorrect, and if so, how do we deal with it?
Example 2: Observed abnormality that's
...
a lesion, but "non-target" for study intervention, it is not treated and continuously monitored
...
.
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
PRTRT
...
VISIT
...
...
A small aneurysm is revealed by the abdomen CT scan. This aneurysm is small and is considered as "non-target" for study intervention even though it can be considered as a lesion, it should still be represented in CV. This includes its initial identification as well as all measurements of this aneurysm. , it is untreated and continuously monitored. Not sure whether this can be mapped to TU/TR, hence mapped to CV.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| hi3 | TURESLOC |
|---|
| hi2style | yellow |
|---|
| hi3style | BOLD |
|---|
|
ROW | STUDYID | DOMAIN | USUBJID | CVSEQ |
|
| CVGRPID | CVLNKGRP | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVCAT | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
| CVTUFLAG |
|---|
| 1 | ABC | CV | ABC-123 | 1 |
|
|
|
| AR | ABNIND | Abnormality Indicator | Abdominal regionNON-TARGET FOR STUDY TREATMENT (MONITORING) | Y |
| Y | Y |
|
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
| | 2 | ABC | CV | ABC-123 | 2 |
|
| NON-TARGET |
| AR-Aneurysm | ABNEXAM | Examination for Abnormality | Abdominal region | NON-TARGET FOR STUDY TREATMENT (MONITORING) | Aneurysm |
| Aneurysm | Aneurysm |
| Infrarenal aorta | proximal to the iliac bifurcation | CT SCAN | 1 | BASELINE | 2020-04-27 |
|
| | 3 | ABC | CV | ABC-123 | 3 |
|
| NON-TARGET |
| AR-Aneurysm | LENGTH | Length | NON-TARGET FOR STUDY TREATMENT (MONITORING) | ABNROID | Abnormality (Role) Identification |
| Non-target for study intervention, monitor progression |
| Non-target for study intervention, monitor progression | Non-target for study intervention, monitor progression |
|
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
| | 4 | ABC | CV | ABC-123 | 4 |
|
| NON-TARGET |
| AR-Aneurysm | LENGTH | Length |
| 2 | cm | 2 | 2 | cm |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
| | 45 | ABC | CV | ABC-123 | 54 |
|
| NON-TARGET |
| AR-Aneurysm | MAXLDIA | Maximal Luminal Diameter | NON-TARGET FOR STUDY TREATMENT (MONITORING) |
| 2.5 | cm | 2.5 | 2.5 | cm |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
|
|
| Nsvmeta |
|---|
|
| Variable | Label | Type | Role | Origin |
|---|
| CVTUFLAG | Flag for TU, TR or RS Data | text | Non-Standard Record Qualifier | CRF |
|
|
Example
...
3: Observed abnormality that's also a lesion and "target" for study intervention
The subject had a chest CT scan.
...
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
PRTRT
...
VISIT
...
The chest CT revealed a large aneurysm in the thoracic aorta which is "target" for study intervention. Note the use of the NSV TUFLAG to show that this abnormality is also considered as a target lesion for study intervention, tracking and/or disease response to treatment assessment. When the TUFLAG is marked with Y, measurements of the lesion should be represented in TU, TR and/or RS.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
|
ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVLOC |
|---|
CVCAT | CVORRES | CVSTRESC | CVSTRESN | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
| CVTUFLAG |
|---|
| 1 | ABC | CV | ABC-123 | 1 | TR | ABNIND | Abnormality Indicator | Thoracic region |
TARGET FOR STUDY TREATMENT | Y | Y | Y |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
| | 2 | ABC | CV | ABC-123 | 2 | TR-Aneurysm | ABNEXAM | Examination for Abnormality | Thoracic region |
TARGET FOR STUDY TREATMENT | | Aneurysm | Aneurysm | Aneurysm | Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Y | | 3 |
|
|
|
| TR-Aneurysm | ABNROID | Abnormality (Role) Identification |
| Target for study intervention | Target for study intervention | Target for study intervention |
|
|
|
|
|
|
|
| | 4 | ABC | CV | ABC-123 | 4 | TR | ABNIND | Abnormality Indicator | Thoracic region |
TARGET FOR STUDY TREATMENT | Y | Y | Y |
|
| CT SCAN | 3 | VISIT 2 | 2020-05-27 |
4
|
| | 5 | ABC | CV | ABC-123 | 5 | TR-Aneurysm | ABNEXAM | Examination for Abnormality | Thoracic region |
TARGET FOR STUDY TREATMENT | Aneurysm decreased in size | Aneurysm decreased in size | Aneurysm decreased in size | Thoracic Aorta | Aortic Arch to Descending aorta | CT SCAN | 3 | VISIT 2 | 2020-05-27 |
| Y |
|
| Nsvmeta |
|---|
|
| Variable | Label | Type | Role | Origin |
|---|
| CVTUFLAG | Flag for TU, TR and/or RS Data | text | Non-Standard Record Qualifier | CRF |
|
|
...