...
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| hi3 | TURESLOC |
|---|
| hi2style | yellow |
|---|
| hi3style | BOLD |
|---|
|
ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVGRPID | CVTESTCD | CVTEST | CVLOC | CVCAT | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC | CVTNTSIN |
| CVTUFLAG |
|---|
| 1 | ABC | CV | ABC-123 | 1 | AR | ABNIND | Abnormality Indicator | Abdominal region | NON-TARGET FOR STUDY TREATMENT (MONITORING) | Y |
| Y | Y |
|
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
| | 2 | ABC | CV | ABC-123 | 2 | 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 | 2020-04-27Non-target for study intervention |
|
| | 3 | ABC | CV | ABC-123 | 3 | AR-Aneurysm | LENGTH | Length |
| NON-TARGET FOR STUDY TREATMENT (MONITORING) | 2 | cm | 2 | 2 | cm |
|
| CT SCAN | 1 | BASELINE | 2020-04-27 |
|
| | 4 | ABC | CV | ABC-123 | 4 | 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 |
|
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| Nsvmeta |
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| Variable | Label | Type | Role | Origin | CVTNTSIN |
|---|
| Target/non-target for study intervention | text | Non-Standard Record Qualifier | CRF | CVTUFLAG | Flag for TU, TR or RS Data | text | Non-Standard Record Qualifier | CRF |
|
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...
The chest CT revealed a large aneurysm in the thoracic aorta which is "target" for study intervention. Note the use of the NSVs TNTSIN and 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 |
|---|
| hi3 | TURESLOC |
|---|
| hi2style | yellow |
|---|
| hi3style | BOLD |
|---|
|
ROW | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVLOC | CVCAT | CVORRES | CVSTRESC | CVSTRESN | CVRESLOC | CVRLODTL | CVMETHOD | VISITNUM | VISIT | CVDTC |
|---|
CVTNTSIN |
| 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 |
Target |
| Y | | 3 | 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 | 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 |
Target |
|
| Nsvmeta |
|---|
|
| Variable | Label | Type | Role | Origin | CVTNTSIN | Target/non-target for study intervention | text | Non-Standard Record Qualifier | CRF |
|---|
| CVTUFLAG | Flag for TU, TR and/or RS Data | text | Non-Standard Record Qualifier | CRF |
|
|
...