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| Row 1: | I examined the MRI image of the thoracic region (test location) and didn't find the presence of an aneurysm. |
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| Row 2: | I examined the MRI image of the abdominal region (test location) and found an aneurysm in the left (Result LAT) renal artery (Result Loc). |
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| Row 3: | I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (Result Loc). |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TULNKID | TUTEST | TUORRES | TULOC | TUMETHOD | VISITNUM | VISIT | TUDTC |
| TURESLOC | TURESLAT |
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| 1 | ABC | TU | ABC-456 | 1 |
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| Aneurysm Indicator | N | Thoracic Region | MRI | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | TU | ABC-456 | 2 | 1 | Aneurysm 1 | Aneurysm Indicator | Y | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
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| 3 | ABC | TU | ABC-456 | 3 | 1 | Aneurysm 1 | Aneurysm Location/Identification | Target? Identified | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
| Renal Artery | Left |
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| 4 | ABC | TU | ABC-456 | 4 | 2 | Aneurysm 2 | Aneurysm Indicator | Y | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
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| 5 | ABC | TU | ABC-456 | 5 | 2 | Aneurysm 2 | Aneurysm Location/Identification | Target? Identified | Abdominal Region | MRI | 1 | BASELINE | 2020-04-27 |
| Infrarenal Aorta |
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| Rows 1-2: | I examined the image of the thoracic region (test location) and found an aneurysm in the Thoracic Aorta (result location) spanning from the aortic arch to the descending aorta (result location detail). In this case result location detail further qualifies both ORRES and RESLOC, hence this is a variable qualifier. |
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| Rows 3-4: | I examined the image of the thoracic region (test location) and found that the descending aorta (result location) had dissected (the artery is tore and a false lumen had formed), most likely due to the enormous pressure caused by the large aneurysm in this area. |
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| Rows 5-6: | I examined the image of the abdominal region (test location) and found an aneurysm in the infrarenal aorta (result location), proximal to the iliac bifurcation (result location detail). In this case result location detail is a variable qualifier for the result, I am trying to say that the aneurysm is located in the segment of the infrarenal aorta closer (proximal) to the iliac bifurcation. |
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| Rows 7-8: | I examined the image of the abdominal region (test location) and found that the infrarenal aorta (result location) had dissected. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TUGRPID | TULNKID | TUTEST | TUORRES | TULOC | TUMETHOD | VISITNUM | VISIT | TUDTC |
| TURESLOCTURESLOC | TU Result Loc Detail |
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| 1 | ABC | TU | ABC-123 | 1 | 1 | Aneurysm 1 | Aneurysm Indicator | Y | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 2 | ABC | TU | ABC-123 | 2 | 1 | Aneurysm 1 | Aneurysm Location/Identification | Target? Identified | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Thoracic Aorta | Aortic Arch to Descending aorta |
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| 3 | ABC | TU | ABC-123 | 3 | 2 | Dissection 1 | Dissection Indicator | Y | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 4 | ABC | TU | ABC-123 | 4 | 2 | Dissection 1 | Dissection Location/Identification | Target? Identified | Thoracic region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Descending aorta |
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| 5 | ABC | TU | ABC-123 | 5 | 3 | Aneurysm 2 | Aneurysm Indicator | Y | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 6 | ABC | TU | ABC-123 | 6 | 3 | Aneurysm 2 | Aneurysm Location/Identification | Target? Identified | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Infrarenal aorta | proximal to the iliac bifurcation |
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| 7 | ABC | TU | ABC-123 | 7 | 4 | Dissection 2 | Dissection Indicator | Y | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
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| 8 | ABC | TU | ABC-123 | 8 | 4 | Dissection 2 | Dissection Location/Identification | Target? Identified | Abdominal region | CT SCAN | 1 | BASELINE | 2020-04-27 |
| Infrarenal aorta | proximal to the iliac bifurcation |
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The dissected descending aorta (test locationLNKID =Dissection 1) is classified based on the Stanford Aortic Dissection System as type B.
This test was originally created as a CVTEST, based on SDTMIG 3.4, this is considered as a grading scale and therefore should now be represented as CC/RS. Note the RSTEST still takes the original CV domain terminology naming convention, it does not comply with QRS rules.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKID | RSTEST | RSCAT | RSORRES | VISITNUM | VISIT | CVDTC |
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| 1 | ABC | RS | ABC-123 | 3 | Dissection 1 | Stanford AoD Classification | STAN01 | Stanford B | 1 | BASELINE | 2020-04-27 |
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| title | Questions and Thoughts |
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The results for TU, TUORRES = target, non-target, or new target. This convention was designed for tumor assessment. Target and non-target have very specific definitions depending on the tumor under study. Generally for solid tumor, according to RECIST: Measurable lesions - lesions that can be accurately measured in at least one dimension with longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan. - All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.
Non-measurable lesions - all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques. - All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up.
Since TU is also shared by Lesion Identification, to have a result as "target" is misleading and doesn't always apply to non-tumor settings. When you say there is a target aneurysm, what does that mean? Target for treatment and response evaluation? what is the criteria that makes it a target? Usually an aneurysm larger than 5cm requires surgery. Does that mean the ones that are smaller than 5 cm are considered "non-target"? and non-target for what? surgery not needed? The values for TU responses right now, doesn't make sense for non-tumor lesion identification process. |
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