...
| Dataset wrap |
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| Rowcaps |
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Row 1: Show that the QVAL for Reason Response Not Evaluable (QNAM = "REASNE"). |
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|
| 1 | EX11111 | RS | 90001 | RSSEQ | 3 | REASNERSREASNE | Reason Response Not Evaluable | Imaging quality issues and not all scan performed | CRF |
|
|
...
| Dataset wrap |
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| Rowcaps |
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Rows 1-2: Show the one-to-many relationship between TU and TR using --LNKID. --LNKID is the tumor identifier. The matching RELID value indicates that the two rows form the relationship. Rows 3-4: Show the many-to-one relationship between TR and RS using --LNKGRP. --LNKGRP is the identifier used to group and link all of the measurement/assessment records used in the assessment of the overall response record in the RS domain. The matching RELID value indicates that the two rows form the relationship. Rows 5-6: Show the one-to-many relationship between TU and PR using --REFID. --REFID contains the image identifier. The matching RELID value indicates that the two rows form the relationship. |
| Dataset2 |
|---|
| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID | | 1 | ABC12345 | TU |
| TULNKID |
| One | TUTR1 | | 2 | ABC12345 | TR |
| TRLNKID |
| Many | TUTR1 | | 3 | ABC12345 | TR |
| TRLNKGRP |
| Many | TRRS1 | | 4 | ABC12345 | RS |
| RSLNKGRP |
| One | TRRS1 | | 5 | ABC12345 | PR |
| PRREFID |
| One | PRTU1 | | 6 | ABC12345 | TU |
| TUREFID |
| Many | PRTU1 |
|
|
6
...
Non-Standard Variable (NSV) Suffix Names
The following table contains additional standard name codes for use in the Supplement Qualifiers for Supplemental Qualifiers for SUPPRS, SUPPTU and SUPPPR datasets.
| Dataset wrap |
|---|
|
QNAMRDOMAINQLABELTYPECODELIST| ROLE | REASNERS | | Reason Response Not Evaluable |
textFree text from CRF | PRVIR | TUTUPRVIR | Previously Irradiated Indicator |
text| Char | (NY) | Non-Standard Qualifier |
PRVIRPTU | | Previously Irradiated Progression |
text| Char | (NY) | Non-Standard Qualifier |
PRTYPTU | | Tumor or Lesion Presentation Type |
textTU| Char | (DSPRTYP) | Non-Standard Qualifier |
LOCDTL | Free text from CRFtext | | Char |
| Non-Standard Qualifier |
SLNUMTU | textFree text from CRF | ANTPLNTU | textFree text from CRF | LOC1 | PR| PRLOC1 | Anatomical Location 1 |
textPR| Char | (LOC) | Non-Standard Qualifier |
LOC2 | | PRLOC2 | Anatomical Location 2 |
textPR| Char | (LOC) | Non-Standard Qualifier |
SLTHK | textFree text from CRF | OIQPR | Free text from CRFtext | | Char |
| Non-Standard Qualifier |
|
End of Document
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| Info |
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| title | Information for Reviewers |
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Text in black is part of the template used to create this document and is not under review. Please review the blue text and all examples; this text represents the changes made to the template that are specific to this disease response criteria. |