DOCX《READ ME》

READ ME Worksheet , Column , Description ,,

Summary , Organized by User Guide sections, shows SDTM domains and variables used.

, User Guide Section Number , Section number or other identifier of a portion of the User Guide Section Name , Examples , Section and example numbers for User Guide examples in the section SDTM domains used , Listed by domain code. Additional information on domains and their status in versions of the SDTMIG is in the Domains worksheet. New SDTM variables used , New SDTM variables are standard variables added or proposed since SDTM 1.2 and non-standard variables (supplemental qualifiers). Additional information on variables and their status in versions of the SDTMIG is in the Variables worksheet. Comments Known Issues , Modeling issues not yet resolved at the time of publication of this TA User Guide. Domains , Shows domains which were not in SDTMIG version 3.1.2 which have since been added to the SDTMIG or proposed for addition in future. The SDTMIG for Associated Persons is not listed in the FDA Data Standards catalog, although the variables and datasets it introduced are included in SDTM v1.4, which is listed in the catalog. - General observation class domains from the Associated Persons SDTMIG can be handled as AP domains. They are listed in the table as AP Domain . They are described as Non-standard for SDTM versions prior to 1.4. For SDTMIG 3.2 and following, AP Domains are Standard or Custom depending on the status of the domain on which they are based. , Variables , For variables listed in the Summary worksheet, shows how to handle data in various SDTMIG versions. - Variables included as standard in a version of the SDTMIG are handled as standard variables. - Variables not included in a version of the SDTMIG can generally be handled as non-standard variables (supplemental qualifiers). For non-standard variables, metadata submitted would depend on whether variables were handled as supplemental qualifiers or as non-standard variables in the parent domain. Data Type and Controlled Terms, Codelist, or Format would be available in the latter case. ADaM , Shows proposed additions to ADaM. Summary User Guide Section Number , Section Name , Examples, Concept Maps, Tables, Lists , SDTM Domains used , New SDTM variables used , Comments

2 , Overview of Breast Cancer ,,

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3 , Subject and Disease Characteristics , Figure 3: Treatment Settings in Breast Cancer ,,

, 3.1, Diagnosis , Concept Map 1: Initial Diagnosis of Breast Cancer ,,

, 3.2, Staging , Concept Map 2: Breast Cancer Staging ,,

, 3.3, Pathology , Concept Map 3: Removal of Cancer Tissue ,,

, Table 3.3.1: Molecular Measurements , See 3.3.1 Example

1 Table 3.3.2: Cancer Measurements , See 3.3.1 Example

2 Table 3.3.3: Primary Tumor Grade Assessments , Table 3.3.4: Prespecified Findings , , Table 3.3.5: Genetic Molecular Analysis , Table 3.3.6: Histologic/Morphologic Types of Breast Cancer 3.3.1 , Examples for Pathology ,,

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Estrogen receptor by IHC , 3.3.1 Example

1 (SDTM dataset) , MI , TSTDTL PTSCL , Gross pathology on lumpectomy tissue , 3.3.1 Example

2 (SDTM datasets) , TU TR MI , EVALID 3.4 , Prior Treatments ,,

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3.4.1 , Examples for Prior Treatments ,,

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Prior antineoplastic medications , 3.4.1 Example

1 SDTM dataset , CM , TRTINT TRTSTT RSDISC Radiation therapy , 3.4.1 Example

2 Annotated CRF 1.1 Radiation Therapy , PR , TRTINT, TRTSTT, TRTDTL, RRLTLC, CMLDOS, RITLFR, TRTBOR Radiation therapy , 3.4.1 Example