DOCX《READ ME》

2 SDTM dataset , PR , TRTSTT 3.5 , Risk Factors ,,

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Major Comorbid Conditions , Bulleted list of conditions , MH , Data can be represented using MH domain , Family History , Bulleted list of data of interest , APMH , Data can be represented using APMH domain

4 , Disease Management and Assessments ,,

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4.1 , Treatments , Concept Map 4: Treatment of Breast Cancer ,,

, , Bulleted list of systemic treatments , Bulleted list of local treatments 4.1.1 , Examples for Treatments ,,

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, Surgeries , 4.4.1 Example

1 SDTM dataset , PR , TRTINT PRLOC1, PRLOC2 Radiation therapy , 4.4.1 Example

2 SDTM dataset , PR , 4.1.2 , Treatment Side Effects ,,

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4.2 , Tumor Identification, Assessment, and Disease Response ,,

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4.2.1 , Examples for Tumor Identification and Assessment ,,

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, Example CRF: Tumor Identification/Results Target Lesions , TU, TR, RS , LOCTXT , Example CRF: Tumor Identification/Results Non-Target Lesions , TU, TR, RS , LOCTXT , Example CRF: Tumor Identification/Results New Lesions , TU, TR, RS , LOCTXT , Example CRF: Disease Response , RS , 4.2.1 Example

1 (SDTM dataset) , PR TU , PRTYP , tumor imaging at screening 4.2.1 Example

2 (SDTM dataset) , PR, TU, TR, RS , LINKID, LINKGRP LOCTXT PRTYP PRLOC1, PRLOC2, PRLOC3 , tumor assessment over time Note: The User Guide also refers to examples in the spreadsheet of examples for the TU, TR, and RS domains in the SDTMIG. A version of the spreadsheet which includes revisions and additions proposed for the next version of the SDTMIG is available at http://wiki.cdisc.org/display/PUB/Draft+Standards+of+Interest+to+TAUG-BrCa ,,

, 4.3 , Disease Recurrence , Concept Map 5: Disease Recurrence ,,

, concept map 4.3.1 , Examples for Disease Recurrence ,,

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4.3.1 Example

1 (SDTM dataset) , PR, TU, TR, RS , LINKID, LINKGRP , disease response 4.3.1 Example

2 (SDTM dataset) , RS , pathologic complete response

5 , Analysis Data ,,

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5.1 , Key Analysis Endpoints ,,

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5.1.1 , Time-to-Event Analysis ,,

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5.1.1.1 , Progression-Free Survival 5.1.1.1.1 , Derivation Considerations ,,

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5.1.1.1.2 , Modifications of Endpoint for Sensitivity Analyses ,,

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5.1.1.2 , Overall Survival 5.1.1.2.1 , Derivation Considerations ,,

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5.1.1.2.2 , Modifications of Endpoint for Sensitivity Analyses ,,

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5.1.1.2.3 , Other Relevant Supportive Analyses ,,

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5.1.1.3 , Event Free Survival 5.1.1.4 , Disease Free Survival ,,

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5.1.1.5 , Duration of Response 5.1.1.5.1 , Derivation Considerations ,,

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5.1.2 , Response Analysis ,,

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5.1.2.1 , Best Overall Response 5.2 , Table Shells ,,

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Table 5.2.1: Categorical Analysis of Tumor Response Table 5.2.2: Analysis of Time to Progression 5.3 , Analysis Datasets ,,

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5.3.1 , Subject-Level ,,

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, ADSL variable metadata , Contains important medical history and demographics. , ADSL dataset 5.3.2 , Intermediate Event Datset ,,

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5.3.2.1 , Use of a Provisional Variable ,,

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, ADEVETN variable metadata , An intermediate dataset that contains important dates used for events or censoring. , ADEVENT dataset 5.3.3 , Efficacy Reporting ,,

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ADTTE variable metadata , , Contains time-to-event parameters associated with the primary and secondary efficacy endpoints. ADTTE dataset ADRESP variable metadata , Contains parameters assocaited with categorical analysis of response. ADRESP dataset Known Issues Treatment Regimens , The strategy used to treat breast cancer is often a regimen that may consist of multiple drugs or of drug treatment combined with radiation and/or surgery. , o?? The SDTMIG does not give clear guidance on how to indicate that multiple treatments comprise a regimen. In this document, the relationship among drug treatments given together and considered to be part of a regimen has been represented by assigning a common value of the variable --GRPID (e.g., CMGRPID) to components of the treatment regimen. This solution does not address grouping drug treatments with radiation or surgical treatments, since the latter would be represented in a different domain (PR) than the drug treatments. A currently available solution is to use the Related Records (RELREC) dataset to group all the component treatments. A new variable to indicate that interventions are part of a regimen is under discussion. , o?? Breast cancer studies may col........