DSUR Summary Table Naming Conventions
Let us consider the DSUR Main summary tabulation data structure to explain the naming conventions and drug key table functionality.
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The first group name is G1_DSURSUMTAB. It is different for all DSUR summary sections.
For fatal summary tabulation, the group name is G1_DSURSUMTAB1.
For Cumulative main ST section, the group name is G1_DSURSUMTAB3.
For Cumulative fatal ST section, the group name is G1_DSURSUMTAB4.
The grouping column is Follow-Up text. The element name is G1_TEXT1 and is used in dsur_sum.rtf.
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The second group name is G2_DSURSUMTAB. The second (and subsequent) group names are the same for all DSUR summary tabulation sections. This effectively uses the DSUR summary sub-template. The grouping column is Sponsor study Number. The element name is G2_TEXT1 and is used in dsur_sum.rtf.
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G3_DRUGKEY is the third group which prints Study and Comparator drugs in a table format.
Figure 6-4 Study and Comparator Drugs Format
Description of "Figure 6-4 Study and Comparator Drugs Format"In the summary tabulation, IMP 1 is printed under IMP Treatment1 and IMP 2 is printed under IMP Treatment2. The titles are configurable (flexible code list: BIP_PROD_CATEGORY).
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The fourth group name is G4_DSURSUMTAB. It is the same for all DSUR summary tabulation sections. The grouping column is SOC. The element name is G4_TEXT1 and is used in dsur_sum.rtf.
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The fifth group name is G5_DSURSUMTAB. It is the same for all DSUR summary tabulation sections. The grouping column is Event Reaction. The element name is G5_TEXT1 and is used in dsur_sum.rtf. The Column title appears from the code list BIP_PROD_CATEGORY and element name is G5_TEXT2.
<group name="G1_DSURSUMTAB" label="G1_DSURSUMTAB" source="Q1_MAINDSURSUMTAB"> <element name="G1_TEXT3" value="G1MAINDSURPSURFOLLOWUPFLAG" label="G1MAINDSURPSURFOLLOWUPFLAG" dataType="xsd:string" breakOrder="" fieldOrder="1"/> <element name="G1_TEXT1" value="G1MAINDSURPSURFOLLOWUPTEXT" label="G1MAINDSURPSURFOLLOWUPTEXT" dataType="xsd:string" breakOrder="" fieldOrder="2"/> <element name="CNT_CASEID" value="CNT_CASEID" label="CNT_CASEID" dataType="xsd:double" breakOrder="" fieldOrder="3"/> <group name="G2_DSURSUMTAB" label="G2_DSURSUMTAB" source="Q2_MAINDSURSUMTAB"> <element name="G2_TEXT1" value="G2MAINDSURSPONSORSTUDYNUMB" label="G2MAINDSURSPONSORSTUDYNUMB" dataType="xsd:string" breakOrder="" fieldOrder="1"/> <element name="CNT_CASEID" value="CNT_CASEID" label="CNT_CASEID" dataType="xsd:double" breakOrder="" fieldOrder="2"/> <group name="G3_DRUGKEY" label="G3_DRUGKEY" source="Q3_DRUGKEY1"> <element name="G3_DRUGROLE" value="G3_DRUGROLE" label="G3_DRUGROLE" dataType="xsd:string" breakOrder="" fieldOrder="2"/> <element name="G3_COLUMNNUMBER" value="G3_COLUMNNUMBER" label="G3_COLUMNNUMBER" dataType="xsd:double" breakOrder="" fieldOrder="3"/> <element name="G3_DRUGNAME" value="G3_DRUGNAME" label="G3_DRUGNAME" dataType="xsd:string" breakOrder="" fieldOrder="4"/> <element name="G3_STUDYID" value="G3_STUDYID" label="G3_STUDYID" dataType="xsd:string" breakOrder="" fieldOrder="1"/> </group> <group name="G4_DSURSUMTAB" label="G4_DSURSUMTAB" source="Q4_MAINDSURSUMTAB"> <element name="G4_TEXT1" value="G4MAINDSURSOC" label="G4MAINDSURSOC" dataType="xsd:string" breakOrder="" fieldOrder="1"/> <element name="CNT_CASEID" value="CNT_CASEID" label="CNT_CASEID" dataType="xsd:double" breakOrder="" fieldOrder="2"/> <group name="G5_DSURSUMTAB" label="G5_DSURSUMTAB" source="Q5_MAINDSURSUMTAB"> <element name="G5_TEXT1" value="G5BMAINDSURREACTION" label="G5BMAINDSURREACTION" dataType="xsd:string" breakOrder="" fieldOrder="1"/> <element name="G5_TEXT2" value="G5MAINDSURLISTCOL" label="G5MAINDSURLISTCOL" dataType="xsd:string" breakOrder="" fieldOrder="2"/> <element name="G5_TEXT4" value="G5MAINDSURORD" label="G5MAINDSURORD" dataType="xsd:double" breakOrder="" fieldOrder="3"/> <element name="CNT_CASEID" value="CNT_CASEID" label="CNT_CASEID" dataType="xsd:double" breakOrder="" fieldOrder="4"/> </group> </group> </group> </group>