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.

1. 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.

2. 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.

3. 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).

4. 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.

5. 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>