Appendix A- Tables and Table headings for Clinical Trial Listings Table 1 Overview of Ongoing Studies [Study Drug] – Study Phase Country Study Study Dosing Study Planned Subject FVFP† ID Title design regimen Population enrolment exposure‡ first patient first visit †FVFP = numbers of patients recruited as of [date] and applied randomisation ‡ Based upon total schemes. Table 2 Overview of Studies Completed During the DSUR period [Study drug] – Study ID Phase Country Study Study Dosing Study Subject Title design regimen Population exposure per treatment arm (M/F) Table 3 Examples of Headings for Interval Line Listings of Serious Adverse – Reactions Study ID Case Country Serious Outcome Date Suspect Daily dose Dates of Comments EudraCT ID/Subject Gender Adverse of drug Route treatment number Age Drug onsent Formulation Treatment number† Reactions Time duration (SARs) to onset‡ † Study/Centre/patient SAR only ‡ ‘Primary’
Appendix A- Tables and Table headings for Clinical Trial Listings Table 1 – Overview of Ongoing Studies [Study Drug] Study ID Phase Country Study Title Study design Dosing regimen Study Population FVFP† Planned enrolment Subject exposure‡ †FVFP = first patient first visit ‡ Based upon total numbers of patients recruited as of [date] and applied randomisation schemes. Table 2 – Overview of Studies Completed During the DSUR period [Study drug] Study ID Phase Country Study Title Study design Dosing regimen Study Population Subject exposure per treatment arm (M/F) Table 3 – Examples of Headings for Interval Line Listings of Serious Adverse Reactions Study ID EudraCT number Case ID/Subject number† Country Gender Age Serious Adverse Drug Reactions (SARs) Outcome Date of onsent Time to onset‡ Suspect drug Daily dose Route Formulation Dates of treatment Treatment duration Comments † Study/Centre/patient ‡ ‘Primary’ SAR only