Conclusions This should be very brief and describe any changes to the previous knowledge or efficacy and safety resulting from information gained since the last DSUR. The conclusions should outline the actions that have been or will be taken to address emerging safety issues E.g. The risks remain consistent with experience described in previous DSUR (or in our application to the regulator) and we conclude that in the information obtained in this reporting period warrants continuation of the study, with the modifications outlined in this DSUR. Appendices Possible appendices: Investigators Brochure; Cumulative Table of Important Regulatory Requests; Cumulative Summary Tabulations of Demographic Data; Line Listings of Serious Adverse Reactions (mandatory please see template 1); – Cumulative Summary Tabulation of Serious Adverse Events; Scientific Abstracts (if relevant).
Conclusions This should be very brief and describe any changes to the previous knowledge or efficacy and safety resulting from information gained since the last DSUR. The conclusions should outline the actions that have been or will be taken to address emerging safety issues E.g. The risks remain consistent with experience described in previous DSUR (or in our application to the regulator) and we conclude that in the information obtained in this reporting period warrants continuation of the study, with the modifications outlined in this DSUR. Appendices Possible appendices: Investigators Brochure; Cumulative Table of Important Regulatory Requests; Cumulative Summary Tabulations of Demographic Data; Line Listings of Serious Adverse Reactions (mandatory – please see template 1); Cumulative Summary Tabulation of Serious Adverse Events; Scientific Abstracts (if relevant).
CTT55_LTHT_UoL_DSUR_V2.0_120209.docx