Line Listings of Serious Adverse Reactions during the Reporting Period Study ID Gender SAR Outcome Date of onset Suspect drug Daily dose of treatment Comments (primary SAR Subject ID Age Route Treatment only) duration Centre ID/name Formulation Time of DD MMM From DD MMM YYYY YYYY to DD MMM YYYY HH:MM Where possible the line listings should include each subject only once regardless of how many SAR items are reported for the case. If there is more than one reaction, they should all be mentioned but the case should be listed under the most serious or primary adverse reaction. It is possible that the same subject could experience different SARs on different occasions (e.g. weeks apart). Under such circumstances, the SARs can be listed separately and a single subject can be included in the line listing more than once.
Line Listings of Serious Adverse Reactions during the Reporting Period Study ID Subject ID Centre ID/name Gender Age SAR Outcome Date of onset (primary SAR only) Time of Suspect drug Daily dose Route Formulation of treatment Treatment duration Comments DD MMM YYYY HH:MM From DD MMM YYYY to DD MMM YYYY Where possible the line listings should include each subject only once regardless of how many SAR items are reported for the case. If there is more than one reaction, they should all be mentioned but the case should be listed under the most serious or primary adverse reaction. It is possible that the same subject could experience different SARs on different occasions (e.g. weeks apart). Under such circumstances, the SARs can be listed separately and a single subject can be included in the line listing more than once.
vedl-lm-3-6-1-template-dsur.docx