Template 1: Example Line Listing of All Serious Adverse Events * Indicates event suspected to be related to the IMP a serious adverse reaction (SAR) – ** Indicates event reported as a Suspected Unexpected Serious Adverse Reaction (SUSAR). Study Country/ diagnosis Outcome Time to Onset from Suspected drug Dose, route of Date of Comments Subject ID gender administration administration treatment and formulation 0023* UK - male hypotension resolved 2 hours IMP 10mg/kg, x3, 10-Apr-2011 Describe event. IV 11-Apr-2011 14-May-2011 0168 UK male Metastatic ongoing 3 months blinded 10mg/kg, x3 21-feb-2011 Describe event prostate IV or placebo 18-Mar-2011 cancer 15-June -2011 0109** UK female neutropenia sequale 3 days blinded 10mg/kg, x3 06-May-2011 Describe event IV or placebo 07-May 2011 12-May-2011
Template 1: Example Line Listing of All Serious Adverse Events Study Subject ID Country/ gender diagnosis Outcome Time to Onset from administration Suspected drug Dose, route of administration and formulation Date of treatment Comments 0023* UK - male hypotension resolved 2 hours IMP 10mg/kg, x3, IV 10-Apr-2011 11-Apr-2011 14-May-2011 Describe event. 0168 UK male Metastatic prostate cancer ongoing 3 months blinded 10mg/kg, x3 IV or placebo 21-feb-2011 18-Mar-2011 15-June -2011 Describe event 0109** UK female neutropenia sequale 3 days blinded 10mg/kg, x3 IV or placebo 06-May-2011 07-May 2011 12-May-2011 Describe event * Indicates event suspected to be related to the IMP – a serious adverse reaction (SAR) ** Indicates event reported as a Suspected Unexpected Serious Adverse Reaction (SUSAR).
CTT55_LTHT_UoL_DSUR_V2.0_120209.docx