Appendix 5 Line Listings of Serious Adverse Reactions TO BE COMPLETED BY ACCORD IF RELEVENT Trial Country Subject Subject IMP IMP of Date of Body SAR Outcome Comments Unblinding reference subject in which age sex dose route treatment onset of System details of SAR (EudraCT number case of (if not SAR (medDRA known, best should be number) occurred admin (If not known, estimate of used) best estimate of duration of time to onset treatment) from therapy initiation Example 001 UK 46 F 0.5mg Oral 15/06/10 14/07/2010 CNS Dizziness Resolved None NA to and 28/11/10 numbness right arm Total number of SARs reported during this DSUR reporting period:
reference (EudraCT number) Trial subject number Country in which case occurred Subject age Subject sex IMP dose IMP route of admin of treatment (if not known, best estimate of duration of treatment) Date of onset of SAR (If not known, best estimate of time to onset from therapy initiation Body System SAR details (medDRA should be used) Outcome of SAR Comments Unblinding Example 001 UK 46 F 0.5mg Oral 15/06/10 to 28/11/10 14/07/2010 CNS Dizziness and numbness right arm Resolved None NA Appendix 5 Line Listings of Serious Adverse Reactions TO BE COMPLETED BY ACCORD IF RELEVENT Total number of SARs reported during this DSUR reporting period:
CR008-T01%20DSUR%20Template%20v1.0.docx