Appendix 6: A cumulative tabulation of all Serious Adverse Events and for Appendix 8: A cumulative tabulation of all Serious Adverse Reactions to section table 6 of ICH E2F 2 separate reports are required: A tabulation of all SAEs (including SARs and SUSARs) that have occurred during the course of the trial (appendix 6) A tabulation of all SARs (including SUSARs) that have occurred during the course of the trial (appendix 8) Create a summary table as indicated below Include all SAEs/SARs (as applicable) reported throughout lifetime of trial Amend the number of columns as required to accommodate the appropriate number of treatment arms Report by coding that are referenced within section 7.1 of this document. If no coding has been used, group by body system as appropriate Include a for each category Example 1 for non-blinded trials – The exact detail will be dependent on the events reported. Number of <insert Adverse Events or Adverse Reactions> Adverse Event Term CTCAE Category <insert treatment arm 1> <insert treatment arm 2 etc> Allergic reaction/ hypersensitivity 1* 3 (including drug fever) Allergy / Immunology Vasculitis 4 1 4 5 Sub-total Platelets 0 2 Blood / Bone Marrow 2 0 Sub-total Example 2 for blinded trials – The detail will be dependent on the events reported Reactions should only be listed under the relevant treatment arms where results have been unblinded. All other adverse reactions will be classed as ‘blinded’.
Appendix 6: A cumulative tabulation of all Serious Adverse Events and for Appendix 8: A cumulative tabulation of all Serious Adverse Reactions to section table 6 of ICH E2F 2 separate reports are required: A tabulation of all SAEs (including SARs and SUSARs) that have occurred during the course of the trial (appendix 6) A tabulation of all SARs (including SUSARs) that have occurred during the course of the trial (appendix 8) Create a summary table as indicated below Include all SAEs/SARs (as applicable) reported throughout lifetime of trial Amend the number of columns as required to accommodate the appropriate number of treatment arms Report by coding that are referenced within section 7.1 of this document. If no coding has been used, group by body system as appropriate Include a for each category Example 1 – for non-blinded trials The exact detail will be dependent on the events reported. CTCAE Category Adverse Event Term Number of <insert Adverse Events or Adverse Reactions> <insert treatment arm 1> <insert treatment arm 2 etc> Allergy / Immunology Allergic reaction/ hypersensitivity (including drug fever) 1* 3 Vasculitis 4 1 Sub-total 5 4 Blood / Bone Marrow Platelets 0 2 Sub-total 0 2 Example 2 – for blinded trials The detail will be dependent on the events reported Reactions should only be listed under the relevant treatment arms where results have been unblinded. All other adverse reactions will be classed as ‘blinded’.
UoB-CLN-QCD-002-DSUR-template-v-1-0-for-circulation-doc.docx