Number of <insert Adverse Events or Adverse Reactions> Blinded Unblinded Adverse Event Term CTCAE Category <insert treatment arm 1 > <insert treatment arm 2 etc> Allergic reaction/ hypersensitivity 1* 3 7 (including drug fever) Allergy / Immunology Vasculitis 4 1 7 14 5 4 Platelets 0 2 15 / Bone Marrow 15 0 2 Sub-total
CTCAE Category Adverse Event Term Number of <insert Adverse Events or Adverse Reactions> Unblinded Blinded <insert treatment arm 1 > <insert treatment arm 2 etc> Allergy / Immunology Allergic reaction/ hypersensitivity (including drug fever) 1* 3 7 Vasculitis 4 1 7 5 4 14 / Bone Marrow Platelets 0 2 15 Sub-total 0 2 15
UoB-CLN-QCD-002-DSUR-template-v-1-0-for-circulation-doc.docx