Pharmacodynamic evaluation and safety assessment of treatment with antibodies to serum amyloid P component in patients with cardiac amyloidosis: an open-label Phase 2 study and an adjunctive immuno-PET imaging study

Table 4 Summary of AEs in the Phase 2 study (safety population)

AE, number of participants (%)^b	Anti-SAP treatment^a
AE, number of participants (%)^b	Group 1 (n = 6)	Group 2 (n = 1)
At least one AE	6 (100)	1 (100)
Related AE^c	5 (83)	1 (100)
Leading to withdrawal from study/permanent discontinuation of anti-SAP treatment	0	1 (100)
SAEs	1 (17)	1 (100)
Fatal	0	0
Related to anti-SAP treatment	0	1 (100)^d
Rash category events (maximum CTCAE grade)^e
Any	4 (67)	0
Grade 1	3 (50)	0
Grade 2	1 (17)	0
Temporally associated, potential mAb-related infusion events^f	4 (67)	1 (100)
Medically confirmed infusion-related reactions	1 (17)^d	0

^aAnti-SAP treatment could be dezamizumab and/or miridesap
^bOnly includes AEs assigned to the on-treatment phase, i.e. with AE start date/time between first dose date/time of study drug and last dose date/time of study drug + 56 days, inclusive
^cRelated to dezamizumab or miridesap
^dRelated to dezamizumab
^eAEs categorised as RASH included “rash”, ‘maculopapular rash’, ‘pruritus’, and ‘rash erythematous’. Only those regarded as related to dezamizumab treatment in the opinion of the investigator were included and categorised using the CTCAE grading system
^fTemporally associated potential mAb-related infusion reactions (TPMI) were determined programmatically using the following preferred terms: ‘headache’, ‘flushing’, ‘feeling hot’, ‘feeling cold’, ‘chest discomfort’, ‘chills’, ‘face oedema’, ‘oedema peripheral’, ‘orbital oedema’, ‘nausea’, ‘vomiting’, ‘diarrhoea’, ‘fatigue’, ‘tachycardia’, ‘presyncope’ and ‘infusion-related reaction’. Events with these terms that occurred during the mAb infusion or within 24 h of the end of the mAb infusion were regarded as TPMI events. All TPMI events were medically reviewed to determine infusion-related reactions
AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, mAb monoclonal antibody, SAE serious adverse event, SAP serum amyloid P component

ISSN: 1471-2261