FUNDAMANT: an interventional 72-week phase 1 follow-up study of AADvac1, an active immunotherapy against tau protein pathology in Alzheimer’s disease

Table 3 Adverse events observed in at least 10% of patients in the AC-AD-002 study, by system organ class and preferred term

System organ class	Overall
System organ class	(N = 26)
Preferred term	No.	(%)	Events
General disorders and administration site conditions
Injection site erythema	8	30.8	14
Injection site swelling	7	26.9	10
Injection site warmth	4	15.4	4
Injection site pruritus	3	11.5	4
Nervous system disorders
Cerebral atrophy	5	19.2	5
Restlessness	3	11.5	3
Metabolism and nutrition disorders
Abnormal weight gain	3	11.5	3
Psychiatric disorders
Depression	3	11.5	4
Behavioural and psychiatric symptoms of dementia	3	11.5	3
Infections and infestations
(Genito)urinary tract infection	4	15.4	4

N = number of patients
n = number of patients who experienced the AE
% = percentage of patients who experienced the AE
The term ‘Behavioural and psychiatric symptoms of dementia’ includes one instance of ‘Aggression’, one instance of ‘Acute psychosis’ and one instance of unspecified ‘Behavioural and psychiatric symptoms of dementia’

ISSN: 1758-9193