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

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

System organ class Overall
(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
  1. N = number of patients
  2. n = number of patients who experienced the AE
  3. % = percentage of patients who experienced the AE
  4. 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’