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Table 2 Adverse events that were observed in at least 1 subject during the 12-week follow-up period (all causalities)

From: Intracerebroventricular injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer’s disease dementia: a phase I clinical trial

  Low dose (n = 3) High dose (n = 6)
No. of subjects (%) [no. of events] No. of subjects (%) [no. of events]
Before hUCB-MSC injection
 Total 2 (66.7) [4] 5 (83.3) [5]
 Ommaya site pain 0 [0] 2 (33.3) [2]
 Procedural pain 1 (33.3) [1] 1 (16.7) [1]
  Headache 1 (33.3) [2] 0 [0]
  Device malfunction 0 [0] 1 (16.7) [1]
  Enteritis 1 (33.3) [1] 0 [0]
  Otolithiasis 0 [0] 1 (16.7) [1]
After hUCB-MSC injection
 Total 3 (100.0) [21] 6 (100.0) [48]
 Nervous system disorders   
  Headache 2 (66.7) [5] 5 (83.3) [12]
  Paraesthesia 0 [0] 2 (33.3) [4]
 Gastrointestinal disorders   
  Nausea 2 (66.7) [E2] 3 (50.0) [7]
  Vomiting 1 (33.3) [2] 3 (50.0) [6]
  Abdominal pain 0 [0]E 1 (16.7) [1]
  Dyspepsia 1 (33.3) [1] 0 [0]
 General disorders and administration site conditions
  Fever 3 (100) [7] 6 (100) [13]
  Chills 0 [0] 1 (16.7) [1]
  Ommaya site pain 1 (33.3) [1] 0 [0]
  Pain other than the Ommaya site 0 [0] 1 (16.7) [1]
 Musculoskeletal and connective tissue disorders
  Musculoskeletal stiffness 0 [0] 1 (16.7) [1]
  Myalgia 1 (33.3) [2] 0 [0]
  Arthralgia 0 [0] 1 (16.7) [1]
  Periarthritis 0 [0] 1 (16.7) [1]
 Infections and infestations   
  Impetigo 1 (33.3) [1] 0 [0]
  Psychiatric disorders   
  Delusion 0 [0] 0 [0]