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