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Table 4 Summary of treatment-related adverse events during week 0–24

From: Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE®: a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial

Treatment-relative adverse event (week 0–24) HA
N = 8
16M
N = 17
32M
N = 17
64M
N = 15
Total
N = 57
[Event # (E)/subject # (S) (%)] E S (%) E S (%) E S (%) E S (%) E S (%)
At least one below 1 1 (12.5%) 12 6 (35.3%) 16 10 (58.8%) 17 8 (53.3%) 46 25 (43.9%)
General disorders and administration site conditions 1 1 (12.5%) 4 3 (17.6%) 7 7 (41.2%) 7 6 (40.0%) 19 17 (29.8%)
 ~ Injection site erythema 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
 ~ Injection site joint effusion 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (6.7%) 1 1 (1.8%)
 ~ Injection site joint inflammation 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (1.8%)
 ~ Injection site joint pain 1 1 (12.5%) 1 1 (5.9%) 3 3 (17.6%) 4 4 (26.7%) 9 9 (15.8%)
 ~ Injection site joint swelling 0 0 (0.0%) 2 2 (11.8%) 3 3 (17.6%) 2 2 (13.3%) 7 7 (12.3%)
Infections and infestations 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (1.8%)
 ~ Pharyngitis 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (1.8%)
Injury, poisoning, and procedural complications 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
 ~ Procedural vomiting 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
Investigations 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
 ~ Alpha tumor necrosis factor increased 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
Musculoskeletal and connective tissue disorders 0 0 (0.0%) 4 2 (11.8%) 6 5 (29.4%) 10 4 (26.7%) 20 11 (19.3%)
 ~ Arthralgia 0 0 (0.0%) 3 2 (11.8%) 2 2 (11.8%) 6 4 (26.7%) 11 8 (14.0%)
 ~ Joint stiffness 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 2 1 (6.7%) 3 2 (3.5%)
 ~ Joint swelling 0 0 (0.0%) 1 1 (5.9%) 3 3 (17.6%) 2 2 (13.3%) 6 6 (10.5%)
Neoplasms benign, malignant, and unspecified (including cysts and polyps) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (1.8%)
 ~ Pharyngeal neoplasm benign 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (1.8%)
Nervous system disorders 0 0 (0.0%) 1 1 (5.9%) 1 1 (5.9%) 0 0 (0.0%) 2 2 (3.5%)
 ~ Dizziness 0 0 (0.0%) 1 1 (5.9%) 1 1 (5.9%) 0 0 (0.0%) 2 2 (3.5%)
Skin and subcutaneous tissue disorders 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (1.8%)
 ~ Cold sweat 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (1.8%)
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