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Table 3 Summary of adverse events during week 0–24 (early TEAEs)

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

Adverse event (Week 0–24) HA
N = 8
16 M
N = 17
32 M
N = 17
64 M
N = 15
Total
N = 57
[Event # (E)/Subject # (S) (%)] E S (%) E S (%) E S (%) E S (%) E S (%)
At least one below 11 4 (50.0%) 40 15 (88.2%) 41 14 (82.4%) 25 11 (73.3%) 117 44 (77.2%)
Cardiac disorders 1 1 (12.5%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 2 2 (3.5%)
Eye disorders 1 1 (12.5%) 2 2 (11.8%) 0 0 (0.0%) 0 0 (0.0%) 3 3 (5.3%)
Gastrointestinal disorders 1 1 (12.5%) 3 2 (11.8%) 4 3 (17.6%) 1 1 (6.7%) 9 7 (12.3%)
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%)
Hepatobiliary disorders 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
Infections and infestations 1 1 (12.5%) 6 6 (35.3%) 3 2 (11.8%) 4 3 (20.0%) 14 12 (21.1%)
Injury, poisoning, and procedural complications 0 0 (0.0%) 2 1 (5.9%) 1 1 (5.9%) 0 0 (0.0%) 3 2 (3.5%)
Investigations 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
Metabolism and nutrition disorders 0 0 (0.0%) 2 1 (5.9%) 0 0 (0.0%) 0 0 (0.0%) 2 1 (1.8%)
Musculoskeletal and connective tissue disorders 5 2 (25.0%) 15 6 (35.3%) 13 10 (58.8%) 11 5 (33.3%) 44 23 (40.4%)
Neoplasms benign, malignant, and unspecified (including cysts and polyps) 0 0 (0.0%) 2 2 (11.8%) 1 1 (5.9%) 0 0 (0.0%) 3 3 (5.3%)
Nervous system disorders 1 1 (12.5%) 1 1 (5.9%) 2 2 (11.8%) 1 1 (6.7%) 5 5 (8.8%)
Psychiatric disorders 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
Renal and urinary disorders 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
Respiratory, thoracic, and mediastinal disorders 0 0 (0.0%) 1 1 (5.9%) 2 2 (11.8%) 1 1 (6.7%) 4 4 (7.0%)
Skin and subcutaneous tissue disorders 0 0 (0.0%) 1 1 (5.9%) 1 1 (5.9%) 0 0 (0.0%) 2 2 (3.5%)
Surgical and medical procedures 0 0 (0.0%) 1 1 (5.9%) 2 1 (5.9%) 0 0 (0.0%) 3 2 (3.5%)
  1. Dictionary: MedDRA version 19.0