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Table 2 Summary of treatment-emergent adverse events (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

Treatment-emergent adverse events 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 (%)
Week 0–24 (early TEAEs)
Subjects with AEs 11 4 (50.0%) 40 15 (88.2%) 41 14 (82.4%) 25 11 (73.3%) 117 44 (77.2%)
Subjects with treatment-related AEs 1 1 (12.5%) 12 6 (35.3%) 16 10 (58.8%) 17 8 (53.3%) 46 25 (43.9%)
Subjects with grade ≥ 3 AEs 0 0 (0.0%) 0 0 (0.0%) 2 2 (11.8%) 1 1 (6.7%) 3 3 (5.3%)
Subjects with grade ≥ 3 treatment-related AEs 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 1 1 (6.7%) 1 1 (1.8%)
Subjects with treatment-modified AE 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%)
Subjects with SAEs 0 0 (0.0%) 0 0 (0.0%) 1 1 (5.9%) 0 0 (0.0%) 1 1 (1.8%)
Subjects with SUSARs 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%)
Week 24–96 (Long-term TEAEs)
Subjects with AEs 16 7 (87.5%) 19 7 (41.2%) 23 8 (47.1%) 25 9 (60.0%) 83 31 (54.4%)
Subjects with SAEs 0 0 (0.0%) 0 0 (0.0%) 3 2 (11.8%) 2 2 (13.3%) 5 4 (7.0%)
Subjects with SUSARs 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%) 0 0 (0.0%)
  1. Treatment-related TEAEs included possible, probable, and definite in relation to study treatment
  2. AE, adverse event; TEAE, treatment emergent adverse event; SAE, serious adverse event; SUSAR, suspected unexpected serious adverse reaction