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Table 5 Summary of adverse events

From: Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel®): preclinical and clinical trial in osteoarthritis of the knee joint

  Cohort 1 Cohort 2
System organ class 25 M (n = 10) 50 M (n = 10) P1 (n = 10) 75 M (n = 10) 150 M (n = 10) P2 (n = 10)
Any adverse event 24 (7) 13 (7) 21 (7) 17 (7) 11 (6) 11 (6)
Blood and lymphatic system disorders 0 1 (1) 1 (1) 0 0 0
Endocrine disorders 0 0 0 1 (1) 0 0
Eye disorders 0 1 (1) 0 0 0 0
Gastrointestinal disorders 1 (1) 0 2 (2) 1 (1) 0 3 (3)
General disorders and administration site conditions 2 (1) 4 (2) 0 9 (6) 4 (3) 0
Infections and infestations 3 (3) 1 (1) 4 (3) 0 1 (1) 1 (1)
Injury, poisoning, and procedural complications 0 0 1 (1) 2 (1) 3 (3) 0
Investigations 2 (2) 1 (1) 1 (1) 0 1 (1) 2 (2)
Metabolism and nutrition disorders 4 (3) 0 3 (3) 0 0 1 (1)
Musculoskeletal and connective tissue disorders 6 (3) 3 (3) 5 (4) 4 (2) 2 (2) 3 (2)
Nervous system disorders 1 (1) 0 1 (1) 0 0 0
Renal and urinary disorders 0 1 (1) 0 0 0 0
Reproductive system and breast disorders 1 (1) 0 0 0 0 0
Respiratory, thoracic, and mediastinal disorders 0 0 0 0 0 1 (1)
Skin and subcutaneous tissue disorders 1 (1) 0 1 (1) 0 0 0
Surgical and medical procedures 2 (1) 0 0 0 0 0
Vascular disorders 1 (1) 1 (1) 2 (1) 0 0 0
  1. Values are shown as number of events (number of patients)
  2. 25 M, 50 M, 75 M, 150 M = 25, 50, 75, and 150 million cells, respectively
  3. P1, P2 = placebo 1 and placebo 2, respectively