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Table 4 Summary of AEs

From: A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia

  BM-MSC Placebo
  No. of patients No. of patients
  (No. of events) (No. of events)
System organ class
At least one symptom 6 (13) 7 (45)
  Gastrointestinal disorders 1 (1) 2 (2)
  General disorders and administration site conditions 3 (3) 0
  Hepatobiliary disorders 0 1 (1)
  Infections and infestations 3 (3) 3 (3)
  Injury, poisoning and procedural complications 1 (1) 1 (2)
  Investigations 1 (2) 3 (29)
  Metabolism and nutrition disorders 0 1 (1)
  Musculoskeletal and connective tissue disorders 0 1 (2)
  Nervous system disorders 0 2 (3)
  Psychiatric disorders 0 1 (1)
  Renal and urinary disorders   1 (1)
  Skin and subcutaneous tissue disorders 1 (1) 0
  Vascular disorders 1 (2) 0
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