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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