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Table 3 Adverse events (SAS)

From: Translational development of ABCB5+ dermal mesenchymal stem cells for therapeutic induction of angiogenesis in non-healing diabetic foot ulcers

Event

Number of events

Number (%) of patients

Any adverse eventa

120

21 (91)

Any TEAE

93

20 (87)

Any serious TEAE

12

10 (43)

Any treatment-related TEAE

0

0 (0)

Frequent TEAEs by MedDRA system organ classb

 General disorders and administration site conditions

3 (13)

  Edema peripheral

2 (9)

 Infections and infestations

15 (65)

  Infected skin ulcer

6 (26)

  Localized infection

4 (17)

  Nasopharyngitis

4 (17)

  Wound infection

2 (9)

 Injury, poisoning and procedural complications

5 (22)

  Ligament sprain

2 (9)

 Metabolism and nutrition disorders

4 (17)

  Hyperglycemia

2 (9)

 Musculoskeletal and connective tissue disorders

4 (17)

  Arthralgia

2 (9)

  Back pain

2 (9)

  Pain in extremity

3 (13)

 Skin and subcutaneous tissue disorders

11 (48)

  Blisters

6 (26)

  Skin ulcer

4 (17)

  1. MedDRA Medical Dictionary for Regulatory Activities; TEAE Treatment-emergent adverse event; SAS Safety analysis set (N = 23)
  2. aIncludes pretreatment-emergent (occurring between giving written consent and first cell application) and treatment-emergent (occurring between first cell application and end of safety follow-up) adverse events
  3. bOnly TEAEs that were reported by at least 2 patients