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Table 1 Safety Outcomes of All Patients through 60 months based on worst-case scenarios

From: The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis—a randomized single-blinded non-inferiority trial

  PBMNCs group (n = 25) PCCs group (n = 25) P value
Mobilization-related adverse events*, n (%) 5 (20.0) 7 (28.0) 0.508
Pain at injection site, n (%) 14 (56.0) 2 (8.0)  < 0.001
Elevation of leukocyte counts > 3 days after transplantation, n (%) 1 (4.0) 2 (8.0) 0.552
All-cause mortality, n (%) 0 (0.0) 3 (12.0) 0.074
Cardiovascular events, n (%) 0 (0.0) 1 (4.0) 0.312
Cerebrovascular events, n (%) 0 (0.0) 2 (8.0) 0.149
Pathological retinal angiogenesis, n (%) 0 (0) 0 (0.0) 1.000
  1. The data presented are the numbers (%)
  2. PBMNCs, peripheral blood mononuclear cells; PCCs, purified CD34+ cells
  3. *Mobilization-related adverse events included slight fevers, transient headaches, back pains, and pruritus
  4. A lost patient was calculated based on worst-case scenarios