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Table 1 Safety—serious and non-serious adverse events up to 6 months post intervention

From: Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction

Caverstem intervention1.0 low dose1.0 high dose2.0
Number of patients2020100
Serious adverse event0 (0)0 (0)0 (0)
Loss of injection product (n)0 (0)0 (0)0 (0)
Total volume injected (mL)3620
Injection of allocated amount of product (n)20 (100)20 (100)100 (100)
Adverse event                                                                                                                                          n(%)n(%)n(%)
 Pain at harvest sitea5 (25)7 (35)9 (9)
 Pain at injection sitea6 (30)6 (30)5 (5)
 Brushing at harvest sitea5 (25)5 (25)6 (6)
 Bruising at injection sitea3 (15)4 (20)4 (4)
 Negative impact on penisb0 (0)0 (0)0 (0)
 Fevers0 (0)0 (0)0 (0)
 Infection0 (0)0 (0)0 (0)
  1. aGreater than 24 h post procedure
  2. bAs perceived by the patient