Table 1.

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

Caverstem intervention	1.0 low dose	1.0 high dose	2.0
Number of patients	20	20	100
Serious adverse event	0 (0)	0 (0)	0 (0)
Loss of injection product (n)	0 (0)	0 (0)	0 (0)
Total volume injected (mL)	3	6	20
Injection of allocated amount of product (n)	20 (100)	20 (100)	100 (100)
Adverse event	n(%)	n(%)	n(%)
Pain at harvest sitea	5 (25)	7 (35)	9 (9)
Pain at injection sitea	6 (30)	6 (30)	5 (5)
Brushing at harvest sitea	5 (25)	5 (25)	6 (6)
Bruising at injection sitea	3 (15)	4 (20)	4 (4)
Negative impact on penisb	0 (0)	0 (0)	0 (0)
Fevers	0 (0)	0 (0)	0 (0)
Infection	0 (0)	0 (0)	0 (0)

^aGreater than 24 h post procedure

^bAs perceived by the patient