Table 2

Summary of adverse events
(A) Phase I study
N = 10
Any AE, n (%) 9 (90.0)
SAE, n (%) 0 (0.0)
AEs related to investigational product, n (%) 0 (0.0)
Most common AEs, n (%)
 Nausea 2 (20.0)
 Pyrexia 6 (60.0)
 Procedural site reaction 2 (20.0)
(B) Phase I/II study
Fibrin pad (N = 4) Standard of care (N = 3)
Total number of AEs 2 2
Incidence of AEs, n (%) 1 (25.0) 1 (33.3)
Incidence of SAEs, n (%) 1 (25.0) 0 (0.0)
AEs related to investigational product, n (%)
Post-procedural hemorrhage 1 (25.0) 0 (0.0)
Most common AEs, n (%)
 Epididymitis 1 (25.0) 0 (0.0)
 Atelectasis 0 (0.0) 1 (33.3)
 Postoperative wound infection 0 (0.0) 1 (33.3)

AE, adverse event; SAE, serious adverse event.

Nativ et al.

Nativ et al. BMC Nephrology 2012 13:147   doi:10.1186/1471-2369-13-147

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