Skip to main content

Table 2 Summary of adverse events

From: Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

(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)

  1. AE, adverse event; SAE, serious adverse event.