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Table 3 Occurrence of thromboembolic, major bleeding and immunological events

From: Collagen fleece-bound fibrin sealant is not associated with an increased risk of thromboembolic events or major bleeding after its use for haemostasis in surgery: a prospective multicentre surveillance study

 

All

Mild

Moderate

Severe

Serious

TachoSil-related*

Thromboembolic events

51

12

19

20

46

3

Major bleeding

64

4

27

33

57

8

Immunological events

9

6

3

0

1

2

  1. *Considered at least possibly-related to TachoSil by the participating physician (probable = good reason and sufficient documentation to assume a causal relationship; possible = causal relationship conceivable). Mild = transient symptoms, no interference with daily activities; moderate = marked symptoms, moderate interference with daily activities; severe = considerable interference with daily activities; serious = resulted in death, life-threatening, required overnight inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, involved congenital anomaly or birth defect, or that required intervention to prevent any of the previous occurrence of any of the previously listed.