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. 2009 Jun 22;3:13. doi: 10.1186/1754-9493-3-13

Table 3.

Occurrence of thromboembolic, major bleeding and immunological events

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

*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.