Table 3.
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.