Safety
DISEASE, ADVERSE EVENT, UNILATERAL DEAFNESS
The frequency of observed AEs by patient was 15/22 (68.2%) in the ancrod and 5/9 (55.6%) in the placebo group with no significant difference (No serious adverse event was reported. Just one AE was rated severe: this patient had received ancrod and the AE (unilateral deafness) was classified unrelated to effects of the study medication by the investigator. This was most likely progression of the disease under study, but was classified as AE. All other AEs were rated with mild or moderate intensity.Except fibrinogen no clinically significant changes occurred in results of routine laboratory analyses, physical examination, and vital signs during treatment. One ancrod patient was tested positive for neutralizing anti-ancrod antibodies at screening and subsequently tested negative at day 8 and 30. At day 30, two patients were tested positive that had been tested negative at screening and day 8.