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The PROWESS trial authors state that serious bleeding occurred primarily in patients with an identifiable predisposition to bleeding.
Serious bleeding occurred in 2.4% of patients receiving rhAPC and in 1.2% of patients receiving the placebo (P = 0.02) during the drug-infusion period.
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If serious bleeding occurs, seek help immediately!! Or, you could possibly just hit a vein.
In the 28-day study period (which included the 96-hour infusion), serious bleeds occurred in 3.9% of Canadian patients (6.9% of non-Canadian patients).
One serious bleeding event occurred during the infusion period in each group.
A serious bleeding event occurred in only one patient in the rhAPC group.
Serious bleeding events occurred in 2.4% of DrotAA-treated patients versus 1.2% in the placebo group (P = 0.02) during the drug-infusion period.
Serious bleeding episodes occurred in 13.9%, life-threatening infections in 6.9%, autoimmunity in 12.1%, and malignancy in 5.2% of XLT patients at median ages of 4.9 years, 24.8 years, 12.2 years, and 34.0 years, respectively.
During the study period, one serious adverse event related to bleeding occurred in the rhTM group (5.0%), and two adverse events occurred in the control group (4.4%); however, there was no significant difference in the incidence of this adverse event between groups.
Serious bleeding may occur.
Meanwhile, 40 cases of serious bleeding will occur.
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