Severe thrombocytopenia (for all serious bleeding events, including ICH) and meningitis (for ICH only) may be risk factors for serious bleeding.
On day 1 there were 12 patients with nonprocedure-related serious bleeding events.
Three patients experienced non-ICH serious bleeding events associated with a fatal outcome.
Serious bleeding events by study day in the primary efficacy population are displayed in Table 5.
Serious bleeding in abdominal surgical interventions occurs in approximately 2% to 5% of patients [ 4, 5].
One serious bleeding event occurred during the infusion period in each group.
The data regarding serious bleeding events are summarized in Table 2.
Fatal serious bleeding events during the infusion period occurred in 0.4% (12/2786) of cases.
Baseline demographics, APACHE II score, serious bleeding events, and in-hospital mortality were reported.
Of serious bleeding events on day 1 of therapy, 56% (15/27) were procedure-related.
Serious bleeding complications after treatment with Fab occurred in our study, consistent with past reports.
