Real-world safety outcomes from one ongoing US study
of 27,467 nonvalvular AF patients11
Results based on 15 months of data from an ongoing, 5-year postmarketing safety surveillance study to
evaluate major bleeding in patients receiving XARELTO® in a real-world clinical setting. Cases of major
bleeding were identified through electronic health records from the US Department of Defense database,
from January 1, 2013, to March 31, 2014.
RATES OF BLEEDING
COMORBID PATIENTS STUDIED
EVENT RATE/100 PATIENT-YEARS
20
15
87
%
10
5
0
2.86 0.08
major bleed
(n=478)
with comorbidities
including:
diabetes
heart failure
renal disease
Mean age: 76
fatal bleed
(n=14)
0.1% ICH (n=36)
1.5% GI bleed (n=423)
B:14.25 in
S:13 in
T:14 in
RESULTS ARE NOT INTENDED FOR DIRECT COMPARISON WITH CLINICAL TRIALS
A validated computer database algorithm developed by Cunningham et al, which identifies bleeding-related
hospitalizations from a primary discharge diagnosis, was used to identify major bleeding events in this study.
The definition of major bleeding is not an exact match with the ROCKET AF trial.
LIMITATIONS: This is a retrospective study and t