Real-world safety outcomes from one ongoing US study
11
of 27,467 nonvalvular AF patients
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
10
5
0
87
%
2.86 0.08
with comorbidities
including:
diabetes
heart failure
renal disease
major bleed
(n=478)
fatal bleed
Mean age: 76
(n=14)
0.1% ICH (n=36)
1.5% GI bleed (n=423)
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 there is no comparator arm in the trial. Differences in
study design, patient populations, definition of safety outcomes, and data collection methods make it
difficult to make comparisons with clinical trials.11
RATES OF BLEEDING IN ROCKET AF (N=7,111)12†:
The event rate per 100 patient-years was 3.6 (n=395) for major bleed and 0.20 (n=27) for fatal bleed‡
•
0.8% of patients experienced an ICH (n=55) and 3.1% of patients experienced a GI bleed (n=221)
AF = atrial fibrillation; GI = gastrointestinal; ICH = intracranial hemorrhage.
†XARELTO® was evaluated versus dose-adjusted warfarin in more than 14,000 patients with
nonvalvular AF at moderate to high risk for stroke in a rigorously designed, multicenter,
randomized, double-blind, double-dummy, event-driven phase III trial. XARELTO