XARELTO® (rivaroxaban) tablets
Table 3: Bleeding Events* in EINSTEIN Extension Study
XARELTO†
20 mg
N = 598
n (%)
Placebo†
4 (0.7)
0
Decrease in Hb ≥2 g/dL
4 (0.7)
0
Transfusion of ≥2 units of whole blood
or packed red blood cells
2 (0.3)
0
Gastrointestinal
3 (0.5)
0
Menorrhagia
1 (0.2)
0
Parameter
Major bleeding event‡
Clinically relevant non-major bleeding
Any bleeding
N = 590
n (%)
32 (5.4)
7 (1.2)
104 (17.4)
63 (10.7)
* Bleeding event occurred after the first dose and up to 2 days after the
last dose of study drug. Although a patient may have had 2 or more
events, the patient is counted only once in a category.
† Treatment schedule: XARELTO 20 mg once daily; matched placebo once
daily
‡ There were no fatal or critical organ bleeding events.
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement
Surgery: In the RECORD clinical trials, the overall incidence rate of
adverse reactions leading to permanent treatment discontinuation was
3.7% with XARELTO.
The rates of major bleeding events and any bleeding events observed in
patients in the RECORD clinical trials are shown in Table 4.
Table 4: Bleeding Events* in Patients Undergoing Hip or Knee
Replacement Surgeries (RECORD 1-3)
XARELTO 10 mg Enoxaparin†
Total treated patients
N = 4487
N = 4524
n (%)
n (%)
Major bleeding event
Fatal bleeding
Bleeding into a critical organ
Bleeding that required re-operation
Extra-surgical site bleeding
requiring transfusion of >2 units of
whole blood or packed cells
Any bleeding event‡
Hip Surgery Studies
Major bleeding event
Fatal bleeding
Bleeding into a critical organ
Bleeding that required re-operation
Extra-surgical site bleeding requiring transfusion of >2 units of whole
blood or packed cells
Any bleeding event‡
Knee Surgery Study
14 (0.3)
1 (<0.1)
2 (<0.1)
7 (0.2)
4 (0.1)
9 (0.2)
0
3 (0.1)
5 (0.1)
1 (<0.1)
261 (5.8)
N = 3281
n (%)
7 (0.2)
1 (<0.1)
1 (<0.1)
2 (0.1)
3 (0.1)
251 (5.6)
N = 3298
n (%)
3 (0.1)
0
1 (<0.1)
1 (<0.1)
1 (<0.1)
201 (6.1)
N = 1206
n (%)
7 (0.6)
0
1 (0.1)
5 (0.4)
1 (0.1)
191 (5.8)
N = 1226
n (%)
6 (0.5)
0
2 (0.2)
4 (0.3)
0
Major bleeding event
Fatal bleeding
Bleeding into a critical organ
Bleeding that required re-operation
Extra-surgical site bleeding
requiring transfusion of >2 units of
whole blood or packed cells
60 (5.0)
60 (4.9)
Any bleeding event‡
* Bleeding events occurring any time following the first dose of doubleblind study medication (which may have been prior to administration of
active drug) V